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NCT06125509 · ClinicalTrials.gov registry record
SHARE Project Define
A clinical trial, sponsored by Florida State University.
- Completed
- Registry status
- 105
- Enrollment target
NCT06125509: Completed study, sponsored by Florida State University.
NCT06125509 is a clinical trial that has completed, run by Florida State University. The registered enrollment target is 105 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06125509 has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2025-08-05 |
What the finished NCT06125509 record still lists
NCT06125509 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT06125509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06125509 about?
NCT06125509 is a clinical study titled "SHARE Project Define". 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, longit...
What is the current status of trial NCT06125509?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2022-08-01. Estimated completion is 2025-08-05.
Who is sponsoring clinical trial NCT06125509?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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