This graphic charts how many people in South Africa tested as HIV negative each month vs. how many people commenced oral PrEP from month-to-month. It appears in AVAC Report 2017: Mixed messages and how to untangle them.
The South Africa PrEP Story: What “starting out” looks like
Target Tracking, 2010–2020
Calculating progress toward the UNAIDS Fast Track Goals is complex but ambitious targets are the best kind. AVAC has long argued they propel action even if they aren’t met. But when it comes to achieving epidemic control, progress must be properly calculated, and can never be confused with success. This graphic appears in AVAC Report 2017: Mixed messages and how to untangle them.
Timeline for DAIDS HIV Trials Network Recompetition
This graphic looks ahead from 2017 through 2027 at the DAIDS HIV Trials Network Recompetition process. It appears in AVAC Report 2017: Mixed messages and how to untangle them.
New HIV Prevention Trials Hold Promise for New Prevention Options for Women
Just ahead of another World AIDS Day, two new efficacy trials officially launched in Africa today with the potential of additional HIV prevention methods in the future.
The two trials – one studying a new vaccine strategy from Janssen/Johnson & Johnson that could protect against multiple strains of HIV and the other with an injectable antiretroviral PrEP strategy every two months from ViiV/GSK – join five other efficacy trials that are hoped to expand the options available to meet the varied needs women and men have for HIV prevention over the course of their lives.
“It is unprecedented to have so much diverse activity in the field, with nearly 25,000 trial participants to be enrolled across all of these trials around the world. As we commemorate World AIDS Day, it’s important to pause and be thankful for the many thousands of women and men around the world who have stepped up to volunteer for clinical trials that have given us the means to respond to this epidemic, in whose footsteps the 6,000 African women who will take part in these two new trials now follow,” said Mitchell Warren, executive director of AVAC, a global HIV prevention organization.
“Equally unprecedented is the level of pharmaceutical engagement within these trial partnerships. While both of these new trials are jointly funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation, the two product developers are active financial partners,” said Warren. “We hope that the examples of ViiV and Janssen will prompt additional and sustainable industrial partnerships in HIV prevention research.”
“These new trials come at one of the most dynamic times for HIV prevention. There are more trials of new concepts; more programs beginning to deliver daily oral PrEP; a vaginal ring going through regulatory review; record numbers of people on HIV treatment; new guidelines reflecting the scientific evidence behind undetectable = untransmittable; and real-world evidence from Uganda that scaling up treatment and voluntary medical male circumcision can reduce new HIV infection at a population level,” said Warren.
This dynamism also makes the field far more complex than ever before, as these multiple signs of progress co-exist and compete for resources. Later today, AVAC will be releasing its annual “state of the field” report—Mixed Messages and How to Untangle Them—which addresses these realities. The report will be available online at www.avac.org/report2017.
“Both new trials could pave the way for valuable new long-acting prevention options—in addition to, not instead of, the interventions we have today. As the AVAC Report describes, now is the time to structure research agendas and networks, oral PrEP programs and comprehensive approaches to HIV prevention in such a way that they lay the groundwork for strategies like those being tested in these trials,” Warren said.
Press Release
New HIV Prevention Trials Hold Promise for New Prevention Options for Women
Contacts
Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375
New York — Just ahead of another World AIDS Day, two new efficacy trials officially launched in Africa today with the potential of additional HIV prevention methods in the future.
The two trials – one studying a new vaccine strategy from Janssen/Johnson & Johnson that could protect against multiple strains of HIV and the other with an injectable antiretroviral PrEP strategy every two months from ViiV/GSK – join five other efficacy trials that are hoped to expand the options available to meet the varied needs women and men have for HIV prevention over the course of their lives.
“It is unprecedented to have so much diverse activity in the field, with nearly 25,000 trial participants to be enrolled across all of these trials around the world. As we commemorate World AIDS Day, it’s important to pause and be thankful for the many thousands of women and men around the world who have stepped up to volunteer for clinical trials that have given us the means to respond to this epidemic, in whose footsteps the 6,000 African women who will take part in these two new trials now follow,” said Mitchell Warren, executive director of AVAC, a global HIV prevention organization.
“Equally unprecedented is the level of pharmaceutical engagement within these trial partnerships. While both of these new trials are jointly funded by the US National Institutes of Health and the Bill & Melinda Gates Foundation, the two product developers are active financial partners,” said Warren. “We hope that the examples of ViiV and Janssen will prompt additional and sustainable industrial partnerships in HIV prevention research.”
