Stakeholder Engagement in HIV Cure Research: Lessons Learned from Other HIV Interventions and the Way Forward

Abstract

Clinical and basic science advances have raised considerable hope for achieving an HIV cure by accelerating research. This research is dominated primarily by issues about the nature and design of current and future clinical trials. Stakeholder engagement for HIV cure remains in its early stages. Our analysis examines timing and mechanisms of historical stakeholder engagement in other HIV research areas for HIV-uninfected individuals [vaccine development and pre-exposure prophylaxis (PrEP)], and HIV-infected individuals (treatment as prevention, prevention of mother-to-child transmission, and treatment of acute HIV infection) and articulate a plan for HIV cure stakeholder engagement. The experience from HIV vaccine development shows that early engagement of stakeholders helped manage expectations, mitigating the failure of several vaccine trials, while paving the way for subsequent trials. The relatively late engagement of HIV stakeholders in PrEP research may partly explain some of the implementation challenges. The treatment-related stakeholder engagement was strong and community-led from the onset and helped translation from research to implementation. We outline five steps to initiate and sustain stakeholder engagement in HIV cure research and conclude that stakeholder engagement represents a key investment in which stakeholders mutually agree to share knowledge, benefits, and risk of failure. Effective stakeholder engagement prevents misconceptions. As HIV cure research advances from early trials involving subjects with generally favorable prognosis to studies involving greater risk and uncertainty, success may depend on early and deliberate engagement of stakeholders.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…The extent to which stakeholders are engaged is shaped not only by the clinical trial team, but also by the structural contexts within which clinical trial research is embedded. As noted by others [15], it is important to consider how funders and corporate interests influence stakeholder engagement. For example, the funding of many HIV trials by high-income countries may inadvertently assert norms and activities (e.g.…”

“…Although the importance of stakeholder engagement for HIV clinical trials is widely recognized, little is known about how engagement strategies are being implemented in this field. Existing literature is limited to examining the historical development of stakeholder engagement [15], exploring single sites of stakeholder engagement [16] and reviewing implementation challenges [17]. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to GPP benchmarks.…”

International AIDS Society global scientific strategy: towards an HIV cure 2016

“…The history of HIV intervention research shows how early stakeholder engagement along multiple levels can help increase the likelihood of success and mitigate failure 106 . However, there are many key research areas that require further investigation, including the following: better and more standardized tools for measuring stakeholder engagement and its downstream effects (e.g., changes in retention rates and recruitment pace in cure research projects); optimal timing and substance of HIV community and non-community stakeholder engagement, including investigation of the role of community advisory boards in representing the community research interests; ensuring affordability of community engagement strategies, especially in resource-constrained contexts.…”

Ethics and hepatitis B cure research

“…Meaningful engagement includes developing relationships with community members and involving them in the entire life-cycle of the research effort from planning to implementation to reporting of results. Such a process of engagement, which is now a familiar part of research in many settings including HIV-related research and research concerning genetic conditions, can help to make sure the research is relevant to the community as well as identify locally appropriate ways of overcoming barriers related to stigma during the research process 19 20…”