In early 2021, as COVID-19 pandemic lockdowns and restrictions disrupted public life around the globe, MHRP faced the challenge of safely and ethically enrolling more than 100 participants in a new HIV vaccine adjuvant study in Kericho, Kenya.
Thanks to an experienced community engagement team and an engaged community advisory board, the study achieved full enrollment in just eight months despite ongoing COVID challenges.
The study, RV460, is a Phase 1 vaccine trial to evaluate experimental prime/boost HIV-1 vaccine regimens formulated with combinations of different adjuvants, including one from the Army Liposome Formulation (ALF) family of adjuvants developed by scientists with the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research. RV460 is led by MHRP scientists in partnership with the Kenya Medical Research Institute/Walter Reed Project (WRP) Clinical Research Center in Kericho.
The Kericho site has previously conducted three HIV vaccine trials and belongs to a number of clinical trial networks: the AIDS Clinical Trials Group (ACTG), the HIV Vaccine Trials Network (HVTN) and, most recently, the COVID-19 Prevention Network (CoVPN). Thanks to this large portfolio of clinical research, the WRP community engagement team has built a stellar reputation among the local community and enrolled thousands of participants into previous trials over the years, but the COVID pandemic introduced unprecedented hurdles to the recruitment process.
According to Charles Kilel, WRP’s research community engagement officer, COVID restrictions hampered early mobilization efforts. “Non-essential workers were required to work from home, which slowed down clinic activities,” he said. As restrictions were eased and recruitment efforts began to ramp up, the community engagement team had to adapt their usual messaging and meeting practices to reach potential participants and ensure safety.
“We were holding engagement meetings outdoors, strictly observing social distancing, always carried sanitizers and masks,” said Kilel. “We also invited a limited number of potential participants for screening. This gave people confidence to attend our meetings."
COVID prevention measures also helped the recruiting process because it demonstrated to potential participants that their health and safety is top priority for researchers, a perception that can impact feelings about participating in the trial. Kilel also attributes the success of their recruitment efforts to, “proper messaging and dispelling myths about HIV and the safety of the investigation product (vaccines).”
To maximize the efficiency of a recruitment process already delayed by COVID, the community engagement team relied on a close collaboration with a community advisory board to help them more quickly identify and introduce potential participants. The board is made up of trusted community stakeholders from local civil society groups and sometimes includes representatives of vulnerable key populations.
“COVID was disruptive to HIV vaccine trial implementation,” said MHRP Director COL Julie Ake. “The efforts of the WRP community engagement team and the dedication of the RV460 volunteers were critical to ensuring this HIV vaccine research could continue despite the emergence of a new pandemic.”