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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Enrollment target: 108 to 118v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints: 3 to 2
    • Start date changed from estimate of Feb 28, 2025 to Apr 17, 2025
    • Site details revised at 2 of 2 sites
    v5
  4. Notable Start date: Jul 1, 2023 to Feb 28, 2025v4 Show 4 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Feb 2027 to Feb 28, 2027
    • Study completion date: Feb 2027 to Jul 30, 2027
    • Site details revised at 2 of 2 sites
  5. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Feb 1, 2023 to Jul 1, 2023
    • Primary and study completion dates: Nov 2026 to Feb 2027
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2
  6. Notable Start date: Dec 1, 2022 to Feb 1, 2023v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05624931
Lead Sponsor Boston University Charles River Campus
Collaborators: University of Cape Town, National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Depression, Posttraumatic Stress Disorder, Pregnancy Related, Medication Adherence
Related terms Depression, Medication Adherence, Stress Disorders, Post-Traumatic
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov