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

NCT04242992 | Completed Results DMC

• 2 other identifiers: H-397461R01MH121998
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS; Violence

Keywords

HIV; Retention; Viral suppression; Violence; Cognitive behavioral therapy (CBT); Common Elements Treatment Approach (CETA)

Outcome Measures

Primary Outcomes (1)

• 12 Month Viral Suppression

  The proportion of participants who are virally suppressed (\<50 copies/mL) by 12 months post randomization

  12 months post randomization

Secondary Outcomes (10)

• 3 Month Viral Suppression

  3 months post randomization

• 12 Month Attrition Rate

  12 months post randomization

• Violence Against Women at 3 Months

  3 months

• Violence Against Women at 12 Months

  12 months

• Substance Use at 3 Months

  3 months

Study Arms (2)

CETA (Common Elements Treatment Approach)

EXPERIMENTAL

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.

Behavioral: CETA; Other: Short Message Service (SMS) text reminders

Active control

ACTIVE COMPARATOR

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

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.

CETA (Common Elements Treatment Approach)

Short Message Service (SMS) text reminders OTHER

Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.

Active control; CETA (Common Elements Treatment Approach)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

HIV Clinic

Johannesburg, Gauteng, 02476, South Africa

Location

Related Publications (3)

• Zheng A, Kane JC, Mngadi-Ncube S, Fox MP, Manganye P, Long L, Metz K, Sardana S, Alto M, Greener R, Thea DM, Murray LK, Pascoe S. 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 Jan 27;29(1):e302246. doi: 10.1136/bmjment-2025-302246.

  PMID: 41592903 DERIVED

• Zheng A, Kane JC, Mngadi-Ncube S, Fox MP, Manganye P, Long L, Metz K, Sardana S, Alto M, Greener R, Thea DM, Murray LK, Pascoe S. 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 [Preprint]. 2025 Oct 15:2025.10.14.25337970. doi: 10.1101/2025.10.14.25337970.

  PMID: 41282709 DERIVED

• Pascoe S, Fox M, Kane J, Mngadi S, Manganye P, Long LC, Metz K, Allen T, Sardana S, Greener R, Zheng A, Thea DM, Murray LK. Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa. BMJ Open. 2022 Dec 22;12(12):e065848. doi: 10.1136/bmjopen-2022-065848.

  PMID: 36549749 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Matthew Fox, DSc, MPH
• Organization: Boston University School of Public Health, Epidemiology and Global Health

mfox@bu.edu

617-358-2062

Study Officials

• Matthew Fox, DSc

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the intervention is a behavioral intervention, it will not be possible to blind women to their intervention, but outcome assessors will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women will be randomized 1:1 to either CETA or an active attention control arm.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: November 12, 2021
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Once the primary aims are completed, approximately 12 months after study completion.

Locations

ZA (1)