Health Care UtilizationNCT06224712
Arogya Sangama: 3 Way Partnership of People, Providers, and Panchayat for Health
A study testing Arogya Sangama in people with Health Care Utilization and Health Care Seeking Behavior, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Health Care Seeking Behavior, Health Knowledge, Attitudes, Practice
- What is being tested?
- Arogya Sangama
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,160 participants
- Where
- 2 sitesIndia
- Study dates
- 18 Jan 2024to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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).
Read the detailed description
Specific research questions:
- What are attitudes, perceptions, and experiences of stakeholders about GPTFs involvement in the COVID 19 management and PHC service delivery?
- What strategies and actions can GPTF undertake to improve community engagement, service provider support, and promote equitable access to essential PHC services?
- What capacity building inputs, mechanisms, and resources will be required for GPTFs to strengthen community engagement and serve as collaborative platforms to increase social accountability for PHC services?
- What has been the experience of GPTFs, community and program administrators about the Arogya Sangama model in terms of its applicability, adoption, and feasibility in the project settings?
- How have GPTF interventions within Arogya Sangama project impacted community engagement, service provider support, and equitable access to essential PHC services.
- What has been the effect of the GPTF intervention on utilization, and coverage of essential primary care services?
Empowered people and communities are a key pillar of primary health care (PHC). Within India, several policies, especially decentralization efforts under the National Health Mission had envisioned engagement of Panchayats or local self governments as a key mechanism to achieve large-scale community participation and ensure equitable access for vulnerable people, particularly women, children, and the poor. Empowering village panchayats to implement and provide oversight for National Health Ministry programs through village health committees and panchayat assemblies was expected to facilitate the process. The National Health Policy 2017 recommended an enhanced role of panchayats in health governance, including the social determinants of health and mandating community led accountability mechanisms for health to be driven by these local bodies.
States were expected to develop strategic plans and accountability mechanisms with active involvement of local self-governments for effective monitoring of quality of health care services. Despite several policies and promising vision, there is limited capacity and lack of a clear strategy for panchayat engagement and community ownership for HWCs at the state and district levels. Progress on implementing preventive and promotive services involving community and panchayats has been slow especially in aspirational districts and tribal settings. A recent evaluation of HWCs across 18 states in India including Karnataka further confirms lack of community participation as a key barrier in strengthening comprehensive primary health care (CPHC) delivery. These findings suggest a need to enable the state government to develop a clear community engagement strategy and build capacities of the panchayats in leading these efforts in the HWC service areas.
Building on the legacy of GPTF involvement in COVID 19 mitigation efforts so far, the Department of Rural Development and Panchayat Raj, (DoRDPR), within the Government of Karnataka, is proposing to strengthen and equip GPTFs with the necessary skills and tools to transform into effective forums for local health action and convergence to enhance PHC delivery. The DoRDPR has commissioned a two-year implementation research project in collaboration with the Johns Hopkins Bloomberg School of Public Health and the Karnataka Health Promotion Trust (KHPT), a leading Non Governmental Organization for Public Health action in Karnataka. The pilot project aims to build capacities of GPTFs to function as a "3-way partnership platform" (comprising of people, panchayats, and service providers) to increase community ownership, grassroots convergence, and social accountability for rural HWCs in Karnataka in Devadurga and Kollegal Block of Raichur and Chamarajanagar district respectively.
The Johns Hopkins team will use its expertise in global health and design thinking to develop interventions for GPTF based on end users' perspectives. The team, with KHPT support, will gather insights on stakeholders' perspectives about GPTF, potential new ideas, and intervention strategies required to develop GPTF as an effective 3-way partnership platform. It will develop, implement, test a prototype model, and investigate its applicability, adoption, and feasibility. It will document changes in service provision and formulate an operational framework for GPTF-enabled responsive PHC.
- Conditions
- Health Care Utilization, Health Care Seeking Behavior, Health Knowledge, Attitudes, Practice
- Being tested
- Arogya Sangama
- Medical subject headings
- Patient Acceptance of Health Care, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arogya SangamaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Arogya Sangama |
| Control | No intervention | Same inclusion criteria as above, without Arogya Sangama intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 months
Percent of non-communicable disease screening rate
For Group 2, the percent of non-communicable disease screenings will be assessed.
Measured: 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.
