MedTrace Logo

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

NCT06397690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

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

BEHAVIORAL

Standard of care (control arm)

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    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
2025-02-10
Primary Completion
2025-07-16
Completion
2025-07-16

Countries

  • Malawi

Study Locations

More Related Trials

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 NCT06397690 on ClinicalTrials.gov