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A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

Award Number: R01NR017334
ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2017
PERIOD OF PERFORMANCE END DATE: 02/28/2023

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A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans - PROJECT SUMMARY/ABSTRACT Compared to Whites, Black people living with HIV are less likely to adhere to antiretroviral treatment (ART) and be virally suppressed. Our research has identified culturally relevant factors contributing to disparities among HIV-positive Black Americans, including stigma and medical mistrust (e.g., “conspiracy beliefs,” that ART is poison), in addition to structural and psychosocial factors related to poverty, healthcare access, and mental health. However, ART adherence interventions have rarely been culturally congruent, which may explain why relatively few interventions have shown robust effects on adherence or viral suppression. We propose to conduct a randomized controlled trial (RCT) of Rise, a culturally congruent adherence counseling intervention for HIV-positive Black men and women. Rise counselors possess specialized HIV treatment knowledge and are trained in motivational interviewing (MI) skills to overcome culturally relevant barriers to adherence and retention in care; they also assist with linkage to social services. Rise is ideally implemented in community organizations, enabling clients to seek services in non-medical settings, which helps to overcome mistrust of healthcare, and increase readiness for adherence. In a pilot RCT, Rise led to increased adherence (measured by electronic monitoring) relative to a wait-list control group over time, showing a large effect size (Cohen’s d=.87). However, the pilot did not evaluate effects on viral suppression or include long-term follow-up. Thus, we propose to conduct an RCT of Rise that follows best practices for evidence-based HIV treatment adherence intervention design and testing. The Specific Aims are: (1) To conduct a randomized controlled trial to examine the effects of a culturally congruent adherence intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; (2) To examine culturally relevant mediators (e.g., medical mistrust, stigma) that may help to explain the effects of the intervention on antiretroviral treatment adherence, retention in care, and viral suppression among Black men and women living with HIV; and (3) To conduct a cost effectiveness analysis of the intervention. A total of 350 Black men and women will be randomly assigned to the intervention or usual care control group (175 per group). Adherence will be electronically monitored daily (and downloaded bi-monthly) from baseline to 12- months post-baseline. Viral load will be assessed through venipuncture at baseline and 6- and 12-months post-baseline. If Rise is found to be effective, the next step would be to conduct research to determine effective and feasible methods for intervention implementation and dissemination to community settings.


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: 2023 ( Subtotal = -$19,123 )
2023	2021	THE RAND CORPORATION	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	5	7/7/2023	NON-COMPETING CONTINUATION	-$19,123
														Subtotal = -$19,123

Issue Date FY: 2021 ( Subtotal = $678,640 )
2021	2021	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	5	2/24/2021	NON-COMPETING CONTINUATION	$678,640
														Subtotal = $678,640

Issue Date FY: 2020 ( Subtotal = $650,018 )
2020	2020	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	4	2/19/2020	NON-COMPETING CONTINUATION	$650,018
														Subtotal = $650,018

Issue Date FY: 2019 ( Subtotal = $577,015 )
2019	2019	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	001	3	9/24/2019	NON-COMPETING CONTINUATION	$0
2019	2019	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	3	3/6/2019	NON-COMPETING CONTINUATION	$577,015
														Subtotal = $577,015

Issue Date FY: 2018 ( Subtotal = $552,272 )
2018	2018	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	001	2	4/11/2018	NON-COMPETING CONTINUATION	$55,227
2018	2018	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	2	2/6/2018	NON-COMPETING CONTINUATION	$497,045
														Subtotal = $552,272

Issue Date FY: 2017 ( Subtotal = $647,915 )
2017	2017	RAND CORPORATION, THE	1776 MAIN ST	SANTA MONICA	CA	90401	LOS ANGELES	USA	Nursing Research	000	1	5/1/2017	NEW	$647,915
														Subtotal = $647,915

Grand Total All Awards = $3,086,737

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A Randomized Controlled Trial of an Antiretroviral Treatment Adherence Intervention for HIV+ African Americans

Award Number: R01NR017334

ORGANIZATION: NATIONAL INSTITUTE OF NURSING RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2017

PERIOD OF PERFORMANCE END DATE: 02/28/2023

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