GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201610001763265
• Date of registration: 03/09/2016
• Prospective Registration: Yes
• Primary sponsor: University of California San Francisco
• Public title: GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
• Scientific title: GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
• Date of first enrolment: 01/10/2018
• Target sample size: 5500
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1763
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a randomisation table created by a computer software program,Sealed opaque envelopes
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Katherine Farr
• Affiliation: Research Associate

Key inclusion & exclusion criteria

Inclusion criteria: 1. (Site-level) Use standard (multi-day) sputum smear microscopy as the primary method of TB diagnosis
2. (Site-level) Participate in NTP-sponsored external quality assurance (EQA) for sputum smear microscopy
3. (Site-level) Send samples to a district or regional hospital/health center for Xpert testing
4. (Patient-level) Initiate evaluation for active TB at a study health center

Exclusion criteria: 1. (Site-level) Do not agree to be randomized to standard-of-care vs. intervention arms
2. (Site-level) Perform sputum smear examination on <150 patients per year (based on 2015 data)
3. (Site-level) Diagnose <15 smear-positive TB cases per year (based on 2015 data)
4. (Patient-level) Have sputum collected for monitoring of response to anti-TB therapy
5. (Patient-level) Have sputum collected as part of active, community-based case finding (e.g., contact tracing, community outreach campaign)
6. (Patient-level) Referred to a study health center for TB treatment after a diagnosis is established elsewhere
7. (Patient-level) Started on TB treatment for extra-pulmonary TB only

Age minimum: 1 Day(s)
Age maximum: 100 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Tuberculosis

Intervention(s)

Standard of care

Intervention

Primary Outcome(s)

Proportion treated for microbiologically-confirmed TB within two weeks of initial sputum submission

Number treated for microbiologically-confirmed TB within two weeks of referral for sputum-based TB testing

Secondary Outcome(s)

Intervention arm process metrics

Number treated for microbiologically-confirmed TB

Incremental health system cost per DALY averted

Number treated for TB

Number with microbiologically-confirmed TB completing treatment

Proportion treated for TB

Incremental cost per DALY averted

Proportion completing testing

Proportion diagnosed with microbiologically-confirmed TB

Proportion treated for microbiologically-confirmed TB

Number who died within 6 months

Proportion who died within 6 months

Incremental patient cost per DALY averted

Patient costs (total costs, direct costs, indirect costs)

Patient satisfaction with care survey (general satisfaction with care, convenience of services, health facility environment, provider interpersonal skills, provider technical competence)

Projected reduction in TB incidence over 10 years

Proportion diagnosed with RIF-resistant TB

Proportion with microbiologically-confirmed TB completing treatment

Proportion with microbiologically-confirmed TB treated

Provider survey (intention, attitudes/beliefs, social norms/expectations, self-efficacy/behavioral control)

Projected reduction in TB mortality over 10 years

Time to microbiologically-confirmed TB

Number diagnosed with microbiologically-confirmed TB

Number diagnosed with RIF-resistant TB

Time to treatment of microbiologically-confirmed TB

Variation in and barriers to intervention strategy uptake

Secondary ID(s)

R01HL130192

172155

Source(s) of Monetary Support

National Heart, Lung, and Blood Institute (NHLBI)

Secondary Sponsor(s)

Makerere University College of Health Sciences

Ethics review

Status: Approved
Approval date: 04/04/2016
Contact:

Uganda National Council for Science and Technology (UNCST)

Status: Approved
Approval date: 02/06/2018
Contact:

[e-mail]

Makerere University School of Public Health

256393291397

[e-mail]

Status: Approved
Approval date: 10/07/2018
Contact:

[e-mail]

University of California San Francisco Committee on Human Research Institutional Review Board

0016282219063

[e-mail]