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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 15
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Boston University
NOT_YET_RECRUITING
Boston
Other Locations
South Africa
Gugulethu Midwife Obstetric Unit (MOU)
RECRUITING
Cape Town
Contact Information
Primary
Amelia M Stanton, PhD
stantona@bu.edu
617-353-2580
Time Frame
Start Date: 2025-04-17
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 108
Treatments
Experimental: Treatment Condition: Brief CBT-Based Intervention
This group (n=30) will be guided through an adaptation of Life Steps, a single-session, cognitive behavioral therapy (CBT)-based medication adherence intervention that has been used to increase PrEP adherence. Participants will also receive four additional intervention sessions.
Active_comparator: Control Condition: Enhanced Treatment as Usual
Participants randomized to the control condition (n= 30) will receive enhanced treated as usual.
Sponsors
Leads: Boston University Charles River Campus
Collaborators: National Institute of Mental Health (NIMH), University of Cape Town

This content was sourced from clinicaltrials.gov