# An Adaptive Randomized Evaluation of Nurse-led HIV Treatment Retention Interventions for Women Living with HIV

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2020 · $584,332

## Abstract

ABSTRACT
The goal of this work is to evaluate the individual-level effectiveness and potential population-level impact of
decentralized anti-retroviral therapy programs (DTP) and enhanced social capital to achieve sustained HIV
viral suppression among female sex workers (FSW) living with HIV in South Africa. FSW have been shown to
bear disproportionate burden of HIV across Southern Africa and to be at high risk of onward HIV transmission
given disparities in access to anti-retroviral therapy (ART). These data are consistent across Sub-Saharan
Africa (SSA) and highlight an urgent need to minimize disparities in treatment access for FSW living with HIV,
and interrupt these large chains of transmission with better uptake and retention in ART programs. The
proposed study will first characterize optimal implementation methods for interventions that address underlying
barriers to sustained viral suppression through qualitative interviews with key informants, benefactors, and the
government. The crux of the proposed aims are to describe the effectiveness and durability of decentralized
treatment programs and case management interventions to achieve sustained viral suppression using adaptive
implementation strategies tested through a sequential multiple assignment randomized trial (SMART). The
SMART will randomize 782 non-virally suppressed FSW living with HIV in Durban, South Africa to one of two
experimental conditions including access to decentralized treatment programs (DTP) or DTP and case
management interventions and will follow the participants for 18 months, through multiple randomization
assignments. Not all FSW will benefit from - or need - the same intervention or intensity to achieve sustained
viral suppression. Indeed, it would not be feasible to implement these interventions for all people living with HVI
as neither represent current standard of care. However, the adaptive implementation strategies proposed here
provide a platform to evaluate multicomponent, graduated, intervention intensity to achieve sustained viral
suppression. Finally, we will evaluate the cost-effectiveness of the varying packages of interventions to
measure sustainability and scalability of these approaches. The research will be conducted by Johns Hopkins
University, in partnership with the TB/HIV Care Association (THCA) and the University of Toronto. We will
utilize existing infrastructure and service delivery systems run by THCA in Durban to recruit FSW living with
HIV to participate in the trial. Furthermore, health assessment data routinely collected by THCA and the
National Health Laboratory Service will be used, in addition to data collected by the study team, to assess
treatment outcomes and viral suppression among these women. The study represents an approach to
characterize effective strategies to improve HIV treatment outcomes for a population disproportionately
burdened by HIV, and leverage these data to model the cost-effectiveness in the context of the ge...

## Key facts

- **NIH application ID:** 9960586
- **Project number:** 5R01NR016650-05
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Stefan David Baral
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $584,332
- **Award type:** 5
- **Project period:** 2016-09-26 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9960586

## Citation

> US National Institutes of Health, RePORTER application 9960586, An Adaptive Randomized Evaluation of Nurse-led HIV Treatment Retention Interventions for Women Living with HIV (5R01NR016650-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9960586. Licensed CC0.

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