Supporting Oral and Long-acting PrEP Decision Making Among Pregnant Women in Lilongwe, Malawi

Study design:

Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, CAB-LA, and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.

Study intervention:

The study intervention, My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP. The intervention counseling will be delivered by trained study staff with a background in psychosocial counseling. The intervention consists of counseling facilitated by a SDM tool. The woman's partner may be present depending on her preference. It begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. After understanding participant HIV risk and desire for HIV protection, the counselor presents HIV prevention options including CAB-LA, daily oral PrEP, and internal and external condoms (discussing attributes and potential advantages and disadvantages of each method). This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant (product attributes and personal and interpersonal implications of each method). The counselor reviews information about these valued features for each offered method. This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred method(s).

Standard of care (control arm):

Participants randomized to the control arm will PrEP counseling as based on the current standard of care (SOC) . The SOC counseling will be delivered by a trained study staff member. The SOC counselor PrEP counseling according to national guidelines. Per current guidelines, the SOC counseling may include the following elements: An HIV risk assessment according to PrEP eligibility criteria; discussion of a combination prevention approach (PrEP and condoms) and risk reduction strategies. The women will receive comprehensive education on both the advantages and limitations of PrEP, including guidance on managing potential side effects. Subsequently, the counselor will assess the woman's eligibility, willingness, and readiness to start using PrEP. Women choosing oral PrEP during the SOC counseling session will be referred to government services to initiate PrEP. Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program.

Participants will be randomly assigned 1:1 to one of two study arms (intervention or comparison) using permuted block randomization. Participants will be blinded to their assignment, but study staff will not.

Participants choosing oral PrEP during the counselling session in either intervention or comparison arm will receive an assisted referral to government PrEP services at the study site to initiate their selected PrEP method per national guidelines. Participants choosing CAB-LA will initiate CAB-LA through the ongoing national pilot program. No study drug will be administered. Initiation of either PrEP method (i.e., receipt of prescription or injection) will be confirmed through clinic or pharmacy records, as well as information on reasons for non-initiation if applicable.

Investigators plan study follow-up visits at month 1 and month 2 following enrollment. Interviewer-administered questionnaires will be completed at the month 1 follow-up and the final follow-up visit (month 2). Questionnaires will assess study outcomes and associated social and behavioural measures to contextualize understanding of primary study outcomes. A subset of participants will complete in-depth qualitative interviews at month 1. Interviews will provide additional understanding of participant experiences with the intervention and experience using PrEP (if applicable).