Kadoma, Zimbabwe - More than 50 representatives of Community Based Organisations (CBOs) and media representatives met at Kadoma to strategise on ways to engage local communuties in New Prevention Technologies (NPTs).
In her opening remarks, Deputy Executive Director & Company Secretary of the Southern African AIDS Trust (SAT) Flanny Chiganze spoke about the yawning gaps existing between communities and research. The workshop sought to help SAT assess suitability of NPT modules, strengthen the capacity of media representatives to report on NPT trials with accuracy and sensitivity, raise skills amongst community-based organisations (CBOs) to critically analyse media discourse about HIV prevention trials as well as increase the capacity of community representatives to understand and communicate NPT trial results effectively.
Main on the agenda were discusions around the following:
1. Understanding the Research process
2. Understanding Prevention Trials
3. Understanding Trial Results
4. Interpreting Trial Results (Post)
5. Critical Analysis of Trial Reporting
SAT will be rolling out similar workshops in Zambia and Malawi. Zimbabwe is home to microbicide and PrEP research studies being conducted by the University of Zimbabwe -University of California, San Francisco (UZ-UCSF) Collaborative Research Programme.
Tuesday, October 26, 2010
FDA and CONRAD Chart U.S. Regulatory Path for 1% Tenofovir Gel for HIV Prevention
Arlington, VA - - The U.S. Food and Drug Administration (FDA) held an end-of-Phase II meeting to determine the next steps required for U.S. licensure of 1% tenofovir gel, a microbicide product recently found to be effective at reducing the rate of HIV and herpes infection in women when used before and after sex.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.
During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.
In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s
“Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.
CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.
In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.
The meeting, held on October 20, 2010, was requested by CONRAD, a division of the Eastern Virginia Medical School in Norfolk, VA. CONRAD was one of the partners in the Phase II study, “CAPRISA 004,” which evaluated 1% tenofovir gel in prevention of male-to-female HIV transmission in 889 women in South Africa. USAID provided funding for the trial, conducted by the Centre for Programme Research for AIDS in South Africa and U.S. based FHI, which was the first study to show that a vaginal gel can reduce the risk of HIV and herpes infection in women. CONRAD manufactured and provided the tenofovir gel for the study.
Tenofovir gel was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex and 51% effective in preventing genital herpes infections in the women participating in the trial. Results of the CAPRISA 004 clinical trial were reported in July 2010 and represent the first “proof of concept” for a vaginal microbicide.
A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI.
During the meeting, the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA). The FDA furthermore stated that the NIH-sponsored Phase IIB study, MTN-003, known as VOICE (Vaginal and Oral Interventions to Control the Epidemic), represents a second adequate and well-controlled study that would, if successful, serve as the second pivotal trial together with CAPRISA 004 to support the submission of an NDA for 1% tenofovir gel.
In addition, the FDA has granted Fast Track approval designation for 1% tenofovir gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. With Fast Track designation, an NDA can be submitted as a “rolling review”, which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.
The agency agreed that the current preclinical program for 1% tenofovir gel is sufficient to support a future NDA. However, they stated that additional safety data on adolescents would be needed and that information on in vivo drug interaction studies with commonly used vaginal products should be obtained. Also, the FDA will ultimately need data on post menopausal women. It was also agreed that a future meeting with the FDA would be held to address any outstanding discussions associated with product quality, including chemistry, manufacturing and controls (CMC). Since much of the clinical work on 1% tenofovir gel has been and will be conducted in South Africa, FDA officials indicated that they can work through the FDA’s
“Office of International Programs” with the goal of coordinating the data and review processes with the South African Medicines Control Council.
CONRAD and its partners appreciate the contributions and detailed recommendations put forth by the FDA, which have helped clarify the next steps required for testing and licensure of 1% tenofovir gel.
In 2006, CONRAD and IPM obtained a co-exclusive, royalty-free license from Gilead Sciences to develop 1% tenofovir gel as a topical microbicide for use by women in developing countries to prevent HIV.
Thursday, September 23, 2010
Donors hold key to HIV-free generation
NEW YORK — Top UN health officials are confident that an HIV-free generation is possible by 2015, but have warned of the need to fully fund HIV/AIDS prevention and treatment programmes to ensure that steady progress in recent years does not fall by the wayside.
“This is an unprecedented moment [of] unprecedented momentum. I urge development partners to support the Global Fund [to Fight AIDS, Tuberculosis and Malaria] in their replenishment,” said World Health Organization Director-General Margaret Chan, speaking on 21 September at an event on the sidelines of the three-day Millennium Development Goals summit at the UN headquarters in New York.
Chan added that without adequate funding all the good will, positive interventions and commitments from countries would amount to little.
The importance of preventing mother-to-child transmission of HIV (PMTCT) to achieve three of the Millennium Development Goals (MDGs) - reducing child and maternal deaths, as well as halting and beginning to reverse the spread of HIV/AIDS - “cuts out the fights and competition”, for funding and programming, Chan noted.
Efforts to achieve the three goals could benefit from various women’s health funding and policy commitments rolled out this week during the summit to mark 10 years since countries committed to the MDGs. But HIV, the leading cause of death among reproductive-age women worldwide, could also serve as a weak link causing women’s health targets to veer off track.
About 45 percent of HIV-positive pregnant women received antiretroviral (ARV) treatment to prevent HIV transmission to their children in 2008, an increase from the 35 percent that were treated in 2007.
Scaling up treatment to the 1.4 million pregnant women living with HIV who needed ARV treatment in 2009 to prevent mother-to-child transmission “can be done,” Jimmy Kolker, UN Children’s Fund (UNICEF) chief of HIV/AIDS, told IRIN/PlusNews before the high-level meeting. “It doesn’t require any specific breakthrough or work that isn’t already there.”
Global Fund seeking pledges
But efforts remain partially dependent on donor countries’ contributions to the Global Fund, a major contributor to PMTCT programmes. The international aid agency is seeking replenishment of US$13-20 billion for a three-year period in a “hugely challenging economic environment”, according to Global Fund Executive Director Michel Kazatchkine.
France pledged $1.4 billion to the Global Fund, which provides a fifth of all financing for AIDS globally, this week; Canada later followed with its own pledge of $540 million, while Germany will provide $25 million to Côte d’Ivoire in a debt swap agreement and Norway announced that it will increase its contribution to the Global Fund by 20 percent for the next three years, making a total contribution of $225 million.
Attention is now shifting to the USA, which is being lobbied by advocacy organizations like ONE to donate $6 billion. Kazatchkine said he was expecting an announcement this week from US President Barack Obama, but although Obama spoke of strengthening the US’s commitment to the Global Fund in his speech at the summit on 22 September, he did not reveal any funding pledges.
The US contributed a record-setting $1.05 billion to the Global Fund for the 2010 fiscal year, but has been criticized for not merging AIDS programming and funding laid out in the US President's Emergency Plan for AIDS Relief (PEPFAR), and in its new $63 billion Global Health Initiative with international strategies.
The Global Fund fell short by $3 billion in its last replenishment in 2007. It reached a partial goal of $10 billion to be distributed over 2008, 2009 and 2010.
“Each single dollar counts and when you cut the money short you jeopardize a few more lives,” said Sophio Moyo, Africa director for ONE. “We need to continue to invest in this. Donors have to put their money where their mouth is.”
Scaling up PMTCT services
High-burden countries, specifically in sub-Saharan Africa, have continued to do their part in tackling mother-to-child transmission of HIV, according to Kazatchkine, switching from sub-optimal single-dose nevirapine to “the most appropriate antiretroviral regimens”.
This gradual shift has resulted in an overall increase of 65 percent in PMTCT budgets in high-burden countries.
Seventy out of 123 reporting countries revealed plans to further scale up PMTCT services in 2008, a jump from the 34 countries that presented such plans in 2005.
Namibia, which has a 15 percent rate of HIV prevalence among adults, was singled out for its success in broadening its PMTCT services since 2005. Now more than 60 percent of HIV-positive pregnant women receive ARV treatment and HIV prevalence among children under one dropped from 13.5 percent in 2006 to 7 percent in 2009, according to Namibian President Hifikepunye Lucas Pohamba.
Stigma challenges
Chan praised Pohamba for his commitment to eradicating mother-to-child transmission, maintaining the upbeat tone that characterized much of the event.
“Even just a few years ago it would have been inconceivable that a panel discussion about women living with HIV could be called a time for hope,” said UNICEF’s Executive Director Anthony Lake. “A few years ago, for far too many women a diagnosis of HIV meant, in effect, a double death sentence for the mother and the baby.”
Yet it will take more than confidence, agreement on a common strategy to eliminate PMTCT, and adequate funding, to help HIV-positive pregnant women receive testing and treatment on a universal scale, said UNICEF’s Kolker.
PMTCT could be key to cutting child mortality “In every context there are challenges of stigma so mothers are not tested, or don’t come back for the results,” Kolker explained. “Or they take the medicines home but they don’t take them as instructed. Many things must change in attitude and behaviour to make services readily available.”
In 2008, only 5 percent of pregnant women in low- and middle-income countries reported that their male partners were tested for HIV. Kolker said engaging fathers is “absolutely crucial” in making services more widespread and dispelling notions about women having “low moral character” and bringing the infection into their relationships.
“This is an unprecedented moment [of] unprecedented momentum. I urge development partners to support the Global Fund [to Fight AIDS, Tuberculosis and Malaria] in their replenishment,” said World Health Organization Director-General Margaret Chan, speaking on 21 September at an event on the sidelines of the three-day Millennium Development Goals summit at the UN headquarters in New York.
Chan added that without adequate funding all the good will, positive interventions and commitments from countries would amount to little.
The importance of preventing mother-to-child transmission of HIV (PMTCT) to achieve three of the Millennium Development Goals (MDGs) - reducing child and maternal deaths, as well as halting and beginning to reverse the spread of HIV/AIDS - “cuts out the fights and competition”, for funding and programming, Chan noted.
Efforts to achieve the three goals could benefit from various women’s health funding and policy commitments rolled out this week during the summit to mark 10 years since countries committed to the MDGs. But HIV, the leading cause of death among reproductive-age women worldwide, could also serve as a weak link causing women’s health targets to veer off track.
About 45 percent of HIV-positive pregnant women received antiretroviral (ARV) treatment to prevent HIV transmission to their children in 2008, an increase from the 35 percent that were treated in 2007.
Scaling up treatment to the 1.4 million pregnant women living with HIV who needed ARV treatment in 2009 to prevent mother-to-child transmission “can be done,” Jimmy Kolker, UN Children’s Fund (UNICEF) chief of HIV/AIDS, told IRIN/PlusNews before the high-level meeting. “It doesn’t require any specific breakthrough or work that isn’t already there.”
Global Fund seeking pledges
But efforts remain partially dependent on donor countries’ contributions to the Global Fund, a major contributor to PMTCT programmes. The international aid agency is seeking replenishment of US$13-20 billion for a three-year period in a “hugely challenging economic environment”, according to Global Fund Executive Director Michel Kazatchkine.
France pledged $1.4 billion to the Global Fund, which provides a fifth of all financing for AIDS globally, this week; Canada later followed with its own pledge of $540 million, while Germany will provide $25 million to Côte d’Ivoire in a debt swap agreement and Norway announced that it will increase its contribution to the Global Fund by 20 percent for the next three years, making a total contribution of $225 million.
Attention is now shifting to the USA, which is being lobbied by advocacy organizations like ONE to donate $6 billion. Kazatchkine said he was expecting an announcement this week from US President Barack Obama, but although Obama spoke of strengthening the US’s commitment to the Global Fund in his speech at the summit on 22 September, he did not reveal any funding pledges.
