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

NCT06394323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-02-02

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Lauren Hill, PhD, MSPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2025-02-07
Completion
2025-03-04

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06394323 on ClinicalTrials.gov