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

NCT06394323 | Completed Results

• 2 other identifiers: 23-3102K01MH121186
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Prevention

Keywords

PrEP in pregnancy and breastfeeding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mean Decisional Conflict Scale (DCS) Score

  enrollment visit (month 0)

Study Arms (4)

My Choice for HIV Prevention (MyChoice)

EXPERIMENTAL

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)

Standard of care (control arm)

ACTIVE COMPARATOR

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)

Male Partner In-Depth Interviews

NO INTERVENTION

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).

Clinician and Counselor In-Depth Interviews

NO INTERVENTION

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.

Interventions

Behavioral: My Choice for HIV Prevention (MyChoice) BEHAVIORAL

My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP

My Choice for HIV Prevention (MyChoice); Standard of care (control arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Bwaila Hospital

Lilongwe, Central Region, Malawi

Location

Related Publications (1)

• 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.

  PMID: 41232107 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Lauren Hill, PhD
• Organization: University of North Carolina at Chapel Hill

hilllm@ad.unc.edu

919-966-5771

Study Officials

• Lauren Hill, PhD, MSPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: August 6, 2024
• Primary Completion: February 7, 2025
• Study Completion: March 4, 2025
• Last Updated: February 2, 2026
• Results First Posted: December 24, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (1)