The US contributed a record-setting $1.05 billion to the Global Fund for the 2010 fiscal year, but has been criticized for not merging AIDS programming and funding laid out in the US President's Emergency Plan for AIDS Relief (PEPFAR), and in its new $63 billion Global Health Initiative with international strategies.
The Global Fund fell short by $3 billion in its last replenishment in 2007. It reached a partial goal of $10 billion to be distributed over 2008, 2009 and 2010.
“Each single dollar counts and when you cut the money short you jeopardize a few more lives,” said Sophio Moyo, Africa director for ONE. “We need to continue to invest in this. Donors have to put their money where their mouth is.”
Scaling up PMTCT services
High-burden countries, specifically in sub-Saharan Africa, have continued to do their part in tackling mother-to-child transmission of HIV, according to Kazatchkine, switching from sub-optimal single-dose nevirapine to “the most appropriate antiretroviral regimens”.
This gradual shift has resulted in an overall increase of 65 percent in PMTCT budgets in high-burden countries.
Seventy out of 123 reporting countries revealed plans to further scale up PMTCT services in 2008, a jump from the 34 countries that presented such plans in 2005.
Namibia, which has a 15 percent rate of HIV prevalence among adults, was singled out for its success in broadening its PMTCT services since 2005. Now more than 60 percent of HIV-positive pregnant women receive ARV treatment and HIV prevalence among children under one dropped from 13.5 percent in 2006 to 7 percent in 2009, according to Namibian President Hifikepunye Lucas Pohamba.
Stigma challenges
Chan praised Pohamba for his commitment to eradicating mother-to-child transmission, maintaining the upbeat tone that characterized much of the event.
“Even just a few years ago it would have been inconceivable that a panel discussion about women living with HIV could be called a time for hope,” said UNICEF’s Executive Director Anthony Lake. “A few years ago, for far too many women a diagnosis of HIV meant, in effect, a double death sentence for the mother and the baby.”
Yet it will take more than confidence, agreement on a common strategy to eliminate PMTCT, and adequate funding, to help HIV-positive pregnant women receive testing and treatment on a universal scale, said UNICEF’s Kolker.
PMTCT could be key to cutting child mortality “In every context there are challenges of stigma so mothers are not tested, or don’t come back for the results,” Kolker explained. “Or they take the medicines home but they don’t take them as instructed. Many things must change in attitude and behaviour to make services readily available.”
In 2008, only 5 percent of pregnant women in low- and middle-income countries reported that their male partners were tested for HIV. Kolker said engaging fathers is “absolutely crucial” in making services more widespread and dispelling notions about women having “low moral character” and bringing the infection into their relationships.
Thursday, July 22, 2010
Making Microbicides, Making History
The CAPRISA 004 Study results are out. The results showed a 1% tenofovir gel in 39% in preventing HIV infection and 51% effectiveness in preventing HSV-2 infection, was the highlight of the 18th World AIDS conference in Vienna, Austria.
The study, conducted by the Centre for the Aids Programme of Research in South Africa (Caprisa 004), tested the safety and effectiveness of using 1 percent tenofovir gel tested in 889 women for up to two-and-a-half years in two South African communities, one rural and one urban. Half of the women were randomly assigned to use a gel containing an antiretroviral drug, the other half were given a placebo gel. All were instructed to apply the gel within 12 hours before and 12 hours after intercourse.
The result is outstanding with evidence of high scientific and ethical integrity. No matter how the data is analysed, the analysis consistently showed statistically significant results.
The study showed two things:
1. ARVs can indeed be used as a prophylaxis
2. Microbicides (topical application of a substance in the vagina) is indeed a possible modality for HIV prevention and that women like it.
Futher results show that the observed result was due to high concentration of the tenofovir gel in the vagina and cervical tissues of study participants who remained HIV negative throughout the study. Of significance also is evidence that the higher the level of the tenofovir in the cervico-vaginal fluid, the less the HIV infection and HSV-2 infection observed. Plasma concentration (blood level of tenofovir that could result from systemic absorption of the gel from the vagina) of tenofovir and its metabolite was negligible thereby possibly explaining the absence of resistance in the study.
The result is indeed a proof of concept and exciting for the following reasons:
(i). shows that not only does topical application of 1% tenofovir prevents HIV infection, but that the gel can also prevent HSV infection (thus providing two possible synergistic mechanisms for HIV prevention)
(ii). this is demonstrated consistently across all types of analysis
(iii). consistent with prior results from ARV based prevention studies like the PMTCT study
(iv). has animal studies to support the finding.
Co-chair of the Voice Study, Zimbabwe's CAPRISA equivalent, Prof Mike Chirenje siad, "It is gratifying that we are a step closer to identifying a safe and effective HIV prevention method for women. But to know for certain that tenofovir gel is effective, additional studies must be performed, because we can’t be sure that what worked for the women in Caprisa 004 will be the same for women elsewhere."
However, this finding - as exciting as it may be - is not enough to roll out the product, other studies also need to be conducted - including studying the efficacy of intermittent ARV gel dosing for HIV prevention, rectal safety and efffectiveness and how long an interval between HIV testing will be unacceptable risk for resistance.
The study, conducted by the Centre for the Aids Programme of Research in South Africa (Caprisa 004), tested the safety and effectiveness of using 1 percent tenofovir gel tested in 889 women for up to two-and-a-half years in two South African communities, one rural and one urban. Half of the women were randomly assigned to use a gel containing an antiretroviral drug, the other half were given a placebo gel. All were instructed to apply the gel within 12 hours before and 12 hours after intercourse.
The result is outstanding with evidence of high scientific and ethical integrity. No matter how the data is analysed, the analysis consistently showed statistically significant results.
The study showed two things:
1. ARVs can indeed be used as a prophylaxis
2. Microbicides (topical application of a substance in the vagina) is indeed a possible modality for HIV prevention and that women like it.
Futher results show that the observed result was due to high concentration of the tenofovir gel in the vagina and cervical tissues of study participants who remained HIV negative throughout the study. Of significance also is evidence that the higher the level of the tenofovir in the cervico-vaginal fluid, the less the HIV infection and HSV-2 infection observed. Plasma concentration (blood level of tenofovir that could result from systemic absorption of the gel from the vagina) of tenofovir and its metabolite was negligible thereby possibly explaining the absence of resistance in the study.
The result is indeed a proof of concept and exciting for the following reasons:
(i). shows that not only does topical application of 1% tenofovir prevents HIV infection, but that the gel can also prevent HSV infection (thus providing two possible synergistic mechanisms for HIV prevention)
(ii). this is demonstrated consistently across all types of analysis
(iii). consistent with prior results from ARV based prevention studies like the PMTCT study
(iv). has animal studies to support the finding.
Co-chair of the Voice Study, Zimbabwe's CAPRISA equivalent, Prof Mike Chirenje siad, "It is gratifying that we are a step closer to identifying a safe and effective HIV prevention method for women. But to know for certain that tenofovir gel is effective, additional studies must be performed, because we can’t be sure that what worked for the women in Caprisa 004 will be the same for women elsewhere."
However, this finding - as exciting as it may be - is not enough to roll out the product, other studies also need to be conducted - including studying the efficacy of intermittent ARV gel dosing for HIV prevention, rectal safety and efffectiveness and how long an interval between HIV testing will be unacceptable risk for resistance.
Tuesday, June 1, 2010
Communications Handbook Launched
The Microbicides Media & Communications Initiative (MMCI) on Monday 24 May 2010, on the sidelines of the International Microbicides Conference (M2010), launched a Communications Handbook for Clinical Trials.
The handbook offers strategies, tips and tools to manage controversy, convey messages and disseminate results. The handbook is co-published by the Microbicides Media & Communications Initiative (MMCI), a multi-partner collaboration housed at the global Campaign for Microbicides (GCM) at PATH in Washington, DC, and the Family Health International (FHI) in Research Triangle Park, NC, USA. The project was made possible by the generous support of the American people through the US Agency for International Development (USAID) through dual grants to MMCI and FHI.
The handbook is designed to serve the needs of those who conduct, plan, or implement clinical trials with the objectives of providing practical guidance on how to anticipate and respond to the special communications challenges posed by the conduct of clinical trials in relation to the involvement of the media.
The handbook includes:
1. Sample communication plans for clinical trials
2. Communications and crisis-planning templates and checklists
3. Scenario-planning tools to facilitate planning for the release of trial results
4. Ideas on delegating communications tasks to reduce demands on key site personnel
5. Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media
Chapters of the handbook were shared with over 80 individuals in 13 countries and involved many others who authored case studies, shared materials, and reviewed earlier drafts of the publication.
The preface of the handbook was done by Archbishop Desmond M. Tutu who remarked, "One of the greatest joys and responsibilities of democracy is the freedom of speech. We have the luxury and the burden to communicate our struggles, our hopes, our work, and our passion. In the fight against HIV and the long journey to finding new ways for the most vulnerable to protect themselves, a key challenge is to communicate the logic and the promise of this important work."
The handbook is available on request to: handbook@mmci-communications.org
The handbook offers strategies, tips and tools to manage controversy, convey messages and disseminate results. The handbook is co-published by the Microbicides Media & Communications Initiative (MMCI), a multi-partner collaboration housed at the global Campaign for Microbicides (GCM) at PATH in Washington, DC, and the Family Health International (FHI) in Research Triangle Park, NC, USA. The project was made possible by the generous support of the American people through the US Agency for International Development (USAID) through dual grants to MMCI and FHI.
The handbook is designed to serve the needs of those who conduct, plan, or implement clinical trials with the objectives of providing practical guidance on how to anticipate and respond to the special communications challenges posed by the conduct of clinical trials in relation to the involvement of the media.
The handbook includes:
1. Sample communication plans for clinical trials
2. Communications and crisis-planning templates and checklists
3. Scenario-planning tools to facilitate planning for the release of trial results
4. Ideas on delegating communications tasks to reduce demands on key site personnel
5. Tips and techniques on how to communicate effectively in interviews, in meetings, and with the media
Chapters of the handbook were shared with over 80 individuals in 13 countries and involved many others who authored case studies, shared materials, and reviewed earlier drafts of the publication.
The preface of the handbook was done by Archbishop Desmond M. Tutu who remarked, "One of the greatest joys and responsibilities of democracy is the freedom of speech. We have the luxury and the burden to communicate our struggles, our hopes, our work, and our passion. In the fight against HIV and the long journey to finding new ways for the most vulnerable to protect themselves, a key challenge is to communicate the logic and the promise of this important work."
The handbook is available on request to: handbook@mmci-communications.org
Monday, May 31, 2010
HVTN - Vaccines in HIV Prevention
The 2010 International Microbicides Conference (M2010) has come and gone.
The conference that brought together about 1100 delegates from close to 47 countries sought to brigde the gap between researchers, advocates, the community, the media and regulators.
Appropriately located M2010 whose theme was "Building bridges in HIV Prevention," was held in Pittsburgh, the city of bridges. Pittsburgh is argued to be the city with the highest number of bridges in North America.
An area of special focus during the conference was the Thai vaccine trial whose recently released results resonated with hope for a vaccine that can help fight AIDS. Vaccines have historically been the tried and tested way of fighting and eradicating disease.
