- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01751100
The Feasibility of Using a General Health Screen to Increase HIV Testing in Community Pharmacies
7. mai 2015 oppdatert av: Yvette Calderon,MD, MS, North Bronx Healthcare Network
Building Bridges: Addressing HIV Stigma in At-Risk Groups in Community Pharmacies
The purpose of this study is to see if offering a general health screening tailored towards high-risk groups (African immigrants, injection drug users (IDUs), and minority men who have sex with men (MSM)) will increase human immunodeficiency virus (HIV) testing, counseling, and linkage acceptance rates in community pharmacies.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
About one-fifth of HIV-positive people in the United States remain unaware of their HIV status, and these individuals account for the majority of new transmissions.
The preponderance of barriers to HIV has delayed diagnoses and treatment for HIV-infected individuals in the US, and such late diagnoses result in poorer outcomes for HIV-infected individuals and increased cost of medical care.
The National HIV/AIDS Strategy for the United States has called for expanded HIV testing, but if the investigators simply replicate existing models, the investigators will continue to fail to reach and engage strategic at-risk populations.
Project Building Bridges will use a community setting - the pharmacy - to establish an alternative site for HIV testing to engage large numbers of at risk populations, specifically men who have sex with men (MSM) of color, injection drug users (IDU), and African immigrants; increase HIV awareness, and reduce stigma by placing HIV testing in the context of a general health screening.
There are two specific aims: 1) Build partnerships with community stakeholders to understand current barriers to HIV testing, and 2) Determine the effectiveness of a health screening approach by measuring acceptance of HIV testing.
In the qualitative research phase, we will conduct focus group discussions of MSM of color, IDUs, and African immigrants, led by the Latino Commission on AIDS, a community-based organization with extensive experience in cultural competency training and utilizations of community social networks, especially with higher risk minority populations, to obtain insights that will help increase participation in HIV testing.
Data obtained through qualitative work will guide the development of the "health screening" model, which would include other screening tests (like sugar, blood pressure, hepatitis C, etc) with an HIV test, depending on what the high risk groups preferred in the wellness bundle.
The hypothesis is that, by tailoring the health screens, this bundling model will circumvent the stigma associated with HIV testing in these high-risk populations and increase HIV testing acceptance rates.
The investigators will conduct a two-group randomized control trial comparing the "health screening" model (intervention) to an HIV test offer (control) in community pharmacies in the Bronx.
The trial will help determine the preliminary impact on the acceptance of HIV testing when coupled with an overall health wellness screen.
The investigators will also conduct a secondary analysis on HIV testing acceptance rates based on each high-risk groups.
Studietype
Intervensjonell
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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New York
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Bronx, New York, Forente stater, 10461
- Albert Einstein College of Medicine
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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 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age 18 to 64 at time of recruitment
Exclusion Criteria:
- Known to be HIV positive
- Unable to understand the consent process for the study; or otherwise unable to consent to HIV testing
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: HIV Test Offer
Group 1 (Control) is the current standard of care in HIV testing.
A trained counselor provides required information to obtain informed consent for HIV testing and provides rapid HIV testing on site.
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HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test
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Eksperimentell: General Health Screen Offer
In Group 2 (Intervention), a free general health screening is offered that may include a blood pressure check, blood glucose measurement, a Hepatitis C (HCV) test, and an HIV test.
|
A Research Assistant (RA) will provide health education on diabetes, hypertension, and HIV.
The RA will then offer free blood pressure check, blood glucose measuring, rapid Hepatitis C (HCV) test, and a free, rapid oral HIV test.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acceptance of HIV Testing
Tidsramme: 30 minutes
|
Rate of participation in voluntary rapid oral HIV test in each group
|
30 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of African immigrants that accept HIV testing
Tidsramme: 30 minutes
|
Rate of HIV acceptance among the subgroup African immigrants, comparing between treatment and control groups
|
30 minutes
|
|
Proportion of IDU that accept HIV testing
Tidsramme: 30 minutes
|
Rate of HIV acceptance among the subgroup IDUs, comparing between treatment and control groups
|
30 minutes
|
|
Proportion of minority MSM that accept HIV testing
Tidsramme: 30 minutes
|
Rate of HIV acceptance among the subgroup minority MSM, comparing between treatment and control groups
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30 minutes
|
|
Linkage to Care
Tidsramme: up to one year
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Proportion of positively-screened participants that attend follow-up specialized medical care
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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: Yvette Calderon, MD, MS, Albert Einstein College of Medicine
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. juli 2013
Primær fullføring (Forventet)
1. mai 2016
Studiet fullført (Forventet)
1. juli 2016
Datoer for studieregistrering
Først innsendt
13. desember 2012
Først innsendt som oppfylte QC-kriteriene
14. desember 2012
Først lagt ut (Anslag)
17. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. mai 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2015
Sist bekreftet
1. mai 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RFA-MH-13-092-001
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