N/A
Completed N=40
Smoking Cessation Pilot for People Living With HIV (PLWH)
Smoking Cessation · Smoking · Smoking Behaviors · Smoking Reduction
Source: ClinicalTrials.gov NCT04808609 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence — 15.0; 11.8 percentage of participants — p=0.77
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence |
15.0; 11.8 | 0.77 |
| SECONDARY Percentage of Participants With Self-reported 7-day Point Prevalence Abstinence at 12 Weeks |
30.0; 23.5 | 0.66 |
| SECONDARY Change in eCO in Ppm From Baseline to 12-week Follow-up |
3.35; 2.12 | 0.59 |
| SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score |
16.6; 14.8 | 0.61 |
| SECONDARY Self-reported Number of Cigarettes Smoked Daily at Baseline |
11.9; 11.0 | 0.55 |
| SECONDARY CAGE Substance Abuse Screening Tool Score at Baseline |
0.9; 0.9 | 0.99 |
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.
Data sourced from ClinicalTrials.gov (NCT04808609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.