NCT05339659

Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV

Completed NA Results posted Last updated 1 April 2024

What this trial tests

NA trial testing mHealth Intervention in Smoking in 22 participants. Completed in 20 May 2023.

Timeline

2 June 2022

Primary endpoint
20 May 2023

20 May 2023

Quick facts

Lead sponsor	Kaiser Permanente
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	device feasibility
Enrollment	22
Start date	2 June 2022
Primary completion	20 May 2023
Estimated completion	20 May 2023
Sites	1 location across United States

Drugs / interventions tested

• mHealth Intervention

Conditions studied

• Smoking — all drugs for Smoking →
• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Kaiser Permanente — full company profile →

Who can join

18 and older, any sex, with Smoking or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention (App) Utilization Primary · 3 months post-enrollment

Number of unique app user-sessions

Group	Value	95% CI
Control	4.9	± 1.3
Experimental	8.2	± 6.9

App Installation and Use Secondary · 3 month follow-up

Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.

Group	Value	95% CI
Control	7
Experimental	12

App Utilization - Cumulative Days of Use Secondary · 3 month follow-up

Cumulative number of days between the first and last use of the assigned app

Group	Value	95% CI
Control	54.3	± 39.8
Experimental	30.4	± 20.6

Self-reported 24-hour Quit Attempt Secondary · 3 months post-enrollment

At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.

Group	Value	95% CI
Control	4
Experimental	8

Satisfaction With App Content and Advice Secondary · 1 month follow-up

Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".

Group	Value	95% CI
Control	3.0	± 0.0
Experimental	3.5	± 0.8

Satisfaction With App Content and Advice Secondary · 3 month follow-up

Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".

Group	Value	95% CI
Control	3.2	± 1.3
Experimental	3.6	± 0.8

Earned Nicotine Replacement Therapy (NRT) Secondary · 3 month follow-up

Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy

Group	Value	95% CI
Control	0
Experimental	7

Not Smoking (Even a Puff) in the Last 7 Days Secondary · 3-months post-enrollment

7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.

Group	Value	95% CI
Control	0
Experimental	0

Proportion Who Request Nicotine Replacement Therapy Secondary · 3 month follow-up

Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.

Group	Value	95% CI
Control	0
Experimental	0

Number of Cigarettes Smoked Per Day Secondary · 1 month follow-up

Self-reported average number of cigarettes smoked per day at follow-up

Group	Value	95% CI
Control	7.2	± 3.4
Experimental	8.6	± 6.7

Number of Cigarettes Smoked Per Day Secondary · 3 month follow-up

Self-reported average number of cigarettes smoked per day at follow-up

Group	Value	95% CI
Control	7.4	± 3.4
Experimental	7.9	± 3.6

Motivation for Quitting Smoking Secondary · 1 month follow-up

Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.

Group	Value	95% CI
Control	7.5	± 2.5
Experimental	6.8	± 2.7

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for tobacco use cessation in people living with HIV.
   Mdege ND, Shah S, Dogar O, Pool ER, et al · · 2024 · cited 6× · PMID 39101506 · DOI 10.1002/14651858.cd011120.pub3
2. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study.
   McClure JB, Heffner JL, Krakauer C, Mun S, et al · · 2024 · cited 1× · PMID 38976321 · DOI 10.2196/58063