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

Boston University Charles River Campus

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Medication Adherence; Pregnancy Related; Depression

Treatments: Other: Enhanced Treatment as Usual; Behavioral: Brief CBT-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05624931

K23MH131438 (U.S. NIH Grant/Contract)

6783E

Details and patient eligibility

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. 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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Treatment Condition: Brief CBT-Based Intervention

Experimental group

Description:

This group (n=30) will be guided through an adaptation of Life Steps, a single-session, cognitive behavioral therapy (CBT)-based medication adherence intervention that has been used to increase PrEP adherence. Participants will also receive four additional intervention sessions.

Treatment:

Behavioral: Brief CBT-Based Intervention

Control Condition: Enhanced Treatment as Usual

Active Comparator group

Description:

Participants randomized to the control condition (n= 30) will receive enhanced treated as usual.

Treatment:

Other: Enhanced Treatment as Usual