“These new trials come at one of the most dynamic times for HIV prevention. There are more trials of new concepts; more programs beginning to deliver daily oral PrEP; a vaginal ring going through regulatory review; record numbers of people on HIV treatment; new guidelines reflecting the scientific evidence behind undetectable = untransmittable; and real-world evidence from Uganda that scaling up treatment and voluntary medical male circumcision can reduce new HIV infection at a population level,” said Warren.
This dynamism also makes the field far more complex than ever before, as these multiple signs of progress co-exist and compete for resources. Later today, AVAC will be releasing its annual “state of the field” report—Mixed Messages and How to Untangle Them—which addresses these realities. The report will be available online at www.avac.org/report2017.
“Both new trials could pave the way for valuable new long-acting prevention options—in addition to, not instead of, the interventions we have today. As the AVAC Report describes, now is the time to structure research agendas and networks, oral PrEP programs and comprehensive approaches to HIV prevention in such a way that they lay the groundwork for strategies like those being tested in these trials,” Warren said.
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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.
New Episode of Px Pulse, AVAC’s New Podcast Series
We are excited to share with you our new episode of Px Pulse, AVAC’s podcast covering vital topics in HIV prevention research. Find it at avac.org/px-pulse or listen on iTunes!
This month Px Pulse looks at the standard of care in HIV prevention trials in the era of oral PrEP. This issue has been discussed and hotly debated lately—and for good reason: It’s complicated. In this episode, we take you deeper into this pressing issue.
Around the world, a number of large clinical trials, ongoing and planned, are testing new HIV prevention interventions. Many of these trials are happening in a few regions of Southern Africa. In these same areas, oral PrEP—a proven and highly effective prevention method—is rolling out and reaching some places and populations better than others. The obligation of researchers to provide oral PrEP to participants in HIV prevention trials, and precisely how they should do so, was the focus of a summit convened by the South African Medical Research Council in October in Cape Town.
In this episode, you’ll hear veteran advocate voices, Tian Johnson and Yvette Raphael, challenge the thinking that providing oral PrEP in trials can be separate from national rollout. They call on researchers to partner with advocates so that what happens at the trial site can be integrated with the national PrEP agenda. Director of Research at Wits RHI Sinead Delany-Moretlwe discusses the future of trial design and research, touching on how the prevention options of tomorrow will further complicate these questions.
Don’t miss it—and do let us know what you think!
Testing Long-Acting PrEP, Easier Said Than Done
In this episode of AVAC’s Px Pulse podcast series, leading researcher Dr. Deborah Donnell tells us why the HIV Prevention Trials Network (HPTN) changed the design of one of two trials testing long-acting cabotegravir, as an injectable PrEP.
PrEP and Trial Design — A no brainer for some
In this episode of AVAC’s Px Pulse podcast series, Slim Abdool Karim, co-principal investigator of the landmark CAPRISA 004 study, talks about why designing trials with oral PrEP is a must—scientifically and ethically.
HIV Prevention in the Era of PrEP: The implications of TDF/FTC for biomedical prevention trials
On Thursday, October 26, colleagues from the Treatment Action Group (TAG), along with advocates, researchers and GPP practitioners, discussed the recommendations from the TAG’s recently released white paper, HIV Research in the Era of PrEP: The Implications of TDF/FTC for Biomedical Prevention Trials.
The effectiveness and increasing availability of oral PrEP raises questions about how it should be incorporated into clinical trial designs for next-generation HIV prevention options. This paper explores ethics, the scientific literature to date, and advocates’ views on the issue.
PrEP and Trial Design — A no brainer for some
Clinical trials for new HIV prevention methods offer participants counseling and access to the existing ways to protect oneself from HIV. It’s called the “standard of prevention” and is a package of prevention methods and services.
Now that oral PrEP is a proven HIV prevention method and WHO-recommended, some trials are adding it to the package. And that makes trials more complex. That’s a good problem to have, says Slim Abdool Karim, the director of the Centre for the AIDS Program of Research in South Africa, also known as CAPRISA. As the co-principal investigator of the landmark CAPRISA 004 tenofovir gel study and the recipient of multiple awards for his research, Karim brings incomparable perspective to this question. In this interview with AVAC’s Jeanne Baron, Karim talks about why designing trials with oral PrEP is a must—scientifically and ethically.
This interview is part of an ongoing series, and look out for our upcoming podcast—Px Pulse, which will feature interviews and discussions that explore vital topics in HIV Prevention research today. Tell us what you think!
Click on the links below to learn more about PrEP and standard of prevention in trials: