NCT05624931Recruiting
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 31 Oct 2022
- Start date
- 17 Apr 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Boston University Charles River Campus
- Diseases
- HIV
- NCT number
- NCT05624931
What you commit to
- Study type: Interventional
- Planned participants: 118
- From 17 Apr 2025 to the primary completion date, 28 Feb 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 15 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston University Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| Gugulethu Midwife Obstetric Unit (MOU) Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.