Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)

NCT07126041 | Not Yet Recruiting DMC

• 2 other identifiers: OUCRU-ID.2025.002Grant Number : INV-070822
• Study Type: interventional
• Target: 1,750,000
• Locations: 1 country
• Sites: 2

Brief Summary

SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model. The intervention empowers district health leaders to make data-informed decisions that will enhance outcomes across maternal, child, infectious, and non-communicable disease programs.

Conditions

Pregnancy; Neonatal Mortality; Tuberculosis; Hepatitis B; Hypertension; Diabetes Mellitus

Keywords

Primary health care performance; Digital health transformation; Maternal health; Child health; Immunization; Stunting; Tuberculosis; Hepatitis B; Diabetes mellitus; Hypertension; Health system strengthening; Indonesia; Health governance; Human resource management; Work culture

Outcome Measures

Primary Outcomes (1)

• Difference in neonatal mortality rate between intervention and control periods

  Neonatal mortality per 1,000 live births, calculated using health facility and civil registration data, and community household sampling surveys

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

Secondary Outcomes (7)

• Difference in complete antenatal care (ANC 6) visit coverage between intervention and control periods

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

• Difference in complete basic childhood immunization coverage between the intervention and control period

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

• Difference in TB treatment success rate between intervention and control periods

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

• Difference in screening coverage for diabetes mellitus among adults between the intervention and control periods

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

• Difference in the rate of vertical transmission of hepatitis B between intervention and control periods

  Baseline up to 16 months, with data collected monthly at each site (i.e. baseline, at the end of month 1, at the end of month 2, and so on until at the end of month 16)

Study Arms (2)

SPHERES Intervention Arm

EXPERIMENTAL

Participants (district populations) receive services improved by the SPHERES model, which includes structured prescription-for-action protocols targeting three priority domains (infectious disease, maternal \& child health, and non-communicable diseases).

Other: Prescription for Action (SPHERES Model)

Control

NO INTERVENTION

Standard of care are expected at primary health centers before the SPHERES intervention is deployed

Interventions

Prescription for Action (SPHERES Model) OTHER

A system-level intervention consisting of: * a digital dashboard displaying local health services, outcome indicators, and operational data in a secure Public Health Data Theater; * structured monthly prescription guides targeting service improvements across three priority program areas; * monthly performance monitoring with district health leaders. The intervention is applied at the PHC level, all supported by digital capacity building, district-level deployment of implementation teams, and intersectoral secure health data exchange.

SPHERES Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residing in or participating in the district catchment areas
• Receiving services from participating health care facilities
• Health providers and district health officials consent to participate in data collection

You may not qualify if:

• Individuals (health workers or patients) who decline to provide informed consent.
• Individuals who are not directly involved in or accessing services from health care facilities or district health offices.
• Inability to provide consent due to cognitive impairment or acute illness for health workers or district health officials involved in data collection

Sponsors & Collaborators

• Oxford University Clinical Research Unit Indonesia: lead
• Summit Institute for Development, Indonesia: collaborator

Study Sites (2)

Purbalingga District Health Office

Purbalingga, Central Java, Indonesia

Location

West Lombok District Health Office

Gerung, West Nusa Tenggara, Indonesia

Location

Related Links

• Official project website for SPHERES, providing information on project background, implementation framework, partnerships, project status, and the investigators involved.

MeSH Terms

Conditions

Tuberculosis; Hepatitis B; Hypertension; Diabetes Mellitus; Growth Disorders

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anuraj H Shankar, D. Sc.

  Oxford University Clinical Research Unit Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zamzam Noerzen Djaelani, MD, MBA

CONTACT

+6281385680388; zdjaelani@oucru.org

Rina Agustina, Prof.

CONTACT

+6281297484775; ragustina@oucru.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D. Sc.

Model Details: The study follows a stepped-wedge cluster randomized design in which primary health centers (PHCs) are randomized to receive the intervention in phased steps over time/sequentially. Each cohort enters a digital readiness of up to two months before transitioning into the full SPHERES intervention. Transitions to a new sets of clusters would occur approximately every four months, with full coverage expected within sixteen months of study start.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)