SHARE Project Define

NCT06125509 | Completed Results DMC

• 2 other identifiers: STUDY000025351P01AA029547-01
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH).

Conditions

HIV

Outcome Measures

Primary Outcomes (2)

• Alcohol Use

  Hazardous Drinking: TLFB (Timeline Followback), covering the prior 2 weeks. Hazardous drinking is defined per NIAAA criteria as \>7 drinks/week or \>3 drinks/occasion for women, and \>14 drinks/week or \>4 drinks/occasion for men. Results are reported as number of hazardous drinking days (continuous) over the prior two weeks.

  2 weeks, at baseline and 9 month follow up

• HIV Viral Load

  The viral load outcome (assessed by lab report with results obtained within a 3-month window of the timepoint or study administered Dried Blood Spot (DBS) analysis) was analyzed as binary (undetectable vs. detectable). For the binary outcome, the analysis includes all participants with a valid viral load result at each available time point. The limit of detection (LOD) of the m2000 test (DBS) is 832 copies/mL or Log 2.92 copies/mL. Samples with VL above the LOD (\>Log 2.92) and samples with less than LOD \<2.92 but the presence of HIV virus, are considered detectable. Samples that are not detected are reported as undetectable.

  Baseline and 9 month follow-up

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adults aged 18-29 who reside in Florida and are living with HIV and report having had at least 1 alcoholic drink in the last 30 days (see inclusion criteria).

You may qualify if:

• years and 0 months to 29 years and 11 months
• Currently reside in Florida
• Report having had at least 1 alcoholic drink in the last 30 days
• Able to read and understand English
• Have internet access via smartphone, tablet or computer
• Be diagnosed as HIV positive and;
• Willing to provide informed consent.

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults
• Individuals who are not diagnosed as HIV+
• Prisoners
• Pregnant women

Sponsors & Collaborators

• Florida State University: lead
• University of California, San Diego: collaborator
• Nova Southeastern University: collaborator
• University of Florida: collaborator
• University of Central Florida: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Florida State University, Center for Translational Behavioral Science

Tallahassee, Florida, 32310, United States

Location

Results Point of Contact

• Title: Sylvie Naar, PhD; Contact MPI
• Organization: Florida State University

sylvie.naar@med.fsu.edu

850-644-2334

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: August 1, 2022
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: July 28, 2026
• Results First Posted: July 28, 2026

Record last verified: 2026-06

Locations

US (1)