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

6 de septiembre de 2022 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Haití
      • Port-au-Prince, Haití
        • GHESKIO

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
Otro: Tratamiento estándar
Tratamiento estándar
Experimental: 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.
Otro: Same-Day Treatment
Treatment with ART or TB medication on day of HIV diagnosis

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Retention in care with viral suppression
Periodo de tiempo: 48 weeks after HIV testing
Proportion of participants who are in care with HIV-1 RNA <200 copies/ml
48 weeks after HIV testing

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Brigham and Women's Hospital

Colaboradores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de noviembre de 2017

Finalización primaria (Actual)

16 de abril de 2021

Finalización del estudio (Actual)

16 de abril de 2021

Fechas de registro del estudio

Enviado por primera vez

24 de marzo de 2017

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2017

Publicado por primera vez (Actual)

16 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

6 de septiembre de 2022

Última verificación

1 de septiembre de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AI131998

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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