NCT04609514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 19, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

October 22, 2020

Results QC Date

June 1, 2023

Last Update Submit

October 17, 2023

Conditions

HIV/AIDSSmoking CessationTobacco Use Disorder

Outcome Measures

Primary Outcomes (7)

  • Duration of Daily App Use

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

    3 months

  • Frequency of App Use as Measured by Interactions Per Day

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

    3 months

  • Participant Attrition at One Month

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

    1 month

  • Participant Attrition at Two Months

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

    2 months

  • Participant Attrition at Three Months

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

    3 month

  • Recruitment as Measured by the Proportion of Goal Participants Consented

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

    1 year

  • App Usability as Measured by the Systems Usability Scale

    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.

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

Secondary Outcomes (7)

  • Reduction in Cigarettes Smoked Per Day

    3 months

  • Number of Quit Attempts

    1 month

  • Number of Quit Attempts

    3 months

  • 7-day Point Prevalence Abstinence

    1 month

  • 7-day Point Prevalence Abstinence

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Learn to Quit-HIV

EXPERIMENTAL

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-HIVDrug: Nicotine patchBehavioral: Smartphone coaching

QuitGuide

ACTIVE COMPARATOR

A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS (United States Department of Health and Human Services) 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: QuitGuideDrug: Nicotine patchBehavioral: Smartphone coaching

Interventions

Learn to Quit-HIVDEVICE

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

Also known as: LTQ-H, LTQ-HIV
Learn to Quit-HIV
QuitGuideBEHAVIORAL

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

Also known as: NCI QuitGuide
QuitGuide
Nicotine patchDRUG

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.

Learn to Quit-HIVQuitGuide
Smartphone coachingBEHAVIORAL

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.

Learn to Quit-HIVQuitGuide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSmoking CessationTobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHealth BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Roger Vilardaga Viera, PhD
Organization
Duke University
roger.vilardaga@duke.edu
919-684-3441

Study Officials

  • Lauren Pacek, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 30, 2020

Study Start

January 25, 2021

Primary Completion

June 2, 2022

Study Completion

June 2, 2022

Last Updated

October 19, 2023

Results First Posted

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)