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Brief Cognitive Behavioral Therapy for PrEP Adherence in Pregnant Women

N/A
Recruiting
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability
Feasibility
Secondary outcome measures
Depression
Posttraumatic Stress Disorder (PTSD)
PrEP Adherence
+1 more

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.

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor
114 Previous Clinical Trials
11,869 Total Patients Enrolled
University of Cape TownOTHER
248 Previous Clinical Trials
560,472 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,801 Previous Clinical Trials
2,661,216 Total Patients Enrolled

Media Library

Brief CBT-Based Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05624931 — N/A
Pregnancy Research Study Groups: Treatment Condition: Brief CBT-Based Intervention, Control Condition: Enhanced Treatment as Usual
Pregnancy Clinical Trial 2023: Brief CBT-Based Intervention Highlights & Side Effects. Trial Name: NCT05624931 — N/A
Brief CBT-Based Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624931 — N/A
~72 spots leftby Feb 2027
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