Pittsburgh is also home to the Inactivated Polio Vaccine (IPV), also called the Salk vaccine developed by Dr. Jonas Salk in 1952. The vaccine is a clear, colorless sterile suspension for subcutaneous injection. IPV contains strains of the 3 types of polioviruses (Types 1, 2, and 3), originally grown in monkey kidney cell culture and inactivated by exposure to formaldehyde. Clinical trials of IPV began in 1954, and results were dramatic: the cases of polio in the vaccinated test groups fell amazingly, and permission for IPV distribution was quickly granted by the US government in 1955. In 1987, a new, more potent version of inactivated poliovirus vaccine was introduced that is grown on human cell culture and contains greater antigenic content than the original vaccine.
Unfortunately, HIV has proven to be a challenging virus to vaccinate against during the close to 3 decades of HIV vaccine research efforts. Products tested to date have not worked much to the satisfaction of researchers.The HVTN 505 study will use a DNA prime/rAd5 boost vaccine regimen developed by the Vaccine Research Center at the National Institute of Health (NIH). Parts of the vaccine regimen are similar to the vaccine used in Step and Phambili. However, this vaccine is not on the path to licensure and is not expected to prevent HIV infection but the results of the HVTN 505 study will go a long way in bringing a better understanding and development of T-cell-based vaccines.
On Thursday, September 24, initial results were released from an AIDS vaccine phase III trial in Thailand, which showed, for the first time, that the risk of HIV infection can be reduced by a vaccine.On October 20, at the annual AIDS Vaccine Conference, the investigators for the Thai prime-boost AIDS vaccine trial presented the results of additional data analyses. The Thai prime-boost AIDS vaccine trial was the largest AIDS vaccine trial to date, with over 16,000 participants. It evaluated the efficacy of a vaccine regimen consisting of two candidates, known as ALVAC HIV and AIDSVAX B/E.
The trial data indicated that the vaccine regimen reduced HIV risk by approximately 30 percent. This is the first time a trial has found evidence that it is possible to
reduce the risk of HIV infection with a vaccine. While this does not mean that an AIDS vaccine will be available in clinics anytime soon, the evidence that a vaccine
can protect against infection is unprecedented. Scientists will spend the coming months reviewing the data, and testing blood samples from the trial to discover how
the vaccine may have protected some trial participants.
Researchers are already working hard to understand what these findings mean and to identify key next steps.
The conference that brought together about 1100 delegates from close to 47 countries sought to brigde the gap between researchers, advocates, the community, the media and regulators.
Appropriately located M2010 whose theme was "Building bridges in HIV Prevention," was held in Pittsburgh, the city of bridges. Pittsburgh is argued to be the city with the highest number of bridges in North America.
An area of special focus during the conference was the Thai vaccine trial whose recently released results resonated with hope for a vaccine that can help fight AIDS. Vaccines have historically been the tried and tested way of fighting and eradicating disease.
Pittsburgh is also home to the Inactivated Polio Vaccine (IPV), also called the Salk vaccine developed by Dr. Jonas Salk in 1952. The vaccine is a clear, colorless sterile suspension for subcutaneous injection. IPV contains strains of the 3 types of polioviruses (Types 1, 2, and 3), originally grown in monkey kidney cell culture and inactivated by exposure to formaldehyde. Clinical trials of IPV began in 1954, and results were dramatic: the cases of polio in the vaccinated test groups fell amazingly, and permission for IPV distribution was quickly granted by the US government in 1955. In 1987, a new, more potent version of inactivated poliovirus vaccine was introduced that is grown on human cell culture and contains greater antigenic content than the original vaccine.
Unfortunately, HIV has proven to be a challenging virus to vaccinate against during the close to 3 decades of HIV vaccine research efforts. Products tested to date have not worked much to the satisfaction of researchers.The HVTN 505 study will use a DNA prime/rAd5 boost vaccine regimen developed by the Vaccine Research Center at the National Institute of Health (NIH). Parts of the vaccine regimen are similar to the vaccine used in Step and Phambili. However, this vaccine is not on the path to licensure and is not expected to prevent HIV infection but the results of the HVTN 505 study will go a long way in bringing a better understanding and development of T-cell-based vaccines.
On Thursday, September 24, initial results were released from an AIDS vaccine phase III trial in Thailand, which showed, for the first time, that the risk of HIV infection can be reduced by a vaccine.On October 20, at the annual AIDS Vaccine Conference, the investigators for the Thai prime-boost AIDS vaccine trial presented the results of additional data analyses. The Thai prime-boost AIDS vaccine trial was the largest AIDS vaccine trial to date, with over 16,000 participants. It evaluated the efficacy of a vaccine regimen consisting of two candidates, known as ALVAC HIV and AIDSVAX B/E.
The trial data indicated that the vaccine regimen reduced HIV risk by approximately 30 percent. This is the first time a trial has found evidence that it is possible to
reduce the risk of HIV infection with a vaccine. While this does not mean that an AIDS vaccine will be available in clinics anytime soon, the evidence that a vaccine
can protect against infection is unprecedented. Scientists will spend the coming months reviewing the data, and testing blood samples from the trial to discover how
the vaccine may have protected some trial participants.
Researchers are already working hard to understand what these findings mean and to identify key next steps.
Sunday, May 23, 2010
HIV researchers congregate in the US
Saturday, 22 May 2010 18:34
ZIMBABWEAN researchers will this week join experts from the rest of the world searching for more effective HIV prevention methods at the International Microbicides Conference in Pittsburgh, United States.
The conference that opens today is one of the biggest gatherings bringing together researchers in a forum to share experiences and new trends on HIV research.
Mike Chirenje, the executive director of the University of Zimbabwe and University of California — San Francisco (UZ-USCF) said the bi-annual indaba was a chance to evaluate progress made in finding new HIV prevention methods in the past few years.
UZ-USCF is a collaborative research in women’s health funded by the National Institute of Health in the US. Last year the initiative released results of its microbicide trials that sought to establish the effectiveness of two gels in reducing HIV infection in women when applied before sex.
One of the microbicide gels under study known as pro-2000 was found to reduce HIV infection in women by at least 30%. One of the researchers who will also be attending the Pittsburgh conference Nyaradzo Mgodi said although this was a breakthrough, it was not enough to ensure the gel was registered for use.
But it would help guide other studies in future, she said. The UZ-USCF has several research networks that include the Microbicides Trials Network (MTN).
“As statistics show, the burden of the disease in women is very, very high,” Mgodi said. “If you look at other proven methods of preventing HIV, for example condoms, you find that most women find it difficult to negotiate for condom use because of the gender disparities, this is a culture in which the man is the dominant partner.
“So what we would like to do as researchers is to develop a chemical in which a woman can use without having to depend on a man to protect herself from HIV infection.
“So this is what has guided research into microbicides; to help women get past these gender disparities.” Another research being conducted by the UZ-UCSF is the Vaginal and Oral Interventions to Control the Epidemic (Voice) that aims to find female controlled preventive measures. At least 600 women are taking part in clinical trials to establish if the same antiretroviral drugs (ARV) used to prolong the lives of people infected with HIV can protect women from being infected.
The study began last year and will run over a three-year period.
Women participants who are HIV negative and are between the ages of 18-35 will be asked to either apply a vaginal microbicide gel containing an ARV or take an oral ARV tablet daily. The ARV drugs Tenofivor and Truvada will be used during the study.
“At the end of the study researchers would want to establish whether or not this pre-exposure prophylaxis will reduce the women’s chances of acquiring HIV,” Mgodi said.
According to the United Nations Joint Programme (UNAIDS), at least 60% of adults living with HIV in sub-Saharan Africa are women.
In Zimbabwe, 54% of the 1.2 million HIV positive adults are women. HIV and Aids activists say women are more vulnerable to acquire the infection than men largely because of cultural reasons. The virus was first detected in Zimbabwe in 1985.
BY BERTHA SHOKO
ZIMBABWEAN researchers will this week join experts from the rest of the world searching for more effective HIV prevention methods at the International Microbicides Conference in Pittsburgh, United States.
The conference that opens today is one of the biggest gatherings bringing together researchers in a forum to share experiences and new trends on HIV research.
Mike Chirenje, the executive director of the University of Zimbabwe and University of California — San Francisco (UZ-USCF) said the bi-annual indaba was a chance to evaluate progress made in finding new HIV prevention methods in the past few years.
UZ-USCF is a collaborative research in women’s health funded by the National Institute of Health in the US. Last year the initiative released results of its microbicide trials that sought to establish the effectiveness of two gels in reducing HIV infection in women when applied before sex.
One of the microbicide gels under study known as pro-2000 was found to reduce HIV infection in women by at least 30%. One of the researchers who will also be attending the Pittsburgh conference Nyaradzo Mgodi said although this was a breakthrough, it was not enough to ensure the gel was registered for use.
But it would help guide other studies in future, she said. The UZ-USCF has several research networks that include the Microbicides Trials Network (MTN).
“As statistics show, the burden of the disease in women is very, very high,” Mgodi said. “If you look at other proven methods of preventing HIV, for example condoms, you find that most women find it difficult to negotiate for condom use because of the gender disparities, this is a culture in which the man is the dominant partner.
“So what we would like to do as researchers is to develop a chemical in which a woman can use without having to depend on a man to protect herself from HIV infection.
“So this is what has guided research into microbicides; to help women get past these gender disparities.” Another research being conducted by the UZ-UCSF is the Vaginal and Oral Interventions to Control the Epidemic (Voice) that aims to find female controlled preventive measures. At least 600 women are taking part in clinical trials to establish if the same antiretroviral drugs (ARV) used to prolong the lives of people infected with HIV can protect women from being infected.
The study began last year and will run over a three-year period.
Women participants who are HIV negative and are between the ages of 18-35 will be asked to either apply a vaginal microbicide gel containing an ARV or take an oral ARV tablet daily. The ARV drugs Tenofivor and Truvada will be used during the study.
“At the end of the study researchers would want to establish whether or not this pre-exposure prophylaxis will reduce the women’s chances of acquiring HIV,” Mgodi said.
According to the United Nations Joint Programme (UNAIDS), at least 60% of adults living with HIV in sub-Saharan Africa are women.
In Zimbabwe, 54% of the 1.2 million HIV positive adults are women. HIV and Aids activists say women are more vulnerable to acquire the infection than men largely because of cultural reasons. The virus was first detected in Zimbabwe in 1985.
BY BERTHA SHOKO
Monday, May 17, 2010
Turning the Page in HIV Prevention Research:
New York, NY May 17, 2010 – For more than a decade, researchers and advocates have marked HIV Vaccine Awareness Day with varying degrees of hope, cynicism and despair. This year, in large part because of the results of the Thai Prime-Boost vaccine study, there is greater cause for hope than ever before and a renewed sense of urgency to transform this hope into a reality.
In September 2009, the world’s largest AIDS vaccine trial to date showed the first evidence that an experimental AIDS vaccine could lower the risk of HIV infection. The results were complex; the observed benefit from the vaccine was modest; and the field is still years away from a highly protective vaccine.
“The caveats to the Thai Prime-Boost study results are important and true. But letting them become the entire story does a severe, even dangerous, disservice to the field, the trial and especially the 16,000 people who participated in the trial,” said Mitchell Warren, Executive Director of AVAC: Global Advocacy for HIV Prevention. “Despite the many perspectives on and interpretations of the trial – and its results – the Thai AIDS vaccine trial provides evidence for the first time that it is possible to reduce the risk of HIV infection with a vaccine. AVAC and others have worked to explain the uncertainty of the results and the need for follow-up research. We will continue to do this because the science is complicated, and the future is unknown.”
