Smoking Cessation Pilot for People Living With HIV (PLWH)

NCT04808609 | Completed Results FDA Device

• 1 other identifier: AAAS6990
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation. Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.

Conditions

Smoking Cessation; Smoking; Smoking Behaviors; Smoking Reduction; Smoking, Tobacco; Smoking, Cigarette; Hiv; HIV/AIDS

Keywords

Smoking; Smoking Cessation; Smoking Behaviors; Smoking Reduction; Tobacco; Cigarette; PLWH; HIV; HIV/AIDS; mHealth; Mobile Health; Lumme; Pilot

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence

  7-day point prevalence abstinence was calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visit biochemically verified by exhaled Carbon Monoxide (eCO) collected at 12 weeks. Participants with eCO levels \<6 parts per million (ppm) at 12 weeks were classified as abstinent while participants with eCO levels ≥6ppm at 12 weeks were classified as not abstinent.

  Baseline, 12 weeks follow up

Secondary Outcomes (5)

• Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks

  Baseline, 12 weeks follow up

• Change in eCO in Ppm From Baseline to 12-week Follow-up

  Baseline to 12-week Follow-up

• Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score

  Baseline, 12-week Follow-up

• Self-reported Number of Cigarettes Smoked Daily at Baseline

  Baseline

• CAGE Substance Abuse Screening Tool Score at Baseline

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The Intervention group receives standard smoking cessation counseling and nicotine replacement therapy AND access to the Lumme app that tracks smoking behaviors and provides cessation support.

Device: Lumme mobile phone application; Behavioral: Standard of Care

Control

OTHER

The Control group receives standard smoking cessation counseling and nicotine replacement therapy

Behavioral: Standard of Care

Interventions

Lumme mobile phone application DEVICE

Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors

Intervention

Standard of Care BEHAVIORAL

Smoking cessation counseling and nicotine replacement therapy

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• PLWH
• ≥ 18 years old
• own an Android smartphone
• understand and read English
• not pregnant or breastfeeding
• permanent contact information
• smokes greater than or equal to 5 cigarettes per day for the past 30 days
• interested in quitting smoking within 30 days
• blow ≥ 6 carbon monoxide (CO) into a breath analyzer at baseline

You may not qualify if:

• self-report being HIV-negative or unknown status
• pregnant, breastfeeding, or planning to become pregnant during the study period
• planning to move within 3 months of enrollment
• a positive history of a medical condition that precludes use of the nicotine patch
• current use of nicotine replacement therapy or other smoking cessation medications
• current enrollment in another smoking cessation program
• blows ≤ 5 CO into a breath analyzer at baseline.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Schnall R, Liu J, Alvarez G, Porras T, Ganzhorn S, Boerner S, Huang MC, Trujillo P, Cioe P. A Smoking Cessation Mobile App for Persons Living With HIV: Preliminary Efficacy and Feasibility Study. JMIR Form Res. 2022 Aug 18;6(8):e28626. doi: 10.2196/28626.

  PMID: 35980739 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking; Smoking Reduction; Tobacco Smoking; Cigarette Smoking; Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use; 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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Rebecca Schnall, RN, MPH, PhD, Professor of Disease Prevention and Health Promotion (in Nursing)
• Organization: Columbia University

rb897@cumc.columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, RN

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Disease Prevention and Health Promotion (in Nursing)

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: October 6, 2020
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: February 23, 2023
• Results First Posted: July 18, 2022

Record last verified: 2023-02

Locations

US (1)