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
Tuesday, June 1, 2010
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
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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.
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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.
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