But for HIV Vaccine Awareness Day, AVAC’s loud and clear message is that the Thai Prime-Boost trial changed the game for AIDS vaccines. A preventive AIDS vaccine is possible. The results were surprising to many and prompted some skepticism. But it is potentially disastrous if all that advocates, potential donors and future HIV vaccine trial volunteers and researchers think about the trial is that it gave a murky result, that it failed or that it left us no closer to an AIDS vaccine than we had been before.
“In fact, there’s renewed energy in the AIDS vaccine field today, even as we grapple with what these results mean and where we go from here,” said Warren. “The next steps for the field must involve more not less: more trials, more community volunteerism, more political will and sustained funding. One way to help ensure this is to celebrate what’s happened to date, even as we prepare for everything that still needs to be done.”
AVAC proposes three key steps for the AIDS vaccine field:
· Work aggressively to see what information can be gleaned from further analysis of the biological samples from more than 16,000 Thai men and women who participated in the trial and hope that we might learn why this vaccine combination worked at all.
· Build on this result, testing similar vaccines and combinations in different populations.
· Ensure that there is an increasingly diverse scientific portfolio to develop and test entirely different approaches.
There is no question that more resources are needed for existing AIDS treatment and prevention programs. People living with HIV deserve treatment and care, not waiting lists and death. But people who are at risk of HIV infection also deserve new ways to protect themselves.
Fully funding HIV treatment and prevention programs and HIV research would require only a fraction of the trillions of dollars governments have spent on bailing out big companies, and it would be a wise investment for the long-term economic stability of families, communities and nations.
“It’s easy to call for all of these things, but it is much, much harder to achieve them,” said Warren. “We hope that the next chapter of AIDS vaccine research shows the field capable of greater efficiency and prioritization: triaging current projects, jettisoning some, cutting costs within others, scaling up still others, and developing a clear strategy for collaborative action on key goals. We need a fully funded comprehensive approach to AIDS prevention and treatment, which includes finding new HIV prevention options, such as AIDS vaccines and antiretroviral-based HIV prevention, including pre-exposure prophylaxis (PrEP) and microbicide gels that could be used by women and men to protect themselves from HIV infection.”
The Thai Way Forward: A New Report from the Ground
To mark this HIV Vaccine Awareness Day, AVAC is launching The Thai Way Forward, which tells the story of the world’s largest AIDS vaccine trial using the voices of the people on the ground who made the trial happen.
“Every clinical trial, especially a large HIV prevention efficacy trial, is a complex story with fascinating characters, complex science and many perspectives. Success depends on a combination of coordination, communication, urgency and patience,” said Warren. “With this report, we wanted to delve into what actually happened in Thailand both during and after the trial and to see what the critical lessons are, not just for researchers and funders, but also for advocates and communities who are continuing the work of finding new ways to end the AIDS epidemic.”
Award-winning journalist Tom Paulson traveled to Thailand where he interviewed community leaders, government officials, researchers, trial participants, clinic staff and AIDS activists about what went right and what went wrong with the trial. The resulting report provides lessons about community engagement and approaches to international collaboration as well as important insights for developing trial protocols and planning for follow-up research once a trial is complete.
The Thai Way Forward is an excerpt from AVAC’s annual state of the field report, Turning the Page, which will be released in July ahead of the International AIDS Conference.
As this report from Thailand makes clear, the search for an AIDS vaccine has been tumultuous and often divisive, much like the overall response to the AIDS epidemic.
“The global response to AIDS is in trouble. There are yawning gaps in funding for proven prevention and treatment and a crisis in political will for continued support of AIDS programs.” Warren said. “We face skepticism about whether responding to AIDS is cost effective and whether limited funds for AIDS should include funding for AIDS prevention research. We have to meet this skepticism with honesty about what we know and clarity about the cause for hope that exists today in a way that it never has before.”
The Thai Way Forward is available online at www.avac.org/avacreport.
In September 2009, the world’s largest AIDS vaccine trial to date showed the first evidence that an experimental AIDS vaccine could lower the risk of HIV infection. The results were complex; the observed benefit from the vaccine was modest; and the field is still years away from a highly protective vaccine.
“The caveats to the Thai Prime-Boost study results are important and true. But letting them become the entire story does a severe, even dangerous, disservice to the field, the trial and especially the 16,000 people who participated in the trial,” said Mitchell Warren, Executive Director of AVAC: Global Advocacy for HIV Prevention. “Despite the many perspectives on and interpretations of the trial – and its results – the Thai AIDS vaccine trial provides evidence for the first time that it is possible to reduce the risk of HIV infection with a vaccine. AVAC and others have worked to explain the uncertainty of the results and the need for follow-up research. We will continue to do this because the science is complicated, and the future is unknown.”
But for HIV Vaccine Awareness Day, AVAC’s loud and clear message is that the Thai Prime-Boost trial changed the game for AIDS vaccines. A preventive AIDS vaccine is possible. The results were surprising to many and prompted some skepticism. But it is potentially disastrous if all that advocates, potential donors and future HIV vaccine trial volunteers and researchers think about the trial is that it gave a murky result, that it failed or that it left us no closer to an AIDS vaccine than we had been before.
“In fact, there’s renewed energy in the AIDS vaccine field today, even as we grapple with what these results mean and where we go from here,” said Warren. “The next steps for the field must involve more not less: more trials, more community volunteerism, more political will and sustained funding. One way to help ensure this is to celebrate what’s happened to date, even as we prepare for everything that still needs to be done.”
AVAC proposes three key steps for the AIDS vaccine field:
· Work aggressively to see what information can be gleaned from further analysis of the biological samples from more than 16,000 Thai men and women who participated in the trial and hope that we might learn why this vaccine combination worked at all.
· Build on this result, testing similar vaccines and combinations in different populations.
· Ensure that there is an increasingly diverse scientific portfolio to develop and test entirely different approaches.
There is no question that more resources are needed for existing AIDS treatment and prevention programs. People living with HIV deserve treatment and care, not waiting lists and death. But people who are at risk of HIV infection also deserve new ways to protect themselves.
Fully funding HIV treatment and prevention programs and HIV research would require only a fraction of the trillions of dollars governments have spent on bailing out big companies, and it would be a wise investment for the long-term economic stability of families, communities and nations.
“It’s easy to call for all of these things, but it is much, much harder to achieve them,” said Warren. “We hope that the next chapter of AIDS vaccine research shows the field capable of greater efficiency and prioritization: triaging current projects, jettisoning some, cutting costs within others, scaling up still others, and developing a clear strategy for collaborative action on key goals. We need a fully funded comprehensive approach to AIDS prevention and treatment, which includes finding new HIV prevention options, such as AIDS vaccines and antiretroviral-based HIV prevention, including pre-exposure prophylaxis (PrEP) and microbicide gels that could be used by women and men to protect themselves from HIV infection.”
The Thai Way Forward: A New Report from the Ground
To mark this HIV Vaccine Awareness Day, AVAC is launching The Thai Way Forward, which tells the story of the world’s largest AIDS vaccine trial using the voices of the people on the ground who made the trial happen.
“Every clinical trial, especially a large HIV prevention efficacy trial, is a complex story with fascinating characters, complex science and many perspectives. Success depends on a combination of coordination, communication, urgency and patience,” said Warren. “With this report, we wanted to delve into what actually happened in Thailand both during and after the trial and to see what the critical lessons are, not just for researchers and funders, but also for advocates and communities who are continuing the work of finding new ways to end the AIDS epidemic.”
Award-winning journalist Tom Paulson traveled to Thailand where he interviewed community leaders, government officials, researchers, trial participants, clinic staff and AIDS activists about what went right and what went wrong with the trial. The resulting report provides lessons about community engagement and approaches to international collaboration as well as important insights for developing trial protocols and planning for follow-up research once a trial is complete.
The Thai Way Forward is an excerpt from AVAC’s annual state of the field report, Turning the Page, which will be released in July ahead of the International AIDS Conference.
As this report from Thailand makes clear, the search for an AIDS vaccine has been tumultuous and often divisive, much like the overall response to the AIDS epidemic.
“The global response to AIDS is in trouble. There are yawning gaps in funding for proven prevention and treatment and a crisis in political will for continued support of AIDS programs.” Warren said. “We face skepticism about whether responding to AIDS is cost effective and whether limited funds for AIDS should include funding for AIDS prevention research. We have to meet this skepticism with honesty about what we know and clarity about the cause for hope that exists today in a way that it never has before.”
The Thai Way Forward is available online at www.avac.org/avacreport.
Monday, May 3, 2010
A Case for New HIV Prevention Technologies
I bring to your attention the following extract from a story that I posted previously on this blog:
" HARARE, 14 April 2010 (Plus News) - A new report by Zimbabwe's National AIDS Council (NAC), showing a dramatic rise in sexually transmitted infections (STIs) among people aged 15 to 24 in the capital, Harare, has health experts worried that the country's success in reducing HIV could be unravelling.
STIs heighten vulnerability to HIV infection, and this age group is one of the hardest hit. According to the NAC report, more than 24,000 people were treated for STIs in 2009, compared to 8,500 cases recorded in 2008; over 60 percent of the cases were women."
The bigger problem that most of us may have overlooked is that "60% of the cases were women." Women continue to be at the receiving end of the consequences of bad sexual decisions. No matter how much we can argue about women having been empowered, it is evident from the above statistic that women are still being subjected to unsafe sex.
The sad scenario being painted here is even made worse by the revelation that these are women between the 15-24 year age group. One would have thought that this generation of women is more empowered than those of the 25+ generation.
It therefore goes without argument that there is an urgent need for new alternative HIV prevention technologies that will empower women to protect themselves against STIs and HIV.
Microbicides and Pre-Exposure Prophylaxis (PrEP) trials underway are key biomedical developments that hold a lot of hope for women all over the world who cannot negotiate for safe sex. It is my hope that these clinical researches will yield the desired results and put women in a position to access SAFE & SATISFYING sex.
" HARARE, 14 April 2010 (Plus News) - A new report by Zimbabwe's National AIDS Council (NAC), showing a dramatic rise in sexually transmitted infections (STIs) among people aged 15 to 24 in the capital, Harare, has health experts worried that the country's success in reducing HIV could be unravelling.
STIs heighten vulnerability to HIV infection, and this age group is one of the hardest hit. According to the NAC report, more than 24,000 people were treated for STIs in 2009, compared to 8,500 cases recorded in 2008; over 60 percent of the cases were women."
The bigger problem that most of us may have overlooked is that "60% of the cases were women." Women continue to be at the receiving end of the consequences of bad sexual decisions. No matter how much we can argue about women having been empowered, it is evident from the above statistic that women are still being subjected to unsafe sex.
The sad scenario being painted here is even made worse by the revelation that these are women between the 15-24 year age group. One would have thought that this generation of women is more empowered than those of the 25+ generation.
It therefore goes without argument that there is an urgent need for new alternative HIV prevention technologies that will empower women to protect themselves against STIs and HIV.
Microbicides and Pre-Exposure Prophylaxis (PrEP) trials underway are key biomedical developments that hold a lot of hope for women all over the world who cannot negotiate for safe sex. It is my hope that these clinical researches will yield the desired results and put women in a position to access SAFE & SATISFYING sex.
Friday, April 23, 2010
CAPRISA 004
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women.
Conducted in South Africa this phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel was an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants were provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants were asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants received HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
Further study details as provided by Centre for the AIDS Programme of Research in South Africa:
Primary Outcome Measures:
•Comparison of HIV incidence rates in 2 arms (tenofovir vs placebo) [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
•To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial. [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess tenofovir resistance in HIV seroconvertors in the trial [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
Enrollment: 900
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Results are anticipated in July 2010 and their outcome has a bearing on ongoing trials in Zimbabwe.
