The sustain 2 study - sustained HIV treatment for adherence after interruption in care

Active Project Grant Awarded Last action

Award ID
R01MH138297
Recipient
Awarding agency
Obligated
$2,185,719

Award facts

Assistance listing
93.242 Mental Health Research Grants
Completion date 46% complete
Place of performance
New Haven, CT 06510, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
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 efficient model of care to ensure people living with HIV achieve optimal health and well-being, and south africa reaches the 2030 goals.

Transactions

Action Obligated Date
Amendment $267,429
Amendment $0
Amendment $427,922
Amendment $0
Amendment $260,740
Amendment $449,181
Amendment $0
Amendment $0
Amendment $0
Original award $780,447

Subawards

Subrecipient Amount Awarded
University Of Cape Town Participants who are recruited will be people who are enrolled in the SUSTAIN study. These participants were recruited for SUSTAIN from three City of Cape… $260,740
Trustees Of Boston University Dr. Lora Sabin, based at BUSPH, will be a Multiple Principal Investigator (MPI) on the CARES study along with Drs. Katz and Orrell. Dr. Sabin’s extensive… $383,383
University Of Cape Town Participants who are recruited will be people who are enrolled in the SUSTAIN study. These participants were recruited for SUSTAIN from three City of Cape… $203,699

Quick answers

Who received award R01MH138297?

R01MH138297 was awarded to Yale Univ by National Institute of Mental Health (National Institutes of Health) on September 16, 2024.

How much is award R01MH138297 worth?

$2,185,719 has been obligated on R01MH138297.

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