Study design:
This is a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 100 women will be randomized to receive either the SDM intervention addressing daily oral PrEP and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. Investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in oral PrEP will be referred to government PrEP services.
Study intervention (intervention arm):
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 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). The participant may defer or decline the decision and may request a follow-up counseling visit to take more time to consider her preference or return with a partner or other supporter. If and when a decision is made, the counselor provides post-decision counseling including adherence counseling and disclosure counseling if desired.
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.
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. Initiation of oral PrEP (i.e., receipt of prescription) will be confirmed through clinic or pharmacy records, as well as information on reasons for non-initiation if applicable.
Follow-up:
Participants will complete follow-up visits at month 1, month 2, and month 3. Study visits will be scheduled to align with antenatal care (ANC)/pharmacy visits whenever possible to minimize the number of trips needed at the clinic.
Interviewer-administered questionnaires will be completed at the month 1 and month 3 follow-up visits. 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).
At each follow-up visit, women who have chosen oral PrEP will undergo adherence assessment through self-report and pill counts. Furthermore, investigators will collect dried blood spots (DBS) at month 2 to assess adherence among all oral PrEP users (see below).
Biological specimen collection and testing:
To assess quantify drug concentrations to assess PrEP adherence among participants taking up oral PrEP, a participant blood specimen will be collected via venipuncture at the for applicable participants (those using oral PrEP). This specimen will be used to create a dried blood spot (DBS) specimen at the local designated laboratory, prior to storage and shipment to the reference pharmacology laboratory for testing.
All samples will be obtained from study participants by trained study staff according to approved standard operating procedures. All samples will be processed according to the assay manufacturers' specifications. Specimens will be transported, processed, and temporarily housed at UNC Project Malawi (UNCPM) (Lilongwe, Malawi) and shipped to University of North Carolina (UNC) Chapel Hill for analysis. All laboratory testing will be performed by trained staff using standard operating procedures and according to specific assay manufacturers' specifications.
