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

6 september 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

500

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

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

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / 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.
Övrig: Standardbehandling
Standardbehandling
Experimentell: 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.
Övrig: Same-Day Treatment
Treatment with ART or TB medication on day of HIV diagnosis

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality
Tidsram: 48 weeks after HIV testing
All-cause mortality
48 weeks after HIV testing
Mean treatment cost per participant
Tidsram: 48 weeks after HIV testing
Mean treatment cost per participant
48 weeks after HIV testing
Viral suppression
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 48-week study period
Incidence of paradoxical or unmasking IRIS
48-week study period
Adverse events
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 48-week study period
Days to death
48-week study period
Last missed dose of medication
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Brigham and Women's Hospital

Samarbetspartners

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 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

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)

6 november 2017

Primärt slutförande (Faktisk)

16 april 2021

Avslutad studie (Faktisk)

16 april 2021

Studieregistreringsdatum

Först inskickad

24 mars 2017

Först inskickad som uppfyllde QC-kriterierna

12 maj 2017

Första postat (Faktisk)

16 maj 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 september 2022

Senast verifierad

1 september 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AI131998

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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