Acceptability and Feasibility of Home-based TB Testing

NCT04973371 | Completed

• 1 other identifier: R21EB023679
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the utility of home-based point-of-care TB testing for early diagnosis and linkage to care of household contacts of TB patients, addressing the need for active case finding and early detection of infectious TB. The investigators propose an exploratory study to 1) investigate the acceptability and feasibility of home-based TB testing of household contacts using a new portable GeneXpert point-of-care (PoC) platform, and 2) determine the potential impact of such a home-based testing program on early detection of TB disease and linkage-to-care (LTC).

Conditions

Tuberculosis, Pulmonary; Households

Keywords

Tuberculosis; Household Contacts; Household Contact Investigation; Active Case Finding; Home-based Testing; GeneXpert; Point-of-Care Testing; South Africa; Tuberculosis symptomatic household contacts

Outcome Measures

Primary Outcomes (4)

• Acceptability of home-based TB testing

  ≥ 80% of individuals who screen positive for TB consent to home-based testing using the GeneXpert Platform.

  Within 1 hour

• Feasibility of home-based TB testing

  ≥80% of households visited having a safe space for sputum production. A safe space for sputum production and collection will be defined as per the South African 2014 National TB Management Guidelines.

  Within 1 hour

• Feasibility of home-based TB testing

  \>90% of MTB/Rif tests produce a valid test result

  Immediate upon test completion

• Feasibility of home-based TB testing

  ≥ 80% of household contacts testing positive for TB present at a clinic for care and treatment

  Within 4 weeks of diagnosis

Secondary Outcomes (4)

• Proportion of referral uptake

  Within 30 days

• Time to clinic presentation

  Within 30 days

• Time-to-treatment initiation

  Within 30 days

• Proportion initiating treatment

  Within 30 days

Study Arms (2)

Home-based GeneXpert TB test

EXPERIMENTAL

Screening household contacts + home-based GeneXpert® MTB/RIF TB testing for those with TB symptoms + immediate referral for clinic-based treatment initiation.

Diagnostic Test: Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test

Standard home-based TB symptom screening with immediate referral

NO INTERVENTION

Screening household contacts + immediate referral for clinic-based TB testing

Interventions

Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test DIAGNOSTIC_TEST

Those who screen positive for TB using the standard 4-question screener will be offered a GeneXpert® \[Cepheid, Sunnyvale, CA\] MTB/RIF test in their home with referral for clinic-based TB treatment initiation for those who receive a positive MTB/RIF test result.

Home-based GeneXpert TB test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TB symptomatic household contact of a TB patient
• Not currently on TB treatment
• Able to produce a sputum specimen for testing
• Age ≥18 years
• Provision of written consent

You may not qualify if:

• Unable to speak and answer questions in English, Xhosa or Afrikaans
• Household contact has already been to the facility for TB testing or is already on TB treatment

Sponsors & Collaborators

• Foundation for Professional Development (Pty) Ltd: lead
• National Institutes of Health (NIH): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• Medical Research Council, South Africa: collaborator
• Foundation for Innovative New Diagnostics, Switzerland: collaborator
• University of Witwatersrand, South Africa: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Buffalo City Metro

East London, Eastern Cape, 5217, South Africa

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrew Medina-Marino, PhD

  andrewmedinamarino@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation of study arm is concealed to study staff during randomization. Neither study staff nor participants will be blinded to study treatment arms after the point of randomization. Nonetheless, strict policies will be in place to preserve randomization integrity.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An exploratory study to 1) investigate the acceptability and feasibility of home-based TB testing of household contacts using a new portable GeneXpert point-of-care (PoC) platform, and 2) determine the potential impact of such a home-based testing program on early detection of TB disease and linkage-to-care (LTC). In this study, all participants enrolled in the Treatment arm will be tested for TB at their household, using the GeneXpert device. Participants enrolled in the Control arm will receive a referral letter, which can be used to access treatment at the nearest health facility. No single participant will be randomized, the whole house will receive a "Blanket Randomisation".

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 30, 2019
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Supporting information will be made available as requested 1) in parallel with manuscript publication or 2) within two years of study completion (whichever comes earlier)

Locations

ZA (1)