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Completed

NCT Number: NCT06125509

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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).

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Key information

Conditions

HIV

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida State University, Center for Translational Behavioral Science

Tallahassee, Florida, 32310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Alcohol Use

    Time frame: 2 weeks, at baseline and 9 month follow up

    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. HIV Viral Load

    Time frame: Baseline and 9 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2023
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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