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TuberculosisSAIA-TBNCT06314386

Systems Analysis and Improvement Approach to Prevent TB

A study testing Systems Analysis and Improvement Approach for TB (SAIA-TB) in people with Tuberculosis and TPT, run by Boston College at 16 sites in South Africa.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. Read more about this study

Who is it for?
Ages 0 years and older
Conditions the study is for
Tuberculosis, TPT, TB - Tuberculosis
What is being tested?
Systems Analysis and Improvement Approach for TB (SAIA-TB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19,560 participants
Where
16 sitesSouth Africa
Study dates
6 Feb 2025to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Aim 1:

  1. Inclusion Criteria for clinics:
  • Location in the municipalities of Dr. Beyers Naude, Blue Crane Route, Makana, Ndlambe, Sundays River Valley, Kou-Kamma, or Kouga within the Sarah Baartman district, Eastern Cape, South Africa
  • Within 2 hours' drive to Gqeberha, where the study office is located
  • Only one clinic per town/area/location to ensure a mix of rural, semi-rural, semi urban
  • Clinic capacity/Patient volume > 700 total outpatient attendees per month (8,400 patients per year)
  • Staff size of at least 5 employees with a mixture of at least 2 professional nurses, 1 or 2 pharmacist/pharmacy technicians, at least 1 data capturer, a social worker, and multiple community health workers who are clinic-based or part of ward-based outreach teams.
  • Must have an acting Clinic Manager
  1. Exclusion Criteria for clinics:
  • Clinic managers and/or staff are unwilling to participate

Aim 2:

  1. Inclusion Criteria:
  • 18 years and older
  • Frontline clinical and/or managerial staff, district-level TB management
  • Ability to provide informed consent
  1. Exclusion Criteria:
  • Under age 18
  • Unwilling to provide informed consent

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

South Africa16 sites

  • Addo Clinic

    Addo

  • Lukhanyiso Clinic

    Addo

  • Kwa-Nonqubela Clinic

    Alexandria

  • Marselle Clinic

    Boesmansriviermond

  • Masakhane Clinic

    Hankey

  • Humansdorp Clinic

    Humansdorp

  • Pellsrus Clinic

    Jeffrey's Bay

  • Joubertina CHC

    Joubertina

  • Louterwater Clinic

    Joubertina

  • Twee Riviere Clinic

    Joubertina

  • Kareedouw Clinic

    Kareedouw

  • Kenton On Sea Clinic

    Kenton on Sea

  • Kirkwood Clinic

    Kirkwood

  • Moses Mabida Clinic

    Kirkwood

  • Imizamo Yetho Clinic

    Patensie

  • Nkwenkwezi Clinic

    Port Alfred

Other trials in South Africa

About this study

Official title: SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to Prevent TB in Rural South Africa

This randomized trial uses the evidence-based Systems Analysis and Improvement Approach (SAIA) adapted for tuberculosis (SAIA-TB) to assess the comprehensive tuberculosis (TB) care cascade across 16 clinics in rural Eastern Cape, South Africa to improve patient outcomes. The aims of this study are to:

  • Evaluate the effectiveness of SAIA-TB use in clinics on TB cascade outcomes for TB patients and with high-risk contacts
  • Determine the drivers of SAIA-TB implementation success or failure across clinics

The investigators hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period.

