N/A Completed N=43 Randomized Treatment

Learn to Quit-HIV Pilot Study

HIV · Smoking Cessation · Tobacco Use

Source: ClinicalTrials.gov NCT04609514 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcomePrimary: Duration of Daily App Use — 12; 1.05 minutes — p=0.51

Summary

The study team will conduct a feasibility, acceptability, and preliminary efficacy trial comparing Learn to Quit-HIV (n=30) to an app based on U.S. Clinical Practice Guidelines only (NCI QuitGuide; n=30) among HIV-positive smokers. Both apps will be integrated with NRT and ongoing HIV clinical care.

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Daily App Use	12; 1.05	0.51
PRIMARY Frequency of App Use as Measured by Interactions Per Day	1.91; 1.21	<0.001 sig
PRIMARY Participant Attrition at One Month	2; 5	—
PRIMARY Participant Attrition at Two Months	4; 7	—
PRIMARY Participant Attrition at Three Months	7; 7	—
PRIMARY Recruitment as Measured by the Proportion of Goal Participants Consented	0.85	—
PRIMARY App Usability as Measured by the Systems Usability Scale	73; 78	0.39
SECONDARY Reduction in Cigarettes Smoked Per Day	11.1; 9.2	0.40
SECONDARY Number of Quit Attempts	1.86; 2.50	0.51
SECONDARY Number of Quit Attempts	1.86; 2.50	0.51
SECONDARY 7-day Point Prevalence Abstinence	18.2; 15.8	0.8392
SECONDARY 7-day Point Prevalence Abstinence	18.2; 15.8	0.8392
SECONDARY Overall Adherence to Nicotine Replacement Therapy	31.8; 31.6	1.00
SECONDARY Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions	3; 2	—

Eligibility Criteria

Inclusion Criteria

HIV-positive
Currently engaged with an HIV care provider
Self-report smoking 5 cigarettes or more per day during the past 30 days
Age 18 years or older
Current interest in quitting smoking
Currently own a functioning Android or Apple smartphone

Exclusion Criteria

No desire to quit smoking
Inability to attend study sessions
Inability to provide informed consent
Any medical condition or concomitant medication that could compromise subject safety or treatment, as determined by the Principal Investigators and/or Study Physician
Presence of contraindications for nicotine patch
Previous allergic reaction or hypersensitivity to nicotine patch (lifetime)
Current use of nicotine replacement therapy or other smoking cessation treatment (e.g., bupropion, varenicline)
Pregnant, planning to become pregnant, nursing, or becoming pregnant during the study
Current untreated and unstable diagnosis of alcohol/substance abuse or dependence (eligible if past abuse/dependence and if receiving treatment and stable for >30 days)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04609514). 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.