The Less is More Study

Not Applicable

Recruiting

• Conditions: Alcohol Use
• Interventions: Behavioral: Counseling; Behavioral: mHealth

• Registration Number: NCT05153811
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Study Start: 2022-06-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth and CM	Counseling	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.
Non-Contingent Condition	Counseling	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.
mHealth and CM	mHealth	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.
CM	Counseling	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

Primary Outcome Measures

Name	Time	Method
Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.	30 Days to 60 Days	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.
Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.	Baseline to 30 Days	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.
Drinking reduction through Contingency Management will predict non-drinking outcomes	Baseline to 90 days	Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.
Percent days abstinent via smartphone breathalyzer readings	Baseline to 30 Days	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

Secondary Outcome Measures

Name	Time	Method
Percent days abstinent via wrist biosensor readings	Baseline to 60 Days	Among responders during the Phase 1 Contingency Management induction period, comparison among Phase 2 study conditions regarding percent abstinent days based on wrist biosensor readings. Percent days abstinent at baseline based on self-report and based on smartphone breathalyzer readings during Phase 1 will be included in this model.

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Coral Gables, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States