NCT03999411

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

A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Smoking
• Smoking Cessation
• HIV

Interventions

Type	Name	Description
DRUG	Nicoderm C-Q Transdermal Product	6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
BEHAVIORAL	Adherence to Antiretroviral Therapy Counseling	Brief counseling on adhering to antiretroviral therapy with self-help materials.
BEHAVIORAL	Behavioral Smoking Cessation Counseling	One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
BEHAVIORAL	"Crave-to-Quit" app	Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.
BEHAVIORAL	vDOT "emocha" app	Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.

Timeline

• Start date: 2019-09-09
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2019-06-26
• Last updated: 2024-03-28
• Results posted: 2021-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study