Good participatory practice and community voices are needed now more than ever in the HIV vaccine research arena.
The world has its eyes trained on two large clinical trials in South Africa: HVTN 702, which is testing a classic "active immunization" approach; and the antibody mediated prevention (AMP) study, testing "passive immunization" against HIV. (HVTN 702 study is being conducted under the auspices of the HIV Vaccine Trials Network (HVTN), and the AMP study is jointly led by the HVTN and the HIV Prevention Trials Network (HPTN).
HVTN 702's launch in late 2016 received wide and highly optimistic media coverage. Headlines like "Watch 1st person receive new HIV vaccine," though inaccurate (the product being injected is a test vaccine), signal a widely shared hunger for an HIV vaccine that works. And at the HVTN Regional Meeting in Johannesburg last quarter, you could feel this optimism running through the presentations as updates on HVTN 702 and AMP were shared.
Part of a vaccine research project known locally as Uhambo
, HVTN 702 is a 5-year clinical trial among 5400 individuals in South Africa. It is investigating the efficacy of a two-product vaccine candidate modeled on the prime-boost vaccine candidate that showed partial efficacy in the Thai RV144 trial
8 years ago.
AMP is also testing efficacy, but this time of intravenous infusions (a drip) of VRC01, a broadly-neutralizing anti-HIV antibody. AMP will enroll 1,500 female participants in Africa. (A parallel study is studing the same antibody among 2,700 men and transgender persons who have sex with men.)
Could HVTN 702 lead to a licensed vaccine? Will the AMP study show efficacy? The world should have those answers in about 5 years.
Working with a broad range of partners throughout the world, AVAC tracks, advocates for, and develops tools to support accelerated progress in HIV prevention globally. We monitor the use and spread of existing prevention options, as well as the research into new options such as microbicides, PrEP and vaccines.
The last two decades of the global search for an HIV vaccine has taught us to be patient; even promising candidates have yielded inconclusive, negative, or modestly positive results. With or without efficacy, however, analyses of the results of clinical trials offer tremendous gains, advancing our knowledge and informing future research.
This "learning" aim of clinical research is something trial participants and the larger community should be well informed about. Comprehensive engagement with all stakeholders -- a cornerstone of Good Participatory Practice (GPP) for clinical trials -- can help achieve this awareness.
Good Participatory Practice (GPP) Guidelines were developed by AVAC and UNAIDS in 2007 and updated in 2011. They provide trial funders, sponsors, and implementers with systematic guidance on how to effectively engage all stakeholders in the design and conduct of biomedical HIV prevention trials. Today, GPP is being applied in biomedical research beyond HIV.
Good Participatory Practice makes research literacy a high priority for participants and their communities, providing a concrete foundation for people to understand the process, objectives, and limitations of clinical trials. GPP advocates for face to face engagement with communities and trial participants, complemented by communication through websites, online videos and printed materials. With a firm grasp of research literacy, people are more open to unexpected trial results.
GPP is essential in today's highly complex HIV research landscape, which includes active and passive immunization approaches; novel antibody research; mucosal research to inform vaccine development; different ways to administer the test products (e.g. pills, gels, rings, injections, inserts, implants and infusions); cure research; an evolving Standard of Prevention (the standard package of prevention services offered to every participant who joins a trial); new WHO guidance on a popular contraceptive method... even for the initiated these, and many more, are tough topics.
Which is why we feel the ground is ripe for a fresh new crop of advocates and activists focused on HIV prevention research who will serve as a bridge between researchers and communities.
The HIV Vaccine Advocacy Research Group (VARG) is one of the groups working to intensify the flame of advocacy and activism for HIV vaccine research. This team of advocates for prevention research is focusing a local lens on global advocacy for HIV vaccines.
When the VARG met last month, members agreed to apply tactics such as in-person and online consultations, media engagement, training programs and other communication methods. With these tools, they hope to broaden public awareness, support a rich engagement of stakeholders and sustain broad support for HIV vaccine research.
The VARG is joining hands with AVAC to seek answers to the who, what, when, why and how of HIV prevention studies, analyzing the pipeline, and enquiring where trials fit into the bigger goal of finding an efficacious vaccine for everyone in need. The VARG will provide research groups with guidance on GPP in clinical trials, and monitor its application.
As a community of advocates we applaud inter-disciplinary research and call for more of it. We were happy to hear, at the recent HVTN conference, that HIV vaccine researchers are using lessons from cancer and autoimmune research; such partnerships are essential in the complex puzzle of finding an HIV vaccine.
A licensed safe, effective, affordable and accessible vaccine would fast-track us towards the goal of ending AIDS. It would also help to secure and sustain the massive gains from expanded access to existing treatment and prevention options.
Engaged communities that keep everyone on their toes are good for the field. We need more people to jump onboard the HIV-prevention activist ship.
Daisy Ouya is the communications advisor at AVAC. Morenike Upkong is an associate professor at Obafemi Awolowo University and coordinator of the New HIV Vaccine and Microbicide Advocacy Society (NHVMAS) in Ife, Nigeria.