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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 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor

114 Previous Clinical Trials

12,182 Total Patients Enrolled

University of Cape TownOTHER

245 Previous Clinical Trials

541,210 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,648 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this empirical experiment?

"This trial seeks to evaluate the feasibility of Prep and assess secondary outcomes such as adherence, persistence, and PTSD symptoms. Adherence will be measured via an adapted Wilson three-item self-report scale that includes missed doses, proportion taken as prescribed, and one's aptitude for taking it. Persistence is evaluated with DBS testing measuring TVF-DP concentrations indicative of 7 doses weekly up to 8 weeks while PTSD symptom severity is monitored using the PCL-5 scoring 31 or higher indicating moderate/severe symptoms."

Answered by AI

Is there capacity to include additional participants in this clinical trial?

"This particular medical trial is no longer recruiting patients, as indicated by its latest update on November 14th 2022. Despite this, there are still 1684 different clinical studies that need participants at the present time."

Answered by AI