Clinical trial NCT05153811: The Less is More Study
Official title: Novel Extensions of Alcohol Contingency Management in People Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Miami
name: University of Louisville
name: Florida State University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-12-10
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent days abstinent via smartphone breathalyzer readings
timeFrame: Baseline to 30 Days
measure: Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.
timeFrame: Baseline to 30 Days
measure: Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.
timeFrame: 30 Days to 60 Days
measure: Drinking reduction through Contingency Management will predict non-drinking outcomes
timeFrame: Baseline to 90 days
Secondary outcomes:
measure: Percent days abstinent via wrist biosensor readings
timeFrame: Baseline to 60 Days
Other outcomes:
measure: Percent days abstinent via self-report
timeFrame: Baseline to 180 Days
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Robert Leeman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: