Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa

Sponsor
Boston University
Study ID
NCT04242992
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CETA — BEHAVIORAL
    CETA is a modular, multi-problem, flexible psychotherapy approach that trains a lay provider in nine evidence-based CBT elements so providers can treat a variety of common problems, including violence, substance use, depression, anxiety, risky behaviors (sexual, non-adherence), and other trauma-related symptoms.
  • Short Message Service (SMS) text reminders — OTHER
    Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.

Study Details

This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.

Key Dates

Start date
Nov 12, 2021
Status verified
Feb 2026
Primary completion
May 23, 2025
Completion
May 23, 2025

Study Design

Enrollment
399 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CETA (Common Elements Treatment Approach)
    Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
  • Active Comparator: Active control
    Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.

Primary Outcome Measure

12 Month Viral Suppression [ Time Frame: 12 months post randomization ]

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