En randomiserad kontrollerad studie av en antiretroviral behandlingsadherensintervention för HIV+ afroamerikaner
21 december 2022 uppdaterad av: RAND
Project Rise är en randomiserad kontrollerad studie (RCT) av en innovativ, kulturellt kongruent behandlingsutbildning (TE) intervention för afroamerikaner med HIV som riktar sig till kulturella och sociala frågor som bidrar till hälsoskillnader.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Project Rise är en randomiserad kontrollerad studie (RCT) av en innovativ, kulturellt kongruent behandlingsutbildning (TE) intervention för afroamerikaner med HIV som riktar sig till kulturella och sociala frågor som bidrar till hälsoskillnader. TE underlättar patientnavigering genom det medicinska systemet och tillhandahåller behandlingsutbildning och klientcentrerad rådgivning för att förbättra följsamhet och retention i vården. TE riktar in sig på strukturella frågor inom hälso- och sjukvården och patienternas liv genom att förespråka för vårdgivare att förbättra relationerna mellan patient och vårdgivare, rekommendera förändringar i behandling och/eller vårdgivare, och hänvisa patienter till psykisk hälsa och sociala tjänster.
Totalt 350 svarta deltagare kommer att rekryteras genom APLA Health och slumpmässigt tilldelas kontrollgruppen för intervention eller vanlig vård (175 per grupp). Efterlevnaden kommer att övervakas elektroniskt dagligen (och laddas ner varannan månad) från baslinjen till 13 månader efter baslinjen. Viral belastning kommer att bedömas genom venpunktion vid baslinjen och 6 och 13 månader efter baslinjen. Det antas att interventionsgruppen kommer att visa bättre följsamhet och ha en större sannolikhet för undertryckt virusbelastning än kontrollgruppen över tid.
Studietyp
Interventionell
Inskrivning (Faktisk)
306
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90016
- AIDS Project Los Angeles
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inklusionskriterier:
- HIV-positiv
- 18 år eller äldre
- Självidentifierad som afroamerikan/svart
- Har ordinerats antiretroviral terapi (ART) under de senaste 12 månaderna
- Självrapporterade följsamhetsproblem (dvs. missat minst 1 ART-dos under den senaste månaden) och/eller detekterbar virusmängd
- Villig att använda Medication Event Monitoring System (MEMS) för elektronisk följsamhetsövervakning.
Exklusions kriterier:
- HIV-negativ
- 17 år eller yngre
- Inte självidentifierad som afroamerikan/svart, inte på antiretroviral terapi (ART) eller inte ordinerad ART-behandling under de senaste än 12 månaderna
- Inga självrapporterade vidhäftningsproblem och/eller ingen detekterbar virusmängd
- Inte villig att använda Medication Event Monitoring System (MEMS) för elektronisk följsamhetsövervakning.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Rise - Behandlingsutbildning
Rise består av en enmånads intensiv intervention (med tre grundläggande 60-minuters rådgivningssessioner vid vecka 1, 2 och 4) följt av två boostersessioner (vecka 12 och 20).
Om deltagarna inte följs under boostersessioner erbjuds de upp till fyra extra boostersessioner (d.v.s. extra boostersessioner om <85 % av de ordinerade doserna togs under den senaste månaden).
Således får deltagarna tre core-sessioner under den första månaden, följt av 2-6 booster-sessioner under de kommande fyra månaderna.
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Rise består av en enmånads intensiv intervention (med tre grundläggande 60-minuters rådgivningssessioner vid vecka 1, 2 och 4) följt av två boostersessioner (vecka 12 och 20).
Om deltagarna inte följs under boostersessioner erbjuds de upp till fyra extra boostersessioner (d.v.s. extra boostersessioner om
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Inget ingripande: Kontroll - Ingen behandlingsutbildning
Kontrollgruppen Usual Care kommer endast att få standardvård genom sina HIV-kliniker.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Kontinuerlig efterlevnad
Tidsram: baslinje (förbehandling) och observationer efter behandling vid 7, 8, 9, 10, 11 och 12 månader efter baslinjen
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Andel av doser som tas av de som ordinerats från elektronisk övervakning.
Här presenterar vi all data som samlats in vid alla tidpunkter som används i analysen.
Utvärdering av interventionseffektivitet utfördes med regression med upprepade mätningar med kontinuerliga följsamhetsmätningar under alla 6 månader efter intervention (7:e till 12:e månaden efter baslinjen) och var begränsad till de med följsamhetsdata vid baslinjen.
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baslinje (förbehandling) och observationer efter behandling vid 7, 8, 9, 10, 11 och 12 månader efter baslinjen
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Dikotom följsamhet
Tidsram: baslinje (förbehandling) och observationer efter behandling vid 7, 8, 9, 10, 11 och 12 månader efter baslinjen
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Antal deltagare som rapporterade att de tog mer än eller lika med 75 % av den föreskrivna dosen, baserat på elektronisk övervakning.
Här presenterar vi all data som samlats in vid alla tidpunkter som används i analysen.
Utvärdering av interventionseffektivitet utfördes med regression av upprepade mått med användning av följsamhetsmätningar under alla 6 månader efter intervention (7:e till 12:e månaden efter baslinjen) och var begränsad till de med följsamhetsdata vid baslinjen.
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baslinje (förbehandling) och observationer efter behandling vid 7, 8, 9, 10, 11 och 12 månader efter baslinjen
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Viral dämpning
Tidsram: baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen. För 7M användes medicinska journaler inom 90 dagar efter att undersökningen slutförts; under 13 månader användes journaler inom 90 dagar före eller 180 dagar efter undersökning
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Viral belastning odetekterbar per venpunktion eller medicinska journaler
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baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen. För 7M användes medicinska journaler inom 90 dagar efter att undersökningen slutförts; under 13 månader användes journaler inom 90 dagar före eller 180 dagar efter undersökning
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Internaliserat HIV-stigma
Tidsram: baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen
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Mått är antalet deltagare som "något håller med" eller "instämmer starkt" med antingen "De flesta människor med AIDS är ansvariga för att ha sin sjukdom" eller "En person med AIDS måste ha gjort något fel och förtjänar att bli straffad."
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baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen
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Medicinsk misstro
Tidsram: baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen
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Resultatet är genomsnittlig överensstämmelse med 9 hiv-relaterade konspirationstror, var och en mätt på en 5-gradig skala från 1=Instämmer helt och hållet till 5=Instämmer helt.
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baslinje (förbehandling) och observationer efter behandling vid 7 och 12 månader efter baslinjen
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 januari 2018
Primärt slutförande (Faktisk)
7 november 2021
Avslutad studie (Faktisk)
7 november 2021
Studieregistreringsdatum
Först inskickad
30 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
1 november 2017
Första postat (Faktisk)
6 november 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 januari 2023
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 december 2022
Senast verifierad
1 december 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunologiska bristsyndrom
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
Andra studie-ID-nummer
- R01NR017334 (U.S.S. NIH-anslag/kontrakt)
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Nej
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