Clinical trial NCT04609514: Learn to Quit-HIV Pilot Study
Official title: Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Smoking Cessation
Tobacco Use Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-10-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Duration of Daily App Use
timeFrame: 3 months
measure: Frequency of App Use as Measured by Interactions Per Day
timeFrame: 3 months
measure: Participant Attrition at One Month
timeFrame: 1 month
measure: Participant Attrition at Two Months
timeFrame: 2 months
measure: Participant Attrition at Three Months
timeFrame: 3 month
measure: Recruitment as Measured by the Proportion of Goal Participants Consented
timeFrame: 1 year
measure: App Usability as Measured by the Systems Usability Scale
timeFrame: 1 month or next available time point if participant completed the measure at 3 months.
Secondary outcomes:
measure: Reduction in Cigarettes Smoked Per Day
timeFrame: 3 months
measure: Number of Quit Attempts
timeFrame: 1 month
measure: Number of Quit Attempts
timeFrame: 3 months
measure: 7-day Point Prevalence Abstinence
timeFrame: 1 month
measure: 7-day Point Prevalence Abstinence
timeFrame: 3 months
measure: Overall Adherence to Nicotine Replacement Therapy
timeFrame: baseline to 3 months
measure: Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Lauren Pacek, PhD
role: PRINCIPAL_INVESTIGATOR
References: