Clinical trial NCT03999411: Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
Official title: A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Smoking Cessation
HIV
Keywords: nicotine replacement therapy
antiretroviral
smartphone
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Smoking Cessation
timeFrame: Up to 3 months
measure: Number of Participants With ≥ 95% Adherence to ART Medication Based on the Visual Analogue Scale
timeFrame: 3 months
measure: Usability of Intervention Questionnaire Score
timeFrame: 3 months
measure: Acceptability of Intervention Questionnaire Scores
timeFrame: 3 months
measure: Number of Participants Reporting Engagement With the Intervention
timeFrame: Up to 3 months
measure: Feasibility of Delivery
timeFrame: At screening through study completion (up to 3 months)
Secondary outcomes:
measure: Number of Participants With Reported Relapse
timeFrame: Up to 3 months
measure: Number of Cigarettes Smoked Per Day
timeFrame: At baseline and at 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Taghrid Asfar, MD
role: PRINCIPAL_INVESTIGATOR
References: