JMIR Publications

ABSTRACT

Background:

HIV pre-exposure prophylaxis (PrEP) has potential for preventing HIV during the perinatal period, but few strategies promote person-centred 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.

Objective:

These pilot studies will assess the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to pregnant and breastfeeding women in making informed HIV prevention choices. The intervention will also explore the intervention perspectives of both participants, their male partners and implementers. Each study compares the MyChoice intervention to standard-of-care PrEP counselling, with different HIV prevention method choices available.

Methods:

We will conduct two randomized pilot 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 counselling. In Study 1, 100 participants will be offered oral PrEP and condoms for 3 months. In Study 2, 50 participants will be offered oral PrEP or injectable CAB-LA, and condoms for 2 months.

Results:

Data collection started 30 July 2024 for Study 1 and 10 February 2025 for Study 2. To date, data collection is ongoing.

Conclusions:

The 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. Clinical Trial: NCT06394323 and NCT0639769