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NCT05624931 · ClinicalTrials.gov registry record · NA
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
A NA study of Depression and Posttraumatic Stress Disorder, sponsored by Boston University Charles River Campus.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 2
- Study locations
NCT05624931 is a NA study of Depression and Posttraumatic Stress Disorder that is actively recruiting participants, run by Boston University Charles River Campus. The registered enrollment target is 108 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05624931, a NA study of Depression and Posttraumatic Stress Disorder, is actively recruiting participants, sponsored by Boston University Charles River Campus.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 Studied
Interventions
- BEHAVIORAL Brief CBT-Based Intervention
- OTHER Enhanced Treatment as Usual
Study Locations (2)
Massachusetts
- Boston University - Boston
Western Cape
- Gugulethu Midwife Obstetric Unit (MOU) - Cape Town
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2027-07-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05624931
The ClinicalTrials.gov registry entry for NCT05624931 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (86% lower). The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Brief CBT-Based Intervention is the first listed.
NCT05624931 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Western Cape.
Frequently Asked Questions
What is clinical trial NCT05624931 about?
NCT05624931 is a clinical study titled "Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa". 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 ...
What is the current status of trial NCT05624931?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2025-04-17. Estimated completion is 2027-07-30.
What conditions does trial NCT05624931 study?
This clinical trial studies the following conditions: Depression, Posttraumatic Stress Disorder, Pregnancy Related, Medication Adherence.
What interventions are being tested in trial NCT05624931?
The interventions under investigation include: Brief CBT-Based Intervention (BEHAVIORAL), Enhanced Treatment as Usual (OTHER).
Who is sponsoring clinical trial NCT05624931?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624931 being conducted?
This trial has 2 study locations across Massachusetts, Western Cape. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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