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Behavioral Intervention
SiS-H App for Smoking Cessation
N/A
Recruiting
Led By Bettina Hoeppner, PhD, MS
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and week 20 (3 months after end of treatment)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new app-based smoking cessation treatment called SiS-H for people with HIV who smoke. Participants will be compared to those using the National Cancer Institute's app "QuitGuide".
Who is the study for?
This trial is for adults over 18 who are HIV positive, smoke at least weekly, and have smoked more than 100 cigarettes in their lifetime. Participants must be receiving regular HIV care and willing to attempt quitting smoking as part of the study. They also need to allow access to their medical records and app usage data.
What is being tested?
The trial is testing 'SiS-H,' an integrated mobile health app designed for smoking cessation in people with HIV, against the National Cancer Institute's 'QuitGuide' app. It aims to assess how feasible, acceptable, and effective SiS-H is compared to QuitGuide through a pilot randomized controlled trial.
What are the potential side effects?
Since this trial involves using smartphone apps for smoking cessation rather than medication or medical procedures, there are no direct side effects from interventions like you would expect with drugs or surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline and week 20 (3 months after end of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and week 20 (3 months after end of treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
App usage
Secondary study objectives
App usability rating, System Usability Scale (SUS)
Attitudes Towards Smoking Scale (ATS) - adverse effects of smoking sub-scale
Attitudes Towards Smoking Scale (ATS) - pleasure of smoking sub-scale
+13 moreOther study objectives
30-day point prevalence abstinence (PPA) - biochemically verified
30-day point prevalence abstinence (PPA) - self-reported
HIV Medication Adherence
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Smiling instead of Smoking - HIVExperimental Treatment1 Intervention
Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H), and will be asked to use it for 8 weeks while they quit smoking.
Group II: QuitGuideActive Control1 Intervention
Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,367 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,937 Total Patients Enrolled
Bettina Hoeppner, PhD, MSPrincipal InvestigatorMassachusetts General Hospital
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