HivMENJAGANCT06058286
MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia
A study testing Continuous quality improvement in people with Hiv and Syphilis, run by Yanri Wijayanti Subronto, MD, PhD, at 1 site in Indonesia.
Trial summary
Elimination of mother-to-child-transmission (EMTCT) of HIV, syphilis and hepatitis B are key priorities in Indonesia, the fourth most populous country in the world. Despite national guidelines and strong antenatal care attendance, coverage of antenatal screening for these diseases among pregnant women remains… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Syphilis, Hepatitis B
- What is being tested?
- Continuous quality improvement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 31 Dec 2024
- 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
- If any reason is stated by the facility manager for not implementing the intervention if allocated to the intervention arm. Examples of (non-exhaustive) reasons that would exclude the facility are as follows: refusal to participate because of workload concerns or high turnover of staff, etc.
- Facility does not consent to participate
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Primary Healthcare Centre in Bandung city and Bogor district
Bandung City and Bogor District, West Java
Christa Dewi, PhD, +62 813-2548-5582, christa_dw@yahoo.com
Swasti Sempulur, +62 815-689-3803, swasti274@gmail.com
About this study
Official title: An Implementation Trial of Continuous Quality Improvement for Antenatal Syphilis, HIV and Hepatitis B Detection and Treatment in Indonesia
Elimination of mother-to-child-transmission (EMTCT) of HIV, syphilis and hepatitis B are key priorities in Indonesia, the fourth most populous country in the world. Despite national guidelines and strong antenatal care attendance, coverage of antenatal screening for these diseases among pregnant women remains extremely limited in Indonesia. The Indonesian government is committed to improving the integration of HIV/syphilis/hepatitis B testing and treatment into the antenatal platform but currently lacks comprehensive evidence on interventions to support this. We will evaluate a low-cost and locally driven intervention based on the principles of continuous quality improvement to strengthen antenatal care and promote screening for HIV, syphilis and hepatitis B. Continuous Quality Improvement (CQI), which involves local antenatal care (ANC) teams systematically collecting and reflecting on local data to inform the design and implementation of service delivery, has been effectively used to strengthen ANC in a number of Sub-Saharan African countries but yet to be comprehensively evaluated in ANC services in Indonesia. This approach holds considerable promise for Indonesia, a highly populous and diverse country where a 'one size fits all' approach to the delivery of quality ANC rarely applies.
Read the detailed description
Using a cluster-randomized design, we will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a multi-faceted Continuous Quality Improvement (CQI) intervention to improve antenatal testing and treatment of HIV, syphilis and hepatitis B at primary level healthcare facilities in Indonesia. Under the CQI approach, facility staff drive the development of solutions to quality of care shortcomings that they feel are best suited to the local context, working within existing resource constraints It is expected that through their engagement in the CQI intervention, ANC facilities will be in a stronger position to identify and address barriers to antenatal testing and treatment of HIV/syphilis/hepatitis B while also helping to strengthen the underlying health system. The study will take place in two districts in West Java, Indonesia. Clusters will consist of twenty facilities in each of the two districts (40 facilities total) that will be randomized with a 1:1 allocation ratio to the intervention arm (trained in CQI methods) and the control arm (providing usual care) using a computer-generated randomization schedule stratified by district. Intervention and control arms will be balanced with respect to the following covariates: type of facility (puskesmas -and facility size (number of antenatal care registrations in the previous year). In each district, the study team will train three district-level CQI coaches in quality improvement methods. The CQI coaches, using a train-the-trainer approach, will then train representatives from the 20 intervention arm facilities. Over approximately 12 months, intervention facilities will receive enhanced support in line with the CQI approach to promote implementation of the national guidelines and sustained provision of routine testing for HIV, syphilis and hepatitis B at least once during pregnancy. Facilities randomised to the control arm will continue to provide ANC services and HIV, syphilis and Hepatitis B testing as per the existing standard of care. The primary outcome is the proportion of women tested for HIV,syphilis and hepatitis during their current pregnancy. Current Indonesian guidelines recommend antenatal screening and treatment for HIV/syphilis/hepatitis B according to clinical protocols (for syphilis this is a single rapid test with no further confirmation of positive tests before commencing treatment using one injection of penicillin at an ANC clinic; for HIV there are three sequential rapid tests with confirmed cases initiating HIV antiretroviral therapy from the closest Care Support and Treatment clinic within the pregnancy period, and for hepatitis B, pregnant women with a reactive hepatitis B serum antigen test will be referred to a hospital for management based on clinical features). The overall aim of this study is to eliminate newborn infection with HIV/syphilis/hepatitis B in Indonesia through improved detection and treatment in pregnant women.
