Cape Town, South Africa, December 9, 2013 – In a report released today, AVAC calls on funders and researchers to capitalize on lessons learned from a range of recent HIV prevention trials with better problem solving, more critical thinking and coordinated action around large-scale human trials, faster roll out of proven options and ongoing research for new advances that women and men will want to use.
This year’s AVAC Report, entitled Research and Reality, pays particular attention to the needs of women and girls. Citing recent trials that failed to provide conclusive answers due to low use of products in the studies, the report lays out a broad and ambitious development agenda for female-initiated prevention options including vaginal gels, rings and other emerging biomedical strategies.
The new report also urges researchers, donors and implementers to step up plans for large-scale delivery of recently proven methods for women and men, including pre-exposure prophylaxis (PrEP) and non-surgical male circumcision devices. While pilot studies of these options are in progress, a lack of longer-range plans for program scale-up and roll out means that valuable time, and lives, could be lost.
“Prevention research has had both rough times and revolutionary breakthroughs in the past few years. It’s time to apply lessons from these experiences to work faster and smarter going forward,” said Mitchell Warren, AVAC executive director. “As advocates, we’re looking to make sure that new HIV prevention developments are turned into action—whether that’s delivering new options that work to the people who need them, or revising past assumptions based on trials that didn’t go as planned.”
“We need to keep focused on HIV prevention that’s effective, available and meets the needs of men and women throughout their lives,” Warren said.
Refocusing the Search for New Methods for Women
Research and Reality, released at the 17th International Conference on AIDS and STIs in Africa (ICASA), takes an in-depth, critical look at prevention research for women. There has been a positive, proof of concept finding that a vaginal gel can reduce women’s risk of HIV, as well as positive data on daily oral tenofovir-based PrEP in women. However, there have also been two trials in which participants did not actually use the options being tested regularly enough to answer the study questions.
In the report, AVAC offers recommendations and analysis to move beyond competing interpretations of these data. This is the first advocacy document to provide a full picture of what the trials do and do not reveal about the future of female-initiated prevention. It identifies clear steps to take to address issues from past trials and a core set of questions that need to be answered through strategic research going forward.
“It would be completely unacceptable to throw up our hands and say we don’t know what women want,” said Warren. “With women representing half of the global HIV epidemic, it’s both a practical and a moral imperative to keep up the search for new methods that women can control and want to use.”
“Recent trial results may be puzzling, but one thing we know for sure is that many women at risk want and need new ways to protect themselves from HIV,” said Nono Eland, chairperson of the Women’s Sector of the South African National AIDS Council (SANAC). “The prevention revolution continues. Earlier this year, participants at the SANAC Women’s Sector biennial summit called for better investment in prevention for women. We called for women to be meaningfully involved at all stages—from planning to distribution of HIV prevention products that are developed for us and reiterated the need for prevention research literacy for communities.”
To help resolve questions and challenges about women’s prevention options, Research and Reality recommends that researchers and trial sponsors:
- Continue to explore and measure methods to improve adherence.
- Conduct additional qualitative research to better understand women’s reasons for enrolling in a trial and using (or not using) a study product.
- Use innovative trial designs that would select trial participants who are most likely to adhere to a product regimen so efficacy can be determined – if the trial shows efficacy, bridging studies should be designed to examine how the strategy might work among more diverse populations
“When conventional approaches to science are not working, it’s time to break with convention,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute in South Africa and a member of AVAC’s board of directors. “We urgently need to identify a range of prevention options that can work for women – and then we need to know which options will work best for which women.”
Research and Reality also provides four overarching recommendations on issues that lie at the intersection of research goals and real-world conditions.
- Launch complex trials to answer complex questions – Clinical trials remain the only way to answer the most important scientific questions in HIV prevention. Researchers and funders must continue to launch new trials despite the challenges, complexities and costs. This is especially true for AIDS vaccines, as well as to clarify the effect of hormonal contraception on HIV risk, where research is critical and must proceed.
- Plan for roll out beyond pilot projects – Pilot projects are an important first step toward ensuring that promising research results translate into real impact on people’s lives, but pilot projects alone will not end the AIDS epidemic. To realize their full potential, interventions such as daily oral PrEP and non-surgical devices for voluntary medical male circumcision need to be adequately resourced, ramped up, and included in national HIV/AIDS implementation plans.
- Invest and innovate in virologic suppression – In addition to the life-saving benefits of antiretroviral therapy as treatment for people living with HIV, research shows that ARV treatment can dramatically reduce the risk of HIV transmission to others. But treatment works in this way only when it effectively suppresses virus in the body to very low levels. To achieve and sustain HIV suppression and realize the full preventive potential of treatment, it is critical to invest in treatment adherence programs, new antiretroviral therapies, therapeutic vaccines and a cure.
- Align programs, models and funding to stay on track to end AIDS – Countries are developing HIV prevention plans and targets based on modeling that does not fully account for realities on the ground. Models are essential, but they need to be designed with built-in feedback loops – pulling in surveillance data and other information about the impact of prevention programs, so that results can be improved quickly over time.
The new Research and Reality recommendations build on the AVAC Playbook, a long-term agenda for global HIV prevention efforts first issued in 2011. AVAC assesses and reports on the most critical next steps for the development and delivery of new prevention options each year.
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. The full report, AVAC Report 2013: Research and Reality, is available at www.avac.org/report2013.