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

Обзор

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.

Вмешательства

• Поведенческое 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
• Другое 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.

Первичные конечные точки

• Feasibility of Intervention [Срок оценки: This will be assessed at 2 months post-baseline]
• Acceptability [Срок оценки: This will be assessed at 2 months post-baseline]

Вторичные конечные точки (4)

• PrEP Adherence [Срок оценки: This will be assessed at 2 months post-baseline and at 3 months postpartum]
• PrEP Persistence [Срок оценки: This will be assessed at 2 months post-baseline and at 3 months postpartum]
• Posttraumatic Stress Disorder (PTSD) [Срок оценки: This will be assessed at 2 months post-baseline and at 3 months postpartum]
• Depression [Срок оценки: This will be assessed at 2 months post-baseline and at 3 months postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Boston University — Boston

ЮАР · 1 центр

• Gugulethu Midwife Obstetric Unit (MOU) — Cape Town

Идентификаторы

NCT: NCT05624931 · 6783E · K23MH131438

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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