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Cultural Adaptation and Piloting of a Smoking Cessation Intervention for Smokers With HIV

Cultural Adaptation and Piloting of an Avatar Delivered Smoking Cessation Intervention for Low Income Smokers in Baltimore City Living With HIV

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03580460
Enrollment
40
Registered
2018-07-09
Start date
2018-04-04
Completion date
2018-09-01
Last updated
2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Hiv

Brief summary

One population of tobacco users that is severely affected by the consequences of smoking is people living with HIV (PLWH). Between 40-84% of PLWH smoke, a percentage that has remained constant since the first studies of smoking in HIV were conducted in the 1990's. Overall, smoking related morbidity and mortality is also greatly increased among PLWH smokers. Compared with PLWH nonsmokers, PLWH who smoke have more than 5 times the risk of non-HIV-related mortality and almost 4 times the risk of all-cause mortality. Compared with the general population, incidence ratio of smoking related cancers (eg, lung, head, neck, bladder and esophageal) is more than 5 times higher. At a critical time when advances in HIV care are providing an opportunity for prolonged life, smoking is significantly impeding the health of PLWH. To produce meaningful changes in smoking, however, treatment will have to be acceptable and engaging to this population as well as feasible and sustainable to implement in a busy clinic. Novel technology-based interventions that incorporate evidence-based behavioral and pharmacologic interventions for smoking and are culturally tailored offer real solutions to these implementation barriers. Research shows that internet- or computer-delivered interventions (CDI) that are tailored and interactive can be efficacious in reducing smoking and are significantly more effective than usual care or written self-help materials. CDIs can also be readily adapted to different sociodemographic characteristics of a patient population because content is modular and menu driven. Moreover, technology-based interventions appear as effective as counselor-delivered interventions in reducing smoking. This growing body of evidence strongly suggests that these interventions offer promise in reducing smoking, the potential to reach significantly more patients, and the ability to overcome barriers of cost, implementation, and cultural nonspecificity. The goal of this pilot study is test to examine feasibility, acceptability of a computer-delivered smoking cessation intervention for PLWH, and to determine if intervention participation results in increased readiness to quit smoking and increased confidence in ability to quit smoking.

Detailed description

One population of tobacco users that is severely affected by the consequences of smoking is people living with HIV (PLWH). Between 40-84% of PLWH smoke, a percentage that has remained constant since the first studies of smoking in HIV were conducted in the 1990's. Overall, smoking related morbidity and mortality is also greatly increased among PLWH smokers. Compared with PLWH nonsmokers, PLWH who smoke have more than 5 times the risk of non-HIV-related mortality and almost 4 times the risk of all-cause mortality. Compared with the general population, their incidence ratio of smoking related cancers (eg, lung, head, neck, bladder and esophageal) is more than 5 times higher. At a critical time when advances in HIV care are providing an opportunity for prolonged life, smoking is significantly impeding the health of PLWH. To produce meaningful changes in smoking, however, treatment will have to be acceptable and engaging to this population as well as feasible and sustainable to implement in a busy clinic. Novel technology-based interventions that incorporate evidence-based behavioral and pharmacologic interventions for smoking and are culturally tailored offer real solutions to these implementation barriers. Research shows that internet- or computer-delivered interventions (CDI) that are tailored and interactive can be efficacious in reducing smoking and are significantly more effective than usual care or written self-help materials. CDIs can also be readily adapted to different sociodemographic characteristics of a patient population because content is modular and menu driven. Moreover, technology-based interventions appear as effective as counselor-delivered interventions in reducing smoking. This growing body of evidence strongly suggests that these interventions offer promise in reducing smoking, the potential to reach significantly more patients, and the ability to overcome barriers of cost, implementation, and cultural nonspecificity. The goal of this pilot randomized controlled trial (RCT) is study is test to examine feasibility, acceptability of a computer-delivered smoking cessation intervention for PLWH, and to determine if intervention participation results in increased readiness to quit smoking and increased confidence in ability to quit smoking.To pilot test the computer-delivered intervention among 40 individuals with HIV receiving care in an urban HIV clinic in a small Randomized Controlled Trial 2a) To determine intervention effect on 1) readiness to quit smoking 2) increased confidence in ability to quit smoking 2) uptake of smoking cessation therapy, including a. Quit Line, b. Nicotine replacement therapy c. Pharmacotherapy (varenicline, Wellbutrin) Hypothesis: Investigators hypothesize that intervention participation will be associated with 1) increased readiness to quit and confidence in quitting smoking and 2) increased engagement with smoking cessation services. 2b) To examine feasibility and acceptability of delivering the computer-delivered smoking cessation counseling in this setting.

Interventions

BEHAVIORALComputer delivered smoking cessation counseling

15 to 20 minute computer-delivered interactive smoking cessation counseling

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

2 arm, RCT with waitlist control

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age \>=18 * A patient in the Johns Hopkins University (JHU) Bartlett Clinic * Smoked \>100 cigarettes in their lifetime * Current daily smoker (verified by exhaled carbon monoxide) * English speaking.

Exclusion criteria

* Individuals will be excluded if they do not meet the above requirements

Design outcomes

Primary

MeasureTime frameDescription
Readiness to change smoking behaviourimmediately post-interventionSelf-report on the Alcohol and Other Drug Contemplation Ladder, 1-10 Visual Analog Scale with 0- no readiness and 10- full readiness

Secondary

MeasureTime frameDescription
Engagement in Smoking Cessation Services8 weeks post-interventionSelf-Reported Use of Quitline or pharmacotherapy for smoking cessation which will based on a questionnaire.
Confidence in ability to quit smokingimmediately post-interventionSelf report on visual analog scale measuring confidence in ability to quit smoking on visual analog scale 1-100 with a higher value representing higher confidence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026