Depression, Medication Adherence, Posttraumatic Stress Disorder, Pregnancy Related
Conditions
Keywords
HIV, pregnancy, PrEP
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.
Interventions
BEHAVIORALBrief 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.
OTHEREnhanced 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.
Sponsors
Boston University Charles River Campus
University of Cape Town
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention | This 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. |
| Acceptability | This 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence | This will be assessed at 2 months post-baseline and at 3 months postpartum | PrEP adherence during the previous week will be assessed at the end of the intervention/2 months post-baseline (T2) and at 3-months postpartum (T3) via an adapted version of the Wilson three-item self-report adherence scale, which includes (1) number of missed doses, (2) the percentage of time that PrEP was taken as prescribed, and (3) a rating of one's ability to take PrEP. |
| PrEP Persistence | This will be assessed at 2 months post-baseline and at 3 months postpartum | PrEP persistence at T2 and T3 will be determined via dried blood spot (DBS) testing and defined as tenofovir- diphosphate (TVF-DP) concentrations of at least 650 fmol/punch for pregnant women and 1050 fmol/punch for postpartum women, which are indicative of 7 doses per week over a period of up to eight weeks. |
| Posttraumatic Stress Disorder (PTSD) | This will be assessed at 2 months post-baseline and at 3 months postpartum | Changes in PTSD symptom severity from baseline will be measured using the PTSD Checklist for DSM-5 (PCL-5). A cutoff score of ≥31 will be used to determine moderate or severe PTSD symptoms. |
| Depression | This will be assessed at 2 months post-baseline and at 3 months postpartum | Changes in depression from baseline will be measured using the Edinburgh Postnatal Depression Scales. A cutoff score of ≥13 will be used to determine moderate or severe depression symptoms. |
Countries
South Africa, United States
Contacts
CONTACTAmelia M Stanton, PhD
PRINCIPAL_INVESTIGATORAmelia Stanton, PhD
Boston University
Outcome results
None listed