NCT05845112Befejeződött
Start Taking Action For TB Diagnosis
Start Taking Action For TB Diagnosis (START4ALL)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 21.
Rövid összefoglaló (regiszter, angolul)
Globally, tuberculosis (TB) is one of the main causes of death and the leading cause from a single infectious agent. In 2020, an estimated 9.9 million people developed TB and 1.5 million died. Millions of people remain undiagnosed with TB, hindering efforts to end TB. TB tests have inadequate accuracy or performance characteristics for implementation across all populations and settings. None of the tests meet the WHO-Target-Product Profile for TB screening and most need specialized laboratory staff and infrastructure, making them unsuitable for primary health care (PHC). The overall objectives for this project are to: 1. To evaluate the performance of selected TB tests and test combinations in primary health care settings and KVPs. 2. To identify test combinations that increase the proportion of people diagnosed with microbiologically confirmed TB in comparison to a microbiological reference standard. 3. To demonstrate that test combinations are cost-efficient and feasible for scale-up to facilitate enhanced access to TB diagnosis in locations and for populations where they are not currently available. Methods in brief: Objectives 1 and 2 will use the same methods and will be assessed simultaneously. These objectives will use cross-sectional surveys. Activities will be conducted in Bangladesh, Brazil, Kenya, Cameroon, Malawi, Nigeria, and Viet Nam. Each country will study selected priority populations at risk of TB, including adults attending PHC centers and district hospitals; people living with HIV (PLHIV); marginalized populations (internally displaced, refugees and pastoralists), and children. Activities within countries will use standardized protocols for evaluating diagnostic tests and combinations. Methods for Objective 3 (Phase 1) will be a realist evaluation consisting of a market landscape analysis, evaluation of the costs and cost-efficiency of implementing TB tests and combinations, and a combination of key informant interviews, focus group discussions and/or participatory workshops, depending on appropriateness to stakeholder group and local context, to gather qualitative data on acceptability of TB tests and combinations.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 14747 (tényleges)
- Első benyújtás
- 2023. ápr. 5.
- Kezdés
- 2025. febr. 28.
- Elsődleges befejezés
- 2025. febr. 28.
- Fő szponzor
- Liverpool School of Tropical Medicine
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT05845112
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 14747
- 2025. febr. 28. és az elsődleges befejezés (2025. febr. 28.) között
- 8 helyszín, 7 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- Inclusion criteria for Individuals attending stationary health facilities:
- health-seeking persons presenting at participating study site health facilities who are:
- Age 15 years and above
- PLHIV irrespective of their CD4 count and antiretroviral therapy (ART) status
- At risk of pulmonary and/or extra-pulmonary TB
- OR
- People with a positive WHO-recommended four-symptom screen (W4SS) or parenchymal abnormalities on chest radiography
- Written informed consent and agreement to follow-up after enrolment (e.g. not planning to relocate)
- A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed for those aged 15 years to age of majority
- Exclusion
- Current anti-TB treatment (counting from the third dose)
- Any anti-TB treatment within 60 days prior to enrolment
- Any TB preventive therapy within 6 months prior to enrolment
- Inclusion criteria for refugees and IDPs
- health-seeking persons resident in official refugee camps who have cross international borders from other countries; OR
- internally displaced individuals (IDPs), defined as persons forced or obliged to flee or to leave their homes to avoid the effects of armed conflict, situations of generalized violence, violations of human rights or natural or human-made disasters, and who have not crossed an internationally recognized state border.
- IDPs can be recruited from refugee camps or among individuals sharing accommodation with local residents.
- At the time they are presenting at participating study site health facilities.
- Clinical criteria will be the same as described for individuals attending health facilities
- Exclusion
- Same as described for individuals attending health facilities and
- Individuals who intend to leave the local area in the short term and have no means of contact
- Inclusion criteria for nomadic populations
- Participants will be selected using active case finding through community screening camps targeting the nomadic population (nomadic are defined as a member of a group of people who have no fixed home and move according to the seasons from place to place in search of food, water, and grazing land and are usually herders with traditional hierarchies.
- The dates and locations of screening days will coincide with community market days, after consultation with nomadic community leaders
- Clinical criteria will be the same as described for individuals attending health facilities
- Exclusion
- Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact
- Inclusion criteria for informal settlements, urban vulnerable groups and the rural poor
- Participants will be selected using active case finding through community screening activities targeting urban vulnerable groups and the rural poor.
- Screening will be conducted on dates and in locations agreed with community leaders, depending on the setting.
- Clinical criteria will be the same as described for individuals attending health facilities.
- Exclusion
- Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact.
- Inclusion criteria for children health-seeking children presenting at participating study site health facilities who:
- Are between 12 months and 15 years of age.
- Have presumptive TB based on at least one criterion among the following:
- Persistent cough for more than 2 weeks
- Persistent fever for more than 2 weeks
- Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age < 2)
- Failure of broad-spectrum antibiotics for treatment of pneumonia to improve symptoms and signs
- Suggestive CXR features OR
- History of contact with a person with TB and any of the symptoms listed above with a shorter duration (< 2 weeks), if the child is HIV infected or presents with Severe Acute Malnutrition
- A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed by children > 7 years old.
- > 5 days of anti-TB treatment in the last 3 months or individuals receiving TB preventive therapy
- Children <12 months old
Életkor a regiszterben: 1 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (8)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Icddr,B | Dhaka | Banglades | Ismeretlen állapot |
| Fundação de Apoio à Pesquisa e Extensão de Sergipe | Sergipe | Brazília | Ismeretlen állapot |
| CHPR | Bamenda | Kamerun | Ismeretlen állapot |
| KEMRI | Kisumu | Kenya | Ismeretlen állapot |
| Malawi-Liverpool-Wellcome Clinical | Blantyre | Malawi | Ismeretlen állapot |
| Zankli Research Centre, Bingham University | Abuja | Nigéria | Ismeretlen állapot |
| Janna Health Foundation | Adamawa | Nigéria | Ismeretlen állapot |
| Friends for International TB Relief | Hà Nội | Vietnám | Ismeretlen állapot |
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