CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled / 66 target
Drug / intervention
Smiling instead of Smoking - HIV +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05886621
NCT05886621N/ACompletedHigh Momentum (2.1/mo)Completion was 13mo ago

Pilot RCT to Test the Integrated mHealth App Intervention (SiS-H) for Smoking Cessation for People With HIV

Massachusetts General Hospital·interventional·Posted Jun 2, 2023·Updated Jun 24, 2026

In Brief

A clinical study evaluating Smiling instead of Smoking - HIV and QuitGuide for Smoking Cessation. Completed, enrolled 66 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

The present study is a pilot randomized controlled trial (RCT) that seeks to test the feasibility, acceptability, process outcomes, and exploratory outcomes of a newly integrated, app-based smoking cessation treatment (SiS-H, which stands for "Smiling instead of Smoking for people with HIV") for people with HIV who smoke. This treatment will be compared to onboarding to the National Cancer Institute's smartphone app "QuitGuide" (QG). Persons with HIV who smoke and are engaged in HIV clinical care (n=64) will be randomized (1:1) to smoking cessation support via SiS-H vs. "QuitGuide".

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedJun 2, 2023
Enrollment StartNov 7, 2023
Primary CompletionMay 5, 2025
Study CompletionJul 7, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.1 years ago

Arms & Interventions

Smiling instead of Smoking - HIVexperimental

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.

Behavioral: Smiling instead of Smoking - HIV
QuitGuideactive_comparator

Participants will be onboarded to the smartphone app "QuitGuide" (QG), and will be asked to use it for 8 weeks while they quit smoking.

Behavioral: QuitGuide

Interventions

Smiling instead of Smoking - HIVbehavioral

Participants will be onboarded to the smartphone app "Smiling instead of Smoking - HIV" (SiS-H) and will be asked to complete the integrated SiS-H program while they quit smoking. The integrated SiS-H treatment consists of: (1) face-to-face onboarding to the SiS-H app, (2) one face-to-face session discussing app usage and antiretroviral therapy (ART) adherence (Life Steps), with direct linkage to tools in the app supporting ART adherence, and (3) an 8-week course of the SiS-H app. The SiS-H app is a smoking cessation app that uses a positive psychology framework in conjunction with the US Clinical Practice Guidelines for smoking cessation to guide participants through the process of quitting smoking.

QuitGuidebehavioral

Participants will be onboarded to the NCI smartphone app QuitGuide(QG) and will be asked to use it for 8 weeks to support them in quitting smoking. The QuitGuide app follows the US Clinical Practice Guidelines. The app is freely available on NCI's Smokefree.gov website, which is a recommended resource for treating smokers in the healthcare setting. The QuitGuide app is frequently used as a comparison app in smartphone app smoking cessation studies. It asks participants to set a quit day, track their mood and cravings, and log their cigarettes. It provides app users with guidance on quitting (i.e., "Learn to Quit" information), offers strategies to counter smoking triggers, and allows users to set reminders to stay smoke free (time and location based).