A Mobile Intervention to Promote Cessation in HIV-infected Smokers

NCT ID: NCT02432482

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-04-30

Brief Summary

The purpose of this study is to adapt an existing web-based tobacco treatment program for HIV-infected smokers into a mobile intervention delivered via smartphone. After the adaptation is completed, the investigators will test the program's efficacy at promoting abstinence in a randomized controlled trial.

Detailed Description

There are nearly one million persons living with confirmed HIV infection (PLWH) in the US, 60% of them smoke cigarettes, and 75% of them are interested in quitting. Almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns.

Cigarette smoking is a leading contributor to mortality among PLWH in the HAART era, and it is the direct cause of 30% of non-AIDS defining malignancies. It is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. The lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. The psychosocial profile of the PLWH-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge.

Positively Smoke Free is an intensive, multisession, cessation intervention specifically developed for PLWH smokers. It is currently available as a live, group therapy program and also as a web-based version designed for notebook or desktop computers. In its current form, the web-version is not adoptable to the smartphone platform. Pilot data from randomized, controlled, trials of both formats show promise.

The number of individuals in the US who own smartphones and who use them to access health information on the internet is steadily growing. This growth is most pronounced in the ethnic minority groups that make up the majority of the PLWH community in the US. Behavioral interventions delivered via smartphones offer the advantage of expansive reach, low cost, and immediacy of access to users. A burgeoning body of literature suggests that this may be an especially effective tool for tobacco treatment. mHealth tobacco treatment interventions for PLWH smokers have not yet been explored.

This proposal aims (1) to adapt Positively Smoke Free to the mobile format for smartphones (2) to test the feasibility (i.e. recruitment, adherence, retention, satisfaction, and cost) of mobile Positively Smoke Free (mPSF) in a cohort of 50 PLWH smokers, (3) to complete a pilot randomized controlled trial comparing biochemically confirmed 3-month abstinence rates in subjects (N=50) assigned to the mPSF condition versus those (N=50) assigned to standard care (all subjects will be offered a 3-month supply of nicotine replacement therapy) and (4) to conduct exploratory analyses of putative moderators and mediators of program efficacy.

If the mobile version of PSF is proven to be feasible and efficacious, the project will have short term impact by opening a new vista of tobacco (and other behavioral) treatment for a highly vulnerable group. Study data will provide crucial information for a definitive trial of the intervention. The long-term impact will be reduced tobacco-related morbidity and mortality among PLWH, and a clearer understanding of the role of mHealth in comprehensive HIV care.

Conditions

Tobacco Use; HIV-1-infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care

Brief advice to quit (less than 5 minutes) Self-help brochure Offer of nicotine patches

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

Brief advice to quit (\<5 minutes) Self-help brochure Offer of nicotine patches

mobile Positively Smoke Free (mPSF)

mPSF: a targeted, intensive behavioral cessation intervention for PLWH smokers

• offer of nicotine patches

Group Type: EXPERIMENTAL

mobile Positively Smoke Free (mPSF)

Intervention Type: BEHAVIORAL

mPSF is a targeted, intensive behavioral cessation intervention designed for HIV-infected smokers. It is guided by the Social Cognitive Theory model. It includes 8 weekly sessions of audio/video messages to users, daily text messages, and a variety of other smartphone capabilities, e.g. play-a-tune, play-a-game, phone-a-friend, call the quitline.

Interventions

mobile Positively Smoke Free (mPSF)

mPSF is a targeted, intensive behavioral cessation intervention designed for HIV-infected smokers. It is guided by the Social Cognitive Theory model. It includes 8 weekly sessions of audio/video messages to users, daily text messages, and a variety of other smartphone capabilities, e.g. play-a-tune, play-a-game, phone-a-friend, call the quitline.

Intervention Type: BEHAVIORAL

Standard care

Brief advice to quit (\<5 minutes) Self-help brochure Offer of nicotine patches

Intervention Type: BEHAVIORAL

Other Intervention Names

mPSF; SC

Eligibility Criteria

Inclusion Criteria

• HIV-infected
• Current cigarette smoker
• Has a smartphone
• Interested in quitting
• Receives care at the Montefiore Center for Positive Living

Exclusion Criteria

• Pregnancy
• Contraindication to nicotine patch use

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Shuter, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

Shuter J, Morales DA, Considine-Dunn SE, An LC, Stanton CA. Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):59-66. doi: 10.1097/QAI.0000000000000226.

Reference Type: BACKGROUND

PMID: 25118794 (View on PubMed)

Other Identifiers

1R34DA037042-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014-3094

Identifier Type: -

Identifier Source: org_study_id