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

NCT06397690 | Completed

• 2 other identifiers: 24-0511P30AI050410
• Study Type: interventional
• Target: 75
• 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 Pre-exposure prophylaxis (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. The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period. Investigators will recruit 50 women to participate in the feasibility pilot study. A subset of these participants will participate in qualitative interviews. Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews. Procedures (methods): 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, Long-acting injectable cabotegravir (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.

Conditions

HIV Prevention

Keywords

PrEP in pregnancy and breastfeeding

Outcome Measures

Primary Outcomes (2)

• Acceptability of Intervention Measure Score

  Intervention acceptability will be defined as the extent to which participants perceive the intervention to be agreeable, palatable, or satisfactory. Acceptability will be assessed through participant self-report using a validated 4-item scale. This scale measures how agreeable and satisfactory women find the intervention (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate a greater acceptability.

  enrollment, final follow up visit (Month 2)

• Intervention Appropriateness Measure Score

  Intervention appropriateness will be defined as the perceived relevance and usefulness of the intervention to support decision making about HIV prevention methods. Appropriateness will be assessed through self-report using a validated 4-item scale to measure women's perceptions of its relevance and usefulness (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate a greater appropriateness.

  enrollment, final follow up visit (Month 2)

Secondary Outcomes (5)

• Mean Number of Women Screened Weekly

  At screening

• Proportion of Screened Eligible Women Enrolling in the study

  At the time of enrollment

• Proportion of Enrolled Participants Returning for Follow-Up Visits

  1-month follow-up, 2-month follow-up

• Number of Days Taken to Achieve Enrollment Targets from the Date of Enrollment Initiation

  At the time of enrollment

• Number of Days Taken to Achieve Retention Targets from the Date of the First Scheduled Follow-up Visit

  At the time of enrollment, 2-month follow-up

Study Arms (2)

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 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).

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 each PrEP method, including guidance on potential side effects. The SOC counselor will assess the woman's eligibility, willingness, and readiness to start using PrEP.

Behavioral: Standard of care (control arm)

Interventions

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) BEHAVIORAL

Standard of care (control arm) participants will receive comprehensive education on both the advantages and limitations of each PrEP method, including guidance on potential side effects.

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:

• The criteria for pregnant women participants is as follows:
• 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
• 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

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): 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

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lauren Hill, PhD,MSPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

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 19, 2024
• First Posted: May 3, 2024
• Study Start: February 10, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

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)