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A hierarchical factorial cluster-randomized controlled trial to evaluate a multi-level intervention to address stigma for women living with HIV

Award Number: R01MH142180
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/06/2026
PERIOD OF PERFORMANCE END DATE: 02/28/2031

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A hierarchical factorial cluster-randomized controlled trial to evaluate a multi-level intervention to address stigma for women living with HIV - Achieving durable viral suppression among women living with HIV (WLWH) is critical to decreasing HIV transmission and ending the HIV epidemic in the United States and globally. However, for a subset of the population, sustained engagement in HIV services remains challenging. This situation is a primary contributor to persistent HIV transmission and a fundamental barrier to eradicating HIV. Stigma has been associated with suboptimal antiretroviral therapy adherence and viral load suppression. HIV stigma is a complex, multilevel barrier that has not been adequately addressed in existing service delivery. Although other barriers exist, stigma is a driving factor in low engagement of WLWH in HIV care, and evidence suggests that addressing stigma will improve sustained engagement in HIV care. Despite the well-documented negative impacts of stigma on HIV outcomes, there is a critical gap in innovative, evidence-based, multilevel interventions to reduce stigma. To address stigma and support lifetime HIV viral suppression among WLWH, we need multilevel strategies that can be readily implemented at scale. Our interdisciplinary and experienced team of Investigators will address this key gap. To support the multi-factorial research design required to rigorously evaluate multilevel stigma reduction interventions in a time- and cost-efficient manner, the following conditions are required: (1) A high geographical concentration of WLWH who struggle to engage with HIV care residing in the catchment area of a large enough number of HIV clinics to support randomization of health facilities and; (2) evidence-based stigma reduction interventions at both the health care facility (HCF) and individual WLWH levels to combine into a multilevel intervention. With all these conditions present, Tanzania offers a unique opportunity to evaluate the impact of a multilevel HIV stigma reduction intervention and generate translatable evidence for other settings where stigma is a significant barrier to sustained HIV care engagement but the conditions to evaluate a multilevel intervention are not present (e.g., the southern U.S.). This project builds on our team’s pioneering research on HIV stigma reduction interventions at the HCF and individual levels. We have previously adapted two complementary HIV stigma reduction interventions in Tanzania. The first, the Total Facility Approach (TFA), addresses HIV stigma among HCF staff. The second intervention, the Labda Siku Moja (LSM), is an internalized stigma reduction intervention. We will refine and combine these two interventions into a multilevel stigma reduction intervention to address HIV stigma faced by WLWH. In Aim 1, we will implement a hierarchical 2×2 factorial cluster-randomized controlled trial to determine the effectiveness of the multilevel stigma reduction intervention on quality of life and HIV viral suppression among WLWH who have missed scheduled clinic visits. In Aim 2, we will conduct a prospective mixed-methods process evaluation to assess implementation processes, theorized mediators influencing intervention effectiveness, and preliminary costs. In Aim 3, we will convene a series of study advisory group workshops to interpret Aims 1 and 2 findings and refine the intervention for broader implementation. The proposed research will fill a critical gap in our knowledge for supporting sustained engagement in lifetime HIV care, essential to eradicating HIV from the U.S. and globally. HCF and internalized stigma are significant barriers to maintaining viral load suppression and preventing onward transmission of HIV. This study provides the unique conditions necessary to evaluate a multilevel stigma reduction intervention and, if effective, will provide a translatable multilevel stigma reduction approach to fill the significant unmet need for stigma reduction in the U.S., thereby improving the lives of American WLWH and their families while advancing public health.


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: 2026 ( Subtotal = $776,566 )
2026	2026	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Mental Health Research Grants	001	1	6/24/2026	NEW	$0
2026	2026	RESEARCH TRIANGLE INSTITUTE	3040 CORNWALLIS RD	DURHAM	NC	27709	DURHAM	USA	Mental Health Research Grants	000	1	5/7/2026	NEW	$776,566
														Subtotal = $776,566

Grand Total All Awards = $776,566

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A hierarchical factorial cluster-randomized controlled trial to evaluate a multi-level intervention to address stigma for women living with HIV

Award Number: R01MH142180

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/06/2026

PERIOD OF PERFORMANCE END DATE: 02/28/2031

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