MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia

NCT06058286 | Unknown

• 2 other identifiers: 000MR/T038837/1
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Syphilis; Hepatitis B

Keywords

quality improvement; triple elimination; EMTCT; Antenatal care; Indonesia

Outcome Measures

Primary Outcomes (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.

  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.

  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

  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

  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

  Over a period of 2-3 months at baseline and endline

Study Arms (2)

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.

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)

Interventions

Continuous quality improvement OTHER

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.

Continuous quality improvement of antenatal HIV, syphilis and hepatitis B testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yanri Wijayanti Subronto, MD, PhD,: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kirby Institute: collaborator

Study Sites (1)

Primary Healthcare Centre in Bandung city and Bogor district

Bandung City and Bogor District, West Java, Indonesia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Syphilis; Hepatitis B

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the intervention, district health officials and healthcare providers will be aware of allocation. Fieldworkers collecting outcome data and women interviewed for the process evaluation will be masked as to allocation. The team analysing the outcome data and interpreting the results will be masked to the study arm until all primary outcome analyses outlined in the statistical analysis plan are completed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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).
• Access Criteria: 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.

Locations

ID (1)