SHARE Project Define

HIV Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125509
• Other study ID #: STUDY00002535
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: Scott M Pickett, PhD
• Phone: (850) 644-4203
• Email: scott.pickett[@]med.fsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
United States	Florida State University, Center for Translational Behavioral Science	Tallahassee	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Florida State University	Nova Southeastern University, University of California, San Diego, University of Central Florida, University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use	Hazardous Drinking	9 months
Primary	HIV Viral Load	Viral Suppression	9 months