NCT05339659

Brief Summary

This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

April 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

April 11, 2022

Results QC Date

February 21, 2024

Last Update Submit

March 28, 2024

Conditions

SmokingSmoking Cessation

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Intervention (App) Utilization

    Number of unique app user-sessions

    3 months post-enrollment

Secondary Outcomes (14)

  • App Installation and Use

    3 month follow-up

  • App Utilization - Cumulative Days of Use

    3 month follow-up

  • Self-reported 24-hour Quit Attempt

    3 months post-enrollment

  • Satisfaction With App Content and Advice

    1 month follow-up

  • Satisfaction With App Content and Advice

    3 month follow-up

  • +9 more secondary outcomes

Other Outcomes (10)

  • Utilization - Personal Experiments

    3 month follow-up

  • Quit Guide Participation

    3 month follow-up

  • Quit Guide Completion

    3 month follow-up

  • +7 more other outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.

Device: mHealth Intervention

Experimental

EXPERIMENTAL

mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.

Device: mHealth Intervention

Interventions

mHealth InterventionDEVICE

Mobile health (mHealth) app to motivate and support quitting smoking.

ControlExperimental

Eligibility Criteria

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

You may qualify if:

  • years of age or older;
  • Comfortable speaking and reading in English;
  • Smoked at least 100 cigarettes in their lifetime;
  • Smoked, even a puff, in the past 7 days;
  • Smoked at least 5 cigarettes a day;
  • Are interested in quitting smoking someday, but not in the next month;
  • Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
  • Are willing to upgrade their phone operating system, if needed;
  • Agree to download and try the app;
  • Do not use Virtual Private Network (VPN) on their smart phone;
  • Live in the United States and have a valid U.S.-based mailing address and phone number;
  • Have been diagnosed with HIV

You may not qualify if:

  • Refusing to answer all screening questions
  • History of dementia or psychosis
  • Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
  • Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente WA Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • McClure JB, Heffner JL, Krakauer C, Mun S, Catz SL. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study. JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063.

    PMID: 38976321DERIVED

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Limitations and Caveats

The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 19) and are subject to missingness for some outcomes. This pilot study was not powered to provide definitive answers about the efficacy of the intervention. A larger trial is needed for this.

Results Point of Contact

Title
Dr. Jennifer McClure
Organization
Kaiser Permanente
jennifer.b.mcclure@kp.org
206-287-2737

Study Officials

  • Jennifer McClure, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Faculty & Development

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 21, 2022

Study Start

June 2, 2022

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

April 1, 2024

Results First Posted

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)