The Less is More Study

University of Florida

Status: Enrolling

Conditions: Alcohol Use

Treatments: Behavioral: Counseling; Behavioral: mHealth

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05153811

CED000000577 (Other Identifier)

PRO00035889 (Other Identifier)

P01AA029543 (U.S. NIH Grant/Contract)

OCR41499 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Non-Contingent Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Counseling

Behavioral: Counseling

mHealth and CM

Experimental group

Description:

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.

Treatment:

Behavioral: Counseling

Behavioral: mHealth

Behavioral: Counseling

CM

Experimental group

Description:

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

Treatment:

Behavioral: Counseling

Behavioral: Counseling