# The SUSTAIN 2 study - SUStained HIV Treatment for Adherence After Interruption in Care

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2024 · $780,447

## Abstract

PROJECT SUMMARY
 South Africa bears the brunt of the global HIV epidemic, with over one-fifth of the 37 million people living
with HIV within its borders. While we have seen tremendous success with the scale-up of effective treatment to
over 20 million people, we are at a pivotal moment in the global HIV response, and South Africa lies at the
center of the effort to reach the UN Sustainable Development Goal of ending HIV as a public health threat by
2030. A critical challenge in the care continuum in South Africa is the number of people living with HIV who are
not virally suppressed. In 2022, over 30% were not on ART or had a detectable viral load. Individuals with gaps
in care represent a substantial proportion of those who are not virally suppressed, and those who manage to
return to care continue to face challenges. In the Western Cape Province, only 29% of those with prior gaps
were virally suppressed one year after restarting treatment. Drivers of engagement behavior are
heterogeneous, and include individual, social, and system factors that interact dynamically over years of
treatment. Differentiated Service Delivery (DSD) models of person-centered care have been shown to
effectively address these barriers to care, however, to date, DSD models have been offered only to people with
HIV considered ‘stable’ (i.e., retained in care and virally suppressed). Thus, those at high risk of poor outcomes
are ineligible for DSD models. In response, our team intends to work with the City of Cape Town and
provide the critical data needed to impact policy guidelines. We designed CARES–Club-based
Adherence support for Reinforcing Engagement and Sustaining Viral Suppression for South Africans with
Gaps in HIV Care–to test a scalable, evidence-based DSD model (CARES-DSD) to address individual, social,
and structural barriers to long-term engagement among people with HIV who have experienced an ART
interruption or unsuppressed VL (PWH-Gaps). CARES-DSD is a six-month adherence club model of care that
offers flexible services with multi-month dispensing of medication de-linked from clinic processes and support
from lay counselors and peers, which has been proven to sustain retention and viral suppression in the
Western Cape. We propose a Hybrid Type 1 trial to evaluate the effectiveness of CARES-DSD on viral
suppression among PWH-Gaps at 24 months post-enrollment, as compared to an enhanced standard-of-care
(an optimized guidelines-based approach). We will recruit 300 participants from our current study (SUSTAIN,
R01MH125703, MPI: Orrell/Sabin), through which we have identified persistent engagement gaps in 43% of
the participants despite adherence counseling, to test this model of care. We will then assess the mechanisms
of intervention impact using mixed methods, guided by the Capability, Opportunity, and Motivation model of
Behavior (COM-B), and determine the implementation outcomes using Proctor’s model. Ultimately, our goal is
to provide an effective and ef...

## Key facts

- **NIH application ID:** 11014017
- **Project number:** 1R01MH138297-01
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Ingrid T. Katz
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $780,447
- **Award type:** 1
- **Project period:** 2024-09-16 → 2029-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11014017

## Citation

> US National Institutes of Health, RePORTER application 11014017, The SUSTAIN 2 study - SUStained HIV Treatment for Adherence After Interruption in Care (1R01MH138297-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/11014017. Licensed CC0.

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