Source: http://clinicaltrials.gov
Conducted in South Africa this phase IIb, two-arm, double-blinded, randomised, placebo controlled trial comparing 1% Tenofovir gel with a placebo gel was an expanded safety and effectiveness trial involving 900 young women at risk of sexually transmitted HIV infection. Participants were provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants were asked to apply a first dose of the assigned study gel within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. All participants received HIV risk reduction counselling, condoms, and syndromic treatment of sexually transmitted infections, if required.
Further study details as provided by Centre for the AIDS Programme of Research in South Africa:
Primary Outcome Measures:
•Comparison of HIV incidence rates in 2 arms (tenofovir vs placebo) [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
•To assess the impact, if any, of tenofovir gel on the incidence rate of deep epithelial disruption [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess the impact, if any, of tenofovir gel on viral load in women who become infected with HIV during the trial. [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess tenofovir resistance in HIV seroconvertors in the trial [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To ascertain the impact, if any, of tenofovir gel on pregnancy rates and outcomes [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
•To assess the impact, if any, of product hold at study exit on HIV infection and tenofovir resistance [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]
Enrollment: 900
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Results are anticipated in July 2010 and their outcome has a bearing on ongoing trials in Zimbabwe.
Source: http://clinicaltrials.gov
Tuesday, April 20, 2010
Civil society and media have shared responsibility to ensure accurate, non-stigmatising reporting on HIV
News: SAfAIDS Media Desk
16 April 2010
************
PRETORIA - The fight against HIV needs to be multi-sectoral and inclusive, and the media should remain a strategic partner in interventions. This was said by Mr. Jason Wessenaar, Project Director of the Siyasi Counselling and Testing Project in response to assertions that the language used by media practitioners when talking about HIV and AIDS issues often stigmatises and has done a lot of harm to, and compromised the fight against the epidemic.
The discussion followed his presentation titled using culture to address HIV and discrimination among people living with HIV' where he spoke about the importance of being careful of the language stakeholders use, as it may further stigma; terms including HIV/AIDS as opposed to HIV and AIDS, AIDS orphans as opposed to orphans and being clear to distinguish between people living with HIV and those who have AIDS were discussed.
Mr. Wessenaar explained that in South Africa, non-stigma guidelines for use in work with media practitioners - both journalists and editors - to inform reporting on HIV and gender issues have been developed. These guidelines can also be used in the workplace, and with faith based organisations. Further, a National Stigma Framework has also been developed for use by all sectors.
Media practitioners attending the Conference asserted that in their studies, journalists are not afforded the opportunity to specialise, in HIV and gender reporting for instance. Specialisation comes through the information and training that journalists receive in workshops, trainings and conferences; so civil society organisations and activists need to take some responsibility for the information that the media takes forward and circulates.
The meeting agreed that the fight against HIV must be a collective effort which includes all relevant sectors; there should be no exclusion.
Both the non-stigma guidelines and the National Stigma Framework were developed by the Siyam'kela Stigma Project at the Centre for the Study of AIDS at the University of Pretoria.
---------
This article covers the recently ended Changing the River's Flow Conference held at Birchwood Hotel, Johannesburg, South Africa from the 12th to the 13th of April 2010.
16 April 2010
************
PRETORIA - The fight against HIV needs to be multi-sectoral and inclusive, and the media should remain a strategic partner in interventions. This was said by Mr. Jason Wessenaar, Project Director of the Siyasi Counselling and Testing Project in response to assertions that the language used by media practitioners when talking about HIV and AIDS issues often stigmatises and has done a lot of harm to, and compromised the fight against the epidemic.
The discussion followed his presentation titled using culture to address HIV and discrimination among people living with HIV' where he spoke about the importance of being careful of the language stakeholders use, as it may further stigma; terms including HIV/AIDS as opposed to HIV and AIDS, AIDS orphans as opposed to orphans and being clear to distinguish between people living with HIV and those who have AIDS were discussed.
Mr. Wessenaar explained that in South Africa, non-stigma guidelines for use in work with media practitioners - both journalists and editors - to inform reporting on HIV and gender issues have been developed. These guidelines can also be used in the workplace, and with faith based organisations. Further, a National Stigma Framework has also been developed for use by all sectors.
Media practitioners attending the Conference asserted that in their studies, journalists are not afforded the opportunity to specialise, in HIV and gender reporting for instance. Specialisation comes through the information and training that journalists receive in workshops, trainings and conferences; so civil society organisations and activists need to take some responsibility for the information that the media takes forward and circulates.
The meeting agreed that the fight against HIV must be a collective effort which includes all relevant sectors; there should be no exclusion.
Both the non-stigma guidelines and the National Stigma Framework were developed by the Siyam'kela Stigma Project at the Centre for the Study of AIDS at the University of Pretoria.
---------
This article covers the recently ended Changing the River's Flow Conference held at Birchwood Hotel, Johannesburg, South Africa from the 12th to the 13th of April 2010.
Friday, April 16, 2010
Worrying rise in STIs among young people
News:14 April 2010
************
HARARE, 14 April 2010 (PlusNews) - A new report by Zimbabwe's National AIDS Council (NAC), showing a dramatic rise in sexually transmitted infections (STIs) among people aged 15 to 24 in the capital, Harare, has health experts worried that the country's success in reducing HIV could be unravelling.
STIs heighten vulnerability to HIV infection, and this age group is one of the hardest hit. According to the NAC report, more than 24,000 people were treated for STIs in 2009, compared to 8,500 cases recorded in 2008; over 60 percent of the cases were women.
During this time almost 900,000 male condoms and over 155,000 female condoms were distributed in Harare. Itai Rusike, executive director of the Community Working Group on Health (CWGH), a network of civic groups that promote health awareness, blamed the rise in STIs on a too narrow focus on HIV and AIDS treatment.
"In the last two to four years we have concentrated our focus on access to treatment, especially access to ARVs (antiretrovirals), at the expense of preventive services," he told IRIN/PlusNews.
"Right now the bulk of our AIDS levy money [a 3 percent tax on income] is going towards procurement of ARVs, to the detriment of health education awareness campaigns, especially for the young adults who are supposed to be our hope for the future."
Zimbabwe's adult HIV prevalence has been on a downward trend, dropping from 14.1 percent in 2008 to 13.7 percent in 2009.
Young people neglected
In 2009 the CWGH conducted an assessment of young people's needs for sexual reproductive health and HIV and AIDS interventions, which indicated that sex work, intergenerational relationships, early marriage, early sexual debut and unplanned pregnancy were among the challenges they faced.
In its recently published 2009 annual report the CWGH noted that young people had limited access to reproductive health information and services. "If we do not invest in preventive services, all the gains we have scored so far in HIV prevalence rate will be eroded," Rusike warned.
''If we do not invest in preventive services, all the gains we have scored so far in HIV prevalence rate will be eroded''
"Youth-led peer education activities need to be well co-ordinated and supported with financial resources, education materials, mentoring and capacity building, in order for them to be sustainable," he pointed out.
Orirando Manwere, a National AIDS Council (NAC) information officer, agreed that the rise in STI infections was an urgent call to action. "There is a need to carry out a study on why this is the trend, but generally this could be attributed to early sexual debut among the youth, unprotected sex, abuse by older men - particularly among the women and girls."
Manwere said Zimbabwe's current policy on sex education did not allow HIV and AIDS organizations to go into schools and teach young people about issues like condom use, but discussions between non-governmental organisations and government were ongoing. "It is clear that the youth are indeed sexually active and need to be empowered on sexual and reproductive health issues."
Political disruptions
AIDS activist Martha Tholanah attributed the STI increase to the violence that occurred in the aftermath of the March 2008 election.
"Youths were used to target other youths - we had reported cases of a sexual violence, which I do not think were followed up adequately, as many actors were very fearful of the repercussions if they dealt with these issues."
Many organizations, especially those working with young people, are still struggling to get on their feet after the economic and political disruptions of 2008 and beyond.
"I do not think many organisations working on sexual and reproductive health have regained the impetus they had before political and economic disruptions," Tholanah commented. "I believe we will still see more negative health effects resulting from that era."
Online at: http://www.plusnews.org/report.aspx?ReportID=88810
************
HARARE, 14 April 2010 (PlusNews) - A new report by Zimbabwe's National AIDS Council (NAC), showing a dramatic rise in sexually transmitted infections (STIs) among people aged 15 to 24 in the capital, Harare, has health experts worried that the country's success in reducing HIV could be unravelling.
STIs heighten vulnerability to HIV infection, and this age group is one of the hardest hit. According to the NAC report, more than 24,000 people were treated for STIs in 2009, compared to 8,500 cases recorded in 2008; over 60 percent of the cases were women.
During this time almost 900,000 male condoms and over 155,000 female condoms were distributed in Harare. Itai Rusike, executive director of the Community Working Group on Health (CWGH), a network of civic groups that promote health awareness, blamed the rise in STIs on a too narrow focus on HIV and AIDS treatment.
"In the last two to four years we have concentrated our focus on access to treatment, especially access to ARVs (antiretrovirals), at the expense of preventive services," he told IRIN/PlusNews.
"Right now the bulk of our AIDS levy money [a 3 percent tax on income] is going towards procurement of ARVs, to the detriment of health education awareness campaigns, especially for the young adults who are supposed to be our hope for the future."
Zimbabwe's adult HIV prevalence has been on a downward trend, dropping from 14.1 percent in 2008 to 13.7 percent in 2009.
Young people neglected
In 2009 the CWGH conducted an assessment of young people's needs for sexual reproductive health and HIV and AIDS interventions, which indicated that sex work, intergenerational relationships, early marriage, early sexual debut and unplanned pregnancy were among the challenges they faced.
In its recently published 2009 annual report the CWGH noted that young people had limited access to reproductive health information and services. "If we do not invest in preventive services, all the gains we have scored so far in HIV prevalence rate will be eroded," Rusike warned.
''If we do not invest in preventive services, all the gains we have scored so far in HIV prevalence rate will be eroded''
"Youth-led peer education activities need to be well co-ordinated and supported with financial resources, education materials, mentoring and capacity building, in order for them to be sustainable," he pointed out.
Orirando Manwere, a National AIDS Council (NAC) information officer, agreed that the rise in STI infections was an urgent call to action. "There is a need to carry out a study on why this is the trend, but generally this could be attributed to early sexual debut among the youth, unprotected sex, abuse by older men - particularly among the women and girls."
Manwere said Zimbabwe's current policy on sex education did not allow HIV and AIDS organizations to go into schools and teach young people about issues like condom use, but discussions between non-governmental organisations and government were ongoing. "It is clear that the youth are indeed sexually active and need to be empowered on sexual and reproductive health issues."
Political disruptions
AIDS activist Martha Tholanah attributed the STI increase to the violence that occurred in the aftermath of the March 2008 election.
"Youths were used to target other youths - we had reported cases of a sexual violence, which I do not think were followed up adequately, as many actors were very fearful of the repercussions if they dealt with these issues."
Many organizations, especially those working with young people, are still struggling to get on their feet after the economic and political disruptions of 2008 and beyond.
"I do not think many organisations working on sexual and reproductive health have regained the impetus they had before political and economic disruptions," Tholanah commented. "I believe we will still see more negative health effects resulting from that era."
