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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2023-05-20

Brief Summary

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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.

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Detailed Description

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This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.

Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

mHealth Intervention

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

mHealth Intervention

Intervention Type DEVICE

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

Interventions

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mHealth Intervention

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No