- Conditions
- Hiv, Syphilis, Hepatitis B
- Being tested
- Continuous quality improvement
- Keywords
- quality improvement, triple elimination, EMTCT, Antenatal care, Indonesia
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Syphilis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous quality improvementOther
Continuous quality improvement (CQI) is an approach to develop healthcare providers' capacity to improve quality of care processes and improve adherence to clinical guidelines. Key features of CQI include systematic, data-guided activities, designing interventions (or changes to facility processes) with local conditions in mind, and iterative development and testing of interventions. The approach is based on the premise that valuable improvement in organisational processes can be achieved through bottom-up initiatives of stakeholders and providers. It requires a 'team-based' culture of staff working together to collect and use available data to evaluate the effect of local solutions. Facility staff drive the development of solutions to quality of care shortcomings that they feel are best suited to the local context, and CQI works within existing resource constraints so it does not require large long-term investments to sustain improvements.
| Study group | Role | What they receive |
|---|---|---|
| Continuous quality improvement of antenatal HIV, syphilis and hepatitis B testing | Experimental | Intervention facilities will receive targeted and enhanced support in line with the continuous quality improvement (CQI) approach, over a period of approximately 12 months, to promote implementation of the national guidelines and sustained provision of routine testing for HIV, syphilis and hepatitis B at least once during pregnancy. District-level CQI coaches will provide training in CQI methods to two facility representatives from each of the 20 intervention arm facilities. The CQI coaches will then work with these facility-level 'CQI advocates' to implement a process of quality improvement to identify and address barriers to antenatal testing. Receives: Other: Continuous quality improvement |
| Routine antenatal care and testing | No intervention | In the control clusters, pregnant women will receive the existing standard of antenatal care, including antenatal testing for HIV, syphilis and hepatitis B (usual care). Current Indonesian guidelines recommend antenatal screening and treatment for HIV/syphilis/hepatitis B according to clinical protocols (for syphilis this is a single rapid test with no further confirmation of positive tests before commencing treatment using one injection of penicillin at an ANC clinic; for HIV there are three sequential rapid tests with confirmed cases initiating HIV antiretroviral therapy from the closest Care Support and Treatment clinic within the pregnancy period, and for hepatitis B, pregnant women with a reactive hepatitis B serum antigen test will be referred to a hospital for management based on clinical features) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women attending for ANC at one of the participating facilities for the first time, at any point in her pregnancy, who were tested for HIV, syphilis and hepatitis B during that visit.
This will be calculated as the number of women tested for HIV, syphilis and hepatitis B during their first visit to the facility for antenatal care out of the total number of pregnant women attending the facility for antenatal care for the first time.
Measured: Over a period of 2-3 months at endline
Secondary outcomes (3)
Proportion of women tested for HIV during their first visit to the facility for antenatal care
This will be calculated as the number of women tested for HIV during their first visit to the facility for antenatal care out of the total number of pregnant women attending the facility for antenatal care for the first time.
Measured: Over a period of 2-3 months at baseline and endline
Proportion of women tested for syphilis during their first visit to the facility for antenatal care
This will be calculated as the number of women tested for syphilis during their first visit to the facility for antenatal care out of the total number of pregnant women attending the facility for antenatal care for the first time.
Measured: Over a period of 2-3 months at baseline and endline
Proportion of women tested for hepatitis B during their first visit to the facility for antenatal care
This will be calculated as the number of women tested for hepatitis B during their first visit to the facility for antenatal care out of the total number of pregnant women attending the facility for antenatal care for the first time.
