Acceptability and Feasibility of Home-based TB Testing

Investigating the Acceptability and Feasibility of Home-based TB Testing of Household Contacts Using a New, Mobile Point-of-care Technology

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).

Study Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary; Households
• Intervention / Treatment: Diagnostic test: Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test

Detailed Description

In 2013, WHO estimated that 3.3 million cases of TB had been missed (undiagnosed or with a significant delay in diagnosis or treatment). "Missed" TB cases are a key driver of TB transmission, with approximately 9 million individuals developing TB globally each year, equivalent to 126 cases per 100,000 population. The overall goal of this proposal is 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 intensive case finding and early detection of infectious TB. Although well-accepted as an effective strategy for boosting HIV diagnosis and treatment rates, until recently home-based testing for TB has been impossible, as there has never existed an effective, mobile PoC technology for rapid diagnosis of TB. With the development of the new GeneXpert® Omni diagnostic platform from Cepheid, home-based TB testing is now possible. Now is the time to study whether home-based testing for TB is feasible, and will contribute to early case detection or improve time-to-treatment rates.

This project has two Specific Aims:

1. To determine the acceptability and feasibility of using point-of-care technology to perform home-based TB testing of household contacts of TB patients, with subaim 1(a): To assess the intent-to-seek care of household contacts symptomatic for TB, and subaim 1(b): To determine the proportion of household contacts symptomatic for TB consenting to be tested (acceptability) and uptake of treatment referrals by those individuals infected with TB within 30 days of testing (feasibility);
2. To describe the outcomes of household contacts screened and tested for TB in their home compared to those screened and referred for testing in a health facility, with subaim 2(a): To describe the barriers and facilitators to clinic follow-up by household contacts symptomatic for TB and provided with referral for TB testing or treatment initiation, and subaim 2(b): To determine whether point-of-care home-based TB testing reduces time-to-treatment initiation.

An exploratory study will be conducted in a high TB prevalence area of Eastern Cape Province, South Africa. Specifically, households of TB patients initiating treatment at one of 6 collaborating clinics will be offered a point-of-care home-based TB test, with referral for immediate treatment when testing positive. In accordance with the South African National TB Management Guidelines (SA-NTMG), all smear positive pulmonary TB (PTB) patients recruited and consented will be asked to provide a list of all household contacts for a household contact investigation. The household contact investigation team will then, in keeping with South African National Department of Health guidelines, seek verbal consent from all household contacts to conduct TB symptom screening. During symptom screening, intent-to-seek care will be assessed for all reported symptoms. If one household member screens positive, then the whole household will be randomized to either the Intervention; home-based GeneXpert point-of-care (PoC) test or Control arm; standard home-based TB symptom screening with referral for testing.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Eastern Cape
    • East London, Eastern Cape, South Africa, 5217
      • Buffalo City Metro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based GeneXpert TB test; 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; 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.
No Intervention: Standard home-based TB symptom screening with immediate referral; Screening household contacts + immediate referral for clinic-based TB testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of referral uptake	Proportion of household contacts presenting for clinical follow up. (Number of household contacts presenting for clinical follow up / total household contacts referred for clinical follow-up)	Within 30 days
Time to clinic presentation	Number of days elapsed between date of household contact investigation and date of initial presentation to the clinic.	Within 30 days
Time-to-treatment initiation	Number of days elapsed between date of household contact investigation and date of TB treatment initiation.	Within 30 days
Proportion initiating treatment	Number household contacts diagnosed with TB initiating treatment / total household contacts diagnosed with TB	Within 30 days

Collaborators and Investigators

• Sponsor: Foundation for Professional Development (Pty) Ltd
• Collaborators: National Institutes of Health (NIH); University of California, Irvine; National Institute for Biomedical Imaging and Bioengineering (NIBIB); Medical Research Council, South Africa; Foundation for Innovative New Diagnostics, Switzerland; University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Andrew Medina-Marino, PhD, andrewmedinamarino@gmail.com

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Tuberculosis; Household Contacts; Household Contact Investigation; Active Case Finding; Home-based Testing; GeneXpert; Point-of-Care Testing; South Africa; Tuberculosis symptomatic household contacts
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: R21EB023679 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be made available on public repository 1) in parallel with manuscript publication or 2) within two years of study completion (whichever comes earlier)
• IPD Sharing 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)
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No