Online at: http://www.plusnews.org/report.aspx?ReportID=88810
Wednesday, April 14, 2010
THE IMPACT OF MEDIA ON ADOLESCENTS' SEXUAL BEHAVIOUR
The effects of media consumption on young people's attitudes and behaviour
regarding sex should be of increasing interest to policy makers and program planners.
One concern is the extent to which frequent consumption of media with high levels of sexual content and low levels of portrayal of responsible sexual conduct is a causal influence on young people's subsequent sexual behaviour, including the responsible use of protection from pregnancy and disease.
Three basic areas for concern:
(1) What sexual content do youth pay attention to, and how they interpret what
they see and hear;
(2) Effect of media content on adolescents’ sexual beliefs and behaviour; and
(3) How the mass media can be used to promote responsible sexual behavior among
youth
The effects, if any, of growing up in an environment saturated by media that focuses on sexual behavior.
Frequent consumption of media with high levels of sexual content and low levels of portrayal of responsible sexual conduct is a causal influence on young people's subsequent sexual behaviour and young people's understanding of the dynamics and risks of sexual intercourse and its consequences are improved via their use of media. The content of various forms of media affects young people's attitudes and behaviour with regard to sexual intercourse.
Young people are heavy consumers of sexually-oriented media including TV, broadcast and satellite channels, videos, movies, magazines, and, more recently, the Internet. Content analysis has also demonstrated that broadcast satellite television contains a high, growing and increasingly explicit dose of sexual messages, and that a low proportion of such messages display or model either restraint or contraceptive use.
Forms of media are changing constantly, so that media "diets" may be changing in
unknown, and as yet, uncharted ways. Developmentally, young people gain more
control over their media use as they mature. Individuals may selectively use and
change their use of media, in ways not clearly understood. Age, gender,
race/ethnicity and social class may influence what media individuals have access
to and choose to pay attention to. There are also suggestions that self-definition as a member of a particular clique or crowd may influence young people's choice of media. No one form of media use predominates in adolescence.
For the purposes of this article, "media" are taken to mean information and images
delivered via: printed matter, such as newspapers, magazines, and comic books;
radio, both music and talk; TV, broadcast, satellite and video, including music
videos; movies, tapes and compact discs and the games and information accessible
through computers on the Internet and World Wide Web. Program content and
advertising are both included. Unlimited access to the Internet and to the wide
range of services available on the World Wide Web is of growing interest. The
number of individuals who have ready access to computers is growing daily.
Mass media are to a great extent fueled by commercial enterprises which have as
their goals influencing individuals' purchasing decisions. While messages may
be targeted to one or another group of individuals, there is limited or no
control over who actually listens to or understands or acts upon the information
or images disseminated.
There is therefore a need for policy makers and programme planners to recognise the role played by the mass media in modelling the sexual orientation and behaviour of adolescents.
regarding sex should be of increasing interest to policy makers and program planners.
One concern is the extent to which frequent consumption of media with high levels of sexual content and low levels of portrayal of responsible sexual conduct is a causal influence on young people's subsequent sexual behaviour, including the responsible use of protection from pregnancy and disease.
Three basic areas for concern:
(1) What sexual content do youth pay attention to, and how they interpret what
they see and hear;
(2) Effect of media content on adolescents’ sexual beliefs and behaviour; and
(3) How the mass media can be used to promote responsible sexual behavior among
youth
The effects, if any, of growing up in an environment saturated by media that focuses on sexual behavior.
Frequent consumption of media with high levels of sexual content and low levels of portrayal of responsible sexual conduct is a causal influence on young people's subsequent sexual behaviour and young people's understanding of the dynamics and risks of sexual intercourse and its consequences are improved via their use of media. The content of various forms of media affects young people's attitudes and behaviour with regard to sexual intercourse.
Young people are heavy consumers of sexually-oriented media including TV, broadcast and satellite channels, videos, movies, magazines, and, more recently, the Internet. Content analysis has also demonstrated that broadcast satellite television contains a high, growing and increasingly explicit dose of sexual messages, and that a low proportion of such messages display or model either restraint or contraceptive use.
Forms of media are changing constantly, so that media "diets" may be changing in
unknown, and as yet, uncharted ways. Developmentally, young people gain more
control over their media use as they mature. Individuals may selectively use and
change their use of media, in ways not clearly understood. Age, gender,
race/ethnicity and social class may influence what media individuals have access
to and choose to pay attention to. There are also suggestions that self-definition as a member of a particular clique or crowd may influence young people's choice of media. No one form of media use predominates in adolescence.
For the purposes of this article, "media" are taken to mean information and images
delivered via: printed matter, such as newspapers, magazines, and comic books;
radio, both music and talk; TV, broadcast, satellite and video, including music
videos; movies, tapes and compact discs and the games and information accessible
through computers on the Internet and World Wide Web. Program content and
advertising are both included. Unlimited access to the Internet and to the wide
range of services available on the World Wide Web is of growing interest. The
number of individuals who have ready access to computers is growing daily.
Mass media are to a great extent fueled by commercial enterprises which have as
their goals influencing individuals' purchasing decisions. While messages may
be targeted to one or another group of individuals, there is limited or no
control over who actually listens to or understands or acts upon the information
or images disseminated.
There is therefore a need for policy makers and programme planners to recognise the role played by the mass media in modelling the sexual orientation and behaviour of adolescents.
Tuesday, April 13, 2010
Microbicides, vaccines may need to repel HIV contact at mucosa
http://www.aidsmap.com/en/news/5B7B6E24-E8DE-4E40-86A9-3BB6E18F043C.asp
April 9, 2010
*****************************
Found in today’s AIDSmap news. Informs ecology between HIV and mucosa; also enlightens an increasingly prevalent topic in AIDS pathology studies, the phenomena – and implications – of chronic inflammation within GI tract:
Keith Alcorn, Friday, April 09, 2010
HIV can damage the walls of cells in the mucous membranes in the genital tract and the intestines, permitting the virus to pass across these barriers and infect vulnerable cells below, even when the tissue is undamaged, Canadian researchers report this week in the journal PLoS Pathogens.
The findings suggest that microbicides and vaccines may have the greatest chance of success if they can limit or prevent completely contacts between HIV's gp120 surface protein and cells in the mucous membranes of the genital tract and the intestines.
The events taking place when HIV comes into contact with mucous membranes and the immune reactions that occur within the mucosa are a critical area of research for scientists hoping to develop new methods of preventing HIV infection. All sexual transmission of HIV occurs through mucous membranes.
In their research the group from McMaster University, Ontario, with colleagues from the University of Toronto and Laval University found that in the test tube HIV’s envelope protein gp120 stimulated production of inflammatory cytokines in mucous membrane cells which made the membrane more permeable.
The authors say that this mechanism could allow HIV to enter cells below the mucous membrane surface even when it is undamaged, and may also explain why bacteria `translocate` across the intestinal wall in people with HIV more frequently than in uninfected people.
This translocation of bacteria is responsible for immune activation in people with HIV, in the view of some researchers, and may drive not only HIV disease progression but also the development of serious conditions such as atherosclerosis which are promoted by the inflammatory state that exists in people with highly activated immune systems.
Previously researchers into HIV transmission had thought that transmission was most likely to occur either when the mucous membrane was damaged (for example through trauma or ulceration) or when many activated immune cells were present (such as during a sexually transmitted infection like gonorrhoea).
But the McMaster University group found that HIV can weaken the integrity of surface cells, even when they are undamaged.
"What it does is that it makes the electrical barrier resistance of epithelial cells decrease. By doing that, the virus can cross the barrier," said lead researcher Charu Kaushic, associate professor in the Centre for Gene Therapeutics at McMaster University.
Scientists have been faced with the question of how HIV actually gets underneath epithelial cells to infect other cells that are susceptible to HIV. "It's not the cells on top," Kaushic said. "It is the immune cells underneath that have all the receptors that HIV likes to latch on to and that allow the virus to replicate and establish infection. But it has to cross the epithelial barrier first!"
The McMaster researchers grew purified primary epithelial cells in the laboratory from small pieces of tissues that were removed from women's uterus during hysterectomies, with their consent. Then, they began to study how HIV actually interacts with these cells. The electrical resistance in these cultures is used to monitor how well the epithelial cell cultures are growing and functioning.
Aisha Nazli, a researcher in Kaushic's laboratory, noticed every time she put HIV on epithelial cells their resistance went down significantly. Repeated tests confirmed this.
Kaushic said the surface protein of the virus causes the epithelial barrier to break. "The surface protein signals to the inside of the epithelial cells by binding to it", she said. "The epithelial cells start making inflammatory proteins which cause these cells to go on their self-destructive pathway."
The researchers say that providing viral load and exposure time are sufficient, HIV can probably disrupt any mucosal barrier in the body, although infection may not necessarily occur every time.
"This is a significant step forward in defining where prevention strategies, such as microbicides and vaccine, need to focus. Instead of trying to stop HIV from infecting the target cells underneath the epithelium, we need to think about ways to stop the virus from attaching to epithelial cells themselves," said Charu Kaushic.
Reference
Nazli A et al. Exposure to HIV-1 directly impairs mucosal epithelial barrier integrity allowing microbial translocation. PLoS Pathogens 6 (4): e1000852, 2010.
April 9, 2010
*****************************
Found in today’s AIDSmap news. Informs ecology between HIV and mucosa; also enlightens an increasingly prevalent topic in AIDS pathology studies, the phenomena – and implications – of chronic inflammation within GI tract:
Keith Alcorn, Friday, April 09, 2010
HIV can damage the walls of cells in the mucous membranes in the genital tract and the intestines, permitting the virus to pass across these barriers and infect vulnerable cells below, even when the tissue is undamaged, Canadian researchers report this week in the journal PLoS Pathogens.
The findings suggest that microbicides and vaccines may have the greatest chance of success if they can limit or prevent completely contacts between HIV's gp120 surface protein and cells in the mucous membranes of the genital tract and the intestines.
The events taking place when HIV comes into contact with mucous membranes and the immune reactions that occur within the mucosa are a critical area of research for scientists hoping to develop new methods of preventing HIV infection. All sexual transmission of HIV occurs through mucous membranes.
In their research the group from McMaster University, Ontario, with colleagues from the University of Toronto and Laval University found that in the test tube HIV’s envelope protein gp120 stimulated production of inflammatory cytokines in mucous membrane cells which made the membrane more permeable.
The authors say that this mechanism could allow HIV to enter cells below the mucous membrane surface even when it is undamaged, and may also explain why bacteria `translocate` across the intestinal wall in people with HIV more frequently than in uninfected people.
This translocation of bacteria is responsible for immune activation in people with HIV, in the view of some researchers, and may drive not only HIV disease progression but also the development of serious conditions such as atherosclerosis which are promoted by the inflammatory state that exists in people with highly activated immune systems.
Previously researchers into HIV transmission had thought that transmission was most likely to occur either when the mucous membrane was damaged (for example through trauma or ulceration) or when many activated immune cells were present (such as during a sexually transmitted infection like gonorrhoea).
But the McMaster University group found that HIV can weaken the integrity of surface cells, even when they are undamaged.
"What it does is that it makes the electrical barrier resistance of epithelial cells decrease. By doing that, the virus can cross the barrier," said lead researcher Charu Kaushic, associate professor in the Centre for Gene Therapeutics at McMaster University.
Scientists have been faced with the question of how HIV actually gets underneath epithelial cells to infect other cells that are susceptible to HIV. "It's not the cells on top," Kaushic said. "It is the immune cells underneath that have all the receptors that HIV likes to latch on to and that allow the virus to replicate and establish infection. But it has to cross the epithelial barrier first!"
