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NCT05624931
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
NA trial testing Brief CBT-Based Intervention in Depression in 108 participants. Currently enrolling.
28 February 2027
Quick facts
| Lead sponsor | Boston University Charles River Campus |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 108 |
| Start date | 17 April 2025 |
| Primary completion | 28 February 2027 |
| Estimated completion | 30 July 2027 |
| Sites | 2 locations across South Africa, United States |
Drugs / interventions tested
- Brief CBT-Based Intervention
- Enhanced Treatment as Usual
Conditions studied
- Depression — all drugs for Depression →
- Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
- Pregnancy Related — all drugs for Pregnancy Related →
- Medication Adherence — all drugs for Medication Adherence →
Sponsor
Boston University Charles River Campus
Who can join
15 and older, female only, with Depression or Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05624931
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05624931 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston University Charles River Campus
- Last refreshed: 24 June 2025
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