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

HIV Clinical Trial

— GLADLY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02562092
• Other study ID #: IRB00080817
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: January 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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.

Exclusion Criteria:

• Unmet inclusion criteria

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Reducing Risk Behavior
A small survey will be conducted to identify risk factors and assess demographics. Participants will receive psychological support and counseling on reducing risk behavior for one year.
• Support and Guidance
A small survey will be conducted to identify risk factors and assess demographics. Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year.

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Ponce De Leon Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days to Linkage to Care	For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.	Post Diagnosis (Up to 3 months)
Secondary	Number of medical care visits	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.	Post Diagnosis (Up to one year)
Secondary	Change in CD4 count	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.	Baseline (Post Diagnosis), One year assessment (Up to one year)
Secondary	Change in viral load	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.	Baseline (Post Diagnosis), One year assessment (Up to one year)
Secondary	Rate of venue acceptance	The rate of venue acceptance is measured as the number of venues that allow rapid HIV testing over he number of venues approached.	One year assessment (Up to one year)
Secondary	Rate of study subject acceptance	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.	One year assessment (Up to one year)
Secondary	Change in HIV stigma scale score	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.	Baseline (Post Diagnosis), One year assessment (Up to one year)
Secondary	Change in HIV-AIDS stress scale score	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.	Baseline (Post Diagnosis), One year assessment (Up to one year)