Evaluating Support Strategies to Improve Continuation of Injectable and Oral HIV Prevention Treatments in Malawi

What this Trial Is About

Researchers are evaluating a package of strategies to help people continue using pre-exposure prophylaxis PrEP for HIV prevention, focusing especially on long-acting injectable cabotegravir CAB LA. This study compares standard care with an enhanced support program across various clinics and community centers serving prioritized groups such as female sex workers, men who have sex with men, transgender individuals, and others at high risk. The goal is to see which approach better supports ongoing use of PrEP over time. Participants in the study will be part of clusters randomized to either receive the standard Ministry of Health care for PrEP continuation or an enhanced bundle of support including improved communication, peer support, and flexible clinic hours. The study uses passive enrollment from clinics and collects data on PrEP initiation, switching between oral and injectable forms, and continuation rates. Additional research includes surveys, interviews, and fidelity assessments to understand the acceptability and implementation of these strategies. Participants will be followed for at least five months after starting PrEP, with data collected through program records and additional research activities. Researchers will measure continuation of CAB LA PrEP use at five months as the main outcome, along with continuation of oral PrEP and other secondary measures. The study includes interviews to capture participant experiences and uses both quantitative and qualitative methods to analyze findings. Follow-up data will span from five to eleven months depending on enrollment timing.

PathToScale: The PERSIST Trial