The McMaster researchers grew purified primary epithelial cells in the laboratory from small pieces of tissues that were removed from women's uterus during hysterectomies, with their consent. Then, they began to study how HIV actually interacts with these cells. The electrical resistance in these cultures is used to monitor how well the epithelial cell cultures are growing and functioning.
Aisha Nazli, a researcher in Kaushic's laboratory, noticed every time she put HIV on epithelial cells their resistance went down significantly. Repeated tests confirmed this.
Kaushic said the surface protein of the virus causes the epithelial barrier to break. "The surface protein signals to the inside of the epithelial cells by binding to it", she said. "The epithelial cells start making inflammatory proteins which cause these cells to go on their self-destructive pathway."
The researchers say that providing viral load and exposure time are sufficient, HIV can probably disrupt any mucosal barrier in the body, although infection may not necessarily occur every time.
"This is a significant step forward in defining where prevention strategies, such as microbicides and vaccine, need to focus. Instead of trying to stop HIV from infecting the target cells underneath the epithelium, we need to think about ways to stop the virus from attaching to epithelial cells themselves," said Charu Kaushic.
Reference
Nazli A et al. Exposure to HIV-1 directly impairs mucosal epithelial barrier integrity allowing microbial translocation. PLoS Pathogens 6 (4): e1000852, 2010.
Thursday, March 25, 2010
Mass Media & African Renaissance
The African Renaissance is a concept that Africa, African people and African nations can overcome the challenges that they are currently confronting and achieve cultural, scientific, economic and social renewal. Popularised by Thabo Mbeki the former President of South Africa, the concept was first articulated in the 1990s and resonates with hope for a new and refreshed Africa.
What if any, is the role of the Mass Media in the African Renaissance?
The type of information that is produced by the mass media has a significant influence on the way that Africa and Africans can address particular socio-economic, development or environmental issues. Africa’s colonial background which resulted in the concentration of black people in small regions in the country with little access to resources, limited investment in development resulted in the excessive exploitation of natural resources for the benefit of the coloniser. Mass media coverage of such issues must reflect these imbalances for purposes of reconstruction and development in Africa.
The achievement of the African Renaissance requires that Africans develop a comprehensive information creation and dissemination system for all countries on the continent at both the national and sub-national levels. The information should reflect African development ethos, African development values, African development concepts and the fundamental aspect of Ubuntu. Mass media coverage needs to address the origins, the direction and path through which development issues should be addressed. The ability to develop such a system requires commitment from all African countries to work together and to allocate sufficient financial and institutional resources.
URTNA
URTNA is a professional body with more than 48 active member organizations committed to the development of all aspects of broadcasting in Africa. It encourages the exchange of indigenous programming via satellite and videocassette; strives to obtain preferential satellite tariffs to facilitate news and program exchange; represents the African point of view on legal matters such as conventions and agreements; and works with the ITU as an advisor for the PANAFTEL project.
Since 1972, a working group conducted jointly with other international organizations has been studying the contribution of communications satellites to education, culture, and development in Africa. URTNA has conducted a long-term project with governments of member organizations to evaluate rural telecommunications needs in Africa. URTNA also presents seminars, workshops, and conferences on topics such as news, educational broadcasting and television development of communications, satellite communications, and training.
URTNA is composed of the national radio and television organizations of African states that are members of the OAU. Associate members are national radio and/or television organizations from non-African countries.
The URTNA initiative was and still is a step in the right direction in terms of addressing Africa’s information needs. African countries will have to work together and possibly set aside their own national interests to ensure that poor countries spruce up investment in developing incountry Mass Media structures that can play an important role in bringing about reconstruction and development. Only through this approach will Africa be able to use the Mass Media to drive the African agenda for Africans and counter information from the north whose development agenda may not reflect the will and aspirations of the African continent. By so doing, Africans can slowly lift their standards of living to levels that may make the African Renaissance a reality.
What if any, is the role of the Mass Media in the African Renaissance?
The type of information that is produced by the mass media has a significant influence on the way that Africa and Africans can address particular socio-economic, development or environmental issues. Africa’s colonial background which resulted in the concentration of black people in small regions in the country with little access to resources, limited investment in development resulted in the excessive exploitation of natural resources for the benefit of the coloniser. Mass media coverage of such issues must reflect these imbalances for purposes of reconstruction and development in Africa.
The achievement of the African Renaissance requires that Africans develop a comprehensive information creation and dissemination system for all countries on the continent at both the national and sub-national levels. The information should reflect African development ethos, African development values, African development concepts and the fundamental aspect of Ubuntu. Mass media coverage needs to address the origins, the direction and path through which development issues should be addressed. The ability to develop such a system requires commitment from all African countries to work together and to allocate sufficient financial and institutional resources.
URTNA
URTNA is a professional body with more than 48 active member organizations committed to the development of all aspects of broadcasting in Africa. It encourages the exchange of indigenous programming via satellite and videocassette; strives to obtain preferential satellite tariffs to facilitate news and program exchange; represents the African point of view on legal matters such as conventions and agreements; and works with the ITU as an advisor for the PANAFTEL project.
Since 1972, a working group conducted jointly with other international organizations has been studying the contribution of communications satellites to education, culture, and development in Africa. URTNA has conducted a long-term project with governments of member organizations to evaluate rural telecommunications needs in Africa. URTNA also presents seminars, workshops, and conferences on topics such as news, educational broadcasting and television development of communications, satellite communications, and training.
URTNA is composed of the national radio and television organizations of African states that are members of the OAU. Associate members are national radio and/or television organizations from non-African countries.
The URTNA initiative was and still is a step in the right direction in terms of addressing Africa’s information needs. African countries will have to work together and possibly set aside their own national interests to ensure that poor countries spruce up investment in developing incountry Mass Media structures that can play an important role in bringing about reconstruction and development. Only through this approach will Africa be able to use the Mass Media to drive the African agenda for Africans and counter information from the north whose development agenda may not reflect the will and aspirations of the African continent. By so doing, Africans can slowly lift their standards of living to levels that may make the African Renaissance a reality.
Thursday, March 11, 2010
Microbicides: What Do They Mean For Women?
What is a “microbicide”?
“Microbicide” (mī-KRO′-bĭ-sīd) just means anything that kills microbes (like bacteria and viruses). In connection with HIV prevention, a microbicide is any substance that can substantially reduce the risk of getting or transmitting sexually transmitted infections, including HIV, when it is inserted in the vagina or rectum. No proven microbicides are on the market yet. But several candidate products are in clinical trials and the search to find one that is both safe and effective is ongoing.
What will microbicides look like and how will they work?
Some of the microbicide candidates look just like over-the-counter vaginal products—the gels, foams, films, and suppositories that are already sold for birth control or to treat vaginal infections. The difference is that microbicides are designed to stop HIV, instead of treating infections or preventing pregnancy.
Scientists are also developing some new formulations that can be used without an applicator and that women will be able to leave in place for weeks. A hollow vaginal ring (similar to the NuvaRing® contraceptive device), for example, might release the microbicide slowly for up to a month and provide round-the-clock protection.
Almost all candidate microbicides being tested right now are made with antiretroviral drugs, (ARVs ). These are the same types of drugs people who are HIV-positive use for treatment. They are re-formulated in lower doses as gels, films, etc. so they can be applied as a microbicide.
How effective would a microbicide be?
Male and female condoms are by far the most effective tools for preventing HIV infection when used consistently and correctly. But they often are not. Mathematical modelling has shown that, if a woman uses a 50% effective microbicide at least 50% of the times she has sex, her risk of HIV would be lower overall than if her partner uses a condom only once in a while (for example if he uses it only two out of every ten times they have sex).
The effectiveness of a method is shaped by:
(1) how effective the prevention tool is and
(2) how often people use it.
Less effective methods used regularly protect better than more effective methods used occasionally.
Microbicides will likely be much less effective than condoms (perhaps in the 40% - 60% range) on a “per sex act” basis. But people who do not use condoms every time—especially women whose partners often refuse condoms—could benefit from a microbicide that they could apply, themselves, every time they have sex.
Prevention tools are just one part of what is needed for women to protect themselves from HIV. More work must also be done on the structural issues that make it hard for women to insist on condoms in the first place—like not having the economic opportunities and social autonomy to make their own choices about sex.
When and how will microbicides be available?
When: Developing new drugs is a complicated process. It often takes more than a decade to find one that is both safe and effective. At each step along the way, potential products are dropped because they fail to meet the necessary standards. Only about one out of 100 original candidates make it to the final stages of testing.
The trial results of a candidate microbicide called tenofovir will be announced in 2010. If the trial shows that tenofovir gel is effective, it will likely take another larger trial to confirm the product is effective. The current trial is a phase IIB, and regulators may require a phase III trial to confirm the results. Even after a successful phase III trial, it could take two to three years for the product to be reviewed and licensed in countries where it would be first introduced. Several candidates are already in the testing pipeline but have not yet progressed to full-scale effectiveness trials.
How:
How a microbicide is made available will depend partly on whether it is ARV-based or non-ARV-based. ARV-based microbicides are likely to be more potent against HIV and may be longer-lasting. But they also might cause more side effects, including a particular problem called drug resistance , if they are accidentally used by someone who is HIV-positive already. For this reason, women will have to see a health care provider and get an HIV test before receiving these products. They will only be available by prescription.
Non-ARV-based microbicides may be less effective against HIV than ARV-based products. And they may have to be used closer to the time of sex (likely within a few hours) because they may be harder to put into time-released devices like vaginal rings. But it is likely that non-ARV-based microbicides could be available over-the-counter in shops, without a prescription. Each type of product has advantages and disadvantages.
What could microbicides mean for women?
The possibility of a microbicide offers real hope to women who want to have their own HIV prevention tools, as well as to both women and men who have anal sex and want additional methods of protection.
Many women participating in microbicide trials have said that they would probably tell a male partner if they were using something for HIV prevention—even if the method is not as obvious to him as condoms. But, unlike condoms, microbicide use wouldn’t require a partner’s active cooperation. Talking about microbicides could be a one time conversation and does not have to happen right before sex. After that, the woman could use them on her own without need to “negotiate” or interrupt sexual spontaneity every time.
Here are some other questions women have raised about microbicides:
“If my man knows I am using microbicides to prevent HIV, will he still use condoms?” His refusal to use one could raise her risk, even if she has a microbicide. On the other hand, women in some microbicide trials report that using a lubricating gel along with condoms makes sex more pleasurable for both partners. Some say this actually makes negotiation for condom use easier for them (that is they can say to their partners “I will use the gel if you use the condom”).
“What will people say about me if they find out I’m using a microbicide?” Even if she is at high HIV risk, a woman may choose not to use a microbicide if she fears that doing so will make people will think she is promiscuous. So messages to promote them must steer around this kind of stigma.
“How much will it cost and where will I get it?” In many countries, it will be essential for governments and development agencies to purchase microbicides in bulk and distribute them through public health agencies and social marketers at little or no cost. No matter how well it works, a microbicide that costs much more than a male condom will not be within reach of all women who need it.
What are the advocacy issues?
Collectively, we need to advocate for stronger support for the research and development of both ARV-based and non-ARV-based microbicides. We also need much more data on some important questions, such as how these products will affect pregnancy, breast-feeding, and the lives of women already living with HIV. Most importantly, we need to start addressing the cost and access issues now while research is still underway. Those who will eventually use microbicides must be involved in setting research priorities and helping to find answers to these questions. After all, microbicides are all about putting HIV prevention into women’s hands.
