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

Last updated: June 21, 2024
Sponsor: Boston University Charles River Campus
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Depression

Post-traumatic Stress Disorders

Treatment

Brief CBT-Based Intervention

Enhanced Treatment as Usual

Clinical Study ID

NCT05624931
6783E
K23MH131438
  • Ages > 15
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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, eitherdocumented (>2 weeks late to pick up PrEP refill) or self-reported

  • Moderate to severe symptoms of posttraumatic stress and/or depression (definedas a score of ≥31 on PTSD Checklist for DSM-5 (PCL-5) and/or a score of ≥13 onthe Edinburgh Postnatal Depression Scale (EPDS). Cutoff scores may be adjustedby 3-5 points to facilitate recruitment.

Exclusion

Exclusion Criteria:

  • There are no exclusion criteria with respect to parity or gravidity.

  • Participants who are unable to provide informed consent or assent in English orXhosa

  • Have a significant psychiatric illness (e.g., active psychotic disorder oruntreated bipolar disorder) that could interfere with participation will beexcluded. Positive symptoms of active psychosis or mania will be assessed bythe research assistants. They will be trained to identify delusions,hallucinations, disorganized or pressured speech, flight of ideas, andgrandiosity as they speak to potential participants.

  • Potential participants will also be asked if they have any health conditionsthat make it difficult for them to travel to the clinic.

Study Design

Total Participants: 108
Treatment Group(s): 2
Primary Treatment: Brief CBT-Based Intervention
Phase:
Study Start date:
February 28, 2025
Estimated Completion Date:
July 30, 2027

Connect with a study center

  • Gugulethu Midwife Obstetric Unit (MOU)

    Cape Town, Western Cape 8001
    South Africa

    Site Not Available

  • Boston University

    Boston, Massachusetts 02215
    United States

    Site Not Available

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