Reducing psychological barriers to PrEP use during pregnancy and postpartum in Cape Town

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional project develops and tests the feasibility and acceptability of a brief cognitive-behavioral therapy (CBT)-based intervention delivered alongside enhanced usual care to address depression and posttraumatic stress among pregnant and postpartum women. Participants are HIV-negative pregnant women (age 15+) who recently started PrEP or have documented adherence challenges and screen positive for moderate-to-severe PTSD and/or depression. The intervention is delivered at the Gugulethu Midwife Obstetric Unit in collaboration with Boston University and the University of Cape Town, with outcomes focused on PrEP adherence and persistence during pregnancy and the postpartum transition. The study compares the CBT intervention to enhanced treatment-as-usual and examines mechanisms linking mental health symptoms to PrEP adherence.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gugulethu Midwife Obstetric Unit (MOU)
  Cape Town, Western Cape, South Africa Recruiting
• Boston University
  Boston, Massachusetts, United States Not yet recruiting

Study contacts

• Principal investigator: Amelia Stanton, PhD — Boston University
• Study coordinator: Amelia M Stanton, PhD
• Email: stantona@bu.edu
• Phone: 617-353-2580

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.