Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.

NCT04594109 | Completed

• 1 other identifier: 00022163
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. The investigators 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.

Conditions

Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence

  7-day point prevalence plus exhaled breath carbon monoxide \< 7 parts per million (ppm)

  30 day follow-up

Secondary Outcomes (3)

• Cigarettes per day

  30 day follow-up

• Exhaled breath carbon monoxide

  30 day follow-up

• Self-efficacy

  30 day follow-up

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

One-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.

Behavioral: Standard of Care

Tailored Counseling

EXPERIMENTAL

Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.

Behavioral: Tailored behavioral counseling

Interventions

Tailored behavioral counseling BEHAVIORAL

Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.

Tailored Counseling

Standard of Care BEHAVIORAL

One-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• report being HIV-infected
• be a resident of the Washington, D.C. area
• current, daily smokers of tobacco
• have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor
• agree to participate
• be willing to set a quit date within 7 days of baseline assessment.

You may not qualify if:

• are currently using smokeless tobacco or electronic cigarettes at least every day
• are currently using nicotine replacement therapy or other smoking cessation treatment
• report being HIV-uninfected
• report having heart disease or high blood pressure not controlled by medication
• are currently in an alcohol treatment program
• do not have a primary care provider or HIV care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (1)

• Kierstead EC, Harvey E, Sanchez D, Horn K, Abroms LC, Spielberg F, Stanton CA, Debnam C, Cohn AM, Gray T, Magnus M, Patel M, Niaura R, Elf JL. A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area. BMC Res Notes. 2021 Jan 6;14(1):2. doi: 10.1186/s13104-020-05417-3.

  PMID: 33407848 DERIVED

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jessica Elf, PhD MPH

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: June 30, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 30, 2018
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)