Florida State University, Center for Translational Behavioral Science
Tallahassee, Florida, 32310, United States
NCT Number: NCT06125509
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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Notify Me18 year–29 year
All sexes
Observational
Tallahassee, Florida, 32310, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Florida State University
Other
Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)
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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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