Read the detailed description

This four-wave stepped wedge crossover cluster randomized trial will assess the effectiveness of the SAIA-TB intervention (Aim 1). A total of 16 clinics in four municipalities within the Sarah Baartman-district, Eastern Cape, South Africa will be included. The SAIA-TB intervention will be implemented at the clinic level. Public sector clinic staff and clinic managers, supported by study personnel, will deliver the intervention over an 18-month implementation phase, followed by a 12-month maintenance phase led by clinic managers without additional study personnel support, to provide evidence on intervention impact under ideal circumstances, as well as sustained effect over time. Aim 2 will consist of interviews and using the organization readiness for implementing change (ORIC) with facilities early in SAIA-TB implementation (within 3 months of initiating the intervention) to identify clinic-level attributes that affect intervention adoption. Additionally, the Consolidated Framework for Implementation Research (CFIR) will guide data collection and interpretation related to implementation, assess fidelity to intervention protocol, describe intervention adaptations when integrated into routine management systems, and identify clinic-level determinants of successful SAIA-TB implementation. Recurrent measurement of structural readiness and implementation dose (as a function of quality and quantity) at the clinic level will inform guidance on essential structural needs to implement SAIA-TB. The trial will culminate in a dissemination package, summarizing results and providing implementation guidance to support scale-up.

Being tested
Systems Analysis and Improvement Approach for TB (SAIA-TB)
Keywords
tuberculosis
Medical subject headings
Tuberculosis, Latent Tuberculosis

What participants receive

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

  • Systems Analysis and Improvement Approach for TB (SAIA-TB)Other

    The Systems Analysis and Improvement Approach for TB (SAIA-TB) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by clinic staff with support from study personnel in intervention clinics. Components of the intervention include TB cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally optimize TB screening, evaluation, diagnosis, TB preventive therapy and TB disease treatment initiation, successful treatment, and TB-free survival among the population at the intervention clinics.

Study groups in NCT06314386
Study groupRoleWhat they receive
ExposedOtherClinics are considered exposed after intensive SAIA-TB intervention, implementation phase, and maintenance phase.
Receives: Other: Systems Analysis and Improvement Approach for TB (SAIA-TB)
UnexposedNo interventionClinics are considered unexposed prior to the initiation of SAIA-TB in their clinic

What is being measured

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

  1. TB Screening

    The proportion of individuals screened with WHO TB symptom screen in the target population

    Measured: 18 months

  2. Linkage to care for TB disease treatment

    The proportion of individuals initiating TB disease treatment among those with a positive diagnostic evaluation

    Measured: 18 months

  3. Linkage to care for TB preventive treatment

    The proportion of individuals initiating TB preventive treatment among those with a negative diagnostic evaluation and eligible for TPT

    Measured: 18 months

Secondary outcomes (4)

  1. Successful TB Prevention Treatment (TPT) Outcome

    The proportion of individuals who complete TB Prevention Treatment (TPT) among those who initiate TPT

    Measured: 18 months

  2. Successful TB Outcome

    The proportion of individuals cured or completing treatment for TB disease among those who initiate TB treatment

    Measured: 18 months

  3. TB Evaluation

    The proportion of individuals receiving a diagnostic evaluation among those with a positive screening

    Measured: 18 months

  4. TB Diagnosis

    The proportion of individuals diagnosed with TB among those who completed a diagnostic evaluation

    Measured: 18 months

Timeline

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

  1. First posted18 Mar 2024
  2. Study start6 Feb 2025
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion28 Feb 2029 (estimated)

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped Wedge Crossover Cluster
Masking
None (open label)
Enrolment
19,560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314386
Sponsor's protocol ID
23.139.01
Other IDs
R01NR020866
Acronym
SAIA-TB
Status last verified
Sep 2026
First submitted
11 Mar 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van de Water BJ, Brooks MB, Matji R, Ncanywa B, Dikgale F, Abuelezam NN, Mzileni B, Nokwe M, Moko S, Mvusi L, Loveday M, Gimbel S. Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial. Implement Sci Commun. 2024 Apr 16;5(1):40. doi: 10.1186/s43058-024-00582-z.

    PubMed 38627799

Questions about this trial

What is this clinical trial studying?

A study testing Systems Analysis and Improvement Approach for TB (SAIA-TB) in people with Tuberculosis and TPT, run by Boston College at 16 sites 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?

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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

TB Screening (time frame: 18 months). The study lists 3 primary outcomes in all. 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 NCT06314386, 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 1 Oct 2026.

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