Design
The CHARISMA trial was a two-arm, randomized (1:1), controlled study of a behavioral intervention—CHARISMA—to reduce social harms (SHs) and intimate partner violence (IPV), increase healthy relationship dynamics, and improve oral PrEP adherence (ClinicalTrials.gov registration id: NCT04092114). The trial enrolled 407 women from a densely populated urban neighborhood in Johannesburg, South Africa who had to be ages 18–45, HIV-negative and interested in using PrEP for HIV prevention, have a current sexual partner, be sexually active, and have no previous history of participating in clinical trials or longitudinal studies on HIV prevention to be eligible for trial enrollment. Enrollment occurred from October 2018- October 2019. Participants were dispensed with oral PrEP and followed for a period of six-months. Study visits included screening, enrollment, and months 1, 3, and 6 of follow-up. At months 3 and 6, behavioral questionnaires were administered where participants were asked about sexual relationships and behavior, and experience of violence. Dried blood spots (DBS) were collected at each timepoint to assess PrEP adherence and analyzed following the study as part of the primary study outcomes [