Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05624931 | NOT YET RECRUITING | Depression

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

Boston University Charles River Campus

Brief 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.

Condition or disease

Depression

Posttraumatic Stress Disorder

Pregnancy Related

Medication Adherence

Intervention/treatment

Brief CBT-Based Intervention

Enhanced Treatment as Usual

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 108 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
Actual Study Start Date : 2025-02-28
Estimated Primary Completion Date : 2027-02-28
Estimated Study Completion Date : 2027-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

Location Details

NCT05624931

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Massachusetts

Boston University

Boston, Massachusetts, United States, 02215

Not yet recruiting

South Africa, Western Cape

Gugulethu Midwife Obstetric Unit (MOU)

Cape Town, Western Cape, South Africa, 8001