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TuberculosisSiyasizaNCT02298309

Test and Treat TB: A Proof of Concept Trial in South Africa

A study testing Test-and-Treat TB in people with Tuberculosis, run by Massachusetts General Hospital at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis
What is being tested?
Test-and-Treat TB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,815 participants
Where
1 siteSouth Africa
Study dates
Apr 2015to Nov 2017
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

  • English or Zulu speaking
  • presenting for screening at mobile unit
  • voluntarily undergoing HIV testing
  • able and willing to give informed consent
  • willing to share HIV and TB test results
  • willing to attend one of six local clinics for treatment
  • access to a mobile phone

Who cannot join

  • pregnant

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • iThembalabantu Clinic/AIDS Healthcare Foundation

    Durban, KwaZulu-Natal

Other trials in South Africa

About this study

The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.

Conditions
Tuberculosis
Being tested
Test-and-Treat TB
Keywords
TB, HIV, Test and Treat, Linkage
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test-and-Treat TBOther

Study groups in NCT02298309
Study groupRoleWhat they receive
Usual CareNo interventionPatients in the usual care arm will be screened for tuberculosis (TB) on a mobile unit and referred for treatment according to the current standard of care in South Africa
Test-and-Treat InterventionActive comparatorPatients in the intervention arm will partake in a Test-and-Treat TB strategy involving mobile GeneXpert MTB/RIF testing, facilitated TB treatment initiation, SMS reminders for clinic visits, and cashless incentives.
Receives: Other: Test-and-Treat TB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who complete tuberculosis treatment

    Measured: 6 months

Secondary outcomes (8)

  1. Proportion of mobile testers screened for tuberculosis

    Measured: 20 months

  2. Proportion of eligible participants able to produce sputum samples

    Measured: 20 months

  3. Prevalence of TB among those tested

    Measured: 20 months

  4. Prevalence of tuberculosis and rifampin resistance

    The GeneXpert test can detect rifampin resistant strains of tuberculosis

    Measured: 20 months

  5. Distribution of TB symptoms ascertained from TB symptom screen questionnaire

    Measured: 20 months

  6. Proportion returning to the mobile tester for TB test result

    Measured: 20 months

  7. Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record)

    Measured: 1 month

  8. ART initiation date as documented by clinic record for those HIV co-infected

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4,815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02298309
Sponsor's protocol ID
2014P001173/MGH
Other IDs
R21AI110264
Acronym
Siyasiza
Status last verified
Apr 2018
First submitted
18 Nov 2014
Last updated
4 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Bassett IV, Forman LS, Govere S, Thulare H, Frank SC, Mhlongo B, Losina E. Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa. BMC Infect Dis. 2019 Feb 4;19(1):110. doi: 10.1186/s12879-019-3738-4.

    PubMed 30717693

Questions about this trial

What is this clinical trial studying?

A study testing Test-and-Treat TB in people with Tuberculosis, run by Massachusetts General Hospital 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 7 inclusion and 1 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 4 Apr 2018. 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?

Number of patients who complete tuberculosis treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02298309, which also lists 1 linked publication.

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 4 Apr 2018.

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