NCT05624931 · Boston University Charles River Campus
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Brief CBT-Based Intervention
Aims 1 (n=30) and 2 (n=18) will inform the Aim 3 intervention. We anticipate that the intervention will be comprised of four treatment sessions. These sessions will likely target two pathways to PrEP adherence and persistence: (1) decreased withdrawal and avoidance and (2) behavioral skill building to increase self-care/health behaviors. To decrease withdrawal and avoidance, we will likely include CBT-based exercises that improve distress tolerance and coping. To help participants build new behavioral skills, we will likely incorporate behavioral activation and problem-solving. Behavioral activation is a CBT strategy that promotes scheduling activities that align with an individual's values, which will also break maladaptive patterns of withdrawal and avoidance. Problem-solving is an empirically-supported treatment for depression; training patients to problem-solve adaptively will help them "approach" PrEP use by navigating barriers.
OTHER
Enhanced Treatment as Usual
This is the control intervention. Participants will receive antenatal care as usual, which is monthly visits to the MOU, information about using PrEP during pregnancy (information sheet or pamphlet), and a psychological services referral.
Primary outcome measures
Feasibility of Intervention
Time frame: This will be assessed at 2 months post-baseline
Feasibility will be assessed by (1) interventionist fidelity to the protocol, (2) treatment session attendance, and (3) participant retention at 3-months postpartum (T3). Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions addressed 90% of the key session components, (2) 75% of the participants (at least 23 of 30) attended at least two of the four treatment sessions; and (3) 60% of the participants (at least 18 of 30) completed the three-month postpartum assessment (T3). To measure fidelity, we will review 20% of the session audio-recordings randomly selected from each of the four sessions and determine whether key session components were addressed.
Acceptability
Time frame: This will be assessed at 2 months post-baseline
Acceptability will be assessed (1) in the qualitative exit interviews and (2) with the brief acceptability questionnaire completed after each intervention session. Acceptability data from the qualitative exit interviews will be described, and the intervention will be deemed acceptable if at least 75% of the participants rate three or more of the items on the acceptability questionnaires with "high satisfaction" (4 or 5 on the Likert-style scale).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For participants across all three aims are:
- 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
- Boston, Massachusetts
Collaborators
University of Cape Town, National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations