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Reducing Psychological Barriers to PrEP Persistence in Pregnant and Postpartum Women

This study is for pregnant women in Cape Town, South Africa, who are HIV-negative and have recently started PrEP (Pre-exposure prophylaxis, a medicine to prevent HIV) or are having trouble taking it regularly. It's also for women experiencing moderate to severe symptoms of posttraumatic stress or depression. The study is testing a Brief CBT-Based Intervention, which is a type of talk therapy, to see if it helps women continue taking their PrEP. The goal is to see if this intervention is practical to deliver and if women find it acceptable. The study aims to enroll 118 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 118 participants. It compares a Brief CBT-Based Intervention to Enhanced Treatment as Usual.
What's involved
Participants will receive four treatment sessions for the intervention group, or antenatal care as usual, information about PrEP, and a psychological services referral for the control group.
Compensation
Not stated in the trial record.
Follow-up
Feasibility and acceptability of the intervention will be assessed at 2 months post-baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05624931

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

Recruiting
NAAges 15+InterventionalPrevention
Boston University Charles River Campus
~118 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Brief CBT-Based InterventionEnhanced Treatment as Usual

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Intervention
Measured over This will be assessed at 2 months post-baseline
+1 more outcome measured

Conditions

Depression
Posttraumatic Stress Disorder
Pregnancy Related
Medication Adherence

Explore related trials

DepressionHIV InfectionPost-Traumatic Stress DisorderPregnancy

NCT05624931

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston University

    Boston, Massachusettsstudy coordinator listed

    Not yet recruiting

  • Gugulethu Midwife Obstetric Unit (MOU)

    Cape Town, Western Cape, South Africastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amelia Stanton, PhD · PRINCIPAL_INVESTIGATOR · Boston University

Who to contact

Amelia M Stanton, PhD
[email protected]
617-353-2580
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Feasibility of InterventionThis will be assessed at 2 months post-baseline

    Feasibility will be assessed by (1) interventionist fidelity to the protocol, (2) treatment session attendance, and (3) participant retention at 3-months postpartum (T3). Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions addressed 90% of the key session components, (2) 75% of the participants (at least 23 of 30) attended at least two of the four treatment sessions; and (3) 60% of the participants (at least 18 of 30) completed the three-month postpartum assessment (T3). To measure fidelity, we will review 20% of the session audio-recordings randomly selected from each of the four sessions and determine whether key session components were addressed.

  • AcceptabilityThis will be assessed at 2 months post-baseline

    Acceptability will be assessed (1) in the qualitative exit interviews and (2) with the brief acceptability questionnaire completed after each intervention session. Acceptability data from the qualitative exit interviews will be described, and the intervention will be deemed acceptable if at least 75% of the participants rate three or more of the items on the acceptability questionnaires with "high satisfaction" (4 or 5 on the Likert-style scale).