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临床试验/NCT06125509
NCT06125509已完成不适用

Defining Intervention Targets Along Pathways From Cumulative Stress and Trauma to Alcohol and HIV Self-management Among Young People Living With HIV (Project DEFINE)

Florida State University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
HIV Viral Load

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Adults unable to consent
  • Individuals who are not yet adults
  • Individuals who are not diagnosed as HIV+
  • Prisoners
  • Pregnant women

结局指标

主要结局

HIV Viral Load

时间窗: 9 months

Viral Suppression

Alcohol Use

时间窗: 9 months

Hazardous Drinking

Alcohol Use

时间窗: 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.

HIV Viral Load

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Naar

Principal Investigator

Florida State University

研究点 (2)

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