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

February 2, 2026 updated by: Boston University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are just under one million people with HIV in South Africa who have initiated antiretroviral therapy (ART) but remain unsuppressed. South Africa has been making progress towards UNAIDS 90-90-90 targets but currently only 47% of those infected are suppressed. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV); nearly 50% of women have experienced IPV. The Common Elements Treatment Approach (CETA) is an evidence-based intervention intended to provide coping skills to women who have experienced IPV, and is comprised of cognitive-behavioral therapy elements. It is a transdiagnostic tool that can flexibly address a range of mental health problems (e.g. depression, anxiety) and represents the current best practice in global mental health as a more cost-effective, scalable and sustainable model. CETA is one of the most promising interventions to impact HIV outcomes through addressing the indirect effects of IPV on adherence and continuity of care.

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 retention and viral suppression, and reducing violence. The study aim is:

• Among HIV-infected women on ART who have experienced IPV and have an unsuppressed viral load, assess the effectiveness of CETA vs. active control at increasing the proportion retained and virally suppressed by 12 months and at decreasing the severity and incidence of IPV and other mental and behavioral health problems using a randomized trial;

Study staff will obtain full informed consent from those who meet inclusion criteria. For those that agree to participate, study staff will then randomize patients to CETA or control using sealed randomization envelopes. All subjects will be followed for 12 months to ensure data for primary and secondary outcomes is complete. Follow-up HIV data will be passive using routinely collected medical records from the clinics. HIV outcomes will be assessed at 3 and 12-months post-baseline. Questionnaires on violence, substance use, and mental health will be administered at baseline, and at 3 months (following CETA end) and 12 months post-baseline. These include: Severity of Violence Against Women Scale, Center for Epidemiological Studies-Depression Scale, Harvard Trauma Questionnaire, and Alcohol, Smoking, and Substance Involvement Screening Test. The primary outcome will be retention and viral suppression (<50 copies/mL) by 12 months after randomization. Secondary outcomes will include: 1) Viral suppression at 3 months; 2) Attrition at 12 months; and 3) IPV, mental/behavioral health, alcohol and other substance use at 3 and 12 months.

The primary aim is to analyze the impact of CETA in the full study population; however, our sample size was calculated to ensure our ability to detect differences separately among women who include a partner in the CETA intervention and those who do not not (noting that partners are not enrolled in the study, they are only enrolled in CETA and as such are not study subjects). A sample of 400 women will be included which will give us 80% power to detect an absolute 21% difference between arms. The primary analysis will be a comparison of intervention and control by risk differences with 95% confidence intervals. The investigators will analyze direct effects of CETA on continuous outcomes (e.g., mental health) with linear mixed models. The impact of potential moderators on retention and mental health outcomes using interaction terms will be assessed.

Study Type

Interventional

Enrollment (Actual)

399

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 02476
        • HIV Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Short Message Service (SMS) text reminders
Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.
Behavioral: CETA
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.
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.
Other: Short Message Service (SMS) text reminders
Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 Month Viral Suppression
Time Frame: 12 months post randomization
The proportion of participants who are virally suppressed (<50 copies/mL) by 12 months post randomization
12 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Month Viral Suppression
Time Frame: 3 months post randomization
The proportion of participants who are virally suppressed (<50 copies/mL) by 3 months post randomization of those with a viral load at 3 months of follow-up
3 months post randomization
12 Month Attrition Rate
Time Frame: 12 months post randomization
Attrition rate (the opposite of retention) will be defined as the proportion of participants being more than 90 days late for a study visit 12 months post randomization.
12 months post randomization
Violence Against Women at 3 Months
Time Frame: 3 months
Violence will be measured using the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, a 27 item measure with a possible range of 27-108 and higher scores associated with greater severity of experienced violence.
3 months
Violence Against Women at 12 Months
Time Frame: 12 months
Violence will be measured using the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, a 27 item measure with a possible range of 27-108 and higher scores associated with greater severity of experienced violence.
12 months
Substance Use at 3 Months
Time Frame: 3 months
Substance use will be measured with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which includes 7 items on frequency of use, abuse, and dependence symptoms for the following substance types: tobacco, alcohol, inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids , or other substance. Higher scores are associated with greater substance involvement. ASSIST is a binary outcome of yes/no to any past-three month substance use, it is not a continuous measure. Scores can range from 0 to 1.
3 months
Substance Use at 12 Months
Time Frame: 12 months
Substance use will be measured with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST), which includes 7 items on frequency of use, abuse, and dependence symptoms for the following substance types: tobacco, alcohol, inhalants, marijuana, cocaine, amphetamines, sedatives, hallucinogens, opioids , or other substance. Higher scores are associated with greater substance involvement. ASSIST is a binary outcome of yes/no to any past-three month substance use, it is not a continuous measure. Scores can range from 0 to 1.
12 months
Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months
Time Frame: 3 months
PTSD symptoms will be assessed using 16 items scored on a four-point scale (1 = none, 2 = some of the time, 3 = a lot of the time, 4 = most of the time) from the Harvard Trauma Questionnaire (HTQ). HTQ scores can range from 1-4. Higher scores are associated with greater PTSD symptom severity.
3 months
Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months
Time Frame: 12 months
PTSD symptoms will be assessed using 16 items scored on a four-point scale (1 = none, 2 = some of the time, 3 = a lot of the time, 4 = most of the time) from the Harvard Trauma Questionnaire (HTQ). HTQ scores can range from 1-4. Higher scores are associated with greater PTSD symptom severity.
12 months
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months
Time Frame: 3 months
CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
3 months
Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months
Time Frame: 12 months
CES-D is a 20-item scale of depression with a possible range of 0-60 (total scale score). Higher scores are associated with greater depression symptom severity.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Matthew Fox, DSc, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2021

Primary Completion (Actual)

May 23, 2025

Study Completion (Actual)

May 23, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-39746
  • 1R01MH121998 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the research team has had sufficient time to analyze the data and submit the results for the primary study aims, the data will be made available on request in de-identified format for selected outcome measures. Only those original data collected by the study team can be shared, clinical records owned by the government cannot.

IPD Sharing Time Frame

Once the primary aims are completed, approximately 12 months after study completion.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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