Acceptability and Feasibility of Home-based TB Testing

Tuberculosis, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973371
• Other study ID #: R21EB023679
• Secondary ID: R21EB023679
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2021
• Source: Foundation for Professional Development (Pty) Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Households
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
South Africa	Buffalo City Metro	East London	Eastern Cape

Sponsors (7)

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

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Feasibility of home-based TB testing	>90% of MTB/Rif tests produce a valid test result	Immediate upon test completion
Primary	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	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
Secondary	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
Secondary	Time-to-treatment initiation	Number of days elapsed between date of household contact investigation and date of TB treatment initiation.	Within 30 days
Secondary	Proportion initiating treatment	Number household contacts diagnosed with TB initiating treatment / total household contacts diagnosed with TB	Within 30 days