There are currently 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 has only reached 47% of those infected being virally suppressed. Therefore, if effective approaches can be found to keep patients on treatment, adhering, and virally suppressed, the impact could be significant. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV) as nearly 50% of women have experienced IPV. Addressing IPV could have effects in supporting patients on HIV treatment to continue to adhere. The Common Elements Treatment Approach (CETA) is an evidence-based intervention comprised of cognitive-behavioral therapy elements. It is transdiagnostic in that it can flexibly address a range of problems and represents the current movement 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 violence To evaluate CETA, we propose 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 on increasing viral suppression and reducing violence. The study has three aims:
Aim 1 : Among HIV-infected women on ART who have experienced IPV and have an unsuppressed viral load, to assess the effectiveness of CETA vs. active control at increasing the proportion retained and virally suppressed by 12 months and at decreasing the severity of IPV and other mental and behavioral health problems using an individually randomized trial.
Aim 2 : To identify mediators and moderators of CETA?s effect on the primary outcome (retention and viral suppression).
Aim 3 : To assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion of women who have experienced IPV who are retained and virally suppressed by 12 months. The study question is significant given the prevalence of IPV in female patients with unsuppressed viral loads in South Africa and the potential for improving viral suppression by addressing IPV and its sequelae. If effective, this approach could have a significant global impact on outcomes for virally unsuppressed women and reduce transmission to uninfected partners. It is innovative in utilizing an evidence-based approach (CETA) shown to affect IPV as well as many other problems that contribute to poor HIV treatment outcomes.

Public Health Relevance

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, we 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. We 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH121998-02
Application #
10126063
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Senn, Theresa Elaine
Project Start
2020-03-15
Project End
2025-01-31
Budget Start
2021-02-01
Budget End
2022-01-31
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Boston University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118