Evaluation of Cepheid GeneXpert Omni combined...

In the News

Study establishes link between gender, extramarital affairs and HIV

Dar es Salaam. A new Ifakara Health Institute study has found “a significant association between lifetime (proxy) extramarital affairs and HIV infection among women only,” with the risk being significantly …

IHI names winners of research, innovation fund

[Right-Left] Getrud, Beatrice, Theckla, and Tutu.Ifakara Health Institute (IHI) has named recipients of the 2017/18 Director’s Research and Innovation Fund. This is an internal funding mechanism aimed to support specific …

Recent Projects

Development of a new tool for malaria mosquito surveillance to improve vector control

Malaria transmission is influenced not only by vector abundance, but as well by demographic traits such as vector species and age structure, as these influence the intensity by which the …

Demonstrating complete disruption of residual malaria transmission by eliminating Anopheles funestus mosquitoes from rural Tanzanian villages

In rural south-eastern Tanzania, where malaria prevalence has reduced by >60% since 2000, low-to-moderate transmission still persists despite very high coverage with long-lasting insecticidal bednets. Like in most residual transmission …

Cepheid GeneXpert Omni combined with the Xpert MTB/RIF Ultra for detection of tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis at primary-level diagnostic centers in Tanzania: a pragmatic, cluster-randomized controlled trial

GeneXpert Omni (Omni) is a new developed diagnostic tool with characteristic suitable for use in resource limited settings e.g. portability, battery powered. The GeneXpert Omni is considered the next generation of the current existing GeneXpert platform and is developed to address challenges encountered by the current GeneXpert platform in resource limited settings. A new cartridge, Xpert MTB/RIF Ultra (Ultra) has been developed with higher sensitivity approximately similar to culture, the gold standard for tuberculosis (TB) diagnosis. The combination of both Omni and Ultra is expected to impact on important clinical outcomes and hence control TB. The Omni/Ultra trial is pragmatic cluster randomized trial which will evaluate Omni combined with Ultra for TB detection in primary healthcare facilities in Bagamoyo and Dar es Salaam in Tanzania. Fourteen clusters (primary healthcare facilities), seven in each arm, fulfilling inclusion criteria, will be randomized to either the intervention (Omni/Ultra) or remain on standard of care (smear microscopy) for diagnosis of TB. Presumptive TB patients attending selected facilities will undergo diagnostic procedures of TB test using Omni/Ulta or smear microscopy as per randomization arm. Omni/Ultra is planned to recruit 1600 presumptive adult TB patients, who are able to produce sputum. The trial is expected run for 18 months. The primary ends points are;

  • Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 60 days of enrolment
  • Additionally notified TB cases during intervention compared to the standard of care (direct yield)

Omni/Ultra is an investigator initiated trial, implemented by the Ifakara Health Institute in collaboration with the Swiss Tropical and Public Health Institute and the National TB program Tanzania. Omni/Ultra trial is funded by both the STOP TB Partneship|TB REACH initiative and the Foundation for Innovative New Diagnostics.

Partners

Swiss Tropical and Public Health Institute

Funders

Foundation for Innovative New Diagnostics (FIND) and Stop TB Partnership

Projects Location

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