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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 SA

Award Number: R01MH121998
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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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 SA - Project Summary 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $609,371 )
2024	2024	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	000	5	1/17/2024	NON-COMPETING CONTINUATION	$548,435
2024	2024	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	001	5	8/14/2024	NON-COMPETING CONTINUATION	$60,936
														Subtotal = $609,371

Issue Date FY: 2023 ( Subtotal = $614,648 )
2023	2023	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	000	4	1/31/2023	NON-COMPETING CONTINUATION	$614,648
														Subtotal = $614,648

Issue Date FY: 2022 ( Subtotal = $616,850 )
2022	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	000	3	1/25/2022	NON-COMPETING CONTINUATION	$555,164
2022	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	001	3	5/23/2022	NON-COMPETING CONTINUATION	$61,686
														Subtotal = $616,850

Issue Date FY: 2021 ( Subtotal = $633,871 )
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	000	2	1/26/2021	NON-COMPETING CONTINUATION	$633,871
														Subtotal = $633,871

Issue Date FY: 2020 ( Subtotal = $723,660 )
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	000	1	3/11/2020	NEW	$723,660
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Mental Health Research Grants	001	1	3/19/2020	NEW	$0
														Subtotal = $723,660

Grand Total All Awards = $3,198,400

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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 SA

Award Number: R01MH121998

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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