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OpenTrials
Completed

NCT Number: NCT04594109

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

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.

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Key information

Conditions

Tobacco Smoking Behavior Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Truth Initiative

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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
  • are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided)
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Smoking Abstinence

    Time frame: 30 day follow-up

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

Secondary outcomes

  1. Cigarettes per day

    Time frame: 30 day follow-up

    Number of cigarettes smoked per day

  2. Exhaled breath carbon monoxide

    Time frame: 30 day follow-up

    Exhaled breath carbon monoxide in parts per million (ppm)

  3. Self-efficacy

    Time frame: 30 day follow-up

    Self-efficacy for smoking abstinence

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2020
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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