Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV

6. september 2022 opdateret af: Serena Patricia Koenig, Brigham and Women's Hospital
This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is a randomized trial that will compare outcomes with standard and same-day treatment among patients with TB symptoms at HIV diagnosis. The standard group will receive same-day chest x-ray as well as Xpert Ultra testing with a spot specimen (with 48-hour turn-around-time). Participants will return for Xpert Ultra results and early morning sputum testing on Day 2. TB treatment will be provided on the day of diagnosis (Day 0 for those with high clinical and radiographic suspicion of TB, and Day 2 for those diagnosed by spot Xpert Ultra). Standard group participants who are not diagnosed with TB will be tested and treated for other opportunistic infections (OIs), as clinically indicated, and will initiate ART on Day 7. The same-day group will receive Xpert Ultra testing (with same-day results) and chest x-ray with same-day ART or TB treatment (on Day 0) based on test results. They will also be tested and treated for other OIs as clinically indicated. They will provide early morning sputum for repeat testing on Day 1. Both groups will receive Xpert Ultra testing on both spot and early morning specimens, with liquid culture on both specimens as the diagnostic gold standard; those with TB will start ART according to WHO guidelines.

Three specific aims are proposed:

Aim 1: To compare the proportion of participants in each group who are alive and in care with undetectable viral load (<200 copies/ml) at 48 weeks after HIV testing. Hypothesis: The proportion of participants retained in care with undetectable viral load will be 51% in the standard and 65% in the same-day group.

Aim 2: To compare mortality in each group at 48 weeks after HIV testing. Hypothesis: Mortality will be 10% in the standard group and 4% in the same-day group.

Aim 3: To conduct a comparison of cost and cost-effectiveness of standard and same-day care, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with plasma HIV-1 RNA level <200 copies/ml at 48 weeks after HIV testing. Hypothesis: Same-day treatment will cost less per patient retained in care with undetectable viral load.

Aim 4: To determine the rates of ART and TB treatment initiation, TB diagnosis after ART initiation, IRIS, adverse events, and adherence in both groups, and to evaluate the sensitivity, specificity, and predictive values of single tests and different testing combinations compared to liquid mycobacterial culture results.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Haiti
      • Port-au-Prince, Haiti
        • GHESKIO

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:

  • Men and women of ≥18 years of age
  • Presence of cough, fever, night sweats or weight loss
  • Ability and willingness to give written informed consent
  • Documentation of positive HIV status (test conducted at GHESKIO)
  • Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".

Exclusion Criteria:

  • Any use of ART in the past
  • Treatment for TB in the year prior to screening visit
  • Pregnancy or breastfeeding at the screening visit
  • Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
  • Score of <3 for any of the 7 questions on the ART readiness survey
  • Planning to transfer care to another clinic during the study period
  • Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive multifocal leukoencephalopathy)
  • Severe illness, classified as one of the WHO "danger signs" of temperature >39 degrees Celsius, pulse >120 beats/minutes, respiratory rate >30, or inability to walk unaided.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard Group
On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and provide a sputum specimen for spot Xpert Ultra testing (48-hour results). Those with high clinical/radiographic suspicion for TB will start same-day TB treatment. On Day 2, participants will return for results of Xpert Ultra testing (spot specimen) and to provide a specimen for early morning Xpert Ultra testing. Those who are Xpert Ultra positive will start TB treatment. Those who are not diagnosed with TB will start ART on Day 7, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens.
Andet: Standard behandling
Standard behandling
Eksperimentel: Same-Day Treatment Group
On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and Xpert Ultra testing with same-day results. Based on clinical symptoms, Xpert Ultra results, and chest x-ray, physician will determine whether or not the participant has tuberculosis. Those who are diagnosed with TB will start same-day TB treatment. Those who are not diagnosed with TB will start same-day ART.
Andet: Same-Day Treatment
Treatment with ART or TB medication on day of HIV diagnosis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Retention in care with viral suppression
Tidsramme: 48 weeks after HIV testing
Proportion of participants who are in care with HIV-1 RNA <200 copies/ml
48 weeks after HIV testing

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: 48 weeks after HIV testing
All-cause mortality
48 weeks after HIV testing
Mean treatment cost per participant
Tidsramme: 48 weeks after HIV testing
Mean treatment cost per participant
48 weeks after HIV testing
Viral suppression
Tidsramme: 48 weeks after HIV testing
Proportion of participants with HIV-1 RNA <50 copies/ml and <1000 copies/ml
48 weeks after HIV testing
Adherence by medication possession ratio
Tidsramme: 48 weeks after HIV testing
Proportion of participants with 48-week adherence to ART of at least 90% by pharmacy refill records
48 weeks after HIV testing
Adherence by 3-day self-report
Tidsramme: 48 weeks after HIV testing
Proportion of participants with perfect (100%) adherence as measured by 3-day self-report at 48 weeks after HIV testing
48 weeks after HIV testing
Treatment failure
Tidsramme: 48 weeks
Proportion of participants meeting WHO criteria for ART failure and proportion initiating second-line ART during the study period
48 weeks
TB testing characteristics
Tidsramme: These diagnostic tests will be conducted during the first week of study enrollment
Sensitivity, specificity, predictive values, and likelihood ratios of spot and early morning Xpert Ultra results and chest x-ray, as single and as combined tests, with liquid culture as gold standard
These diagnostic tests will be conducted during the first week of study enrollment
Time in clinic
Tidsramme: First study day and first study month
Median time spent in clinic during first day and month of the study
First study day and first study month
Coping with HIV diagnosis
Tidsramme: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Scores on the COPE survey
2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Connectedness to Treatment Setting
Tidsramme: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Scores on the Connectedness to Treatment Setting Scale
2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
TB diagnosis after ART initiation
Tidsramme: 48-week study period
Diagnosis of culture-positive TB after ART initiation (BACTEC MGIT 960, Becton Dickinson)
48-week study period
Incidence of immune reconstitution inflammatory syndrome (IRIS)
Tidsramme: 48-week study period
Incidence of paradoxical or unmasking IRIS
48-week study period
Adverse events
Tidsramme: 48-week study period
New Division of AIDS Grade 3 or Grade 4 signs, symptoms, or laboratory abnormalities that are at least a one-grade increase from baseline
48-week study period
Measure of hope and optimism
Tidsramme: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Scores on the State Hope Scale
2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Patient satisfaction
Tidsramme: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Scores on the HRSA Patient Satisfaction Survey
12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Time to death
Tidsramme: 48-week study period
Days to death
48-week study period
Last missed dose of medication
Tidsramme: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Proportion of participants who report last missed dose of ART was at least 2 weeks ago
2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Brigham and Women's Hospital

Samarbejdspartnere

Weill Medical College of Cornell University
University of California, Davis
Florida International University
Analysis Group, Inc.
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

6. november 2017

Primær færdiggørelse (Faktiske)

16. april 2021

Studieafslutning (Faktiske)

16. april 2021

Datoer for studieregistrering

Først indsendt

24. marts 2017

Først indsendt, der opfyldte QC-kriterier

12. maj 2017

Først opslået (Faktiske)

16. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI131998

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

When the study has been completed, anonymized data will be made publicly available, which will permit replication of reported outcomes.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV/AIDS

Kliniske forsøg med Standard behandling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner