MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in In… (NCT06058286) | Clinical Trial Compass
UnknownNot Applicable
MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia
Indonesia2,000 participantsStarted 2023-10-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
This is cluster randomized control trial that unit of analysis is health facility. The following are the eligibility criteria for health facilities to be included in the trial:
* Facility with at least 320 first antenatal care visits or registrations per year (based on previous year's data).
* Facility is not currently engaged in another quality improvement intervention or other health-related research.
* Facility expected to provide antenatal care services and HIV/syphilis/hepatitis B testing for the duration of the study.
* Facility recorded 30% or less coverage of HIV testing amongst pregnant women (based on previous year's data).
Exclusion Criteria:
• 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.