Clinical trial NCT05624931: Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
Official title: Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Posttraumatic Stress Disorder
Pregnancy Related
Medication Adherence
Keywords: HIV, pregnancy, PrEP
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Cape Town
name: National Institute of Mental Health (NIMH)
First posted: 2022-11-22
Enrollment: 108
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aims 1 and 2 will assess a single group of pregnant women. In Aim 3, a randomized control trial will include an intervention group and control group that are running in parallel.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Feasibility
timeFrame: This will be assessed at 2 months post-baseline
measure: Feasibility
timeFrame: This will be assessed at 3 months postpartum
measure: Acceptability
timeFrame: This will be assessed at 2 months post-baseline
Secondary outcomes:
measure: PrEP Adherence
timeFrame: This will be assessed at 2 months post-baseline and at 3 months postpartum
measure: PrEP Persistence
timeFrame: This will be assessed at 2 months post-baseline and at 3 months postpartum
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: This will be assessed at 2 months post-baseline and at 3 months postpartum
measure: Depression
timeFrame: This will be assessed at 2 months post-baseline and at 3 months postpartum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Cape Town
country: South Africa
facility: Gugulethu Midwife Obstetric Unit (MOU)
state: Western Cape
Study officials:
affiliation: Boston University
name: Amelia Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
References: