N/A
N=399
Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
HIV/AIDS · Violence
Bottom Line
View on ClinicalTrials.gov: NCT04242992 ↗Enrolled (actual)
399
Serious AEs
3.3%
Results posted
Feb 2026
Primary outcome: Primary: 12 Month Viral Suppression — 86; 86 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CETA (Behavioral); Short Message Service (SMS) text reminders (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston University
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12 Month Viral Suppression |
86; 86 | — |
| SECONDARY 3 Month Viral Suppression |
25; 13 | — |
| SECONDARY 12 Month Attrition Rate |
49; 38 | — |
| SECONDARY Violence Against Women at 3 Months |
37.0; 37.0 | — |
| SECONDARY Violence Against Women at 12 Months |
35.2; 37.1 | — |
| SECONDARY Substance Use at 3 Months |
0.1; 0.1 | — |
| SECONDARY Substance Use at 12 Months |
0.1; 0.2 | — |
| SECONDARY Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months |
1.6; 1.8 | — |
| SECONDARY Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months |
1.7; 1.9 | — |
| SECONDARY Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months |
15.3; 16.1 | — |
| SECONDARY Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months |
16.7; 20.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Unwilling to complete the informed consent process
- Currently psychotic or on unstable psychiatric regimen
- Suicide attempt/ideation with intent and plan, and/or self-harm in the past month
- Enrolled in any other HIV treatment intervention study
Data sourced from ClinicalTrials.gov (NCT04242992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.