RECRUITING

The Less is More Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Novel Extensions of Alcohol Contingency Management in People Living With HIV

Quick Facts

Study Start:2022-06-10
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05153811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
  2. * HIV positive
  3. * Fluency in English
  4. * Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
  5. * 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
  1. * Psychiatric conditions that would interfere with participation in the study
  2. * 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
  3. * 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.
  4. * Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
  5. * Psychosis or other severe psychiatric disability
  6. * Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Contacts and Locations

Study Contact

Emmely Pavila
CONTACT
352-273-9562
empavila17@ufl.edu

Principal Investigator

Robert Leeman, Ph.D
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Miami
Coral Gables, Florida, 33146
United States
University of Florida
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Robert Leeman, Ph.D, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-10
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-06-10
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use