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

Launched by BOSTON UNIVERSITY CHARLES RIVER CAMPUS · Nov 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to help pregnant and postpartum women in Cape Town, South Africa, stick with their PrEP medication to prevent HIV. PrEP is a safe and effective way to lower the risk of getting HIV, but many women struggle to keep taking it because of issues like depression and post-traumatic stress, often caused by past traumas. The goal of the study is to create a supportive program that helps these women manage their mental health and improve their ability to consistently take PrEP during pregnancy and after giving birth.

To be eligible for this trial, women must be aged 15 or older, currently pregnant, and attending antenatal care at a specific clinic in Gugulethu. They also need to be HIV-negative and either new to PrEP or have had trouble sticking with it. Participants will engage in a few sessions focused on improving their mental health and building skills to help them take their medication regularly. The study will gather feedback to see how well the program works and if women find it helpful. This research is important for ensuring that more women can protect themselves from HIV during a critical time in their lives.

Gender

FEMALE

Eligibility criteria

• 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.