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Completed

NCT Number: NCT04609514

Learn to Quit-HIV Pilot Study

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Smoking Cessation Substance-Related Disorders Tobacco Use Disorder Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Learn to Quit-HIV

Device

A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.

Other names: LTQ-H, LTQ-HIV

QuitGuide

Behavioral

A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.

Other names: NCI QuitGuide

Nicotine patch

Drug

All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches.

Smartphone coaching

Behavioral

All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app.

Primary outcomes

  1. Duration of Daily App Use

    Time frame: 3 months

    Average duration of app use per arm over participants' 3 months of study participation

  2. Frequency of App Use as Measured by Interactions Per Day

    Time frame: 3 months

    Average frequency of app use per arm over participants' 3 months of study participation.

  3. Participant Attrition at One Month

    Time frame: 1 month

    Number of participants lost to follow-up at one month.

  4. Participant Attrition at Two Months

    Time frame: 2 months

    Number of participants lost-to-follow-up at two months.

  5. Participant Attrition at Three Months

    Time frame: 3 month

    Number of participants lost-to-follow-up at three months.

  6. Recruitment as Measured by the Proportion of Goal Participants Consented

    Time frame: 1 year

    Number of participants consented divided by goal of consenting 60 participants.

  7. App Usability as Measured by the Systems Usability Scale

    Time frame: 1 month or next available time point if participant completed the measure at 3 months.

    Average app usability scores as measured by the Systems Usability Scale. The scale has a score range of 0 to 100 with higher scores representing better outcomes.

Secondary outcomes

  1. Reduction in Cigarettes Smoked Per Day

    Time frame: 3 months

    Change in cigarettes smoked per day from baseline to the 12-week follow up. Cigarettes smoked per day are measured with a self-report item at baseline and at the 3-month follow up. This outcome is calculated as the difference between cigarettes smoked per day at baseline and the cigarettes smoked per day at the 3 month timepoint. A positive and large values in this outcome indicate larger reductions in cigarettes smoked per day per group, indicating a more positive outcome. A negative and large value indicate an increase in cigarettes smoked per day per group, indicating a clinically negative outcome.

  2. Number of Quit Attempts

    Time frame: 1 month

    Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.

  3. Number of Quit Attempts

    Time frame: 3 months

    Quit attempts defined as self-reported no smoking at all for 24 hours; assessed via a Timeline Followback procedure.

  4. 7-day Point Prevalence Abstinence

    Time frame: 1 month

    Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent.

  5. 7-day Point Prevalence Abstinence

    Time frame: 3 months

    Percent of subjects in each group reporting 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, or if they do not provide data at the time-point they are not considered abstinent.

  6. Overall Adherence to Nicotine Replacement Therapy

    Time frame: baseline to 3 months

    Reported as percent of participants who used the patch at least 80% of the days of the required 8 weeks. Adherence determined by timeline follow back interview.

  7. Number of Participants With at Least One Adverse Event Determined to be Related to the Study Interventions

    Time frame: 3 months

    Adverse events reported here will only include those that are determined to be related to the study interventions.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2020
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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