- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06162897
Saksbehandling Dyad (CM2)
Implementering av en Triadic Network Case Management Intervention for yngre svarte seksuelle minoritetsmenn
The overall goal of this study is to test whether dyadic and focused case management coupled with contingency management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with HIV or those taking PrEP (PrEP persistence), and (4) increase the proportion of individuals living with HIV who are virally suppressed (viral suppression) when compared to routine Ryan White Non-Medical Case Management.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this research is to test the impact of dyadic, focused case management coupled with contingency management on financial well-being, access to food, linkage to and retention in care outcomes for individuals living with or vulnerable to HIV.
The study team will be testing the hypotheses that dyadic case management that is focused on financial wellness coupled with contingency management, will have better outcomes for folks living with or vulnerable to HIV. Analyses will be used to assess the efficacy of the intervention as an emerging practice.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Rebecca Eavou
- Telefonnummer: 773-834-2336
- E-post: reavou@bsd.uchicago.edu
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago
-
Ta kontakt med:
- Rebecca Eavou, AM
- Telefonnummer: 231-357-5995
- E-post: reavou@bsd.uchicago.edu
-
Hovedetterforsker:
- John A Schneider, MD, MPH
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Underetterforsker:
- Alida Bouris, PhD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Gap in HIV or PrEP care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months
Self-reported financial or food insecurity
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: Treatment as usual
Participants will be offered the current standard of care, Ryan White Non-Medical Case Management. Case management services are need focused and contact is client initiated. |
|
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Eksperimentell: Dyadic Case Management
Participants will receive dyadic case management, specifically they will have two case managers assigned to their case. Case management services will be goal focused and will utilize components from Appreciative Inquiry to orient work to future planning, goals, and financial stability. |
Subjects enrolled in the intervention arm will be offered focused case management centered around goal setting and future orientation. Subjects will be assigned two case managers to support their goals. Clients will receive conditional cash transfers for medical visit attendance and negative HIV/syphilis tests or undetectable viral loads. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Financial wellbeing
Tidsramme: 18 months
|
Proportion of subjects who report improved financial wellbeing (e.g. consistent income, ability to pay bills). |
18 months
|
|
Food Security
Tidsramme: 18 months
|
Proportion of individuals who report improved access to food (e.g. fewer gaps in access to food, reduced concern about access to food). |
18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PrEP Persistence
Tidsramme: 18 months
|
Proportion of individuals who have engaged in PrEP care regularly (beyond 6 months). |
18 months
|
|
Viral Suppression
Tidsramme: 18 months
|
Proportion of individuals who have a viral load below 200 copies/mL |
18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: John Schneider, MD, University of Chicago
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Bailey ZD, Krieger N, Agenor M, Graves J, Linos N, Bassett MT. Structural racism and health inequities in the USA: evidence and interventions. Lancet. 2017 Apr 8;389(10077):1453-1463. doi: 10.1016/S0140-6736(17)30569-X.
- Singer AW, Weiser SD, McCoy SI. Does Food Insecurity Undermine Adherence to Antiretroviral Therapy? A Systematic Review. AIDS Behav. 2015 Aug;19(8):1510-26. doi: 10.1007/s10461-014-0873-1.
- Evans WN, Sullivan JX, Wallskog M. The impact of homelessness prevention programs on homelessness. Science. 2016 Aug 12;353(6300):694-9. doi: 10.1126/science.aag0833. Epub 2016 Aug 11.
- Wheeler DP, Fields SD, Beauchamp G, Chen YQ, Emel LM, Hightow-Weidman L, Hucks-Ortiz C, Kuo I, Lucas J, Magnus M, Mayer KH, Nelson LE, Hendrix CW, Piwowar-Manning E, Shoptaw S, Watkins P, Watson CC, Wilton L. Pre-exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study. J Int AIDS Soc. 2019 Feb;22(2):e25223. doi: 10.1002/jia2.25223.
- Lopez JD, Shacham E, Brown T. The Impact of Clinic Policy Attendance and the Ryan White HIV/AIDS Medical Case Management Program on HIV Clinical Outcomes: A Retrospective Longitudinal Study. AIDS Behav. 2020 Apr;24(4):1161-1169. doi: 10.1007/s10461-019-02738-8.
- Bouris A, Jaffe K, Eavou R, Liao C, Kuhns L, Voisin D, Schneider JA. Project nGage: Results of a Randomized Controlled Trial of a Dyadic Network Support Intervention to Retain Young Black Men Who Have Sex With Men in HIV Care. AIDS Behav. 2017 Dec;21(12):3618-3629. doi: 10.1007/s10461-017-1954-8.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Andre studie-ID-numre
- IRB23-0938
- 5R01MH131476-02 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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