Supporting Oral and Long-Acting HIV Preexposure Prophylaxis Decision-Making Among Pregnant Women (MyChoice Intervention): Protocol for 2 Pilot Randomized Controlled Trials.

backgroundHIV preexposure prophylaxis (PrEP) has potential for preventing HIV during the perinatal period, but few strategies promote person-centered shared decision-making (SDM) about PrEP use in these contexts. The MyChoice study aims to evaluate the feasibility, acceptability, and appropriateness of an SDM approach to support pregnant and breastfeeding women in Lilongwe, Malawi, integrating PrEP into antenatal care to encourage consistent use.

objectiveTwo pilot studies will assess the feasibility, acceptability, and appropriateness of an SDM intervention to support pregnant and breastfeeding women in making informed HIV prevention choices. The intervention will also explore the perspectives of participants, their male partners, and implementers. Each study compares the MyChoice intervention to standard-of-care PrEP counseling, with different HIV prevention method choices available.

methodsWe will conduct 2 pilot randomized trials to evaluate the MyChoice intervention, designed to support PrEP decision-making among pregnant women in Lilongwe. Both studies will compare the MyChoice intervention to standard-of-care PrEP counseling. Study 1 will include 100 participants who will be offered oral PrEP and condoms for 3 months. Study 2 will include 50 participants who will be offered oral PrEP or injectable long-acting cabotegravir and condoms for 2 months. The primary end points for MyChoice study 1 are intervention acceptability, intervention appropriateness, and intervention feasibility, whereas for MyChoice study 2 they are intervention acceptability and intervention appropriateness. The secondary end point for MyChoice study 1 is decisional conflict, and for MyChoice study 2, it is the feasibility of study procedures. Exploratory end points include PrEP uptake assessment and dried blood spot measurement of PrEP adherence for MyChoice study 1 and PrEP uptake assessment for MyChoice study 2.

resultsData collection started on July 30, 2024, for study 1 and on February 10, 2025, for study 2. A total of 100 participants were enrolled in MyChoice study 1, and 50 participants were enrolled in MyChoice study 2. Study follow-up has been completed. Data analysis is expected to be completed by November 2025.

conclusionsThe MyChoice pilot studies will provide critical evidence on a novel intervention for PrEP decision-making during pregnancy and breastfeeding. If feasible and acceptable, these results will form the basis for larger efficacy trials to promote PrEP uptake during pregnancy.

trial registrationClinicalTrials.gov NCT06394323; https://clinicaltrials.gov/study/NCT06394323 and ClinicalTrials.gov NCT06397690; https://www.clinicaltrials.gov/study/NCT06397690. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/76442.