Measured: 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
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start18 Jan 2024
- Primary completion1 Aug 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Karnataka Health Promotion Trust
- Responsible party
- Sponsor
- Investigators
- Svea Closser, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224712
- Sponsor's protocol ID
- IRB00023305
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arogya Sangama: 3 Way Partnership of People, Providers, and Panchayat for Health
- ClinicalTrials.gov ID
- NCT06224712
- Acronym / sponsor ID
- IRB00023305
- Conditions
- Health Care Utilization, Health Care Seeking Behavior, Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,160 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Karnataka Health Promotion Trust
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Specific research questions:
- What are attitudes, perceptions, and experiences of stakeholders about GPTFs involvement in the COVID 19 management and PHC service delivery?
- What strategies and actions can GPTF undertake to improve community engagement, service provider support, and promote equitable access to essential PHC services?
- What capacity building inputs, mechanisms, and resources will be required for GPTFs to strengthen community engagement and serve as collaborative platforms to increase social accountability for PHC services?
- What has been the experience of GPTFs, community and program administrators about the Arogya Sangama model in terms of its applicability, adoption, and feasibility in the project settings?
- How have GPTF interventions within Arogya Sangama project impacted community engagement, service provider support, and equitable access to essential PHC services.
- What has been the effect of the GPTF intervention on utilization, and coverage of essential primary care services?
Empowered people and communities are a key pillar of primary health care (PHC). Within India, several policies, especially decentralization efforts under the National Health Mission had envisioned engagement of Panchayats or local self governments as a key mechanism to achieve large-scale community participation and ensure equitable access for vulnerable people, particularly women, children, and the poor. Empowering village panchayats to implement and provide oversight for National Health Ministry programs through village health committees and panchayat assemblies was expected to facilitate the process. The National Health Policy 2017 recommended an enhanced role of panchayats in health governance, including the social determinants of health and mandating community led accountability mechanisms for health to be driven by these local bodies.
States were expected to develop strategic plans and accountability mechanisms with active involvement of local self-governments for effective monitoring of quality of health care services. Despite several policies and promising vision, there is limited capacity and lack of a clear strategy for panchayat engagement and community ownership for HWCs at the state and district levels. Progress on implementing preventive and promotive services involving community and panchayats has been slow especially in aspirational districts and tribal settings. A recent evaluation of HWCs across 18 states in India including Karnataka further confirms lack of community participation as a key barrier in strengthening comprehensive primary health care (CPHC) delivery. These findings suggest a need to enable the state government to develop a clear community engagement strategy and build capacities of the panchayats in leading these efforts in the HWC service areas.
Building on the legacy of GPTF involvement in COVID 19 mitigation efforts so far, the Department of Rural Development and Panchayat Raj, (DoRDPR), within the Government of Karnataka, is proposing to strengthen and equip GPTFs with the necessary skills and tools to transform into effective forums for local health action and convergence to enhance PHC delivery. The DoRDPR has commissioned a two-year implementation research project in collaboration with the Johns Hopkins Bloomberg School of Public Health and the Karnataka Health Promotion Trust (KHPT), a leading Non Governmental Organization for Public Health action in Karnataka. The pilot project aims to build capacities of GPTFs to function as a "3-way partnership platform" (comprising of people, panchayats, and service providers) to increase community ownership, grassroots convergence, and social accountability for rural HWCs in Karnataka in Devadurga and Kollegal Block of Raichur and Chamarajanagar district respectively.
The Johns Hopkins team will use its expertise in global health and design thinking to develop interventions for GPTF based on end users' perspectives. The team, with KHPT support, will gather insights on stakeholders' perspectives about GPTF, potential new ideas, and intervention strategies required to develop GPTF as an effective 3-way partnership platform. It will develop, implement, test a prototype model, and investigate its applicability, adoption, and feasibility. It will document changes in service provision and formulate an operational framework for GPTF-enabled responsive PHC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arogya Sangama Intervention | Experimental | Behavioral: Arogya SangamaThe 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. |
| Control | No intervention | –Same inclusion criteria as above, without Arogya Sangama intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arogya SangamaUsing 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. | Behavioural | Arogya Sangama Intervention |
Primary outcome
Percent of antenatal care utilization rates
Time frame: 21 months
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.
Percent of non-communicable disease screening rate
Time frame: 21 months
For Group 2, the percent of non-communicable disease screenings will be assessed.
Percent of coverage of essential primary health care (PHC) services
Time frame: 21 months
The study team will analyze whether there is a difference in coverage of essential PHC services.
Percent of patients satisfied with treatment
Time frame: 21 months
The study team will analyze percent of patients satisfied with the treatment at the Health and Wellness Centres
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svea Closser, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arogya Sangama in people with Health Care Utilization and Health Care Seeking Behavior, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in India.
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 0 inclusion and 5 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
Percent of antenatal care utilization rates (time frame: 21 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.