Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
NCT ID: NCT03999411
Last Updated: 2024-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
39 participants
INTERVENTIONAL
2019-09-09
2020-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual Care
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.
Nicoderm C-Q Transdermal Product
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Adherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
Smoking cessation only intervention
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.
Nicoderm C-Q Transdermal Product
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Adherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
"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.
Combined smoking cessation and HIV intervention
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.
Nicoderm C-Q Transdermal Product
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Adherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
"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.
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.
Interventions
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Nicoderm C-Q Transdermal Product
6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
Adherence to Antiretroviral Therapy Counseling
Brief counseling on adhering to antiretroviral therapy with self-help materials.
Behavioral Smoking Cessation Counseling
One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
"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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Taghrid Asfar
Research Assistant Professor
Principal Investigators
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Taghrid Asfar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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20190181
Identifier Type: -
Identifier Source: org_study_id
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