TuberculosisINSTEP2NCT04187313
Increasing Notifications of Tuberculosis From Private Practitioners
A study testing INSTEP2 intervention package in people with Tuberculosis, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Tuberculosis (TB) is the third leading cause of death in Indonesia. Disturbingly, the prevalence survey showed that over half of TB cases in Indonesia are not notified. The huge private sector in Indonesia, comprising an estimated 70,000 practitioners, provides over 50% of health care but notifies less than 10% of all… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis
- What is being tested?
- INSTEP2 intervention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2020to 31 Aug 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All medically qualified private practitioners (PPs) in the intervention arm who reported having diagnosed at least one TB case in the past 3 months
- Intend to work in the current location for the duration of the study as their primary place of private practice
Who cannot join
- Unable to use an electronic device for referral/notification
- More than 3 months of non-practice during the study period is anticipated
- They are not a qualified medical practitioner, with the appropriate medical authority in Indonesia
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Padjadjaran Teaching Hospital
Bandung, West Java, 40161
About this study
Official title: Increasing Notifications of Tuberculosis From Private Practitioners: A Randomised Controlled Trial
Tuberculosis (TB) is the third leading cause of death in Indonesia. Disturbingly, the prevalence survey showed that over half of TB cases in Indonesia are not notified. The huge private sector in Indonesia, comprising an estimated 70,000 practitioners, provides over 50% of health care but notifies less than 10% of all diagnosed TB cases.
INSTEP2 is a cluster randomised controlled intervention trial. The multi-component public health intervention will be administered to private practitioners (PP) in Community Health Centre (CHC) clusters. The change in the number of TB notifications over 12 months before, and 12 months after, the intervention will be compared between study arms. Hypothesis related to the Primary Efficacy Endpoint: A tailored intervention in PPs will increase TB notifications.
Read the detailed description
As part of advancing Public-Private Mix (PPM), the government made TB notification mandatory in 2016, but intervention is likely to be needed for notifications to increase substantially. Such intervention needs to be based on a sound understanding of contextual factors around PPs and how they relate to the public sector with respect to the diagnosis, treatment and reporting of TB cases.
This is a cluster randomised controlled trial of a multi-component public health intervention to increase notifications of TB from PPs in Bandung, Indonesia. Clusters are CHC areas and the intervention will be administered directly to PPs in sub-districts randomised to the intervention arm. The CHCs in both arms will be informed about the study and asked, through the National TB Control Programme, to make their notification data available and their willingness will be recorded. No intervention will be given to PPs in the control arm. Notifications will be obtained directly from routine records, with accompanying information gathered about the address of the patient and referring doctor. Notified TB cases are, by definition, TB cases who have been commenced on TB treatment, noting that some referred 'TB cases' will be diagnosed as not having TB by CHC staff.
The intervention will be administered to PPs in areas around 15 CHCs (clusters), at their place of practice. PPs in the control areas will receive no intervention. The intervention will comprise: (1) An electronic referral and notification system; (2) Education about signs and symptoms of TB and TB management; (3) An individualised practitioner plan for diagnostic and management pathways.
The primary endpoint is the change in the number of notifications of TB from the 12 months before to the 12 months after the intervention is fully implemented. This change in the number of notifications will be compared between intervention clusters and control clusters.
Safety oversight by a Data and Safety Monitoring Board (DSMB) will not be required for this public health intervention trial. However, an internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. A quality management plan will be developed to describe a site's quality management. Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be automatically generated on a weekly basis and any quality issues identified will be reviewed by the DMC and a plan put in place for resolution. Following written Standard Operating Procedures (SOPs), visiting investigators will verify that the trial is conducted and data are generated, documented (recorded), and reported in compliance with the protocol. The investigational site will provide direct access to all source data/documents, and reports for the purpose of the verification visits.
- Conditions
- Tuberculosis
- Being tested
- INSTEP2 intervention package
- Keywords
- Tuberculosis, Public-Private Sector Partnership, Mobile Applications
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTEP2 intervention packageOther
The Intervention will comprise: An electronic notification system, a standardized education about the signs and symptoms of TB and TB management and an individualised plan for each PP with respect to their approach to the diagnosis and management of TB suspects.
The electronic system is a refinement of the electronic referral and report-back system using a mobile phone 'app'. The system will enable essential data to be uploaded, consistent with National TB Control Programme forms.
