Beyond the Trial: What impact does engagement and participatory practice have on HIV research outcomes?

This post originally appeared on FHI 360’s Research for Evidence blog.

Good Participatory Practice (GPP) has become a central part of biomedical HIV prevention research over the past 10 years. Developed in response to global controversies that disrupted the first trials seeking to test whether antiretroviral drugs could prevent the sexual transmission of HIV, GPP provides a framework for researchers working amid historically-based concerns about exploitation and within the pervasive social, economic and political inequalities that travel with the HIV pandemic. GPP guidelines are built on a broader movement toward partnerships between health researchers and sponsors on the one hand, and patients, communities and advocates on the other.

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Doing participatory research well requires expertise, resources and time. It is also an approach where everyone learns mainly by doing, whether they are researchers, funders, patients or advocates. It is challenging to evaluate principled, action-based approaches. But without thoughtful evaluation we may end up investing in well-intended practices that align poorly with desired long-term outcomes or miss opportunities to innovate for greater impact.

To highlight the accumulating evidence on how engagement and participatory practices have been applied, and with what results for HIV prevention, I recently collaborated with Judy Auerbach (UCSF) to guest edit a special supplement of the Journal of the International AIDS Society (JIAS), on “Science, theory, and practice of engaged research: Good Participatory Practice and beyond.” The supplement was released in conjunction with the HIV Research for Prevention (HIVR4P) conference held in Madrid in October 2018. Here I highlight three articles from the supplement.

Theory: Ethics review to strengthen engagement

While there is considerable overlap between the goals of GPP and those of research ethics review, they are nonetheless distinct and complementary processes. Ethics review is a largely regulatory process that establishes standards and formalizes accountability, as a way of ensuring that people recruited and enrolled into research are treated with respect, provided optimal benefits while subject to minimal harm, and with fair and equal distribution of both the benefits and risks of participation. In the context of HIV prevention, research participants, community members and other stakeholders may be at risk of harm due to the potential for social marginalization, stigma and discrimination. This could result from intentional exploitation, or from well-intentioned but poorly informed actions by researchers.

GPP, and stakeholder engagement more broadly, centers on fostering collaboration among researchers, the people engaged in the research and the communities impacted by the research. This is quite different than the protectionist framework of most research ethics guidelines. It carries a risk that the trust built with participants and communities could be exploited – as happened with the infamous 40-year CDC study of syphilis in a poor Black area of Tuskegee, Alabama. But it also carries the potential to transform clinical research through increased innovation, better implementation and broader benefits for participants and communities.

Given these tensions, Catherine Slack and colleagues at the HIV AIDS Vaccines Ethics Group (HAVEG) at the University of KwaZulu-Natal in South Africa ask whether stakeholder engagement is a legitimate component of ethics review, and, if so, what core features and practices of engagement should be included in that review.

In their article, “Strengthening stakeholder engagement through ethics review in biomedical HIV prevention trials: Opportunities and complexities,” Slack, et al. note that multiple guidelines direct research ethics committees to consider community participation and engagement as part of their review of HIV prevention research. According to the authors, the key features that committees should consider are whether the engagement is broad and inclusive, early and sustained, and responsive and dynamic. When reviewing practices, committees should consider if researchers appropriately evaluate the local context, put their engagement plans into writing, and adequately resource the plans.

In their discussion, Slack, et al. stress that if research ethics committees find that “planned engagement does not meet ethics recommendations, they should not recommend rejection of a protocol but rather make constructive recommendations for improvement so plans resonate better with ethics guidance” (p. 23). The authors advocate against requiring protocol amendments, emphasizing instead “rapid engagement responses” with notification to the committee as appropriate. If overly rigid, ethics committees with limited understanding of community dynamics could constrain researchers from addressing emergent crises in ways that minimize harm and maximize benefit.

This topic is the focus of a new online course to be released by the AIDS Vaccine Advocacy Coalition (AVAC) in partnership with HAVEG. The course takes a “guidance-grounded” approach – highlighting how ethics guidelines actively encourage research ethics committees to review engagement, and foregrounding the features and practices of engagement valued in ethics guidance. The course will be available in January 2019 on

Practice: Implementing GPP across multiple trials, multiple sites

GPP guidance documents stress the importance of continuous engagement with communities and stakeholders throughout all stages of the clinical research process, from protocol development through planning implementation of clinical trials to post-trial dissemination of results and access to effective interventions and treatments. The documents outline practices and activities that can be undertaken at each step in this kind of timeline for a given trial, in a given setting.

In reality, GPP is rarely so easily packaged and delivered. What happens to the relationships built with communities and stakeholders between the end of one trial and the beginning of the next? How is the timeline managed if the research site is implementing multiple trials with overlapping timelines and participant populations? What if that site is leading the implementation of two or more trials across overlapping sets of research sites in multiple country settings? Researchers at the Wits Reproductive Health and HIV Institute (Wits RHI) in Johannesburg, South Africa, find they needed to address all these challenges.

