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…

The National Institute of Mental Health awarded RTI International $1,553,132 on May 6, 2026, under the Mental Health Research Grants program (CFDA 93.242) to conduct a hierarchical factorial cluster-randomized controlled trial evaluating a multilevel intervention to reduce stigma among women living with HIV in Tanzania.

The study addresses gaps in evidence-based, multilevel stigma reduction interventions designed to improve sustained engagement in HIV care and achieve durable viral suppression. The research combines stigma reduction strategies at both the health care facility and individual patient levels, leveraging Tanzania's concentration of women living with HIV who struggle to engage with HIV services and a sufficient number of HIV clinics to support randomization of health facilities.

RTI International, a nonprofit research organization headquartered in Research Triangle Park, North Carolina, serves as the recipient. Work is performed in Research Triangle Park, Durham, North Carolina, with the ultimate completion date of February 28, 2031. The award is structured as a Project Grant, the standard assistance type for NIH research awards supporting specified project periods up to five years.

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.