Phase
Condition
Depression
Post-traumatic Stress Disorders
Treatment
Brief CBT-Based Intervention
Enhanced Treatment as Usual
Clinical Study ID
Ages > 15 Female Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Gugulethu Midwife Obstetric Unit (MOU)
Cape Town, Western Cape 8001
South AfricaSite Not Available
Boston University
Boston, Massachusetts 02215
United StatesSite Not Available
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