Evaluating Accuracy, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons

PHASE4CompletedINTERVENTIONAL
Enrollment

18,696

Participants

Timeline

Start Date

August 1, 2012

Primary Completion Date

July 1, 2017

Study Completion Date

July 1, 2017

Conditions
TuberculosisHuman Immunodeficiency Virus
Interventions
DEVICE

Xpert device

"Interventions in the Experimental phase of this stepped-wedge trial include: (a) ensuring WHO-recommended TB screening adopted, (b) situating trained TB case finding nurses in the clinics, (c) training clinic personnel in the TB diagnostic algorithms, and (d) activation of the Xpert diagnostic device."

OTHER

Intensified TB Case Finding (ICF)

Interventions in the active comparator phase of this stepped wedge trial only include: (a) adoption of the WHO-recommended 4-symptom TB screen for adults; (b) situating trained TB case-finding nurses in the 22 facilities; and (c) training health facility personnel in TB diagnostic algorithms. There is no Xpert device activation in this phase. Only the standard of care microscopy algorithm (smear microscopy and chest x-ray) are available during this phase.

Trial Locations (1)

Unknown

22 HIV care and Treatment clinics in Botswana, Multiple Locations

All Listed Sponsors
collaborator

Botswana Ministry of Health

OTHER_GOV

collaborator

University of Pennsylvania

OTHER

lead

Centers for Disease Control and Prevention

FED

NCT02538952 - Evaluating Accuracy, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons | Biotech Hunter | Biotech Hunter