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

Kaiser Permanente

Status: Completed

Conditions: Smoking; Smoking Cessation

Treatments: Device: mHealth Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05339659

R21CA261199

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Device: mHealth Intervention

Experimental

Experimental group

Description:

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.

Treatment:

Device: mHealth Intervention