The Wits RHI studies described by Deborah Baron and colleagues in the special supplement include five studies with implementation start dates ranging from 2011–2015 and end dates from 2014–2020. All studies include multiple sites within South Africa and two also include sites elsewhere in Africa (Kenya, Swaziland, Tanzania and Zambia). In their article, “Collateral benefits: How the practical application of Good Participatory Practice can strengthen HIV research in sub‐Saharan Africa,” Baron, et al. thoughtfully reflect on what did, and did not work for addressing a wide range of challenges.

Through accumulation of experience, capacity building within the organization, and leveraging of funding resources, Wits RHI institutionalized GPP with the aim of establishing the first GPP Centre of Excellence. Baron and colleagues outline recommendations within four key research phases for advancing GPP.

In the planning and readiness phase, Baron, et al. stress the need for commitments to provide human resources, funding, documentation, and monitoring and evaluation of engagement outcomes and impact. During implementation, they stress training, monitoring for quality improvement, and continuous engagement activities. During close-out, research teams need to pro-actively plan for different outcome scenarios, post-trial access, and how dissemination and communications will be supported after the trial ends but results are not yet available. For overall sustainability, the authors advise research teams to develop generic GPP tools, templates and standard operating procedures they adopt across research projects, ensure knowledge and experience are embedded in institutional memory, and to invest in their GPP champions through training and other internal supports.

Beyond GPP: Community mobilization as intervention

If we assume that “the clinic” is the home base for improving health outcomes, we can quickly lose sight of the fact that many of the drivers of those outcomes are powered outside the clinic, in the communities where people live their day-to-day lives. This is especially true when thinking about prevention or chronic health conditions.

Over the years I have often heard health researchers acknowledge the important determining role of social conditions on health but then throw up their hands and say, “What do you want me to do? Cure poverty? Cure prejudice? Find a cure for gender-based violence?” Well, yes.

Of course, it is important to conduct clinical research that targets pathogens and toxic exposures, or that seeks ways to rebuild broken biological systems (e.g., immune, cardiovascular, digestive, nervous). But if social conditions increase the transmission of pathogens and toxins or help break down bodily systems, why not do research that also targets those social conditions? Why try to cure only the part of the problem that can walk into the clinic setting?

The article by Sheri Lippman and colleagues, “Village community mobilization is associated with reduced HIV incidence in young South African women participating in the HPTN 068 study cohort,” draws on data from multiple studies to evaluate the impact of community mobilization on HIV incidence. The authors derived population-level data from an annual census, the Agincourt Health and socio-Demographic Surveillance System (HDSS), undertaken in a rural area in South Africa. The HIV Prevention Trials Network (HPTN) 068 trial – active through 2012 – used a randomized design to see if cash transfers conditional on school attendance could reduce HIV incidence among a cohort of adolescent girls and young women ages 13 to 20 residing in the Agincourt HDSS study area.

During the same time period, a separate community mobilization intervention study centered on the intersection of HIV risk and gender norms was implemented in 11 of 22 randomly selected villages in the Agincourt HDSS area. The community mobilization study was evaluated through baseline and follow-up cross-sectional surveys in Agincourt HDSS villages, including those where HPTN 068 was implemented. The surveys included measures reflective of seven components describing the level of mobilization in each village.

In their analysis of the combined data, Lippman, et al. find that living in a community with higher levels of mobilization is associated with lower HIV incidence among the adolescent girls and young women enrolled in the HPTN 068 cohort. They also find a relationship between specific mobilization components and HIV incidence. The authors state the “overall findings indicate that [adolescent girls and young women] experience reduced HIV infection in villages where residents feel connected, dialogue and address their circumstances, consider HIV an important community issue and have leadership that is present and accountable” (p. 64).

Taken together, the three articles described above from the JIAS special supplement underscore the ethical basis for participatory, engaged research, the growth of collective expertise in and leadership for its implementation, and the potential for transitioning from participatory support from communities and stakeholders for research to mobilization as a key intervention component. It is time to fully situate clinical research as part of the communities where the work takes place.

Support AVAC This Holiday Season

The Tuesday after the Thanksgiving holiday in the US is often referred to as #GivingTuesday, which is meant to be a day of giving during the holiday season. We are enormously grateful for our partnerships around the world, and we hope you will consider offering your support to AVAC.

With World AIDS Day right around on the corner on December 1st, there’s no better time to reflect on the progress to date and the work that lays ahead to end the epidemic in our lifetimes. Your charitable contribution helps AVAC to continue what we do best—advocating for comprehensive, integrated and sustained HIV prevention.

In our recently released AVAC Report 2018 – No Prevention, No End we look at the challenges that frustrate efforts to bring down the number of new cases of HIV and propose concrete solutions to address these challenges. Confronting these issues is a necessity. The world is not on track to bring down the rate of the new cases fast enough to achieve goals for epidemic control by 2020.

It’s a call to action, and AVAC is answering the call with timely updates from the field, educational materials that help advocates shape the conversation, deep collaboration with partners around the world to accelerate programs, and thoughtful messages that keep pace with the rapidly evolving field. In all this, AVAC puts human rights, sexual and reproductive health, choice and investment in research and development at the center of the conversation.

