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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH131438 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Condition: Brief CBT-Based Intervention | Experimental | This group (n=30) will be guided through an adaptation of Life Steps, a single-session, cognitive behavioral therapy (CBT)-based medication adherence intervention that has been used to increase PrEP adherence. Participants will also receive four additional intervention sessions. |
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| Control Condition: Enhanced Treatment as Usual | Active Comparator | Participants randomized to the control condition (n= 30) will receive enhanced treated as usual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief CBT-Based Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Intervention | 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. | This will be assessed at 2 months post-baseline |
| Acceptability | 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). | This will be assessed at 2 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence | 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. | This will be assessed at 2 months post-baseline and at 3 months postpartum |
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Inclusion Criteria:
For participants across all three aims are:
Exclusion Criteria:
There are no exclusion criteria with respect to parity or gravidity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia M Stanton, PhD | Contact | 617-353-2580 | stantona@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amelia Stanton, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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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.
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| Enhanced Treatment as Usual | Other | 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. |
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| PrEP Persistence | 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. | This will be assessed at 2 months post-baseline and at 3 months postpartum |
| Posttraumatic Stress Disorder (PTSD) | 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. | This will be assessed at 2 months post-baseline and at 3 months postpartum |
| Depression | 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. | This will be assessed at 2 months post-baseline and at 3 months postpartum |
| Gugulethu Midwife Obstetric Unit (MOU) | Recruiting | Cape Town | Western Cape | 8001 | South Africa |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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