Arogya Sangama: 3 Way Partnership of People, Providers, and Panchayat for Health

NCT06224712 | Active Not Recruiting

• 1 other identifier: IRB00023305
• Study Type: interventional
• Target: 4,160
• Locations: 1 country
• Sites: 2

Brief Summary

This is a two-year pilot project in the Raichur and Chamarajanagar districts of Karnataka, India aiming to enhance the overall performance of primary health systems, including service utilization, quality, and responsive care, specifically within the recently developed facilities called the Health and Wellness Centres (HWCs). It will leverage rural local government structures known as Gram Panchayat Task Forces (GPTFs) created during the Covid-19 pandemic to strengthen the services delivered by HWCs. The aim is to build capacities and empower these GPTFs to function as a collaborative platform involving people, panchayats, and healthcare providers. This approach seeks to promote-community ownership, grassroots synergy, and social accountability to strengthen HWC service delivery in rural Karnataka (India).

Conditions

Health Care Utilization; Health Care Seeking Behavior; Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (4)

• Percent of antenatal care utilization rates

  The study team will analyze whether there is a difference in antenatal care utilization rates. The percent of early antenatal care registration (within first trimester of pregnancy) will be assessed.

  21 months

• Percent of non-communicable disease screening rate

  For Group 2, the percent of non-communicable disease screenings will be assessed.

  21 months

• Percent of coverage of essential primary health care (PHC) services

  The study team will analyze whether there is a difference in coverage of essential PHC services.

  21 months

• Percent of patients satisfied with treatment

  The study team will analyze percent of patients satisfied with the treatment at the Health and Wellness Centres

  21 months

Study Arms (2)

Arogya Sangama Intervention

EXPERIMENTAL

The villages in the service area of both the intervention and control PHC-HWCs will be selected randomly, weighted by population size (PPS). There are two different population groups that are being examined to get a comprehensive picture of primary health services. Group 1: To assess the impact of the intervention in improving the coverage and utilisation of antenatal and post-natal services, a cross-sectional sample of 1680 women, 840 in each arm, in the age group of 18-49 years who delivered in the last 12 months will be interviewed in the baseline and similarly in the endline. Group 2: To estimate the effect of the intervention on improving the access to screening and management of NCDs among diabetic and hypertensives, a cross-sectional sample of 200 persons in the age group of 30 years and above from each arm will be interviewed in the baseline and similarly in the endline. Hence in each round the total sample will be 400.

Behavioral: Arogya Sangama

Control

NO INTERVENTION

Same inclusion criteria as above, without Arogya Sangama intervention.

Interventions

Arogya Sangama BEHAVIORAL

Using human-centered design, the investigators will work wit the community to develop a prototype Arogya Sangama model to identify methods to bring GPTF and HWC service providers to create ideas, systems, processes, services, and delivery strategies for the GPTFs. They will help identify and prioritize interventions and address barriers to usability. There will also be capacity building of GPTFs to implement the interventions identified.

Arogya Sangama Intervention

Eligibility Criteria

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

You may qualify if:

• years of age women who delivered in the last 12 months
• Residents of the districts and living within the service área covered by intervention and control PHC-HWCs
• Kannada speaking
• Able to provide consent
• or more years of age
• Not a known case of diabetes and hypertension
• Residents of the districts and living within the service area covered by intervention and control PHC-HWCs
• Kannada speaking
• Able to provide consent

You may not qualify if:

• Group 1: women not in the age group 18-49 years of age
• Group 2: participants younger than 30 years
• Not residing in the service area covered by intervention and control PHC-HWCs
• Unable to speak in Kannada
• Unable to provide consent

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Karnataka Health Promotion Trust: collaborator

Study Sites (2)

Devadurga Block PHC-HWC

Devadurga, India

Location

Kollegal PHC-HWC

Kollegāl, India

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care; Behavior

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior

Study Officials

• Svea Closser, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study team will use a 2 arm(intervention and control), pre and post, mixed-methods quasi experimental design comparing the intervention to the standard interventions in the area. It will be implemented in two PHC-HWCs in the Devadurga and Kollegal blocks of Raichur and Chamrajanagar districts; Two additional PHC- HWCs from these blocks similar in characteristics as the intervention PHC-HWCs will be identified as control.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 18, 2024
• Primary Completion: August 1, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)