Measured: Over a period of 2-3 months at baseline and endline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanri Wijayanti Subronto, MD, PhD,
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kirby Institute
- Responsible party
- Sponsor-investigator, Yanri Wijayanti Subronto, MD, PhD,, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058286
- Sponsor's protocol ID
- 000
- Other IDs
- MR/T038837/1
- Acronym
- MENJAGA
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On project completion, research data will be deposited in the UK Data Archive and LSHTM Research Data Repository. We will only share de-identified study data files.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Implementation Trial of Continuous Quality Improvement for Antenatal Syphilis, HIV and Hepatitis B Detection and Treatment in Indonesia
- ClinicalTrials.gov ID
- NCT06058286
- Acronym / sponsor ID
- MENJAGA / 000
- Conditions
- Hiv, Syphilis, Hepatitis B
- Keywords
- quality improvement, triple elimination, EMTCT, Antenatal care, Indonesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yanri Wijayanti Subronto, MD, PhD,University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kirby Institute
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
Elimination of mother-to-child-transmission (EMTCT) of HIV, syphilis and hepatitis B are key priorities in Indonesia, the fourth most populous country in the world. Despite national guidelines and strong antenatal care attendance, coverage of antenatal screening for these diseases among pregnant women remains extremely limited in Indonesia. The Indonesian government is committed to improving the integration of HIV/syphilis/hepatitis B testing and treatment into the antenatal platform but currently lacks comprehensive evidence on interventions to support this. We will evaluate a low-cost and locally driven intervention based on the principles of continuous quality improvement to strengthen antenatal care and promote screening for HIV, syphilis and hepatitis B. Continuous Quality Improvement (CQI), which involves local antenatal care (ANC) teams systematically collecting and reflecting on local data to inform the design and implementation of service delivery, has been effectively used to strengthen ANC in a number of Sub-Saharan African countries but yet to be comprehensively evaluated in ANC services in Indonesia. This approach holds considerable promise for Indonesia, a highly populous and diverse country where a 'one size fits all' approach to the delivery of quality ANC rarely applies.
Detailed description
Using a cluster-randomized design, we will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a multi-faceted Continuous Quality Improvement (CQI) intervention to improve antenatal testing and treatment of HIV, syphilis and hepatitis B at primary level healthcare facilities in Indonesia. Under the CQI approach, facility staff drive the development of solutions to quality of care shortcomings that they feel are best suited to the local context, working within existing resource constraints It is expected that through their engagement in the CQI intervention, ANC facilities will be in a stronger position to identify and address barriers to antenatal testing and treatment of HIV/syphilis/hepatitis B while also helping to strengthen the underlying health system. The study will take place in two districts in West Java, Indonesia. Clusters will consist of twenty facilities in each of the two districts (40 facilities total) that will be randomized with a 1:1 allocation ratio to the intervention arm (trained in CQI methods) and the control arm (providing usual care) using a computer-generated randomization schedule stratified by district. Intervention and control arms will be balanced with respect to the following covariates: type of facility (puskesmas -and facility size (number of antenatal care registrations in the previous year). In each district, the study team will train three district-level CQI coaches in quality improvement methods. The CQI coaches, using a train-the-trainer approach, will then train representatives from the 20 intervention arm facilities. Over approximately 12 months, intervention facilities will receive enhanced support in line with the CQI approach to promote implementation of the national guidelines and sustained provision of routine testing for HIV, syphilis and hepatitis B at least once during pregnancy. Facilities randomised to the control arm will continue to provide ANC services and HIV, syphilis and Hepatitis B testing as per the existing standard of care. The primary outcome is the proportion of women tested for HIV,syphilis and hepatitis during their current pregnancy. Current Indonesian guidelines recommend antenatal screening and treatment for HIV/syphilis/hepatitis B according to clinical protocols (for syphilis this is a single rapid test with no further confirmation of positive tests before commencing treatment using one injection of penicillin at an ANC clinic; for HIV there are three sequential rapid tests with confirmed cases initiating HIV antiretroviral therapy from the closest Care Support and Treatment clinic within the pregnancy period, and for hepatitis B, pregnant women with a reactive hepatitis B serum antigen test will be referred to a hospital for management based on clinical features). The overall aim of this study is to eliminate newborn infection with HIV/syphilis/hepatitis B in Indonesia through improved detection and treatment in pregnant women.