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N/A Completed N=22 Randomized Double-blind Device Feasibility

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

Source: ClinicalTrials.gov NCT05339659 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Intervention (App) Utilization — 4.9; 8.2 User sessions — p=0.219

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Intervention (App) Utilization
4.9; 8.2 0.219
SECONDARY
App Installation and Use
7; 12
SECONDARY
App Utilization - Cumulative Days of Use
54.3; 30.4 0.153
SECONDARY
Self-reported 24-hour Quit Attempt
4; 8 0.727
SECONDARY
Satisfaction With App Content and Advice
3.2; 3.6 0.745
SECONDARY
Earned Nicotine Replacement Therapy (NRT)
0; 7 0.009 sig
SECONDARY
Not Smoking (Even a Puff) in the Last 7 Days
0; 0
SECONDARY
Proportion Who Request Nicotine Replacement Therapy
0; 0
SECONDARY
Number of Cigarettes Smoked Per Day
7.4; 7.9 0.614
SECONDARY
Motivation for Quitting Smoking
7.8; 6.8 0.632
SECONDARY
Self-efficacy for Quitting Smoking
8.6; 7.0 0.274

Eligibility Criteria

Inclusion Criteria Include:

  • 18 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

Exclusion Criteria Include:

  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05339659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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