Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi

UNCPM 22323 - Supporting Oral Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi: a Pilot Study

Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about PrEP use during pregnancy and breastfeeding.

Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. 100 HIV-negative pregnant women will be recruited to participate in the pilot study. A subset of these participants will participate in qualitative interviews. Up to 20 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews.

Procedures (methods): 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 Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Behavioral: My Choice for HIV Prevention (MyChoice)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Central Region
    • Lilongwe, Central Region, Malawi
      • Bwaila Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The criteria for pregnant women participants is as follows:

Inclusion Criteria:

• Age 18 or older
• Documented pregnancy by urine pregnancy test or physical exam
• Documented negative HIV status within the past three months
• Identified factor(s) for elevated risk for HIV acquisition per PrEP national eligibility guidelines
• Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
• Ability and willingness to provide informed consent

Exclusion Criteria:

• Positive HIV test at time of screening
• No identified HIV risk factors per national PrEP guidelines
• Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel

Investigators will also conduct interviews with male partners and study staff to assess exploratory qualitative outcomes. All study staff will be eligible to participate in an interview. Male partners will be eligible to participate if they meet the following criteria:

• Referred by a study participant as her romantic partner
• Age 18 or older
• Able and willing to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My Choice for HIV Prevention (MyChoice); The MyChoice intervention consists of PrEP shared decision-making counseling delivered by a trained counselor. It begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. Next, the counselor presents HIV prevention options including 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).	Behavioral: Behavioral: My Choice for HIV Prevention (MyChoice); My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP
Active Comparator: Standard of care (control arm); Participants randomized to the control arm will receive 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. Control arm participants will receive comprehensive education on both the advantages and limitations of oral PrEP, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using PrEP.	Behavioral: Behavioral: My Choice for HIV Prevention (MyChoice); My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP
No Intervention: Male Partner In-Depth Interviews; Male partners of a subset of women enrolled in the study completed qualitative in-depth interviews. Each male partner completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their involvement in the woman's PrEP decision making, attitudes towards women's use of PrEP, role supporting women's use of PrEP, and impact of women's use of PrEP on their use of antiretroviral therapy (if applicable).
No Intervention: Clinician and Counselor In-Depth Interviews; Study staff including intervention counselors and clinicians completed qualitative in-depth interviews. Each staff member completed a single in-depth interview conducted by a trained interviewer using a semi-structured interview guide including topics related to their impressions of the study counseling, perceptions of participants' decision making regarding PrEP use, opinions regarding future implementation of the study intervention, and experiences with study procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Acceptability of Intervention (AIM) Scale Score	Intervention acceptability was defined as the extent to which participants perceived the intervention to be agreeable, palatable, or satisfactory. Acceptability was assessed through participant self-report using a validated 4-item scale (AIM). This scale measures how agreeable and satisfactory women find the intervention (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 5="Completely Agree"). For each participant at each timepoint, a mean AIM scale score was calculated ranging from 1 to 5. Higher scores indicate greater acceptability. Individuals' mean AIM scale scores were averaged at each timepoint, and a 95% confidence interval around the mean of means was calculated using the common standard error.	enrollment visit (month 0), month 2 follow up visit
Mean Intervention Appropriateness Measure (IAM) Scale Score	Intervention appropriateness was defined as the perceived relevance and usefulness of the intervention to support decision making about HIV prevention methods. Appropriateness was assessed through self-report using a validated 4-item scale (IAM) to measure women's perceptions of its relevance and usefulness (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 5="Completely Agree"). For each participant at each timepoint, a mean IAM scale score was calculated ranging from 1 to 5. Higher scores indicate greater appropriateness. Individuals' mean IAM scale scores were averaged at each timepoint, and a 95% confidence interval around the mean of means was calculated using the common standard error.	enrollment visit (month 0), month 2 follow up visit
Mean Feasibility Intervention Measure (FIM) Scale Score	Intervention feasibility was defined as extent to which the intervention is perceived to be feasible or practical. Feasibility was assessed through self-report using a validated 4-item scale (FIM) to measure women's perceptions of its practicability and ease of use (responses rated on a 5-point Likert scale ranging from 1="Completely Disagree" to 1="Completely Agree"). For each participant at month 0, a mean FIM scale score was calculated ranging from 1 to 5. Higher scores indicate greater feasibility. Individuals' mean FIM scale scores were averaged, and a 95% confidence interval around the mean of means was calculated using the common standard error.	enrollment visit (month 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Decisional Conflict Scale (DCS) Score	A validated scale (DCS) was utilized to assess participants' perceptions decisional conflict regarding the decision whether to use PrEP following receipt of MyChoice or SOC counseling. The 16 items in the scale assess these perceptions by asking participants to rate statements regarding their perceived level of uncertainty, satisfaction, clarity of personal values, and support for decision-making. Responses are rated on a 5-point Likert scale ranging from 0="Strongly agree" to 4="Strongly Disagree". DCS scores range from 0 to 100 points (mean item rating multiplied by 25), with higher scores indicating a higher level of decisional conflict. At month 0 after the intervention, individuals' mean DCS scores were averaged, and a 95% confidence interval around the mean of means was calculated using the common standard error. Only participants that had one or more completed items of the DCS were included.	enrollment visit (month 0)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Lauren Hill, PhD, MSPH, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Saidi F, Welch S, Phanga T, Sulpizio C, Paile L, Ngo'ma D, Tsidya M, Chindebvu M, Nkhoma G, Nkhalamba L, Kaliati I, Mkochi N, Chakala H, Kumwenda W, Bula A, Winner P, Munthali T, Nyamaizi A, Keys J, Maman S, Pearce L, Golin C, Chi BH, Hill LM. Supporting Oral and Long-Acting HIV Preexposure Prophylaxis Decision-Making Among Pregnant Women (MyChoice Intervention): Protocol for 2 Pilot Randomized Controlled Trials. JMIR Res Protoc. 2025 Nov 13;14:e76442. doi: 10.2196/76442.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): March 4, 2025

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PrEP in pregnancy and breastfeeding
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: 23-3102; K01MH121186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No