Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief CBT-Based Intervention, Enhanced Treatment as Usual.
- Who it may be relevant to
- Registry conditions: Depression, Posttraumatic Stress Disorder, Pregnancy Related, Medication Adherence. Basic parameters: from 15 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 beha - Other 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.
Primary outcome measures
- Feasibility of Intervention [Time frame: This will be assessed at 2 months post-baseline]
- Acceptability [Time frame: This will be assessed at 2 months post-baseline]
Secondary outcome measures (4)
- PrEP Adherence [Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum]
- PrEP Persistence [Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum]
- Posttraumatic Stress Disorder (PTSD) [Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum]
- Depression [Time frame: This will be assessed at 2 months post-baseline and at 3 months postpartum]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Boston University — Boston
South Africa · 1 center
- Gugulethu Midwife Obstetric Unit (MOU) — Cape Town
Identifiers
NCT: NCT05624931 · 6783E · K23MH131438