Clinical trial NCT04808609: Smoking Cessation Pilot for People Living With HIV (PLWH)
Official title: A Pilot Trial of a Smoking Cessation App in People Living With HIV (PLWH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Of the approximately one million persons living with HIV (PLWH) in the United States (U.S.), it is estimated that between 34-47% smoke cigarettes, around three times the prevalence (12.5%) observed in the general U.S. adult population. Consequently, PLWH experience substantial tobacco-related morbidity and mortality. In PLWH, after achieving and maintaining a suppressed viral load, smoking cessation is the next most important health behavior to maximize both quality of life and life expectancy. Given the high prevalence of cigarette smoking among PLWH and the benefit of smoking cessation, there is an urgent need for swift action to intervene to reduce tobacco use rates. However, evidence to improve tobacco cessation among PLWH is inadequate. Given the need for improving smoking cessation in PLWH, and the great promise of mHealth tools, this research study will assess smoking behaviors in people living with HIV and the subsequent efficacy of mHealth intervention for improving tobacco cessation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence
timeFrame: Baseline, 12 weeks follow up
Secondary outcomes:
measure: Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks
timeFrame: Baseline, 12 weeks follow up
measure: Change in eCO in Ppm From Baseline to 12-week Follow-up
timeFrame: Baseline to 12-week Follow-up
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: Baseline, 12-week Follow-up
measure: Self-reported Number of Cigarettes Smoked Daily at Baseline
timeFrame: Baseline
measure: CAGE Substance Abuse Screening Tool Score at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.