The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project

Not Applicable

Terminated

• Conditions: HIV
• Interventions: Behavioral: Reducing Risk Behavior; Behavioral: Support and Guidance

• Registration Number: NCT02562092
• Lead Sponsor: Emory University

Brief Summary

This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.

Detailed Description

This study aims to identify factors that can facilitate or impede the use of non-clinical HIV testing venues as well as identify potential testing sites and assess acceptability of an HIV prevention intervention. In addition, the study will implement a pilot intervention to test the feasibility non-clinical HIV testing and follow up events for HIV positive youth.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-29
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Sexually active
• HIV positive or negative
• Latino youth ages 18-24 years
• Residents of the state of Georgia and can understand spoken and written English or Spanish.

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Exclusion Criteria

• Unmet inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venue Testing Group- Negative Test	Reducing Risk Behavior	Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. No followup is needed for a negative HIV test.
Venue Testing Group- Positive Test	Support and Guidance	Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. Participants with a positive HIV test will receive care from a psychologist and case manager for one year.

Primary Outcome Measures

Name	Time	Method
Days to Linkage to Care	Post Diagnosis (Up to 3 months)	For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.

Secondary Outcome Measures

Name	Time	Method
Change in viral load	Baseline (Post Diagnosis), One year assessment (Up to one year)	A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A high viral load indicates the presence of more HIV within the body. Change is measured as the difference in viral load from baseline to the end of the study period.
Number of medical care visits	Post Diagnosis (Up to one year)	For participants who test positive, engagement to care is measured as the number of medical care visits in a six month period after diagnosis. One HIV medical care visit every six months is considered engaged.
Change in CD4 count	Baseline (Post Diagnosis), One year assessment (Up to one year)	A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a blood sample. A very low CD4 count (less than 200 cells/mm3) is a way to determine whether an HIV infection has progressed. Change is measured as the difference in CD4 count from baseline to the end of the study period.
Rate of venue acceptance	One year assessment (Up to one year)	The rate of venue acceptance is measured as the number of venues that allow rapid HIV testing over he number of venues approached.
Rate of study subject acceptance	One year assessment (Up to one year)	The rate of study subject acceptance is measured as the number of participants who agree to participate in rapid HIV testing over the number of people approached.
Change in HIV stigma scale score	Baseline (Post Diagnosis), One year assessment (Up to one year)	The HIV stigma scale is a ten question self report measure that assesses perceived feelings of being stigmatized. Answers are reported on a scale from 0 (not at all) to 4 (extremely). A higher score indicates feelings of greater stigmatization.
Change in HIV-AIDS stress scale score	Baseline (Post Diagnosis), One year assessment (Up to one year)	The HIV-AIDS stress scale is a self report measure that assesses perceived emotional stress related to HIV. Answers are reported on a scale from 0 (not at all) to 4 (extremely). A higher score indicates more emotional stress.

Trial Locations

Locations (2)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Ponce De Leon Center; 🇺🇸 Atlanta, Georgia, United States