Efficacy of an mhealth + e-navigator stepped care intervention for art adherence among latino MSM

Active Project Grant Awarded Last action

Award ID
R01MD017205
Recipient
Awarding agency
Obligated
$6,633,495

Award facts

Completion date 91% complete
Funding
  • $6,119,154.00 Federal
  • $514,341.00 Non-federal
Place of performance
Miami, FL 33199, USA

Award details come from USAspending.gov.

Description

Abstract
Approximately 40% of latino MSM with HIV do not achieve viral suppression-an estimate that has likely worsened due to covid-19 pandemic stressors such as unemployment, loss of health insurance, homelessness, and exacerbated mental health and substance use disorders caused by the covid-19 pandemic. Antiretroviral therapy (art) adherence is associated with decreased viral load, increased CD4 counts, fewer hospital days, slower disease progression, and longer survival. Adherence also helps prevent drug resistance and reduces HIV transmission risk. The primary objective of this study is to evaluate the efficacy of stepped care strategies to improve art adherence among adult latino MSM with HIV using a sequential, multiple assignment, randomized trial (smart). The trial will compare a stepped care strategy of delivering txtxt first and stepping up to remote patient navigation for non-responders VS. A stepped care strategy of delivering txtxt + e-navigation first and stepping up to EMA-supported e-navigation for non- responders. Both, txtxt ("treatment text") and the foundations of the e-navigation interventions are CDC evidence-based interventions (EBI). We propose to use a smart design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims: aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (txtxt alone VS. Txtxt + e-navigation) on art adherence and viral suppression among latino MSM with HIV. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (txtxt with added e-navigation for non-responders VS. Txtxt + e-navigation with added EMA support for non-responders) on art adherence and viral suppression among latino MSM with HIV. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and art adherence and viral suppression among latino MSM with HIV. The proposed study is innovative by culturally adapting and combining two ebis, using a stepped care approach, remote patient navigators, adaptive EMA components, and a smart design. The proposed study is significant because IT provides data on the efficacy of two scalable ebis in one efficient design and provides data on enhanced treatment options for non-responders. The study is also significant because IT targets an NIH health disparity population (latino MSM) and addresses multiple domains and levels of influence on health and health disparities. IT also targets people living in an ending the HIV epidemic geographic focus area with the highest HIV diagnosis rate in the nation (south florida), thereby supporting the objectives of reducing HIV disparities in populations at high risk and living in the southern US.

Transactions

Action Federal Non-federal Date
Amendment $401,762 $0
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Amendment Efficacy of mhealth + e-navigator stepped care intervention for art adherence among latino men with HIV - approximately 70% of latino men with HIV do not… $502,090 $0
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Amendment $514,341 $0
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Original award $514,341 $0
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Subawards

Subrecipient Amount Awarded
ANN & Robert H Lurie Childrens Hospital Of Chicago The primary objective of this study is to use a sequential multiple assignment randomized trial (SMART) to evaluate the efficacy of stepped care intervention to… $73,064
Care Resource Community Health Centers Inc. Scope of Work of Cooperating/Subrecipient Institution: a) For the remaining duration of the project, Care Resource will facilitate the recruitment of men… $79,845
ANN & Robert H Lurie Childrens Hospital Of Chicago TASKS/SCIENTIFIC GOALS: Aim 1. Using focus groups (N=4; 2 English/2 Spanish), culturally adapt TXTXT for 18-34 year old Latino MSM with HIV, including the… $167,457
ANN & Robert H Lurie Childrens Hospital Of Chicago SCOPE: The primary objective of this study is to use a sequential multiple assignment randomized trial (SMART) to evaluate the efficacy of stepped care… $167,457
Care Resource Community Health Centers Inc. Tasks: - Recruit eligible HIV-positive MSM for the study through flyers posted at the clinic sites and referrals from medical case managers, physicians and… $312,887

Quick answers

Who received award R01MD017205?

R01MD017205 was awarded to Florida International University by National Institute for Minority Health and Health Disparities (National Institutes of Health) on July 13, 2022.

How much is award R01MD017205 worth?

$6,633,495 has been obligated on R01MD017205: $6,119,154 in federal funding and $514,341 in non-federal funding.

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