Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02562092
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Camacho-Gonzalez, 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Reducing Risk Behavior Behavioral: Support and Guidance Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project
Study Start Date : August 2015
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562092


Contacts
Layout table for location contacts
Contact: Andres Camacho-Gonzalez 404-727-5642 acamac2@emory.edu

Locations
Layout table for location information
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Andres Camacho-Gonzalez    404-727-5642    acamac2@emory.edu   
Ponce De Leon Center Recruiting
Atlanta, Georgia, United States, 30308
Contact: Andres Camacho-Gonzalez    404-727-5642    acamac2@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Andres Camacho-Gonzalez Emory University

Layout table for additonal information
Responsible Party: Andres Camacho-Gonzalez, Assistant Professor of Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT02562092     History of Changes
Other Study ID Numbers: IRB00080817
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Keywords provided by Andres Camacho-Gonzalez, Emory University:
AIDS
Health Promotion