HIV Infections, Smoking Cessation
Conditions
Keywords
Sense2Quit, Tobacco Use
Brief summary
This is a pilot randomized controlled trial to examine the feasibility, acceptability and preliminary efficacy of the Sense2Quit App in a sample of 60 PLWH who smoke.
Detailed description
The estimated 40-70% of persons living with HIV (PLWH) who smoke cigarettes experience substantial tobacco-related morbidity and mortality. For PLWH, apart from achieving and maintaining a suppressed viral load, tobacco cessation is the most important health behavior they can undertake to maximize both quality of life and life expectancy. However, the currently available evidence for improving tobacco cessation among PLWH is inadequate. Few tobacco cessation interventions have been tested among PLWH, and of those which have, there is 'very low' quality evidence that they were effective in the short-term and 'moderate' quality evidence indicating similar outcomes to controls in the long-term. Thus, it is critical to develop evidence-based tobacco cessation interventions to address the complex and unique needs of PLWH. In response to this need, the investigators propose to develop a mobile intervention for PLWH who smoke building on Sense2Quit, a multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential trigger. This real-time feedback is critical especially in the first few weeks of a quit attempt. The proposed Sense2Quit intervention for PLWH who smoke cigarettes is a novel and evidence-driven intervention using mobile technology to improve tobacco cessation. This will be the first study to develop and pilot test an innovative tobacco cessation intervention for PLWH. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population. The investigators are confident that the proposed intervention will be a high impact intervention for improving tobacco cessation among PLWH and have long-term implications for overall improvement in the public's health.
Interventions
BEHAVIORALSense2Quit App
Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch.
Sponsors
Case Western Reserve University
National Cancer Institute (NCI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Intervention assignment will be masked to participants only
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PLWH confirmed through medical records or pill bottles for antiretroviral therapy (ART)medications. * ≥ 18 years of age; * Own an Android smartphone; * Understand and read English; * Not pregnant or breastfeeding (due to contraindications for Nicotine Replacement Therapy \[NRT\]); * Permanent contact information; * Smokes ≥5 cigarettes per day for the past 30 days; * Interested in quitting smoking within 30 days; * Blows ≥5 ppm eCO into a breath analyzer at baseline.
Exclusion criteria
* Use of tobacco products other than cigarettes (i.e. cigars, piped tobacco, chew, snuff) * Planning to move within 3 months of enrollment; * Positive history of a medical condition that precludes nicotine patch use; * Current use of NRT or other smoking cessation medications (e.g., Chantix or Zyban); * Current enrollment in another smoking cessation program. * Alcohol dependence measured through the AUDIT-C * A household member is also participating in the Sense2Quit study (due to study contamination).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks | 12 weeks after baseline (or quit date if later than baseline visit) | 7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels \<5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention (App Arm) Participants randomized to the intervention arm will receive access to the Sense2Quit App (A multi-component intervention that links a smartphone app to a smartwatch to provide real-time quit reminders to curtail relapses and avoid potential triggers), standard smoking cessation counseling, and nicotine replacement therapy.
Sense2Quit App: Participants in the intervention arm will receive access to Sense2Quit, a smartphone app that links to a smartwatch. | 30 |
| Control Participants randomized to the control arm will receive standard smoking cessation counseling and referral to quitline. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Intervention (App Arm) | Total |
|---|---|---|---|
| Age, Continuous | 58.83 years STANDARD_DEVIATION 7.9 | 53.97 years STANDARD_DEVIATION 12.05 | 56.40 years STANDARD_DEVIATION 10.4 |
| Annual Income $10,000-$19,999 | 17 Participants | 9 Participants | 26 Participants |
| Annual Income $20,000-$39,999 | 4 Participants | 5 Participants | 9 Participants |
| Annual Income $40,000-$59,999 | 0 Participants | 1 Participants | 1 Participants |
| Annual Income Don't know | 0 Participants | 1 Participants | 1 Participants |
| Annual Income Less than $10,000 | 9 Participants | 14 Participants | 23 Participants |
| Education Associate degree or technical degree | 2 Participants | 1 Participants | 3 Participants |
| Education Bachelor/college degree | 3 Participants | 1 Participants | 4 Participants |
| Education High school diploma or equivalent | 7 Participants | 13 Participants | 20 Participants |
| Education None | 1 Participants | 1 Participants | 2 Participants |
| Education Professional or graduate degree | 0 Participants | 3 Participants | 3 Participants |
| Education Some College | 9 Participants | 5 Participants | 14 Participants |
| Education Some high school, no diploma | 8 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 29 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 24 Participants | 24 Participants | 48 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex/Gender, Customized Female | 12 Participants | 15 Participants | 27 Participants |
| Sex/Gender, Customized Male | 16 Participants | 13 Participants | 29 Participants |
| Sex/Gender, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Female/Transwoman/Male-to-Female | 1 Participants | 2 Participants | 3 Participants |
| Sexual Orientation Asexual | 0 Participants | 1 Participants | 1 Participants |
| Sexual Orientation Bisexual | 3 Participants | 2 Participants | 5 Participants |
| Sexual Orientation Heterosexual/straight | 17 Participants | 15 Participants | 32 Participants |
| Sexual Orientation Homosexual/gay/lesbian | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks
7-day point prevalence abstinence is calculated as the percentage of participants who reported no smoking/tobacco use in the 7 days prior to their 12-week follow-up visits biochemically verified by exhaled Carbon Monoxide (eCO) collected at 4 and 12 weeks via breathalyzer (Micro+TM basic Smokerlyzer®). At each of the 2 follow-up timepoints, participants with eCO levels \<5 parts per million (ppm) will be classified as abstinent while participants with eCO levels ≥5ppm will be classified as not abstinent.
Time frame: 12 weeks after baseline (or quit date if later than baseline visit)
Population: 28 of the 29 control arm participants analyzed as the smokerlyzer data was not collected from one participant at the 12 week timepoint
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (App Arm) | Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks | 2 Participants |
| Control | Percentage of Participants With Biochemically Verified 7-day Point Prevalence Smoking/Tobacco Abstinence at 12 Weeks | 4 Participants |