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SHARE Project Define - Trial NCT06125509

Access comprehensive clinical trial information for NCT06125509 through Pure Global AI's free database. This phase not specified trial is sponsored by Florida State University and is currently Recruiting. The study focuses on HIV. Target enrollment is 175 participants.

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NCT06125509
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Trial Details
ClinicalTrials.gov โ€ข NCT06125509
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SHARE Project Define
Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)

Study Focus

HIV

Observational

Sponsor & Location

Florida State University

Tallahassee, United States of America

Timeline & Enrollment

N/A

Aug 01, 2022

Nov 30, 2024

175 participants

Primary Outcome

Alcohol Use,HIV Viral Load

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.

ICD-10 Classifications

Human immunodeficiency virus [HIV] disease
Human immunodeficiency virus [HIV] disease resulting in other conditions
HIV disease resulting in other viral infections
Unspecified human immunodeficiency virus [HIV] disease
Human immunodeficiency virus [HIV] disease resulting in other specified diseases

Data Source

ClinicalTrials.gov

NCT06125509

Non-Device Trial