The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project (GLADLY)
19. januar 2021 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
2
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Georgia
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Atlanta, Georgia, Forente stater, 30303
- Grady Health System
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Atlanta, Georgia, Forente stater, 30308
- Ponce De Leon Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 24 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: 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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Annen: 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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Andres Camacho-Gonzalez, Emory University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2015
Primær fullføring (Faktiske)
1. august 2017
Studiet fullført (Faktiske)
1. august 2017
Datoer for studieregistrering
Først innsendt
24. september 2015
Først innsendt som oppfylte QC-kriteriene
25. september 2015
Først lagt ut (Anslag)
29. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00080817
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .