Clinical trial NCT06314386: Systems Analysis and Improvement Approach to Prevent TB
Official title: SAIA-TB: Using the Systems Analysis and Improvement Approach (SAIA) to Prevent TB in Rural South Africa
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tuberculosis
TPT
TB - Tuberculosis
Keywords: tuberculosis
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Boston University
name: University of Washington
name: Medical Research Council, South Africa
name: National Institute of Nursing Research (NINR)
First posted: 2024-03-18
Enrollment: 19560
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped Wedge Crossover Cluster
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

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.

Eligibility criteria: 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
2. 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
2. Exclusion Criteria:

   * Under age 18
   * Unwilling to provide informed consent

Primary outcomes:
measure: TB Screening
timeFrame: 18 months
measure: Linkage to care for TB disease treatment
timeFrame: 18 months
measure: Linkage to care for TB preventive treatment
timeFrame: 18 months
Secondary outcomes:
measure: Successful TB Prevention Treatment (TPT) Outcome
timeFrame: 18 months
measure: Successful TB Outcome
timeFrame: 18 months
measure: TB Evaluation
timeFrame: 18 months
measure: TB Diagnosis
timeFrame: 18 months
Other outcomes:
Locations:
city: Addo
country: South Africa
facility: Addo Clinic
city: Addo
country: South Africa
facility: Lukhanyiso Clinic
city: Alexandria
country: South Africa
facility: Kwa-Nonqubela Clinic
city: Boesmansriviermond
country: South Africa
facility: Marselle Clinic
city: Hankey
country: South Africa
facility: Masakhane Clinic
city: Humansdorp
country: South Africa
facility: Humansdorp Clinic
city: Jeffrey's Bay
country: South Africa
facility: Pellsrus Clinic
city: Joubertina
country: South Africa
facility: Joubertina CHC
city: Joubertina
country: South Africa
facility: Louterwater Clinic
city: Joubertina
country: South Africa
facility: Twee Riviere Clinic
city: Kareedouw
country: South Africa
facility: Kareedouw Clinic
city: Kenton on Sea
country: South Africa
facility: Kenton On Sea Clinic
city: Kirkwood
country: South Africa
facility: Kirkwood Clinic
city: Kirkwood
country: South Africa
facility: Moses Mabida Clinic
city: Patensie
country: South Africa
facility: Imizamo Yetho Clinic
city: Port Alfred
country: South Africa
facility: Nkwenkwezi Clinic
Study officials:
affiliation: Boston College
name: Brittney J van de Water, PhD
role: PRINCIPAL_INVESTIGATOR
References: