Continuous quality improvement for antenatal HIV, syphilis and hepatitis B testing in Indonesia
| ISRCTN | ISRCTN11251878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11251878 |
| ClinicalTrials.gov number | NCT06058286 |
| Secondary identifying numbers | MR/T038837/1 |
- Submission date
- 01/11/2024
- Registration date
- 12/11/2024
- Last edited
- 07/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
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.
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.
This study will evaluate the effectiveness, cost-effectiveness, acceptability, fidelity and reach of a CQI intervention to improve antenatal testing and treatment of HIV, syphilis and hepatitis B in public and private antenatal clinics in two districts in West Java province.
Who can participate?
Primary level healthcare facilities in Bogor and Bandung districts in Indonesia will participate in the study.
What does the study involve?
The study 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. The CQI intervention will involve local antenatal care (ANC) teams systematically collecting and reflecting on local data to inform the design and implementation of service delivery.
What are the possible risks and benefits of participating?
Participants may not benefit directly from being involved in the study. Healthcare facility staff participating in the intervention will receive training in continuous quality improvement methods, which can be flexibly applied to other health concerns or issues faced by healthcare facilities. Further, we hope that if our intervention is successful, more pregnant women will be screened, and if testing positive, then receive appropriate treatment, which will lead to improved health outcomes for women and newborns.
Some of the interview questions may make the participants feel uncomfortable, but they are free to stop the interview or skip to the next question. There are no other risks to participation in this study because all the answers provided will be kept confidential, and only the researchers will have access. When the study findings are shared, the participant name and the name of the health facility where the research was conducted will not be used.
Where is the study run from?
This is a collaboration between Universitas Gadjah Mada, the London School of Hygiene and Tropical Medicine, United Kingdom (UK), and the Kirby Institute University of New South Wales, Australia.
When is the study starting and how long is it expected to run for?
March 2023 to March 2025
Who is funding the study?
The study is funded by the Medical Research Council, UK.
Who is the main contact?
Christa Dewi, christa_dw@yahoo.com
Swasti Sempulur, swasti274@gmail.com
Contact information
Scientific, Principal Investigator
The Kirby Institute, University of New South Wales (UNSW)
Sydney
NSW 2052
Australia
 ORCID ID |
0000-0002-7911-0741 |
|---|---|
| Phone | +61 (2) 9385 9998 |
| virginia.wiseman@lshtm.ac.uk |
Public, Scientific
Universitas Gadjah Mada (UGM)
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| ORCID ID |
0000-0002-6367-4884 |
|---|---|
| Phone | +62 274 547147 |
| ysubronto@ugm.ac.id |
Scientific, Principal Investigator
Universitas Gadjah Mada (UGM)
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| ORCID ID |
0000-0003-3171-5271 |
|---|---|
| Phone | +62 274 547147 |
| ari.probandari@staff.uns.ac.id |
Scientific, Principal Investigator
London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
| ORCID ID |
0000-0002-0997-0850 |
|---|---|
| Phone | +44 (0) 2079 272657 |
| shunmay.yeung@lshtm.ac.uk |
Scientific
London School of Hygiene & Tropical Medicine
Faculty of Infection and Tropical Diseases
Department of Clinical Research
Keppel Street
London
WC1E 7HT
United Kingdom
| ORCID ID |
0000-0002-1572-6790 |
|---|---|
| Phone | +44 (0)20 7927 2256 |
| Tsitsi.Penduka@lshtm.ac.uk |
Scientific
Universitas Gadjah Mada (UGM)
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| ORCID ID |
0000-0003-0116-7120 |
|---|---|
| Phone | +62 (0)274 547147 |
| vitri_w@staff.uns.ac.id |
Scientific
Kirby Institute, UNSW Sydney
Wallace Wurth Building
High Street
Sydney
2031
Australia
| ORCID ID |
0000-0002-3397-3648 |
|---|---|
| Phone | +61 (0)2 93851000 |
| lwulandari@kirby.unsw.edu.au |
Scientific
Universitas Gadjah Mada (UGM)
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| Phone | +62 (0)274 547147 |
|---|---|
| juniatirahmadani@gmail.com |
Universitas Gadjah Mada (UGM)
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| ORCID ID |
0000-0003-1580-4514 |
|---|---|
| Phone | +62 (0)274 547147 |
| christa_dw@yahoo.com |
Study information
| Study design | Multi-centre two-arm parallel open-label cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | 46326 PIS case studies v3 19.01.23.pdf |
| Scientific title | An implementation trial of continuous quality improvement for antenatal syphilis, HIV and hepatitis B detection and treatment in Indonesia |
| Study acronym | MENJAGA |
| Study hypothesis | What is 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. |
| Ethics approval(s) |
1. Approved 04/04/2023, LSHTM Research Ethics Committee (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)20 7636 8636; Ethics@lshtm.ac.uk), ref: 28328 2. Approved 26/05/2023, UNSW Human Research Ethics Committee (UNSW Sydney, Sydney, NSW 2052, Australia; +61 2 93851000; humanethics@unsw.edu.au), ref: 28328 3. Approved 30/03/2023, Medical and Health Research Ethics Committee (Bulaksumur, Depok, Sleman Regency, Special Region of Yogyakarta, 55281, Indonesia; +628112666869; mhrec_fmugm@ugm.ac.id), ref: KE/FK/0485/EC/2023 |
