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

January 19, 2021 updated by: Andres Camacho-Gonzalez, Emory University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30308
        • Ponce De Leon Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Focus Group
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
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
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.
Other: Venue Testing Group- Positive Test
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to Linkage to Care
Time Frame: 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.
Post Diagnosis (Up to 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of medical care visits
Time Frame: 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.
Post Diagnosis (Up to one year)
Change in CD4 count
Time Frame: 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.
Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in viral load
Time Frame: 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.
Baseline (Post Diagnosis), One year assessment (Up to one year)
Rate of venue acceptance
Time Frame: 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.
One year assessment (Up to one year)
Rate of study subject acceptance
Time Frame: 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.
One year assessment (Up to one year)
Change in HIV stigma scale score
Time Frame: 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.
Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in HIV-AIDS stress scale score
Time Frame: 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.
Baseline (Post Diagnosis), One year assessment (Up to one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Andres Camacho-Gonzalez, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00080817

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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