Skip to content

The Less is More Study

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05153811
Enrollment
120
Registered
2021-12-10
Start date
2022-06-10
Completion date
2026-09-01
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use

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.

Interventions

BEHAVIORALCounseling

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

BEHAVIORALmHealth

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

Sponsors

University of Miami
CollaboratorOTHER
University of Louisville
CollaboratorOTHER
Florida State University
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Percent days abstinent via wrist biosensor readingsBaseline to 60 DaysAmong 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.

Other

MeasureTime frameDescription
Percent days abstinent via self-reportBaseline to 180 DaysAmong responders during the Phase 1 Contingency Management induction period, comparison among Phase 2 study conditions regarding percent abstinent days during the post-intervention, follow-up period based on self-report assessed with the timeline followback from days 61-180. Percent days abstinent at baseline based on self-report and based on smartphone breathalyzer readings during Phase 1 and based on wrist biosensor readings during Phase 2 will be included in this model.

Countries

United States

Contacts

Primary ContactEmmely Pavila
empavila17@ufl.edu352-273-9562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026