| Condition | Detection of HIV, syphilis. hepatitis B among pregnant women seeking antenatal care |
| Intervention | 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. |
| Intervention type | Behavioural |
| 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] 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. |
| Secondary outcome measures | 1. 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]. 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 2. 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]. 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 3. 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]. 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 |
| Overall study start date | 30/03/2023 |
| Overall study end date | 31/03/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient, Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 6300 |
| Participant inclusion criteria | 1. Facility with at least 320 first ANC visits or registrations per year (based on previous year’s data) 2. Facility is not currently engaged in another quality improvement intervention or other health-related research 3.Facility expected to provide ANC services and HIV/syphilis/hepatitis B testing for the duration of the study 4. Facility recorded 30% or less coverage of HIV testing amongst pregnant women (based on previous year’s data) |
| Participant exclusion criteria | Facilities deemed by the manager not able to implement the intervention |
| Recruitment start date | 01/10/2023 |
| Recruitment end date | 31/10/2024 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
-
Indonesia
-
Indonesia
Sponsor information
University/education
Center for Tropical Medicine
Bulaksumur
Yogyakarta
55281
Indonesia
| Phone | +62(274)588688 |
|---|---|
| yanrisubronto@gmail.com | |
| Website | https://centertropmed-ugm.org/about-us/ |
"ROR" |
https://ror.org/03ke6d638 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | A plain language summary report in Indonesian and English will be produced and provided to people who took part in the study, including at health facilities, community groups and key stakeholders. The results of the study will also be written up and submitted for publication in medical journals and may also be presented at national and international meetings and scientific conferences. The information provided during the interviews maybe shared in the form of individual quotes in research reports or presentations. (added 17/12/2024) The protocol will be submitted to a peer-reviewed journal for publication before data collection ends. It will also be submitted to LSHTM Research Online, the institutional repository, for archiving. The protocol will be assigned a DOI and will be accessible via https://researchonline.lshtm.ac.uk/ |
| IPD sharing plan | On project completion, research data will be deposited in the UK Data Archive (https://www.data-archive.ac.uk/find/ )and LSHTM Research Data Repository (https://datacompass.lshtm.ac.uk/). Data in the repositories will be made accessible to other users (outside of the project) at the end of the analysis and publication period (after 24 months of completion of the project). This period is requested to allow time for necessary authorisations, data preparation and additional analysis and publication of key research findings. Documentation will be produced for both qualitative and quantitative datasets, including background and contextual information, characteristics of participants in qualitative interviews, data collection tools, variable names, labels and descriptions. The drafting of documentation will be informed by the UK Data Service recommendations (https://www.ukdataservice.ac.uk/manage-data/document/data-level). We will only share de-identified study data files. Sharing data with researchers outside the project will be permitted under strict data-sharing agreements and/or user registration. As part of the registration/data-sharing agreement process, users must agree to conditions including: 1) restrictions against attempting to identify participants, 2) commitment to securing the data using appropriate technology, 3) destruction of data after analyses are completed, 4) reporting responsibilities, 5) restrictions on redistribution of data, and 6) proper acknowledgement of the data source. For the qualitative data, wherever possible, the project will make available the anonymised transcripts. Any transcripts that cannot be fully anonymized may be made available for other researchers through a controlled access method, with access reviewed and agreed by study PIs. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Case studies version 3 |
19/01/2023 | 11/11/2024 | No | Yes |
| Participant information sheet | Interviews version 3 |
19/01/2023 | 11/11/2024 | No | Yes |
Additional files
- 46326 PIS interviews.pdf
- Interviews
- 46326 PIS case studies v3 19.01.23.pdf
- Case studies
Editorial Notes
07/03/2025: The overall study end date was changed from 01/03/2025 to 31/03/2025.
06/02/2024: Total final enrolment added.
17/12/2024: The following changes were made to the trial record:
1. The overall study end date was changed from 31/12/2024 to 01/03/2025.
2. The publication and dissemination plan was updated.
04/12/2024: Contact details updated.
01/11/2024: Trial's existence confirmed by Universitas Gadjah Mada.
