Actively Recruiting

Phase Not Applicable
Age: 15Years +
FEMALE
Healthy Volunteers
NCT05624931

Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Led by Boston University Charles River Campus · Updated on 2025-06-24

108

Participants Needed

2

Research Sites

119 weeks

Total Duration

On this page

Sponsors

B

Boston University Charles River Campus

Lead Sponsor

U

University of Cape Town

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pregnant women in South Africa (SA) are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) use during pregnancy is both safe and effective in preventing HIV. However, posttraumatic stress (associated with intimate partner violence and/or other traumas) and depression negatively impact PrEP adherence among women in SA. Addressing posttraumatic stress and depression will likely improve PrEP adherence and persistence (i.e., sustained PrEP adherence over time) during pregnancy and breastfeeding, which are periods of dramatically increased HIV risk. The overarching goal of this proposal is to develop and test the feasibility and acceptability of a cognitive behavioral intervention that targets common underlying factors of posttraumatic stress and depression to improve PrEP adherence and persistence during pregnancy and the postpartum transition. The specific aims of the project are to (1) explore the mechanisms by which posttraumatic stress and depression impact PrEP adherence and persistence during pregnancy via qualitative interviews; (2) develop a brief PrEP adherence and persistence intervention (\~4 sessions) that reduces the negative impact of psychological mechanisms common to posttraumatic stress and depression on PrEP use, and builds behavioral skills to improve self-care; and (3) evaluate the feasibility, acceptability, and signals of preliminary efficacy of the intervention, which will be integrated into antenatal care, in a pilot randomized controlled trial. All data will be collected in the Midwife Obstetrics Unit (MOU) in Gugulethu, a peri-urban settlement and former township community outside of Cape Town, SA.

CONDITIONS

Official Title

Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Who Can Participate

Age: 15Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Age 15 years or older
  • Pregnant and receiving antenatal care at the Gugulethu Midwife Obstetrics Unit
  • HIV-negative
  • Recently started PrEP (less than 1 month ago) or having challenges adhering to PrEP (more than 2 weeks late for refill or self-reported)
  • Moderate to severe symptoms of posttraumatic stress and/or depression based on specific symptom scores (PTSD Checklist for DSM-5 score of 31 or higher and/or Edinburgh Postnatal Depression Scale score of 13 or higher)
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent or assent in English or Xhosa
  • Having a significant psychiatric illness such as active psychotic disorder or untreated bipolar disorder that interferes with participation
  • Experiencing positive symptoms of psychosis or mania (delusions, hallucinations, disorganized or pressured speech, flight of ideas, grandiosity)
  • Having health conditions that make it difficult to travel to the clinic

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Boston University

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

2

Gugulethu Midwife Obstetric Unit (MOU)

Cape Town, Western Cape, South Africa, 8001

Actively Recruiting

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Research Team

A

Amelia M Stanton, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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