Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05153811

Conditions

Alcohol Use

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

Interventions

Counseling

mHealth

Counseling

Study Details

Brief summary:

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.

Conditions

Alcohol Use

Study ID

NCT05153811

Start date

Jun 10, 2022

Status verified date

Jul, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
  • HIV positive
  • Fluency in English
  • Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
  • Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study

Exclusion Criteria:

  • Psychiatric conditions that would interfere with participation in the study
  • Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification
  • Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
  • Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  • Psychosis or other severe psychiatric disability
  • Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Non-Contingent Condition

Participants 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 CM

Participants 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: CM

Participants 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

Interventions

Counseling

Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning

mHealth

Participants will engage with an application designed to gamify drinking reduction.

Counseling

Brief counseling including personalized feedback on breath alcohol concentration, cognitive task performance and physical functioning.

Primary outcome measure

  • Percent days abstinent via smartphone breathalyzer readings [ Time Frame: Baseline to 30 Days ]
  • Predict percent days abstinent via smartphone breathalyzer readings based on risk factors. [ Time Frame: Baseline to 30 Days ]
  • Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption. [ Time Frame: 30 Days to 60 Days ]
  • Drinking reduction through Contingency Management will predict non-drinking outcomes [ Time Frame: Baseline to 90 days ]

Central Contacts and Locations

Central contacts

Emmely Pavila

352-273-9562empavila17@ufl.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Varan Govind, PhD

305-243-8096vgovind@med.miami.edu

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Emmely Pavila, B.A., B.S.

352-273-9562empavila17@ufl.edu

Principal Investigator:

Yan Wang, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-31.