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Effectivenss of an Integrated Treatment to Address Smoking Cessation and Anxiety/Depression in People Living with HIV

Award Number: R01DA047933
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2025

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Effectivenss of an Integrated Treatment to Address Smoking Cessation and Anxiety/Depression in People Living with HIV - ABSTRACT Although the prevalence of smoking has declined over the past 50 years, large disparities in tobacco use remain across several subgroups, particularly disadvantaged and health compromised populations.1 Smokers living with HIV represent a major health disparity population in the United States (US) and the world more generally, and their unique healthcare needs are not being adequately addressed.2 For people living with HIV, smoking is related to poorer survival3,4 and among those who are adherent to their antiretroviral treatment regimens, smoking reduces life expectancy more than HIV.5–7 Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression.8 The proposed intervention is informed, in part, by the success of our recently completed NIDA-funded R34 research project (1R34DA031038-01A1) in which we specified and tested in a small open trial, and then, a pilot randomized controlled trial (RCT) the feasibility, acceptability and initial efficacy of a 9-session, cognitive- behavioral-based intervention (named QUIT) to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia). This intervention was specifically adapted and designed for smokers living with HIV. The results from this study revealed that, when compared to a brief enhanced treatment as usual control intervention (ETAU), patients assigned to QUIT achieved higher short-term (end of treatment [EOT]: QUIT: 59% vs. ETAU: 9%) and long- term (6-month follow-up: QUIT: 46% vs. ETAU: 5%) abstinence rates.9 We now propose to conduct a fully powered, 3-arm efficacy/effectiveness trial. We propose to enroll 180 smokers living with HIV across three implementation sites [(1) Infectious Disease Clinic, Massachusetts General Hospital (MGH), Boston, (2) Fenway Community Health, Boston, and (3) Thomas Street Health Center, Houston]. We seek to test the efficacy/effectiveness of the QUIT intervention at increasing point prevalence abstinence (primary outcome), by reducing anxiety and depression (secondary outcomes), and to determine if it outperforms an active, credible time-matched control, and a standard-of-care (SOC) control. The integration of resource utilization and cost-effectiveness analyses and the third SOC control arm support estimation of cost and effectiveness. If successful, the intervention would be ready for translation studies to examine implementation and dissemination into “real-world” health, mental health, and social service 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: 2026 ( Subtotal = -$232,632 )
2026	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	4	12/3/2025	NON-COMPETING CONTINUATION	-$232,632
														Subtotal = -$232,632

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	4	2/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,108,803 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	4	3/28/2023	NON-COMPETING CONTINUATION	$1,108,803
														Subtotal = $1,108,803

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	3	3/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,234,696 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	002	3	5/27/2021	SUPPLEMENT FOR EXPANSION	$9,742
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	001	3	2/11/2021	NON-COMPETING CONTINUATION	$1,224,954
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	003	3	9/7/2021	NON-COMPETING CONTINUATION	$0
2021	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	2	11/24/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,234,696

Issue Date FY: 2020 ( Subtotal = $1,227,506 )
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	2	2/7/2020	NON-COMPETING CONTINUATION	$1,060,548
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	001	2	9/21/2020	SUPPLEMENT FOR EXPANSION	$166,958
														Subtotal = $1,227,506

Issue Date FY: 2019 ( Subtotal = $1,197,167 )
2019	2019	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	001	1	5/10/2019	SUPPLEMENT FOR EXPANSION	$13,170
2019	2019	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	1	5/3/2019	NEW	$1,183,997
														Subtotal = $1,197,167

Grand Total All Awards = $4,535,540

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Effectivenss of an Integrated Treatment to Address Smoking Cessation and Anxiety/Depression in People Living with HIV

Award Number: R01DA047933

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/15/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2025

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