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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Reducing Risk Behavior
* Behavioral: Support and Guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Focus Group<br>Participants will complete a questionnaire and will be involved in a group discussion regarding good sites within the community to perform HIV testing. | |
| Other: Venue Testing Group- Negative Test<br>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. | Behavioral: Reducing Risk Behavior<br>* 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.<br>|
| Other: Venue Testing Group- Positive Test<br>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. | Behavioral: Support and Guidance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS, Health Promotion