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

Primary Purpose

Tobacco Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored behavioral counseling
Standard of Care
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Truth Initiative

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Tailored Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cigarettes per day
Number of cigarettes smoked per day
Exhaled breath carbon monoxide
Exhaled breath carbon monoxide in parts per million (ppm)
Self-efficacy
Self-efficacy for smoking abstinence

Full Information

First Posted
October 14, 2020
Last Updated
April 17, 2023
Sponsor
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT04594109
Brief Title
Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.
Official Title
Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tailored Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored behavioral counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
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 Outcome Measure Information:
Title
Smoking Abstinence
Description
7-day point prevalence plus exhaled breath carbon monoxide < 7 parts per million (ppm)
Time Frame
30 day follow-up
Secondary Outcome Measure Information:
Title
Cigarettes per day
Description
Number of cigarettes smoked per day
Time Frame
30 day follow-up
Title
Exhaled breath carbon monoxide
Description
Exhaled breath carbon monoxide in parts per million (ppm)
Time Frame
30 day follow-up
Title
Self-efficacy
Description
Self-efficacy for smoking abstinence
Time Frame
30 day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Elf, PhD MPH
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Truth Initiative
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33407848
Citation
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.
Results Reference
derived

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

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