Utilizing standardized metrics to track recruitment strategies in a global preventive HIV vaccine study during the COVID-19 pandemic


BACKGROUND: Though Good Participatory Practice (GPP) are implemented globally, there are no standardized metrics to evaluate or refine its application. Utilizing an approach developed by the HIV Vaccine Trials(HVTN)and HIV Prevention Trials Networks (HPTN), we sought to describe, monitor, and evaluate the recruitment practices of the Mosaico study (HVTN706/HPX3002), a phase 3 HIV vaccine clinical trial conducted among cisgender men and transgender people who have sex with cisgender men and/or transgender people from communities in the United States, Latin America and Europe. Recruitment and enrollment for Mosaico occurred during evolving local and national COVID-19 mitigation efforts, which varied by country.
METHODS: Recruitment strategy descriptors were used in the study based on knowledge of site practices to characterize responses to 'How did you hear about the Mosaico Study?' These descriptors were vetted and edited by Community Working.
Groups of prior HIV prevention trials of the HVTN and HPTN and were not modified in the Mosaico study. Definitions were established and timepoints selected to allow comparisons across sites. Clinical Research Sites (CRSs)were required to develop recruitment plans and reports in REDCap, a web-based application to capture data for clinical research, using specific measurable objectives. Data were collected by48 global CRSs from June 2020 ' August 2021
RESULTS: All 47 sites utilized multiple recruitment strategies successfully. Globally, internet use resulted in the most screens (5059 of 8121, 62%) and enrollments (2404 of 3806, 63%) while in-person outreach was most efficient (screening: enrollment ratio of1.5:1in Europe and South America and 5.6:1 in the United States). In the United States, referrals were most efficient (4.8:1). In Europe and South America, referrals were also efficient (3.3:1 and 2:1respectively) whereas print materials were the least efficient recruitment strategy (24.8:1 and 5.3:1respectively).
CONCLUSIONS: While CRSs had to adapt their recruitment plans due to COVID-19, the recruitment practices were broad enough that they did not require changes. Implementing a system to monitor screening-to-enrollment ratios reveals effective use of outreach staff time and available resources. Although Internet use, such as social media advertising, was predominant due to the COVID-19 global pandemic, in person outreach was still the most efficient strategy to achieve enrollment goals.

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