GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

Summary

The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.

Conditions

• Tuberculosis, Pulmonary
• Rifampicin Resistant Tuberculosis

Interventions

DEVICE

GeneXpert I

Onsite molecular testing with GeneXpert I as a replacement for microscopy

BEHAVIORAL

Process re-design

Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.

OTHER

Performance Feedback

Feedback of TB diagnostic evaluation quality indicators to health center staff

Sponsors & Collaborators

• Makerere University

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Yale University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Adithya Cattamanchi, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-22

Primary Completion

2020-03-31

Completion

2022-07-31

Countries

• Uganda

Study Locations