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

Recruiting now · Not applicable

Conditions studied: Depression, Posttraumatic Stress Disorder, Pregnancy Related, Medication Adherence

In brief

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.

Key facts

Study ID: NCT05624931
Run by: Boston University Charles River Campus
People needed: 118
Starts: 2025-04-17
Expected to finish: 2027-07-30
Last updated by the study team: 2026-07-17

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

For participants across all three aims are:
Female sex
Aged 15+
Pregnant and presenting antenatal care at the Gugulethu MOU
HIV-negative
Recent PrEP initiation (<1 month ago) or PrEP adherence challenges, either documented (>2 weeks late to pick up PrEP refill) or self-reported
Moderate to severe symptoms of posttraumatic stress and/or depression (defined as a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 on the Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjusted by 3-5 points to facilitate recruitment.

You may not qualify if…

There are no exclusion criteria with respect to parity or gravidity.
Participants who are unable to provide informed consent or assent in English or Xhosa
Have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Positive symptoms of active psychosis or mania will be assessed by the research assistants. They will be trained to identify delusions, hallucinations, disorganized or pressured speech, flight of ideas, and grandiosity as they speak to potential participants.
Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.

Where it is running

Gugulethu Midwife Obstetric Unit (MOU) — Cape Town, Western Cape, South Africa (enrolling)
Boston University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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