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An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease (ENCORE)

9. juli 2022 opdateret af: Makerere University

A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study will be carried out in a population of HIV-infected adults with advanced HIV disease (CD4 <200 cells/µL) in Uganda. It will be a Randomized controlled trial, Phase III in Uganda over a duration of 5 years assessing 24 weeks survival with retention in care. @4 clinic will be randomized to either receive the enhanced package or standard of care.

Description of Intervention Arm

  1. Point-of-care CD4 testing via Visitect (point of care semi Quantitaive CD4 LFA) lateral flow assay (LFA)

  2. Enhanced package of opportunistic infection screening and prophylaxis for CD4<200, including:

    • FujiFilm SILVAMP TB LAM (FujiLAM)
    • Isoniazid (INH) + rifapentine: 1 month of therapy for latent TB(Tuberculosis) infection
    • Cryptococcal Antigen semi-quantitative (CrAg-SQ) LFA (Immy)
    • Treatment for disseminated CNS cryptococcal infection if high blood CrAg titer (>3+ CrAg SQ)

Description of Standard of Care Arm

  1. CD4 testing by flow cytometry

  2. WHO recommended package of OI screening and prophylaxis, including:

    • Urine TB LAM
    • INH ( isoniazid 6 months)
    • CrAg LFA
    • Fluconazole for asymptomatic CrAg+ o 800mg daily x 2 weeks, then 400mg daily x 8 weeks, then 200mg daily.

Problem statement: Current lab-based CD4 testing results in a delay to either start ART(Antiretroviral therapy) or a delay in screening persons with low CD4s for OIs. At present, prioritization has been on ART initiation without systematic OI screening. Those with subclinical OIs started on ART unmask their OIs, with hospitalization / deaths for OIs such as cryptococcosis and TB.

We hypothesize that with point of care CD4 testing, same-day OI screening can occur, yet not interrupt prompt ART initiation for those at low risk (FujiLAM and CrAg-SQ negative) of unmasking immune reconstitution syndrome.

We hypothesize that point-of-care CD4 testing will improve 6-month survival by reducing lag time in CD4 results, thereby facilitating ART initiation, retention-in-care, and OI screening and prophylaxis.

We hypothesize that enhanced screening with the point-of-care FujiLAM, CrAg-SQ LFA, with enhanced prophylaxis for TB (1 month of INH and rifapentine) and with treatment for disseminated CNS cryptococcal infection in those CrAg+ with high titers (>3+) will improve 6-month survival compared to current WHO-recommended standard practice in persons with advanced HIV disease.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2400

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Radha Rajasingham, MD
  • Telefonnummer: 612 626-8171
  • E-mail: radha@umn.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Rekruttering
        • kisugu health center IV
        • Kontakt:
          • Teopista Namuli

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age >18 years
  • CD4<200 cells/µL
  • Ability and willingness to give informed consent for the enhanced package of care arm.

Exclusion Criteria:

  • Known virologic suppression (viral load <1000 copies/mL) within prior 3 months
  • Cannot or unlikely to attend regular clinic visits

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: intervention(Enhanced package of care) Arm
The patients with advanced HIV disease that receive HIV care at the intervention clinics will receive the enhanced intervention package which will include: point of care CD4 testing with visitect, screening for TB and cryptococcal meningitis using Fujifilm LAM and semiquantitative crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for one month. Those with a high crAg titers will receive treatment for CNS cryptococcal disease.
Andet: Enhanced care package
The intervention is an improved package of care for patients with advanced HIV disease with point of care CD4 testing, more sensitive screening tests for opportunistic infections and more intensive pre-emptive treatment for opportunistic infections
Ingen indgriben: Standard of care Arm
The patients with advanced HIV disease that receive HIV care at the standard of care clinics will receive the usual routine HIV care as per the Uganda national guidelines. That is CD4 testing with flowcytometry or other CD4 testing modalities available, screening for TB and cryptococcal meningitis using Alere LAM and crAg LFA respectively and pre-emptive treatment with isoniazid and rifapentine for 3-6 month. Treatment of all asymptomatic crAG positives with fluconazole as per guidelines.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
24-week survival with retention in care
Tidsramme: 24 weeks
Comparison will be made between study arms of those who receive POC CD4 testing vs. those who receive standard flow cytometry, and those who receive the enhanced package of OI screening and prophylaxis, vs. those who receive the current WHO standard.
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate sensitivity and specificity of the different TB point of care tests.
Tidsramme: 24 weeks
After a positive FujiFilm TB LAM test, incidence of Xpert-positive or culture positive TB, and clinical outcomes to distinguish between false positive vs. true positive urine tests
24 weeks
Incidence of OIs and associated hospitalization and mortality
Tidsramme: Six months
Incidence of active TB within 6 months, Incidence of cryptococcal meningitis and associated mortality.
Six months
Tolerability and adherence to prophylaxis regimen and associated grade 3 to 5 adverse events
Tidsramme: 24 weeks
percentage completion of regimen and proportions that get grade 3 and above AEs.
24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Makerere University

Samarbejdspartnere

University of Minnesota

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. maj 2022

Primær færdiggørelse (Forventet)

1. marts 2027

Studieafslutning (Forventet)

1. september 2027

Datoer for studieregistrering

Først indsendt

8. oktober 2021

Først indsendt, der opfyldte QC-kriterier

8. oktober 2021

Først opslået (Faktiske)

20. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IDIREC REF 007/2021

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

Aggregated patient data will be summarized and disseminated.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med Enhanced care package

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Betingelser

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Kosttilskud

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Placeringer

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