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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05624931
• Other study ID #: 6783E
• Secondary ID: K23MH131438
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: February 2027

Study information

• Verified date: July 2023
• Source: Boston University Charles River Campus
• Contact: Amelia M Stanton, PhD
• Phone: 617-353-2580
• Email: stantona[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Medication Adherence
• Posttraumatic Stress Disorder
• Pregnancy Related
• Stress Disorders, Post-Traumatic

Intervention

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 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.

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.

Locations

Country	Name	City	State
South Africa	Gugulethu Midwife Obstetric Unit (MOU)	Cape Town	Western Cape
United States	Boston University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute of Mental Health (NIMH), University of Cape Town

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	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
Primary	Feasibility	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 3 months postpartum
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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