| NCT ID | NCT05153811 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Alcohol Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-10 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-06-10 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Robert Leeman, Ph.D
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05153811 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 70 Years, studying Alcohol Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05153811 currently recruiting?
Yes, NCT05153811 is actively recruiting participants. Contact the research team at empavila17@ufl.edu for enrollment information.
Where is the NCT05153811 trial being conducted?
This trial is being conducted at Coral Gables, United States, Gainesville, United States.
Who is sponsoring the NCT05153811 clinical trial?
NCT05153811 is sponsored by University of Florida. The principal investigator is Robert Leeman, Ph.D at University of Florida. The trial plans to enroll 120 participants.