“Microbicide” (mī-KRO′-bĭ-sīd) just means anything that kills microbes (like bacteria and viruses). In connection with HIV prevention, a microbicide is any substance that can substantially reduce the risk of getting or transmitting sexually transmitted infections, including HIV, when it is inserted in the vagina or rectum. No proven microbicides are on the market yet. But several candidate products are in clinical trials and the search to find one that is both safe and effective is ongoing.
What will microbicides look like and how will they work?
Some of the microbicide candidates look just like over-the-counter vaginal products—the gels, foams, films, and suppositories that are already sold for birth control or to treat vaginal infections. The difference is that microbicides are designed to stop HIV, instead of treating infections or preventing pregnancy.
Scientists are also developing some new formulations that can be used without an applicator and that women will be able to leave in place for weeks. A hollow vaginal ring (similar to the NuvaRing® contraceptive device), for example, might release the microbicide slowly for up to a month and provide round-the-clock protection.
Almost all candidate microbicides being tested right now are made with antiretroviral drugs, (ARVs ). These are the same types of drugs people who are HIV-positive use for treatment. They are re-formulated in lower doses as gels, films, etc. so they can be applied as a microbicide.
How effective would a microbicide be?
Male and female condoms are by far the most effective tools for preventing HIV infection when used consistently and correctly. But they often are not. Mathematical modelling has shown that, if a woman uses a 50% effective microbicide at least 50% of the times she has sex, her risk of HIV would be lower overall than if her partner uses a condom only once in a while (for example if he uses it only two out of every ten times they have sex).
The effectiveness of a method is shaped by:
(1) how effective the prevention tool is and
(2) how often people use it.
Less effective methods used regularly protect better than more effective methods used occasionally.
Microbicides will likely be much less effective than condoms (perhaps in the 40% - 60% range) on a “per sex act” basis. But people who do not use condoms every time—especially women whose partners often refuse condoms—could benefit from a microbicide that they could apply, themselves, every time they have sex.
Prevention tools are just one part of what is needed for women to protect themselves from HIV. More work must also be done on the structural issues that make it hard for women to insist on condoms in the first place—like not having the economic opportunities and social autonomy to make their own choices about sex.
When and how will microbicides be available?
When: Developing new drugs is a complicated process. It often takes more than a decade to find one that is both safe and effective. At each step along the way, potential products are dropped because they fail to meet the necessary standards. Only about one out of 100 original candidates make it to the final stages of testing.
The trial results of a candidate microbicide called tenofovir will be announced in 2010. If the trial shows that tenofovir gel is effective, it will likely take another larger trial to confirm the product is effective. The current trial is a phase IIB, and regulators may require a phase III trial to confirm the results. Even after a successful phase III trial, it could take two to three years for the product to be reviewed and licensed in countries where it would be first introduced. Several candidates are already in the testing pipeline but have not yet progressed to full-scale effectiveness trials.
How:
How a microbicide is made available will depend partly on whether it is ARV-based or non-ARV-based. ARV-based microbicides are likely to be more potent against HIV and may be longer-lasting. But they also might cause more side effects, including a particular problem called drug resistance , if they are accidentally used by someone who is HIV-positive already. For this reason, women will have to see a health care provider and get an HIV test before receiving these products. They will only be available by prescription.
Non-ARV-based microbicides may be less effective against HIV than ARV-based products. And they may have to be used closer to the time of sex (likely within a few hours) because they may be harder to put into time-released devices like vaginal rings. But it is likely that non-ARV-based microbicides could be available over-the-counter in shops, without a prescription. Each type of product has advantages and disadvantages.
What could microbicides mean for women?
The possibility of a microbicide offers real hope to women who want to have their own HIV prevention tools, as well as to both women and men who have anal sex and want additional methods of protection.
Many women participating in microbicide trials have said that they would probably tell a male partner if they were using something for HIV prevention—even if the method is not as obvious to him as condoms. But, unlike condoms, microbicide use wouldn’t require a partner’s active cooperation. Talking about microbicides could be a one time conversation and does not have to happen right before sex. After that, the woman could use them on her own without need to “negotiate” or interrupt sexual spontaneity every time.
Here are some other questions women have raised about microbicides:
“If my man knows I am using microbicides to prevent HIV, will he still use condoms?” His refusal to use one could raise her risk, even if she has a microbicide. On the other hand, women in some microbicide trials report that using a lubricating gel along with condoms makes sex more pleasurable for both partners. Some say this actually makes negotiation for condom use easier for them (that is they can say to their partners “I will use the gel if you use the condom”).
“What will people say about me if they find out I’m using a microbicide?” Even if she is at high HIV risk, a woman may choose not to use a microbicide if she fears that doing so will make people will think she is promiscuous. So messages to promote them must steer around this kind of stigma.
“How much will it cost and where will I get it?” In many countries, it will be essential for governments and development agencies to purchase microbicides in bulk and distribute them through public health agencies and social marketers at little or no cost. No matter how well it works, a microbicide that costs much more than a male condom will not be within reach of all women who need it.
What are the advocacy issues?
Collectively, we need to advocate for stronger support for the research and development of both ARV-based and non-ARV-based microbicides. We also need much more data on some important questions, such as how these products will affect pregnancy, breast-feeding, and the lives of women already living with HIV. Most importantly, we need to start addressing the cost and access issues now while research is still underway. Those who will eventually use microbicides must be involved in setting research priorities and helping to find answers to these questions. After all, microbicides are all about putting HIV prevention into women’s hands.
M2010: Building Bridges in HIV Prevention
Researchers, policy-makers, community advocates, and other individuals with an interest in the field of HIV / AIDS in general, will this year convege in Pittsburgh, Pennsylvania,USA for the 2010 International Microbicides Conference (M2010). The conference, whose theme is: Building bridges in HIV Prevention will be held from 22 - 25 May 2010.
M2010 will this year inspire more integrated information-sharing and collaboration with themed symposiums that are replacing previous conference scientific tracks. This new format will be representative of the current state of the field of microbicides as it "bridges" across populations, approaches, and disciplines.
Conference Objectives are:
1. To provide updates on HIV prevention research including, but not limited to,
microbicides;
2. To provide a forum for the discussion of new developments in HIV prevention
research including basic science, clinical, social science, behavioral,
community and advocacy issues; and
3. To present opportunities for knowledge-sharing between HIV prevention
researchers, public health workers, communities, and advocacy organizations.
Plenary sessions will include some of the following:
- Updates on microbicide development
- Community issues in HIV prevention
- Biology of HIV transmission
- The role of social science in HIV prevention & HIV vaccines
- Rolling out an effective prevention strategy
The International Microbicides Conference (M2010)is held once every two years and will this year see approximately 1,500 delegates attend this prestigious event from around the world.
M2010 will this year inspire more integrated information-sharing and collaboration with themed symposiums that are replacing previous conference scientific tracks. This new format will be representative of the current state of the field of microbicides as it "bridges" across populations, approaches, and disciplines.
Conference Objectives are:
1. To provide updates on HIV prevention research including, but not limited to,
microbicides;
2. To provide a forum for the discussion of new developments in HIV prevention
research including basic science, clinical, social science, behavioral,
community and advocacy issues; and
3. To present opportunities for knowledge-sharing between HIV prevention
researchers, public health workers, communities, and advocacy organizations.
Plenary sessions will include some of the following:
- Updates on microbicide development
- Community issues in HIV prevention
- Biology of HIV transmission
- The role of social science in HIV prevention & HIV vaccines
- Rolling out an effective prevention strategy
The International Microbicides Conference (M2010)is held once every two years and will this year see approximately 1,500 delegates attend this prestigious event from around the world.
Media & the HIV/AIDS landscape
"When you are working to combat a disastrous and growing emergency, you should use every tool at your disposal. HIV/AIDS is the worst epidemic humanity has ever faced.… Broadcast media have tremendous reach and influence, particularly with young people, who represent the future and who are the key to any successful fight against HIV/AIDS. We must seek to engage these powerful organisations as full partners in the fight to halt HIV/AIDS through awareness, prevention, and education."
(Kofi Annan, UNAIDS, 2004).
The words of the former UN chief, remind us of the urgency with which operatives in the fight against HIV/AIDS need to mobilise media resources as much as all other resources to tap into the "tremendous reach and influence, particularly with young people."
Traditionally, the role of the media was put into three categories:
1. Educate
2. Inform
3. Entertain
Education
The media is still seen, in many parts of the world as a tool for education. To this extend, early scholars were encouraged to scurry through magazines and newspapers to improve their knowledge as well as their English. This was done with the understanding that those working behind the scenes to provide media products had thoroughly looked at their content before passing it off to their consumers.
Inform
The media played the important role of bringing information to the listening, reading or viewing public. Programmes were produced, columns published, which carried in-depth analyses of issues. Researchers referred to articles and news clips in their findings. This role, has remained, albeit, its abuse by the media.
Entertain
The media has for years religiously pursued the role of entertainment. Movies, film, video technology, the internet, music on radio and television, magazine stories - all have maintained a grip on the entertainment starved public. Over the years, especially in the wake of the AIDS pandemic, scholars have at many a forum discussed the role if any, that the media can play in the fight against HIV/AIDS. The effects of media consumption on people's attitudes and behaviour regarding sex are should be increasing interest to policy makers and program planners. Of much concern is the extent to which frequent consumption of media with high levels of sexual content is made available, against low levels of counter portrayal of responsible sexual conduct.
The questions then could be: "How can the mass media be used to promote responsible sexual behaviour?" Can HIV/AIDS media prevention interventions be done in a social context and a culturally sensitive manner that does not erode the impact and effect of the message in the eyes of culture gate-keepers?
Organisations working to use the media need to come up comprehensive proactive media plans if their messages are to be effective.
(Kofi Annan, UNAIDS, 2004).
The words of the former UN chief, remind us of the urgency with which operatives in the fight against HIV/AIDS need to mobilise media resources as much as all other resources to tap into the "tremendous reach and influence, particularly with young people."
Traditionally, the role of the media was put into three categories:
1. Educate
2. Inform
3. Entertain
Education
The media is still seen, in many parts of the world as a tool for education. To this extend, early scholars were encouraged to scurry through magazines and newspapers to improve their knowledge as well as their English. This was done with the understanding that those working behind the scenes to provide media products had thoroughly looked at their content before passing it off to their consumers.
Inform
The media played the important role of bringing information to the listening, reading or viewing public. Programmes were produced, columns published, which carried in-depth analyses of issues. Researchers referred to articles and news clips in their findings. This role, has remained, albeit, its abuse by the media.
Entertain
The media has for years religiously pursued the role of entertainment. Movies, film, video technology, the internet, music on radio and television, magazine stories - all have maintained a grip on the entertainment starved public. Over the years, especially in the wake of the AIDS pandemic, scholars have at many a forum discussed the role if any, that the media can play in the fight against HIV/AIDS. The effects of media consumption on people's attitudes and behaviour regarding sex are should be increasing interest to policy makers and program planners. Of much concern is the extent to which frequent consumption of media with high levels of sexual content is made available, against low levels of counter portrayal of responsible sexual conduct.
The questions then could be: "How can the mass media be used to promote responsible sexual behaviour?" Can HIV/AIDS media prevention interventions be done in a social context and a culturally sensitive manner that does not erode the impact and effect of the message in the eyes of culture gate-keepers?
Organisations working to use the media need to come up comprehensive proactive media plans if their messages are to be effective.
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