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

RecruitingNAAges 15 Years - anyFemaleBoston University Charles River Campus
NCT05624931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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, 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. 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 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.
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What it tests

  • Brief CBT-Based Intervention
  • Enhanced Treatment as Usual
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Where

2 sites
Boston University
Boston, United States
Gugulethu Midwife Obstetric Unit (MOU)
Cape Town, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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