RecruitingNot ApplicableNCT05624931

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


Sponsor

Boston University Charles River Campus

Enrollment

108 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a psychological support program to help HIV-negative pregnant women in Cape Town, South Africa stick with PrEP — a daily medication that prevents HIV. The program targets women who are struggling with depression or trauma symptoms, which can make it hard to take medicine consistently. **You may be eligible if...** - You are female, age 15 or older, and currently pregnant - You are HIV-negative and have recently started PrEP (within the past month) or are having trouble taking it regularly - You are attending antenatal care at the Gugulethu clinic - You have moderate to severe symptoms of PTSD or depression on standard screening tools **You may NOT be eligible if...** - You cannot communicate in English or Xhosa - You have an active severe psychiatric illness (such as untreated psychosis or active mania) - You have health conditions that make it difficult to travel to the clinic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALBrief 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.

OTHEREnhanced 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.


Locations(2)

Boston University

Boston, Massachusetts, United States

Gugulethu Midwife Obstetric Unit (MOU)

Cape Town, Western Cape, South Africa

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05624931


Related Trials