The education package will be focused on TB suspect identification, provisional diagnosis and referral, including how to use the mobile phone 'app'. We will also develop a simple individualised approach for the management of TB suspects, which takes into account the context around each PP's practice, identifying the most efficient and feasible approach to obtaining a diagnosis and notifying TB patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will comprise study participants who receive intervention package (i.e. private practitioners in the selected areas who agree to participate). Receives: Other: INSTEP2 intervention package |
| Control | No intervention | Private practitioners in the control areas will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased notification of tuberculosis (TB) by study participants
Increased notifications of TB by private practitioners in Bandung, Indonesia
Measured: 12 months before to the 12 months after the intervention
Secondary outcomes (2)
Proportion of referred patients in the intervention and control arms that are actually diagnosed with TB
Proportion of referrals from private practitioners that are actually diagnosed with TB (i.e. bacteriologically confirmed TB)
Measured: 12 months before to the 12 months after the intervention
Restricted analysis of primary outcome
Analysis of the primary outcome, limited to notifications of patients who live in the Community Health Center (CHC) area where they are notified
Measured: 12 months before to the 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jul 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be administered to private practitioners in the selected areas (clusters), at their place of practice. Once the study participants have received the intervention, real-time monitoring of referral practice of patients for diagnosis and notification will be undertaken through the web-link to the app.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- University of Otago, Harvard University
- Responsible party
- Principal investigator, Panji Fortuna Hadisoemarto, Universitas Padjadjaran
- Investigators
- Philip Hill, Professor, Principal investigator, University of Otago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187313
- Sponsor's protocol ID
- TB-201911.02
- Acronym
- INSTEP2
- Status last verified
- Oct 2023
- First submitted
- 3 Dec 2019
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahendradhata Y, Lestari T, Probandari A, Indriarini LE, Burhan E, Mustikawati D, Utarini A. How do private general practitioners manage tuberculosis cases? A survey in eight cities in Indonesia. BMC Res Notes. 2015 Oct 14;8:564. doi: 10.1186/s13104-015-1560-7.
PubMed 26468010Irawati SR, Basri C, Arias MS, Prihatini S, Rintiswati N, Voskens J, Kimerling ME. Hospital DOTS linkage in Indonesia: a model for DOTS expansion into government and private hospitals. Int J Tuberc Lung Dis. 2007 Jan;11(1):33-9.
PubMed 17217127Surya A, Setyaningsih B, Suryani Nasution H, Gita Parwati C, Yuzwar YE, Osberg M, Hanson CL, Hymoff A, Mingkwan P, Makayova J, Gebhard A, Waworuntu W. Quality Tuberculosis Care in Indonesia: Using Patient Pathway Analysis to Optimize Public-Private Collaboration. J Infect Dis. 2017 Nov 6;216(suppl_7):S724-S732. doi: 10.1093/infdis/jix379.
PubMed 29117347Probandari A, Utarini A, Hurtig AK. Achieving quality in the Directly Observed Treatment Short-course (DOTS) strategy implementation process: a challenge for hospital Public-Private Mix in Indonesia. Glob Health Action. 2008 Dec 17;1. doi: 10.3402/gha.v1i0.1831.
PubMed 20027243Reviono R, Setianingsih W, Damayanti KE, Ekasari R. The dynamic of tuberculosis case finding in the era of the public-private mix strategy for tuberculosis control in Central Java, Indonesia. Glob Health Action. 2017;10(1):1353777. doi: 10.1080/16549716.2017.1353777.
PubMed 28766465Lestari BW, Arisanti N, Siregar AYM, Sihaloho ED, Budiman G, Hill PC, Alisjahbana B, McAllister S. Feasibility study of strengthening the public-private partnership for tuberculosis case detection in Bandung City, Indonesia. BMC Res Notes. 2017 Aug 14;10(1):404. doi: 10.1186/s13104-017-2701-y.
PubMed 28807020Lei X, Liu Q, Escobar E, Philogene J, Zhu H, Wang Y, Tang S. Public-private mix for tuberculosis care and control: a systematic review. Int J Infect Dis. 2015 May;34:20-32. doi: 10.1016/j.ijid.2015.02.015. Epub 2015 Feb 23.
PubMed 25722284Artawan Eka Putra IW, Utami NW, Suarjana IK, Duana IM, Astiti CI, Putra IW, Probandari A, Tiemersma EW, Wahyuni CU. Factors associated to referral of tuberculosis suspects by private practitioners to community health centres in Bali Province, Indonesia. BMC Health Serv Res. 2013 Oct 28;13:445. doi: 10.1186/1472-6963-13-445.
