Reducing psychological barriers to PrEP use during pregnancy and postpartum in Cape Town
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
This project will test a brief cognitive-behavioral program to see if treating depression and posttraumatic stress helps pregnant and postpartum women in Cape Town stay on PrEP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05624931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are HIV-negative pregnant or postpartum women (aged 15+) receiving antenatal care at the Gugulethu MOU who recently started PrEP or have documented or self-reported PrEP adherence challenges and moderate-to-severe PTSD or depression.
Not a fit: Women without clinically significant PTSD or depression, those who are HIV-positive, or individuals with active psychosis or untreated bipolar disorder are unlikely to benefit from this intervention as tested.
Why it matters
Potential benefit: If successful, the intervention could improve PrEP persistence during pregnancy and breastfeeding and reduce maternal HIV infections by addressing mental health barriers.
How similar studies have performed: CBT and other mental-health interventions have improved medication adherence in other settings, but applying a brief CBT approach specifically to PrEP persistence during pregnancy and postpartum in South Africa is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- Boston University — Boston, Massachusetts, United States (Not_yet_recruiting)
- Gugulethu Midwife Obstetric Unit (MOU) — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Amelia Stanton, PhD — Boston University
- Study coordinator: Amelia M Stanton, PhD
- Email: stantona@bu.edu
- Phone: 617-353-2580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.