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Trial Participant and Courageous Advocate: This year’s winner of the Falobi award

Without women like Gcobisa Madlolo, it’s impossible to see how HIV prevention would advance.
As a young South African woman, she learned about a study called EMPOWER (Enhancing Methods of Prevention and Options for Women Exposed to Risk), which was investigating a combination prevention strategy that included PrEP for young women in Tanzania and South Africa. Madlolo enrolled. She became an early adopter of PrEP and began to speak out about her experience—a loud and proud champion of PrEP, of HIV prevention, and of sexual health rights for women.

Gcobisa Madlolo

When EMPOWER ended in 2017, Madlolo, a mother of twins and a writer and activist, doubled down on her commitment to find and support interventions that work for herself and her community. She transitioned from EMPOWER to a demonstration project known as POWER (Prevention Options for Women Evaluation Research), which is helping to inform the introduction of oral PrEP among African women. Madlolo continued her advocacy too, seizing opportunities to talk openly about PrEP and why it makes sense for her and others.

“I take PrEP because I cannot put the keys to my own health in someone else’s pocket – I want young women and men everywhere to realize that they have to take control of their health,” she said.

For her courageous and inspiring voice and her commitment to participate in these HIV prevention studies, Madlolo was awarded the 2018 Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy.

A group of HIV prevention advocacy organizations—African Microbicides Advocacy Group, AVAC, IRMA, Journalists Against AIDS and NHVMAS—gives the award, established in 2008, in memory of Nigerian activist Omololu Falobi, a talented journalist, social justice activist, and advocate for prevention research. Falobi put a spotlight on the importance of Africans taking ownership of their own HIV care and prevention. This was the first time the Committee sought nominations of young people who were study participants and/or early adopters of new prevention interventions and who used that experience to advocate for prevention rollout and inclusion of other voices.

In nominating Madlolo, Professor Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute (Wits RHI), which sponsored EMPOWER and POWER said, “She’s a real powerhouse, and truly the present and future of women’s HIV prevention advocacy. Gcobisa grabs every opportunity to share her PrEP journey, the importance of support, how she is able to adhere to PrEP and how going on PrEP was a life-changing decision for her.”

For young women to consider and ultimately embrace strategies for HIV prevention the role of women like Madlolo, who stands at once as peer, role model, leader and advocate, is indispensable. Madlolo told an audience at the awards ceremony at the Research for HIV Prevention conference in Madrid in October that she too understands how important her voice can be.

“This recognition means that I must go out there even more, more especially to the communities where young women have very limited resources to share, and inspire and encourage them to make the right health choices. I am more determined than ever to be the face of PrEP. I want to go out there to every village, every town, every city and talk to other young people about the importance of protecting themselves.” she said.

Manju Chatani-Gada, Director of Partnerships & Capacity Strengthening at AVAC said, “Omololu was a visionary leader, journalist and HIV prevention activist, who accomplished much in his too-short life. He dedicated himself to HIV prevention research advocacy in Nigeria, Africa and worldwide and to championing the voices of civil society. Omololu would be so proud that the award is celebrating the contributions of trial participants and he’d be even prouder of Gcobisa and her fierce advocacy on behalf of herself and other young women.”

The world needs many thousands of women like Madlolo to widen the road toward prevention….and they are beginning to make themselves known, for which we should all be grateful. Among them, the award committee honored two other women who participated in studies and used that experience to inspire others:

  • Ruth Nahurira, a former participant in the ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) trial and the HOPE (HIV Open Label Prevention Extension), two studies of the dapivirine vaginal ring. Ruth has used her personal story and experience to help sensitize communities – those close to her home in Kampala, Uganda and even globally – about the importance of HIV prevention research, particularly for women. Within the trials themselves, she mentored other study participants, encouraging them to use their assigned rings and to comply with study procedures.

Ruth Nahurira

  • Mercy Mutonyi Wafula is a passionate advocate and one of the earliest adopters of oral PrEP in Kenya. Mercy has been part of the PrEP journey from trial phase to someone who has chosen PrEP as her intervention of choice for HIV prevention. Her work with sex workers earned her an opportunity to not only work as a lead PrEP Ambassador, but also as a co-investigator of a PrEP demonstration project. She is also the coordinator of a DREAMS Innovations Challenge project at the Bar Hostess Empowerment & Support Programme (BHESP) that is focusing on creating awareness and demand for PrEP among sex workers in Nairobi.

Mercy Wafula

Since 2008, the Omololu Falobi award has been presented as an ongoing legacy that recognizes his commitment and lasting contributions to HIV prevention research advocacy and honors those who follow in his footsteps. Madlolo received support to attend HIV R4P along with a cash award to help advance her advocacy work for prevention options for young people. The runners up also received a cash award.
Profiles of Madlolo and the two runners up as well as more information about the award, Falobi, and previous recipients are online at Click to watch the presentation ceremony at the HIV Research for Prevention Conference.