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Brief Cognitive Behavioral Therapy for PrEP Adherence in Pregnant Women

N/A

Waitlist Available

Led By Amelia Stanton, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed at 2 months post-baseline and at 3 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore how PTSD & depression affect PrEP adherence in pregnant women in South Africa & create a brief intervention to help them stay on PrEP & reduce HIV risk.

Who is the study for?

This trial is for pregnant women over the age of 15 in Gugulethu, South Africa, who are HIV-negative and have recently started PrEP or face challenges with PrEP adherence. Participants should show moderate to severe symptoms of posttraumatic stress or depression. Women with significant psychiatric illnesses that could interfere with participation or unable to consent in English/Xhosa are excluded.

What is being tested?

The study tests a brief cognitive behavioral therapy (CBT) intervention aimed at reducing psychological barriers like posttraumatic stress and depression to improve adherence to PrEP during pregnancy and breastfeeding. The feasibility and acceptability will be evaluated through interviews and a pilot randomized controlled trial integrated into antenatal care.

What are the potential side effects?

Since this is a non-medical intervention focusing on CBT, traditional side effects associated with medications are not expected. However, participants may experience emotional discomfort when discussing traumatic experiences or depressive symptoms during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed at 2 months post-baseline and at 3 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed at 2 months post-baseline and at 3 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed at 2 months post-baseline and at 3 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

Depression

Posttraumatic Stress Disorder (PTSD)

PrEP Adherence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Condition: Brief CBT-Based InterventionExperimental Treatment1 Intervention

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.

Group II: Control Condition: Enhanced Treatment as UsualActive Control1 Intervention

Participants randomized to the control condition (n= 30) will receive enhanced treated as usual.

Do I qualify?Apply below to find out