The Less is More Study

NCT05153811 | Recruiting DMC

• 4 other identifiers: CED000000577P01AA029543PRO00035889OCR41499
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (4)

• Percent days abstinent via smartphone breathalyzer readings

  Within-subject comparison between percent abstinent days based on smartphone breathalyzer readings during the 30-Day Phase 1 Contingency Management induction compared to the 30-day baseline period based on self-report on the timeline followback

  Baseline to 30 Days

• Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.

  All participants will attempt to reduce alcohol consumption. Only those who are able to will continue to the second phase of the intervention. We will seek to identify which factors are predictive of abstinence.

  Baseline to 30 Days

• Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.

  Participants will engage in a Contingency Management program aimed at reducing alcohol consumption. A novel CM delivery system will be used intended to gamify the process.

  30 Days to 60 Days

• Drinking reduction through Contingency Management will predict non-drinking outcomes

  Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.

  Baseline to 90 days

Secondary Outcomes (1)

• Percent days abstinent via wrist biosensor readings

  Baseline to 60 Days

Other Outcomes (1)

• Percent days abstinent via self-report

  Baseline to 180 Days

Study Arms (3)

Non-Contingent Condition

EXPERIMENTAL

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.

Behavioral: Counseling

mHealth and CM

EXPERIMENTAL

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.

Behavioral: Counseling; Behavioral: mHealth

CM

EXPERIMENTAL

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

Behavioral: Counseling

Interventions

Counseling BEHAVIORAL

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

CM; mHealth and CM

mHealth BEHAVIORAL

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

mHealth and CM

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• University of Miami: collaborator
• University of Louisville: collaborator
• Florida State University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of Miami

Coral Gables, Florida, 33146, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Counseling; Telemedicine

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Robert Leeman, Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmely Pavila

CONTACT

352-273-9562; empavila17@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 10, 2021
• Study Start: June 10, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)