Background: Engagement of community stakeholders is essential to the facilitation of community awareness, understanding, and support for research from conceptualization through retention. Recognizing the stigma surrounding HIV and misconceptions about research, ongoing community engagement is especially important for studies of novel biomedical HIV prevention products.
In 2015, the HIV Vaccine Trials Network (HVTN) partnered with the HIV Prevention Trials Network (HPTN) to launch the AMP trials among heterosexual women in sub-Saharan Africa (HVTN 703/HPTN 081) and cisgender men and transgender persons who have sex with men in North and South America and Switzerland (HVTN 704/HPTN 085). These are the first efficacy trials of a broadly neutralizing antibody (bnAb) for HIV prevention. Recruitment began in April (HVTN 704/HPTN 085) and May (HVTN 703/HPTN 081) of 2016. Recruitment and retention were considered major potential barriers for these ongoing trials, which require 2 years of monthly visits and 10 intravenous infusions per participant.
Methods: Community engagement training and implementation began 6 months prior to opening. A series of stakeholder engagement consultations were held to facilitate information exchange and encourage dialogue with in-country ethics, advocacy, spiritual, healthcare and research representatives. A Community-Based Participatory Research approach was utilized to develop and disseminate a set of four educational videos explaining the studies, bnAb science, and trial participation. Print materials and a website were created for each geographic region to educate and direct potential participants to local study sites. Retention workshops and ongoing communication with the studies'' Community Working Groups maintain attention on retention.
Results: Full study enrollment exceeded projected rates. Recruitment was efficient, with a screening-to-enrollment ratio of roughly 2.8:1 in the Americas and Switzerland and 2.4:1 in Africa at selected timepoints. As of January 16, 2019, retention in the AMP studies is 96% in HVTN 703/HPTN 081, 95% in HVTN 704/PHTN 085; early termination is 8% overall. There was tremendous community enthusiasm regarding the overall bnAb concept for HIV prevention.
Conclusions: Community engagement is critical for ethical trial conduct and must be employed in its entirety (education, recruitment and retention). Early and consistent integration throughout the clinical trial process contributes to improved screening, substantial recruitment, and strong retention.