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous quality improvement of antenatal HIV, syphilis and hepatitis B testing | Experimental | Other: Continuous quality improvementIntervention facilities will receive targeted and enhanced support in line with the continuous quality improvement (CQI) approach, over a period of approximately 12 months, to promote implementation of the national guidelines and sustained provision of routine testing for HIV, syphilis and hepatitis B at least once during pregnancy. District-level CQI coaches will provide training in CQI methods to two facility representatives from each of the 20 intervention arm facilities. The CQI coaches will then work with these facility-level 'CQI advocates' to implement a process of quality improvement to identify and address barriers to antenatal testing. |
| Routine antenatal care and testing | No intervention | –In the control clusters, pregnant women will receive the existing standard of antenatal care, including antenatal testing for HIV, syphilis and hepatitis B (usual care). Current Indonesian guidelines recommend antenatal screening and treatment for HIV/syphilis/hepatitis B according to clinical protocols (for syphilis this is a single rapid test with no further confirmation of positive tests before commencing treatment using one injection of penicillin at an ANC clinic; for HIV there are three sequential rapid tests with confirmed cases initiating HIV antiretroviral therapy from the closest Care Support and Treatment clinic within the pregnancy period, and for hepatitis B, pregnant women with a reactive hepatitis B serum antigen test will be referred to a hospital for management based on clinical features) |
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 (2 listed)
- If any reason is stated by the facility manager for not implementing the intervention if allocated to the intervention arm. Examples of (non-exhaustive) reasons that would exclude the facility are as follows: refusal to participate because of workload concerns or high turnover of staff, etc.
- Facility does not consent to participate
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 |
|---|---|---|
| Continuous quality improvementContinuous quality improvement (CQI) is an approach to develop healthcare providers' capacity to improve quality of care processes and improve adherence to clinical guidelines. Key features of CQI include systematic, data-guided activities, designing interventions (or changes to facility processes) with local conditions in mind, and iterative development and testing of interventions. The approach is based on the premise that valuable improvement in organisational processes can be achieved through bottom-up initiatives of stakeholders and providers. It requires a 'team-based' culture of staff working together to collect and use available data to evaluate the effect of local solutions. Facility staff drive the development of solutions to quality of care shortcomings that they feel are best suited to the local context, and CQI works within existing resource constraints so it does not require large long-term investments to sustain improvements. | Other | Continuous quality improvement of antenatal HIV, syphilis and hepatitis B testing |
Primary outcome
Proportion of women attending for ANC at one of the participating facilities for the first time, at any point in her pregnancy, who were tested for HIV, syphilis and hepatitis B during that visit.
Time frame: Over a period of 2-3 months at endline
This will be calculated as the number of women tested for HIV, syphilis and hepatitis B during their first visit to the facility for antenatal care out of the total number of pregnant women attending the facility for antenatal care for the first time.
3 secondary outcomes
Proportion of women tested for HIV during their first visit to the facility for antenatal care
Time frame: Over a period of 2-3 months at baseline and endline
Proportion of women tested for syphilis during their first visit to the facility for antenatal care
Time frame: Over a period of 2-3 months at baseline and endline
Proportion of women tested for hepatitis B during their first visit to the facility for antenatal care
Time frame: Over a period of 2-3 months at baseline and endline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. On project completion, research data will be deposited in the UK Data Archive and LSHTM Research Data Repository. We will only share de-identified study data files.
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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.
Primary Healthcare Centre in Bandung city and Bogor district
Bandung City and Bogor District, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous quality improvement in people with Hiv and Syphilis, run by Yanri Wijayanti Subronto, MD, PhD, 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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women attending for ANC at one of the participating facilities for the first time, at any point in her pregnancy, who were tested for HIV, syphilis and hepatitis B during that visit. (time frame: Over a period of 2-3 months at endline). 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 28 Sep 2023.