Kenya Quality Model for Community Health: a unique model for quality improvement in Antenatal Care

The uptake of antenatal care in early pregnancy is low, especially among rural populations and adolescents in Kenya. All pregnant women should be tested for common conditions that can cause harm to the mother or the baby so that these can be diagnosed and treated as early as possible in the pregnancy, ideally before 20 weeks of pregnancy. Kenyan guidelines recommend testing for HIV, syphilis, malaria (if they have fever) and anaemia. In practice, only HIV testing is done consistently and even this may be done late (and sometimes women who test positive may not get treatment in time). The other tests are very often missed altogether as women from rural areas cannot afford the time and money to go to laboratories at distant facilities and are put off attending antenatal care at lower facilities (like dispensaries) due to poor quality of services. All of these issues combined can lead to poor pregnancy outcomes for mothers and their newborns, especially among these vulnerable populations. Low cost technology that does not require trained laboratory personnel is available to do rapid testing at the point-of-care, giving a result in 20 minutes and overcoming the need to travel to a laboratory that may be far away or expensive to get to. Such rapid tests for the diagnosis of HIV have been in use in Kenya for close to 20 years. Similar tests for syphilis, malaria and anaemia are also available, though less commonly used. We have successfully shown (in separate locations and at separate times) the following: first that it is possible to work with community health workers to improve referral of pregnant women to health facilities for primary care services; and second, that integrated point of care testing can reduce waiting times and improve workflows at the lowest level of the health facility, improving uptake of ANC (Antenatal Care) and of testing respectively. Each of these separate projects was hampered by the absence of an intervention in the corresponding facility or community. In this early phase study, we will for the first time combine these two proven interventions into one combined approach to improve antenatal care, increasing its uptake among rural populations. Our ambition is to increase the number of women being tested for all four conditions in pregnancy by at least 50%. In this early phase we will assess if the combined model works within the existing health systems and if it is acceptable to the community members who utilised it and the health workers who implemented it. If we are successfully able to combine the two into a single feasible intervention that works (we have set targets to define what we mean by this) then we plan to go on to test the impact of this combined approach on pregnancy outcomes through a pragmatic cluster randomised controlled trial in western Kenya (the main study). Our main study has been submitted to, and shortlisted by, the European Union and we hope it will be successfully funded building on this early phase study.

This study will combine the active components of two successful health system strengthening approaches in Kenya: a quality improvement (QI) model for community health programs and the roll out of point-of-care testing at ANC. Our methods will focus on intervention development and evaluation in Migori County in Western Kenya. ANC is a priority intervention for Migori, where maternal mortality is high and preventable causes of poor pregnancy outcomes such as HIV, syphilis, malaria and anaemia are endemic. ANC attendance in the first trimester is only 20% and only 50% receive 4 ANC visits (unpublished). We will use this early phase study to develop and test the acceptability and feasibility of the combined intervention in 3 primary health facilities and their link community health units. The intervention will involve working with the county teams to establish work improvement teams at facility linked to community teams; training health workers to provide point-of-care testing for syphilis, anaemia, and malaria; carrying out QI cycles using local data and sharing learning across the 3 sites. Evaluation methods will include: baseline and endline facility ANC register review; client exit interviews on self-reported testing and management at ANC; facility observations on client flow and workload; realist evaluation - exploratory qualitative study with narrative review of implementation reports, data files, meeting minutes, and interviews with up to 40 key informants. The intervention will progress to the main phase if we show it is feasible and acceptable in facilities and to the community; if there is a 50% or more relative increase in women receiving all 4 tests before 20 weeks; and if there is buy-in of the county government. The main study will evaluate the effectiveness and impact of our combined intervention on self-reported adverse pregnancy outcomes through a pragmatic parallel-arm cluster randomised control trial in two counties in Kenya.

The impact of this study will manifest in the intervention community health units, the linked primary healthcare facilities, at county level and within policy making circles.

Community level: pregnant women will benefit from better linkage with primary healthcare facilities and improved quality of services there, which will enhance trust and confidence in local health services, contributing to a virtuous cycle of improving the early uptake and continuous utilization of Antenatal Care (ANC) and testing services and improved pregnancy outcomes. Engagement in quality improvement teams would have a long-term impact on their capacity and will address power imbalances in community health systems by enabling community members (particularly women) to advocate for improved health services standards that meet their needs.

Primary healthcare facility: By investing in the quality of testing at ANC at facilities, we will strengthen the community's trust in both the community health workers and the capacity of the health system as a whole. The establishment of point-of-care tests for HIV, syphilis, anaemia and malaria embedded in ANC services will promote efficient and integrated service delivery and increase uptake, develop the capacity of health care workers and improve their performance and efficiency. The retention and satisfaction of facility staff is also likely to be enhanced.

Policy and practice: The study is anticipated to lead to a larger trial evaluating the impact of our intervention on pregnancy outcomes (the 'main study'), which will include a realist review and health economic component. Th main study will determine the impact of our unique combined intervention and answer what worked for whom and why. Successful elements of our community health systems strengthening approach and related tools will contribute to the development of a wider Kenyan Quality Model for Community Health that is eagerly awaited by the national quality and standards department, who have committed to its adoption nationally.