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NCT05153811Recruiting

The Less is More Study

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
2 Dec 2021
Start date
10 Jun 2022
Primary completion date
1 Sept 2026
Lead sponsor
University of Florida
Diseases
HIV
NCT number
NCT05153811

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 10 Jun 2022 to the primary completion date, 1 Sept 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  • Psychosis or other severe psychiatric disability

Other

  • 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.
  • Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Who the study is looking for

  • 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

Age in the registry: 35 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
Coral GablesUnited StatesRecruiting
University of Florida
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.