The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project (GLADLY)
19. januar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30303
- Grady Health System
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Atlanta, Georgia, Forenede Stater, 30308
- Ponce De Leon Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 24 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: 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.
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Andet: 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.
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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.
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Andet: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Days to Linkage to Care
Tidsramme: Post Diagnosis (Up to 3 months)
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For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.
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Post Diagnosis (Up to 3 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of medical care visits
Tidsramme: Post Diagnosis (Up to one year)
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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.
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Post Diagnosis (Up to one year)
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Change in CD4 count
Tidsramme: Baseline (Post Diagnosis), One year assessment (Up to one year)
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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.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Change in viral load
Tidsramme: Baseline (Post Diagnosis), One year assessment (Up to one year)
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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.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Rate of venue acceptance
Tidsramme: One year assessment (Up to one year)
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The rate of venue acceptance is measured as the number of venues that allow rapid HIV testing over he number of venues approached.
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One year assessment (Up to one year)
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Rate of study subject acceptance
Tidsramme: One year assessment (Up to one year)
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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.
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One year assessment (Up to one year)
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Change in HIV stigma scale score
Tidsramme: Baseline (Post Diagnosis), One year assessment (Up to one year)
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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.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Change in HIV-AIDS stress scale score
Tidsramme: Baseline (Post Diagnosis), One year assessment (Up to one year)
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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.
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Baseline (Post Diagnosis), One year assessment (Up to one year)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Andres Camacho-Gonzalez, Emory University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2015
Primær færdiggørelse (Faktiske)
1. august 2017
Studieafslutning (Faktiske)
1. august 2017
Datoer for studieregistrering
Først indsendt
24. september 2015
Først indsendt, der opfyldte QC-kriterier
25. september 2015
Først opslået (Skøn)
29. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB00080817
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .