Tuberculosis, PulmonaryNCT04973371
Acceptability and Feasibility of Home-based TB Testing
A study testing Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test in people with Tuberculosis, Pulmonary and Households, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Households
- What is being tested?
- Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- 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);
- 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.
- Conditions
- Tuberculosis, Pulmonary, Households
- Being tested
- Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test
- Keywords
- Tuberculosis, Household Contacts, Household Contact Investigation, Active Case Finding, Home-based Testing, GeneXpert, Point-of-Care Testing, South Africa, Tuberculosis symptomatic household contacts
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of home-based TB testing
≥ 80% of individuals who screen positive for TB consent to home-based testing using the GeneXpert Platform.
Measured: 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.
Measured: Within 1 hour
Feasibility of home-based TB testing
>90% of MTB/Rif tests produce a valid test result
Measured: 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
Measured: Within 4 weeks of diagnosis
Secondary outcomes (4)
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)
Measured: 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.
Measured: Within 30 days
Time-to-treatment initiation
Number of days elapsed between date of household contact investigation and date of TB treatment initiation.
Measured: Within 30 days
Proportion initiating treatment
Number household contacts diagnosed with TB initiating treatment / total household contacts diagnosed with TB
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jul 2018
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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".
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Professional Development (Pty) Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB), Medical Research Council, South Africa, Foundation for Innovative New Diagnostics, Switzerland, University of Witwatersrand, South Africa, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Andrew Medina-Marino, PhD, Principal investigator, andrewmedinamarino@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973371
- Sponsor's protocol ID
- R21EB023679
- Other IDs
- R21EB023679
- Status last verified
- Jul 2021
- First submitted
- 30 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acceptability and Feasibility of Home-based TB Testing of Household Contacts Using a New, Mobile Point-of-care Technology
- ClinicalTrials.gov ID
- NCT04973371
- Acronym / sponsor ID
- R21EB023679
- Conditions
- Tuberculosis, Pulmonary, Households
- Keywords
- Tuberculosis, Household Contacts, Household Contact Investigation, Active Case Finding, Home-based Testing, GeneXpert, Point-of-Care Testing, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Foundation for Professional Development (Pty) LtdUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB), Medical Research Council, South Africa, Foundation for Innovative New Diagnostics, Switzerland, University of Witwatersrand, South Africa, University of California, Irvine
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- 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);
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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".
| Arm | Type | Receives |
|---|---|---|
| Home-based GeneXpert TB test | Experimental | Diagnostic Test: Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF testScreening household contacts + home-based GeneXpert® MTB/RIF TB testing for those with TB symptoms + immediate referral for clinic-based treatment initiation. |
| Standard home-based TB symptom screening with immediate referral | No intervention | –Screening household contacts + immediate referral for clinic-based TB testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF testThose 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. | Diagnostic test | Home-based GeneXpert TB test |
Primary outcome
Acceptability of home-based TB testing
Time frame: Within 1 hour
≥ 80% of individuals who screen positive for TB consent to home-based testing using the GeneXpert Platform.
Feasibility of home-based TB testing
Time frame: Within 1 hour
≥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.
Feasibility of home-based TB testing
Time frame: Immediate upon test completion
>90% of MTB/Rif tests produce a valid test result
Feasibility of home-based TB testing
Time frame: Within 4 weeks of diagnosis
≥ 80% of household contacts testing positive for TB present at a clinic for care and treatment
4 secondary outcomes
Proportion of referral uptake
Time frame: Within 30 days
Time to clinic presentation
Time frame: Within 30 days
Time-to-treatment initiation
Time frame: Within 30 days
Proportion initiating treatment
Time frame: Within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Medina-Marino, PhD principal investigator
andrewmedinamarino@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test in people with Tuberculosis, Pulmonary and Households, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of home-based TB testing (time frame: Within 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.