The Less is More Study
Part of paid clinical trials in Coral Gables, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT05153811
- Status
- Recruiting
Conditions
- Alcohol Use
Eligibility Criteria
- Sex
- ALL
- Age
- 35 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Counseling — BEHAVIORALBrief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning
- mHealth — BEHAVIORALParticipants will engage with an application designed to gamify drinking reduction.
- Counseling — BEHAVIORALBrief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.
Study Details
In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.
Key Dates
- Start date
- Jun 10, 2022
- Status verified
- Jul 2025
- Primary completion
- Sep 1, 2026
- Completion
- Sep 1, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Non-Contingent ConditionParticipants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.
- Experimental: mHealth and CMParticipants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.
- Experimental: CMParticipants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings
Primary Outcome Measure
Percent days abstinent via smartphone breathalyzer readings [ Time Frame: Baseline to 30 Days ]
Central Contacts
- Emmely Pavila352-273-9562
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami | Coral Gables | Florida | 33146 | |
| University of Florida | Gainesville | Florida | 32610 | Yan Wang, PhD (PRINCIPAL_INVESTIGATOR) |
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