PubMed 24165352
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Notifications of Tuberculosis From Private Practitioners: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04187313
- Acronym / sponsor ID
- INSTEP2 / TB-201911.02
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Public-Private Sector Partnership, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- University of Otago, Harvard University
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Dec 2019 (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.
Tuberculosis (TB) is the third leading cause of death in Indonesia. Disturbingly, the prevalence survey showed that over half of TB cases in Indonesia are not notified. The huge private sector in Indonesia, comprising an estimated 70,000 practitioners, provides over 50% of health care but notifies less than 10% of all diagnosed TB cases.
INSTEP2 is a cluster randomised controlled intervention trial. The multi-component public health intervention will be administered to private practitioners (PP) in Community Health Centre (CHC) clusters. The change in the number of TB notifications over 12 months before, and 12 months after, the intervention will be compared between study arms. Hypothesis related to the Primary Efficacy Endpoint: A tailored intervention in PPs will increase TB notifications.
Detailed description
As part of advancing Public-Private Mix (PPM), the government made TB notification mandatory in 2016, but intervention is likely to be needed for notifications to increase substantially. Such intervention needs to be based on a sound understanding of contextual factors around PPs and how they relate to the public sector with respect to the diagnosis, treatment and reporting of TB cases.
This is a cluster randomised controlled trial of a multi-component public health intervention to increase notifications of TB from PPs in Bandung, Indonesia. Clusters are CHC areas and the intervention will be administered directly to PPs in sub-districts randomised to the intervention arm. The CHCs in both arms will be informed about the study and asked, through the National TB Control Programme, to make their notification data available and their willingness will be recorded. No intervention will be given to PPs in the control arm. Notifications will be obtained directly from routine records, with accompanying information gathered about the address of the patient and referring doctor. Notified TB cases are, by definition, TB cases who have been commenced on TB treatment, noting that some referred 'TB cases' will be diagnosed as not having TB by CHC staff.
The intervention will be administered to PPs in areas around 15 CHCs (clusters), at their place of practice. PPs in the control areas will receive no intervention. The intervention will comprise: (1) An electronic referral and notification system; (2) Education about signs and symptoms of TB and TB management; (3) An individualised practitioner plan for diagnostic and management pathways.
The primary endpoint is the change in the number of notifications of TB from the 12 months before to the 12 months after the intervention is fully implemented. This change in the number of notifications will be compared between intervention clusters and control clusters.
Safety oversight by a Data and Safety Monitoring Board (DSMB) will not be required for this public health intervention trial. However, an internal Data Monitoring Committee (DMC) will be established to oversee the study, focused on data quality. A quality management plan will be developed to describe a site's quality management. Quality control (QC) procedures will be implemented beginning with the data entry system and data QC checks that will be run on the database will be automatically generated on a weekly basis and any quality issues identified will be reviewed by the DMC and a plan put in place for resolution. Following written Standard Operating Procedures (SOPs), visiting investigators will verify that the trial is conducted and data are generated, documented (recorded), and reported in compliance with the protocol. The investigational site will provide direct access to all source data/documents, and reports for the purpose of the verification visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention will be administered to private practitioners in the selected areas (clusters), at their place of practice. Once the study participants have received the intervention, real-time monitoring of referral practice of patients for diagnosis and notification will be undertaken through the web-link to the app.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: INSTEP2 intervention packageThe intervention arm will comprise study participants who receive intervention package (i.e. private practitioners in the selected areas who agree to participate). |
| Control | No intervention | –Private practitioners in the control areas will receive no intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All medically qualified private practitioners (PPs) in the intervention arm who reported having diagnosed at least one TB case in the past 3 months
- Intend to work in the current location for the duration of the study as their primary place of private practice
Key exclusion criteria (3 listed)
- Unable to use an electronic device for referral/notification
- More than 3 months of non-practice during the study period is anticipated
- They are not a qualified medical practitioner, with the appropriate medical authority in Indonesia
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 |
|---|---|---|
| INSTEP2 intervention packageThe Intervention will comprise: An electronic notification system, a standardized education about the signs and symptoms of TB and TB management and an individualised plan for each PP with respect to their approach to the diagnosis and management of TB suspects. The electronic system is a refinement of the electronic referral and report-back system using a mobile phone 'app'. The system will enable essential data to be uploaded, consistent with National TB Control Programme forms. The education package will be focused on TB suspect identification, provisional diagnosis and referral, including how to use the mobile phone 'app'. We will also develop a simple individualised approach for the management of TB suspects, which takes into account the context around each PP's practice, identifying the most efficient and feasible approach to obtaining a diagnosis and notifying TB patients. | Other | Intervention |
Primary outcome
Increased notification of tuberculosis (TB) by study participants
Time frame: 12 months before to the 12 months after the intervention
Increased notifications of TB by private practitioners in Bandung, Indonesia
2 secondary outcomes
Proportion of referred patients in the intervention and control arms that are actually diagnosed with TB
Time frame: 12 months before to the 12 months after the intervention
Restricted analysis of primary outcome
Time frame: 12 months before to the 12 months after the intervention
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 18 Oct 2023.
