NCT04242992Completed
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
Testing the Effectiveness of an Evidence-based Transdiagnostic Cognitive Behavioral Therapy Approach for Improving HIV Treatment Outcomes Among Violence-affected and Virally Unsuppressed Women in South Africa
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 399 (actual)
- First submitted
- 23 Jan 2020
- Start date
- 12 Nov 2021
- Primary completion date
- 23 May 2025
- Lead sponsor
- Boston University
- Diseases
- HIV
- NCT number
- NCT04242992
What you commit to
- Study type: Interventional
- Participants enrolled: 399
- From 12 Nov 2021 to the primary completion date, 23 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Currently psychotic or on unstable psychiatric regimen
- Enrolled in any other HIV treatment intervention study
Other
- Unwilling to complete the informed consent process
- Suicide attempt/ideation with intent and plan, and/or self-harm in the past month
Who the study is looking for
- Adult HIV positive women
- Initiated HIV treatment
- Most recent viral load \>50 copies/mL or they have defaulted from treatment or had a missed or late (\>14 days) visit in the last year
- Has experienced IPV in the past 12 months
- Has their own phone and can receive text messages
- Literate and able to speak and read one of: English, Zulu, SeSotho
- If including a partner, the woman has disclosed HIV status to the partner that will be invited to participate (noting that male partners are not study subjects, only the woman is)
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HIV Clinic Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
Related publications
- Effectiveness of the Common Elements Treatment Approach for mental and behavioural health outcomes among women struggling to remain adherent to HIV treatment and who have experienced intimate partner violence in South Africa: secondary outcomes from a randomised controlled trial.BMJ Ment Health · 2026 · PMID 41592903
- Effectiveness of the Common Elements Treatment Approach (CETA) for mental and behavioral health outcomes among women struggling to remain adherent to HIV treatment and who have experienced intimate partner violence in South Africa: A randomised controlled trial.medRxiv · 2025 · PMID 41282709
This page is information, not medical advice. Discuss any trial with your doctor.