Clinical trial NCT06058286: MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia
Official title: An Implementation Trial of Continuous Quality Improvement for Antenatal Syphilis, HIV and Hepatitis B Detection and Treatment in Indonesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Syphilis
Hepatitis B
Keywords: quality improvement
triple elimination
EMTCT
Antenatal care
Indonesia
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Kirby Institute
First posted: 2023-09-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Over a period of 2-3 months at endline
Secondary outcomes:
measure: Proportion of women tested for HIV during their first visit to the facility for antenatal care
timeFrame: Over a period of 2-3 months at baseline and endline
measure: Proportion of women tested for syphilis during their first visit to the facility for antenatal care
timeFrame: Over a period of 2-3 months at baseline and endline
measure: Proportion of women tested for hepatitis B during their first visit to the facility for antenatal care
timeFrame: Over a period of 2-3 months at baseline and endline
Other outcomes:
Locations:
city: Bandung City And Bogor District
country: Indonesia
facility: Primary Healthcare Centre in Bandung city and Bogor district
state: West Java
Study officials:
References: