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Efficacy of mHealth + e-Navigator stepped care intervention for ART adherence among Latino men with HIV

Award Number: R01MD017205
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/13/2022
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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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 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 men 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 men 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 men 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 men with HIV. The proposed study is innovative by 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 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $502,090 )
2025	2025	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	000	4	8/30/2025	NON-COMPETING CONTINUATION	$502,090
														Subtotal = $502,090

Issue Date FY: 2024 ( Subtotal = $544,510 )
2024	2024	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	000	3	2/20/2024	NON-COMPETING CONTINUATION	$490,059
2024	2024	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	001	3	5/29/2024	NON-COMPETING CONTINUATION	$54,451
														Subtotal = $544,510

Issue Date FY: 2023 ( Subtotal = $544,510 )
2023	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	000	2	3/5/2023	NON-COMPETING CONTINUATION	$544,510
														Subtotal = $544,510

Issue Date FY: 2022 ( Subtotal = $514,341 )
2022	2022	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	001	1	7/21/2022	NEW	$0
2022	2022	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Minority Health and Health Disparities Research	000	1	7/13/2022	NEW	$514,341
														Subtotal = $514,341

Grand Total All Awards = $2,105,451

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Efficacy of mHealth + e-Navigator stepped care intervention for ART adherence among Latino men with HIV

Award Number: R01MD017205

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/13/2022

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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