- Background: PubMed 26468010Mahendradhata Y, Lestari T, Probandari A, Indriarini LE, Burhan E, Mustikawati D, Utarini A. How do private general practitioners manage tuberculosis cases? A survey in eight cities in Indonesia. BMC Res Notes. 2015 Oct 14;8:564. doi: 10.1186/s13104-015-1560-7.
- Background: PubMed 17217127Irawati SR, Basri C, Arias MS, Prihatini S, Rintiswati N, Voskens J, Kimerling ME. Hospital DOTS linkage in Indonesia: a model for DOTS expansion into government and private hospitals. Int J Tuberc Lung Dis. 2007 Jan;11(1):33-9.
- Background: PubMed 29117347Surya A, Setyaningsih B, Suryani Nasution H, Gita Parwati C, Yuzwar YE, Osberg M, Hanson CL, Hymoff A, Mingkwan P, Makayova J, Gebhard A, Waworuntu W. Quality Tuberculosis Care in Indonesia: Using Patient Pathway Analysis to Optimize Public-Private Collaboration. J Infect Dis. 2017 Nov 6;216(suppl_7):S724-S732. doi: 10.1093/infdis/jix379.
- Background: PubMed 20027243Probandari A, Utarini A, Hurtig AK. Achieving quality in the Directly Observed Treatment Short-course (DOTS) strategy implementation process: a challenge for hospital Public-Private Mix in Indonesia. Glob Health Action. 2008 Dec 17;1. doi: 10.3402/gha.v1i0.1831.
- Background: PubMed 28766465Reviono R, Setianingsih W, Damayanti KE, Ekasari R. The dynamic of tuberculosis case finding in the era of the public-private mix strategy for tuberculosis control in Central Java, Indonesia. Glob Health Action. 2017;10(1):1353777. doi: 10.1080/16549716.2017.1353777.
- Background: PubMed 28807020Lestari BW, Arisanti N, Siregar AYM, Sihaloho ED, Budiman G, Hill PC, Alisjahbana B, McAllister S. Feasibility study of strengthening the public-private partnership for tuberculosis case detection in Bandung City, Indonesia. BMC Res Notes. 2017 Aug 14;10(1):404. doi: 10.1186/s13104-017-2701-y.
- Background: PubMed 25722284Lei X, Liu Q, Escobar E, Philogene J, Zhu H, Wang Y, Tang S. Public-private mix for tuberculosis care and control: a systematic review. Int J Infect Dis. 2015 May;34:20-32. doi: 10.1016/j.ijid.2015.02.015. Epub 2015 Feb 23.
- Background: PubMed 24165352Artawan Eka Putra IW, Utami NW, Suarjana IK, Duana IM, Astiti CI, Putra IW, Probandari A, Tiemersma EW, Wahyuni CU. Factors associated to referral of tuberculosis suspects by private practitioners to community health centres in Bali Province, Indonesia. BMC Health Serv Res. 2013 Oct 28;13:445. doi: 10.1186/1472-6963-13-445.
- World Health Organisation. PPM DOTS in Indonesia: a strategy for actionLink provided by the sponsor.
- 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.
Philip Hill, Professor principal investigator
University of Otago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTEP2 intervention package in people with Tuberculosis, run by Universitas Padjadjaran at 1 site in Indonesia.
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 2 inclusion and 3 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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?
Increased notification of tuberculosis (TB) by study participants (time frame: 12 months before to the 12 months after the intervention). 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 NCT04187313, which also lists 8 linked publications.
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 18 Oct 2023.