Devising an integrated and creative response to support participant retention in a global biomedical HIV prevention study during the COVID-19 pandemic


BACKGROUND: The COVID-19 pandemic dramatically altered clinical research sites (CRS) approaches to participant follow-up and retention in Microbicide Trials Network (MTN) 035 ' a global open-label crossover study evaluating three placebo products (douche, suppository and fast-dissolving insert) as potential methods for delivery of a rectal biomedical HIV prevention product. Evolving local and national guidelines restricting travel, large gatherings, and nonessential services prompted rapid development of contingency plans to sustain participant follow-up, as well as innovative measures by CRSs to meet these challenges while ensuring participant and staff safety.
METHODS: MTN-035 is being conducted among transgender people and cisgender men who have sex with men (MSM) from communities in Malawi, Peru, South Africa, Thailand and the United States. Enrollment lasted 12 months (April 2019 to March 2020) and participants were followed for 3.5 months. MTN-035 protocol and communication teams developed guidance and key messages for CRSs to support optimal operation during the COVID-19 pandemic. MTN-035 CRSs implemented culturally appropriate site-specific multipronged approaches to decrease the risk of COVID-19 transmission to study participants and staff, and to support study retention.
RESULTS: CRSs adapted various engagement strategies tailored to the local context. In-person study visits were converted to telehealth study visits (computer assisted self-interviews, in-depth interviews, SMS communication, counseling). Transportation in CRS vans sanitized daily was provided for participant study visits. COVID-19 exposure/symptoms screening prior to entering the van or clinic and protective personal equipment (face masks, gloves and hand sanitizer) was provided. Social distancing strategies implemented included operating reduced or adaptive clinic hours, limiting the number of people permitted inside CRSs and offering curbside pick-up or postal delivery of study product. Social and traditional media were utilized to inform participants, key stakeholders, and the broader community of safety modifications and distribute COVID-19 prevention messages. Resulting retention rates were '¥85% weeks 4, 9, and 14.
CONCLUSIONS: Development of rapid response contingency plans and 'out-of-the-box' strategies during a pandemic is an important first step to ensuring participant and staff safety. Providing guidance on study procedures modification and key messages for participants to CRSs while allowing for site-specific culturally appropriate responses can support participant retention and strengthen participant rapport.