- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01616940
Minority AIDS Initiative Retention and Re-Engagement Project
Minority AIDS Initiative Retention and Re-Engagement Project: Peer Re-Engagement Project
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with HIV into HIV primary care and other needed medical or social services. Three demonstration sites are implementing programs in which peers are employed as part of the health care team. Peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits.
Study participants will be current or newly enrolled patients of three clinics: CARE Resources, in Miami FL, the PATH Program at Brooklyn Hospital in Brooklyn, NY, and PR CONCRA located in San Juan Puerto Rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services.
Data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 HIV positive adults. The data collected for this study will allow us to assess changes in: (a) retention in HIV primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) HIV knowledge that may be associated with an enhanced peer intervention.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Florida
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Miami, Florida, Forente stater, 33137
- Care Resource
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Center for Advancing Health Policy and Practice
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New York
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Brooklyn, New York, Forente stater, 11226
- PATH Center, The Brooklyn Hospital
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San Juan, Puerto Rico, 00928-0850
- Puerto Rico Community Network for Clinical Research on AIDS
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- HIV-positive; AND
- Age 18 years or older; AND
- Identifies as belonging to one or more of the following racial/ethnic groups: American Indian or Alaskan Native, Asian, Black or African-American, Hispanic or Latino, native Hawaiian or other Pacific Islander; AND
- New patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; OR
- The individual has been out of medical care at your clinic for 4 months or more.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Standard-of-care
Standard-of-care at 3 demonstration sites includes: HIV medical care, medical case management, and referral to substance abuse, mental health, and housing services.
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Eksperimentell: Enhanced Peer Intervention
Provides emotional, informational, and instrumental peer support, in addition to Standard-of-Care.
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Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention:
Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of participants retained continuously in quality HIV care
Tidsramme: 1 year
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"In HIV care" is defined as having a medical visit with a provider with prescribing privileges in an HIV care setting two or more times at least 3 months apart during the measurement year (HAB Performance Measure and National AIDS Strategy).
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1 year
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Number of participants who are virally suppressed
Tidsramme: 1 year
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline in Health-related Quality of Life
Tidsramme: 1 year
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Health-related quality of life will be measured using the SF-8 Health Survey by QualityMetric Incorporated.
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1 year
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Change from Baseline in Self-Efficacy
Tidsramme: 1 year
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This will be measured using a scale that was developed and tested for the Chronic Disease Self-Management study*. * Lorig, K., Stewart, A., Ritter, P., Gonzalez, V., Laurent, D. & Lynch, J. (1996). Outcome Measures for Health Education and other Health Care Interventions. Thousand Oaks CA: Sage Publications, 24-25, 41-45. |
1 year
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Change from Baseline in HIV knowledge
Tidsramme: 1 year
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HIV Knowledge will be measured using The HIV Treatment Knowledge Scale*. *Balfour, L., MacPherson, P., Garber, G., Beique, L. & Cameron, D. (2007). Development and psychometric validation of the HIV Treatment Knowledge Scale. AIDS Care, 19, 1141-1148. |
1 year
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jane Fox, MPH, Center for Advancing Health Policy and Practice, Boston University School of Public Health
- Hovedetterforsker: Serena Rajabiun, MA, MPH, Center for Advancing Health Policy and Practice, Boston University School of Public Health
- Hovedetterforsker: Howard Cabral, MPH, PhD, Department of Biostatistics, Boston University School of Public Health
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- U69HA23262
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