Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape T… (NCT05624931) | Clinical Trial Compass
RecruitingNot Applicable
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
United States, South Africa118 participantsStarted 2025-04-17
Plain-language 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.
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on reducing psychological barriers like depression and PTSD to help pregnant and postpartum women in Cape Town stick with PrEP — given my mental health history and where I am in my pregnancy or postpartum period, does my situation match who this study is designed for?
2Since this trial is in Phase NA and is measuring feasibility and acceptability rather than clinical outcomes, what does that mean about how much is already known about whether the intervention actually improves PrEP adherence or mental health?
3The study seems to involve some kind of psychological support component alongside PrEP — can you help me understand what that support would look like in practice, and how demanding the time commitment might be during pregnancy or after giving birth?
4If I'm already struggling with depression or trauma symptoms, would it be better for me to get established mental health treatment first before considering a research study like this one?
5Are there standard-of-care options in Cape Town for supporting PrEP adherence during pregnancy that I should compare against what this trial is offering, so I can make the most informed decision with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Intervention
Timeframe: This will be assessed at 2 months post-baseline
2
Acceptability
Timeframe: This will be assessed at 2 months post-baseline