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

6 settembre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

500

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: Trattamento standard
Trattamento standard
Sperimentale: 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.
Altro: Same-Day Treatment
Treatment with ART or TB medication on day of HIV diagnosis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Retention in care with viral suppression
Lasso di tempo: 48 weeks after HIV testing
Proportion of participants who are in care with HIV-1 RNA <200 copies/ml
48 weeks after HIV testing

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality
Lasso di tempo: 48 weeks after HIV testing
All-cause mortality
48 weeks after HIV testing
Mean treatment cost per participant
Lasso di tempo: 48 weeks after HIV testing
Mean treatment cost per participant
48 weeks after HIV testing
Viral suppression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 48-week study period
Incidence of paradoxical or unmasking IRIS
48-week study period
Adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 48-week study period
Days to death
48-week study period
Last missed dose of medication
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Brigham and Women's Hospital

Collaboratori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 novembre 2017

Completamento primario (Effettivo)

16 aprile 2021

Completamento dello studio (Effettivo)

16 aprile 2021

Date di iscrizione allo studio

Primo inviato

24 marzo 2017

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2017

Primo Inserito (Effettivo)

16 maggio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 settembre 2022

Ultimo verificato

1 settembre 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI131998

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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