Trial results for 'Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV' were posted on ClinicalTrials.gov on 2026-03-05, involving 66 participants.
Background
Living with HIV often presents complex health management challenges, including co-occurring conditions and lifestyle factors that can impact overall well-being and treatment adherence. Alcohol use, particularly among young people living with HIV, can complicate health outcomes and disease management. Mobile health (mHealth) solutions, such as biosensors and apps, offer potential tools to monitor and support interventions for behaviors like alcohol consumption, aiming to improve health engagement and outcomes in this specific population.
Trial design
This completed study, designated as Phase NA, enrolled 66 participants living with HIV. The trial investigated a wrist alcohol biosensor-based mHealth suite designed to support alcohol intervention in young people. Participants wore a wrist alcohol biosensor for 30 days and reported alcohol use via an ecological momentary assessment (EMA) app. A subset of participants was micro-randomized to test two engagement strategies—reciprocity and personalized feedback—delivered through an 'eWrapper' app, to promote engagement with the biosensor. Key outcomes measured included engagement in biosensor wearing and feasibility/acceptability of the biosensor and the eWrapper app.
Key results
The trial reported several key measurements and analyses related to biosensor engagement and feasibility:
- Engagement in Biosensor Wearing (percentage of time worn):
- For participants Assigned to eWrapper App, the mean was 20.6 (Standard Deviation 25.5).
- For participants Not Assigned to eWrapper App, the mean was 25.0 (Standard Deviation 33.4).
- Feasibility/Acceptability of Biosensor Wearing (score on a scale):
- For participants Assigned to eWrapper App, the mean was 3.3 (Standard Deviation 0.70).
- For participants Not Assigned to eWrapper App, the mean was 3.1 (Standard Deviation 0.40).
- Feasibility/Accessibility of eWrapper (score on a scale):
- For participants Assigned to eWrapper App, the mean was 3.4 (Standard Deviation 0.60).
Key analyses comparing the groups included:
- A Wilcoxon (Mann-Whitney) analysis for engagement in biosensor wearing showed a mean difference of -4.4, with a p-value of 0.698.
- A Wilcoxon (Mann-Whitney) analysis for feasibility/acceptability of biosensor wearing showed a mean difference of 0.14, with a p-value of 0.268.
What this means
The posted results indicate that the tested engagement strategies, such as the eWrapper app, did not significantly impact biosensor wearing engagement or the perceived feasibility and acceptability of biosensor wearing among young people living with HIV. The mean percentage of time worn was numerically similar between groups, as were the feasibility scores. The p-values of 0.698 and 0.268 suggest no statistically significant difference in these outcomes between participants assigned to the eWrapper app and those not assigned to it. This suggests that while biosensors may be a tool, the specific engagement strategies tested in this study did not enhance user interaction or acceptance in this population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05431855, titled 'Project Engage: A Wrist Biosensor-based mHealth Suite to Support Alcohol Intervention in Young People Living With HIV', were posted on 2026-03-05 on clinicaltrials.gov.