Adopción de enfoques innovadores para garantizar la continuidad de los servicios de TB de calidad durante la pandemia de Covid-19 en Lusaka y Livingstone, Zambia. (Telemedicina en TB) (Telemed TB)
Following the negative impact of public health program services including TB services by the COVID-19 Pandemic in 2020, CIDRZ conducted a program evaluation for remote patient follow up for TB treatment and prevention through a differentiated service delivery model (DSD), offering clinical monitoring and psychosocial support while minimizing contact with the health facilities. The project was implemented between February 2022 to March 2023 and was funded through Centers for Disease Control and Prevention's COVID-19 Response International Task Force - CARES funding. While DSD models have been widely adopted in HIV programs , DSD is a relatively new and exciting approach for TB treatment and prevention programs.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
During the COVID-19 pandemic, government restrictions on movement decreased access to health care. Although DSD models have been widely adopted in HIV programs, this is a relatively new approach for TB programs. Zambia's NTLP has already changed policy to allow for such adaptations of service delivery, but these adaptations are not universally implemented and have not been evaluated at this time. This project aims to evaluate these DSD models for both TB treatment (Anti-TB Treatment ATT) and TPT using standardized indicators. To complement these DSD models, innovative approaches like digital (texting/SMS and phone) treatment support and remote monitoring of adverse events will be adopted using bi-directional SMS through use of the rapid pro system, a tool that allows medical information to be gathered and shared via a cell phone.
- To implement TPT in 6MMD and ATT DSD models at 5 sites in Lusaka and Livingstone districts
- To assess acceptability of TPT in 6MMD and ATT DSD models at implementation sties
- To assess trends in TPT coverage and completion rates from pre-implementation through implementation periods using aggregate program performance data
- To assess trends in ATT completion rates from pre-implementation through implementation periods using aggregate program performance data
- To inform the Ministry of Health on a systematic approach for digital follow up and screening for TB and TPT RoCs aligned to MMD models of care.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lusaka Province
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Lusaka, Lusaka Province, Zambia, 10101
- Lusaka and Livingstone districts
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
TB ARM
- All ROCs presenting to chest clinic for TB treatment between February 2022 and September 2022 were considered for inclusion if:
Diagnosed with TB (new cases or retreatment cases) 18 years and above Willing and able to provide consent Not pregnant or breastfeeding No MDR TB
TPT ARM
All ROCs presenting to the ART clinic between February 2022 and September 2022 were considered for inclusion if they were:
18 years or above virally supressed with no symptoms or diagnosis suggestive of TB on ART for more than 6 months on 6MMD Consented to participate in the project did not receive TPT in the last 3 years not pregnant or breastfeeding women not incarcerated
Exclusion Criteria:
ATT ARM
- RoCs those TB diagnosis is not confirmed
- RoCs who are less than 18 years old
- RoCs not able to provide consent for program evaluation participation
- RoCs with MDR TB
TPT ARM
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RoCs with symptoms suggestive of TB, diagnosed or confirmed with TB diagnosis
- RoCs who received TPT in the last 3 years
- RoCs who are less than 18 years old
- RoCs not able to provide consent for program evaluation participation
- Pregnant and breastfeeding women
- Incarcerated persons
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: TB treatment ARM
Beginning February 2022, we offered ATT via 2-month MMD during intensive and 4-month MMD during continuation phases. In-clinic visits during 6-months of ATT were reduced from 7 under standard of care to 3 visits in DSD, while ensuring robust adherence and adverse event screening. Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. If SMS were not returned, a phone or home visit was triggered. |
Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB. |
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Comparador activo: TPT DSD
Beginning February 2022, we offered TPT aligned to 6MMD ART model following standard of care processes with added support (See below). Remote monitoring consisted of structured SMS (months 1 to 5) and phone (week 2 and month 3) follow-up to assess adherence and screen for side effects. ROCs that did not respond to the SMS within 2 days were further contacted via phone and if not reachable a home visit was done. ROCs that reported at least one side effect or more were followed up with virtual reviews by clinicians. At enrollment ROCs reading language of preference was documented and the SMS was sent in their preferred language. |
Although DSD models have been widely adopted in HIV programs, DSD is a relatively new approach for TB programs because of an historical reliance on directly observed therapy (DOT) (6). DSD provides opportunities to improve health outcomes and reduce the burden of seeking care for people diagnosed with TB. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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TB and TPT Outcomes
Periodo de tiempo: 12 months
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• The primary program evaluation outcomes of interest are the TPT and ATT completion rates in the prospective cohort, defined as the fraction of participants completing TPT or ATT among those who initiated TPT or ATT |
12 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Director de estudio: Mwanza Wa Mwanza, MD, Centre for Infectious Disease Research in Zambia
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- Telemedicine in TB
- NU2GGH002251 (Otro número de subvención/financiamiento: U.S. Centers for Disease Control and Prevention's COVID-19 Response International Task Force)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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