Learn to Quit-HIV Pilot Study

• ClinicalTrials.gov Identifier: NCT04609514
• Recruitment Status: Recruiting
• First Posted: October 30, 2020
• Last Update Posted: February 11, 2022
• Sponsor: Duke University
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS; Smoking Cessation; Tobacco Use Disorder	Device: Learn to Quit-HIV; Behavioral: QuitGuide; Drug: Nicotine patch; Behavioral: Smartphone coaching	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early-phase Studies of a Tailored Evidence-Based Smoking Cessation mHealth App for Persons Living With HIV
• Actual Study Start Date: January 25, 2021
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Learn to Quit-HIV; A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.	Device: Learn to Quit-HIV; 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; Drug: Nicotine patch; 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.; Behavioral: Smartphone coaching; 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.
Active Comparator: QuitGuide; A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches, along with technical smartphone coaching for the first 4 weeks of the study.	Behavioral: QuitGuide; A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.; Other Name: NCI QuitGuide; Drug: Nicotine patch; 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.; Behavioral: Smartphone coaching; 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.

Outcome Measures

Primary Outcome Measures :

1. Duration of app use [ Time Frame: Daily throughout 3 months of participation ]
   Average duration of app use per arm over participants' 3 months of study participation
2. Frequency of app use [ Time Frame: Daily throughout 3 months of participation ]
   Average frequency of app use per arm over participants' 3 months of study participation
3. Participant attrition [ Time Frame: 1 Month Follow-Up ]
   Percent of participants lost-to-follow-up at the specified time point
4. Participant attrition [ Time Frame: 2 Month Follow-Up ]
   Percent of participants lost-to-follow-up at the specified time point
5. Participant attrition [ Time Frame: 3 Month Follow-Up ]
   Percent of participants lost-to-follow-up at the specified time point
6. Recruitment rate [ Time Frame: 1 year ]
   Percent of participants enrolled relative to study enrollment goal (N=60)
7. App usability [ Time Frame: 1 Month Follow-Up ]
   Average app usability scores as measured by the Systems Usability Scale. The scale has a score range of 0- 100 with higher scores representing better outcomes.

Secondary Outcome Measures :

1. Cigarettes smoked per day [ Time Frame: Daily throughout study duration, 3 months ]
   Measured daily with the tracking feature embedded within LTQ-H and NCI QuitGuide; allows users to enter how many cigarettes they smoked each day
2. Quit Attempts [ Time Frame: 1 month follow-up ]
   Defined as self-reported no smoking at all for 24 hours and time to 7-day relapse; assessed via a Timeline Follow Back procedure
3. Quit Attempts [ Time Frame: 3 month follow-up ]
   Defined as self-reported no smoking at all for 24 hours and time to 7-day relapse; assessed via a Timeline Follow Back procedure
4. 7-day point prevalence abstinence [ Time Frame: 1 month follow-up ]
   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 month follow-up ]
   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. Adherence to nicotine replacement therapy [ Time Frame: 1 month follow-up ]
   Percent of subjects adherent to patch directions. Adherence determined by app tracking features and brief interviewer-administered questionnaires.
7. Adherence to nicotine replacement therapy [ Time Frame: 2 month follow-up ]
   Percent of subjects adherent to patch directions. Adherence determined by app tracking features and brief interviewer-administered questionnaires.
8. Adherence to nicotine replacement therapy [ Time Frame: 3 month follow-up ]
   Percent of subjects adherent to patch directions. Adherence determined by app tracking features and brief interviewer-administered questionnaires.
9. Number of participants with at least one adverse event [ Time Frame: 3 month follow-up ]
   Adverse events will only include those that are determined to be related to the study interventions.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Roger Vilardaga, PhD; 9196813441; roger.vilardaga@duke.edu

Contact: Anthony DeVito; 9196841377; anthony.devito@duke.edu

Locations

United States, North Carolina

Duke University; Recruiting

Durham, North Carolina, United States, 27705

Contact: Roger Vilardaga, PhD 919-681-3441 roger.vilardaga@duke.edu

Principal Investigator: Lauren Pacek, PhD

Sponsors and Collaborators

Duke University

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Lauren Pacek, PhD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04609514
• Other Study ID Numbers: Pro00104423
• First Posted: October 30, 2020
• Last Update Posted: February 11, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action