Disseminating complex primary outcome results from a community-randomised trial to Zambian communities: lessons learned using a community dialogue approach in the HPTN 071 (PopART) trial.

The HPTN 071 (PopART) trial of universal HIV testing and treatment to reduce HIV incidence was conducted in nine communities in South Africa and 12 in Zambia. The trial's primary outcome results were complicated to explain. Dissemination of these complicated results in participating communities in Zambia was done using a community dialogue approach.

Standardized metrics can reveal region-specific opportunities in community engagement to aid recruitment in HIV prevention trials.

Good Participatory Practice (GPP) guidelines support and direct community engagement practices in biomedical HIV prevention trials, however no standardized metrics define the implementation and evaluation of these practices. Collaboratively, the Community Program staff of the HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) created a metric to describe, monitor, and evaluate one component of GPP, recruitment practices, in two HIV monoclonal Antibody Mediated Prevention (AMP) clinical trials, HVTN 703/HPTN 081 and HVTN 704/HPTN 085. Through consultation with community representatives from each clinical research site (hereafter "site(s)"), who made up the study Community Working Groups, recruitment strategy descriptors were developed for both trials to characterize responses to "How did you hear about the AMP study?" The Community Working Groups also helped to define and establish time points that were selected to allow comparisons across sites.

Implementing Community Engagement for Combination Prevention: Lessons Learnt From the First Year of the HPTN 071 (PopART) Community-Randomized Study.

Key to the success of a HIV combination prevention strategy, including galvanizing the current push to roll out universal test and treat (UTT), is the involvement and buy-in of the populations that the strategy aims to reach. Drawing on the experiences of engaging with 21 communities in Zambia and South Africa in the design and implementation of a community-randomized study of combination HIV prevention including UTT, this paper reflects on the commitment to, approaches for and benefits of involving communities. Key lessons learnt include that all communities require continuous community engagement (CE) and engagement needs to be adapted to diverse local contexts.

Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women.

Background: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.

Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

Background: Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit.