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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04594109
Other study ID # 00022163
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2017
Est. completion date January 30, 2018

Study information

Verified date April 2023
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 30, 2018
Est. primary completion date January 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tailored behavioral counseling
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
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.

Locations

Country Name City State
United States Truth Initiative Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Abstinence 7-day point prevalence plus exhaled breath carbon monoxide < 7 parts per million (ppm) 30 day follow-up
Secondary Cigarettes per day Number of cigarettes smoked per day 30 day follow-up
Secondary Exhaled breath carbon monoxide Exhaled breath carbon monoxide in parts per million (ppm) 30 day follow-up
Secondary Self-efficacy Self-efficacy for smoking abstinence 30 day follow-up
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