TB-CAPT CORE Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diagnoses Disease
- Tuberculosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: The objective of the trial is to assess Omni/Ultra platform in routine use. The use of Omni/Ultra does not allow blinding of clinicians and participants in this trial. The trial-related procedures will be embedded into the routine practice at the primary-level facility. Data analysts will be blinded to intervention allocation. Randomisation takes place on a cluster level rather than for the individual patients to avoid contamination between the arms within a health facility. Since clinics will be relatively far apart, contamination is unlikely.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
A cluster randomized controlled trial to evaluate the effect of placing GeneXpert Omni platforms at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB. In a setup period (survey of study centers) before randomiza...
A cluster randomized controlled trial to evaluate the effect of placing GeneXpert Omni platforms at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB. In a setup period (survey of study centers) before randomization, the healthcare facilities (=clinics) of 4 sites will be asked to provide information about the number of TB notifications per quarter covering the period 1/2018-6/2020. From this information the foreseeable number of examined patients ("size of a clinic") will be derived, which will be used as a strata variable in randomization process. Facilities will be randomly allocated to the standard of care (control), or GeneXpert OMNI/Ultra® (and MTB/XDR cartridges). A cluster refers to a clinic. The clusters will be assigned to intervention or control arm to one of two diagnostic procedures (SOC [smear microscopy and/or Xpert MTB/RIF Ultra off-site] vs Omni/Ultra on-site) following a restricted randomization strategy, whereby 6 to 8 strata of clusters will be established using the stratification variables site (clinics belong to a site) and size and apply balance criteria for them. The number of strata per site depends on heterogeneity of the sizes of the clinics as established in setup period and may be increased, typically 1 or 2 strata per site will be established. The primary endpoint will be compared in an individual level analysis with strata and intervention as fixed effects and cluster as random effect.
Tracking Information
- NCT #
- NCT04568954
- Collaborators
- Ludwig-Maximilians - University of Munich
- National Institute for Medical Research, Tanzania
- Centro de Investigação em Saúde de Manhiça
- Instituto Nacional de Saúde, Mozambique
- Ifakara Health Institute
- Investigators
- Principal Investigator: Katharina Kranzer Medical Center of the University of Munich
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