Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients

University of Miami

Status and phase: Completed; Phase 4

Conditions: HIV; Smoking; Smoking Cessation

Treatments: Behavioral: "Crave-to-Quit" app; Behavioral: vDOT "emocha" app; Drug: Nicoderm C-Q Transdermal Product; Behavioral: Adherence to Antiretroviral Therapy Counseling; Behavioral: Behavioral Smoking Cessation Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03999411

20190181

Details and patient eligibility

About

The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

Full description

The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years old
• Diagnosed with HIV
• Have been prescribed ART medication in the prior 6 months
• Have smoked ≥ 5 cigarettes/day in the past year
• Be interested in making a quit attempt in the next 30 days
• Own a smartphone (apple/android)and plan to keep it active for the following 3 months
• Read/speak English
• Be able to provide consent
• Have no plans to move in the next 3 months
• Not pregnant or planning to be pregnant in the following 3 months

Exclusion criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
• Currently being treated for a psychiatric condition
• Currently being treated for smoking cessation, alcoholism, or illicit drug use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups, including a placebo group

Usual Care

Placebo Comparator group

Description:

Participants will receive brief advice to adhere to ART brief advice to quit smoking, 6-week supplies of nicotine-replacement therapy (NRT), and self-help materials to quit smoking and adhere to ART.

Treatment:

Behavioral: Adherence to Antiretroviral Therapy Counseling

Drug: Nicoderm C-Q Transdermal Product

Smoking cessation only intervention

Active Comparator group

Description:

Participants in this group will receive the usual care (UC) for adherence to ART, one in-person orientation sessions, 6-week supplies of NRT the "Crave-to-Quit" app, and two brief follow-up phone calls.

Treatment:

Behavioral: Behavioral Smoking Cessation Counseling

Behavioral: "Crave-to-Quit" app

Behavioral: Adherence to Antiretroviral Therapy Counseling

Drug: Nicoderm C-Q Transdermal Product

Combined smoking cessation and HIV intervention

Experimental group

Description:

Participants in this group will receive everything given in the Smoking Cessation Only arm and will also use the emocha app and will receive a tutorial explaining the app content and features. The study team will explain to participants that the app will help them in tracking dose-by-dose medication adherence by recording a video for themselves taking their medication.

Treatment:

Behavioral: Behavioral Smoking Cessation Counseling

Behavioral: "Crave-to-Quit" app

Behavioral: Adherence to Antiretroviral Therapy Counseling

Behavioral: vDOT "emocha" app

Drug: Nicoderm C-Q Transdermal Product