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

NCT03580460 | Completed

• 1 other identifier: IRB00117151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Readiness to change smoking behaviour

  Self-report on the Alcohol and Other Drug Contemplation Ladder, 1-10 Visual Analog Scale with 0- no readiness and 10- full readiness

  immediately post-intervention

Secondary Outcomes (2)

• Engagement in Smoking Cessation Services

  8 weeks post-intervention

• Confidence in ability to quit smoking

  immediately post-intervention

Study Arms (2)

Waitlist control

NO INTERVENTION

After 8 weeks, individuals randomized to this arm receives the computer-delivered smoking cessation counseling intervention

Computer Delivered Intervention

EXPERIMENTAL

Individuals receive a 15-20 minute computer delivered smoking cessation counseling intervention

Behavioral: Computer delivered smoking cessation counseling

Interventions

Computer delivered smoking cessation counseling BEHAVIORAL

15 to 20 minute computer-delivered interactive smoking cessation counseling

Computer Delivered Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cigarette Smoking

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Geetanjali Chander, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arm, RCT with waitlist control

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: April 4, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

US (1)