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Recruiting

NCT Number: NCT05153811

The Less is More Study

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.

Recruiting

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Key information

Conditions

Alcohol Use Alcohol Drinking Behavior Drinking Behavior

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Coral Gables, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

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

mHealth

Behavioral

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

Primary outcomes

  1. Percent days abstinent via smartphone breathalyzer readings

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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.

  4. Drinking reduction through Contingency Management will predict non-drinking outcomes

    Time frame: Baseline to 90 days

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

Secondary outcomes

  1. Percent days abstinent via wrist biosensor readings

    Time frame: 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.

Other outcomes

  1. Percent days abstinent via self-report

    Time frame: Baseline to 180 Days

    Among 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmely Pavila

CONTACT

[email protected]

352-273-9562

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2021
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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