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

NCT ID: NCT05624931

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-17
• Study Completion Date: 2027-07-30

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.

Conditions

Depression; Posttraumatic Stress Disorder; Pregnancy Related; Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Treatment Condition: Brief CBT-Based Intervention

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.

Group Type: EXPERIMENTAL

Brief CBT-Based Intervention

Intervention Type: BEHAVIORAL

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.

Control Condition: Enhanced Treatment as Usual

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

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment as Usual

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cape Town

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amelia Stanton, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University

Boston, Massachusetts, United States

Site Status: NOT_YET_RECRUITING

Gugulethu Midwife Obstetric Unit (MOU)

Cape Town, Western Cape, South Africa

Site Status: RECRUITING

Countries

United States; South Africa

Central Contacts

Amelia M Stanton, PhD

Role: CONTACT

stantona@bu.edu

617-353-2580

Facility Contacts

Amelia M Stanton, PhD

Role: primary

stantona@bu.edu

617-353-2580

Madison R Fertig, MA

Role: backup

mrfertig@bu.edu

617-358-1374

Lucia Knight, PhD

Role: primary

lucia.knight@uct.ac.za

021-650-5313

Other Identifiers

K23MH131438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6783E

Identifier Type: -

Identifier Source: org_study_id