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Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06125509
Collaborator
University of California, San Diego (Other), Nova Southeastern University (Other), University of Florida (Other), University of Central Florida (Other)
175
Enrollment
1
Location
28
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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).

This is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and HIV (viral suppression) among YPLWH. The study will enroll up to 175 participants between the ages of 18-29 who currently reside in Florida and are living with HIV.

In the Model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. The aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among YPLWH to determine potential pathways between cumulative stress and alcohol and HIV outcomes, in the context of individual factors relevant to YPLWH (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators.

In the Adapt phase, 42 of N=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    175 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)
    Actual Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2024
    Anticipated Study Completion Date :
    Nov 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Alcohol Use [9 months]

      Hazardous Drinking

    2. HIV Viral Load [9 months]

      Viral Suppression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 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.

    Exclusion Criteria:

    • Adults unable to consent

    • Individuals who are not yet adults

    • Individuals who are not diagnosed as HIV+

    • Prisoners

    • Pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida State University, Center for Translational Behavioral Science Tallahassee Florida United States 32310

    Sponsors and Collaborators

    • Florida State University
    • University of California, San Diego
    • Nova Southeastern University
    • University of Florida
    • University of Central Florida

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sylvie Naar, Principal Investigator, Florida State University
    ClinicalTrials.gov Identifier:
    NCT06125509
    Other Study ID Numbers:
    • STUDY00002535
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 9, 2023