Randomized Controlled Trial

. 2021 Jan 6;14(1):2.

doi: 10.1186/s13104-020-05417-3.

A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

Elexis C Kierstead^{1

2}, Emily Harvey³, Denisse Sanchez⁴, Kimberly Horn^{5

6}, Lorien C Abroms⁷, Freya Spielberg⁸, Cassandra A Stanton⁹, Charles Debnam¹⁰, Amy M Cohn¹¹, Tiffany Gray¹², Manya Magnus¹³, Minal Patel⁴, Raymond Niaura¹⁴, Jessica L Elf¹⁵

Affiliations

¹ Schroeder Institute, Truth Initiative, 900 G St. NW, Washington, DC, USA. lkierstead@truthinitiative.org.
² Department of Epidemiology, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA. lkierstead@truthinitiative.org.
³ The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
⁴ Schroeder Institute, Truth Initiative, 900 G St. NW, Washington, DC, USA.
⁵ Carilion Fralin Biomedical Research Institute at VTC, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA.
⁶ Department of Population Health Sciences, Virginia-Maryland College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA.
⁷ Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, USA.
⁸ Department of Population Health, Dell Medical School, University of Texas, Austin, TX, USA.
⁹ Behavioral Health and Health Policy Practice, Westat, Rockville, MD, USA.
¹⁰ Community Wellness Alliance, Washington, DC, USA.
¹¹ Department of Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, OK, USA.
¹² Department of Community Health Administration, Department of Health, Washington, DC, USA.
¹³ Department of Epidemiology, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
¹⁴ Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York City, NY, USA.
¹⁵ Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine & Biomedical Sciences, Fort Collins, CO, USA.

PMID: 33407848
PMCID: PMC7789216
DOI: 10.1186/s13104-020-05417-3

Randomized Controlled Trial

A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

Elexis C Kierstead et al. BMC Res Notes. 2021.

. 2021 Jan 6;14(1):2.

doi: 10.1186/s13104-020-05417-3.

Authors

Affiliations

¹ Schroeder Institute, Truth Initiative, 900 G St. NW, Washington, DC, USA. lkierstead@truthinitiative.org.
² Department of Epidemiology, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA. lkierstead@truthinitiative.org.
³ The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
⁴ Schroeder Institute, Truth Initiative, 900 G St. NW, Washington, DC, USA.
⁵ Carilion Fralin Biomedical Research Institute at VTC, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA.
⁶ Department of Population Health Sciences, Virginia-Maryland College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA.
⁷ Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, USA.
⁸ Department of Population Health, Dell Medical School, University of Texas, Austin, TX, USA.
⁹ Behavioral Health and Health Policy Practice, Westat, Rockville, MD, USA.
¹⁰ Community Wellness Alliance, Washington, DC, USA.
¹¹ Department of Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, OK, USA.
¹² Department of Community Health Administration, Department of Health, Washington, DC, USA.
¹³ Department of Epidemiology, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
¹⁴ Department of Social and Behavioral Sciences, School of Global Public Health, New York University, New York City, NY, USA.
¹⁵ Department of Environmental and Radiological Health Sciences, College of Veterinary Medicine & Biomedical Sciences, Fort Collins, CO, USA.

PMID: 33407848
PMCID: PMC7789216
DOI: 10.1186/s13104-020-05417-3

Abstract

Objective: Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. We conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model. We compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.

Results: The primary outcome was smoking cessation. Secondary outcomes included cigarettes per day (CPD), exhaled carbon monoxide (CO), and cessation self-efficacy. A total of 25 participants were enrolled (TI:11, SOC:14), and 2 were lost to follow-up. There were no significant differences in quit rates between study groups. However, there was a significantly greater decrease in CPD in the TI versus SOC (13.5 vs. 0.0, p-value:0.036). Additionally, self-efficacy increased in both groups (TI p-value:0.012, SOC p-value:0.049) and CO decreased in both groups (TI p-value: < 0.001, SOC p-value:0.049). This intervention shows promise to support smoking cessation among PLWH. A larger study is needed to fully evaluate the efficacy of this approach.

Clinical trial: Trial Registration: Retrospectively registered (10/20/2020) NCT04594109.

Keywords: Behavioral health; Cessation; HIV/AIDS; Minority health; Tobacco.

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Conflict of interest statement

One author has potential conflicts of interests to declare. Dr. Manya Magnus (GW) has received grants from the NIH for HIV Prevention Trials Network Clinical Research site and for the DC Center for AIDS, although she has received no funds directly. She is also the author of three epidemiology textbooks through Jones and Barlett Inc. from which she receives royalties.

Figures

**Fig. 1**
Participant flow through a randomized controlled trial of a tailored smoking cessation intervention for people living with HIV in the Washington, D.C. metropolitan area. Participants were assessed for eligibility based on screening criteria, randomized to a study arm, either a tailored intervention (TI) or standard of care (SOC), and asked to complete a 30-day follow-up assessment. Forty were assessed for eligibility, 25 were randomized (11 to TI and 14 to SOC) and 23 completed the 30-day follow-up assessment

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A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

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A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area

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