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Study Protocol

Maximizing Group Antenatal Care (G-ANC) coverage in health facilities: Study Protocol for an Implementation Research in Machakos County, Kenya

[version 1; peer review: awaiting peer review]
PUBLISHED 09 May 2025
Author details Author details

Abstract

Background

Group Antenatal Care (G-ANC) is associated with increased antenatal care (ANC) attendance, improved provision of quality care, and greater satisfaction for women when compared to individual ANC. Positive research results in Kenya led to interest in adopting G-ANC as the local standard of care. A study was designed in Kenya to explore the feasibility, acceptability, effectiveness, fidelity, and sustainability of scaling up G-ANC as the predominant ANC service delivery model.

Methods

A mixed-methods implementation research study with process evaluation of the G-ANC scale-up was conducted in Machakos County, Kenya. Twelve health facilities were purposively selected in consultation with the county health management team. Participants included pregnant women, healthcare providers providing ANC/G-ANC, and county health managers. Baseline quantitative data were collected from March 2021 to February 2022 from study facilities. Data were collected monthly through data abstraction and quarterly through surveys from the start of implementation in March 2022 to November 2023. Midline qualitative data were collected in March/April 2023, and endline data in December 2023 using key informant interviews and focus group discussions. A sub-study was later added with an additional secondary objective of exploring the factors influencing the choice of place of delivery among women participating in G-ANC from eight study facilities.

Results

Overall, 480 cohorts/G-ANC groups of women with same gestation periods were formed. Over 12,000 women attending at least one G-ANC meeting across the 12 health facilities implementing the G-ANC model in Machakos County, Kenya. The final study results will be ready for publication in September 2024.

Conclusions

This is the first study to assess G-ANC scale-up at the facility and the sub-national levels in Kenya. It is expected that the Ministry of Health in Kenya will use the evidence generated from this study to inform the scale-up of G-ANC.

Keywords

Antenatal care, G-ANC, maternal health, scale-up, Machakos, Kenya

Background and study rationale

Maternal mortality has declined globally, yet most countries in sub-Saharan Africa (SSA) still experience significantly high maternal mortality ratios (MMRs). SSA alone accounted for around 70% of maternal deaths in 2020 (WHO, 2023). The MMR in Kenya is estimated at 355 deaths per 100,000 live births, and the neonatal mortality rate at 21 per 1,000 live births (Kenya National Bureau of Statistics, 2023). Strategies aimed at reducing these mortalities prioritize increased antenatal contacts with skilled healthcare providers (WHO, 2016), skilled intrapartum care, and facility-based deliveries (Lindsay et al., 2019). Inadequate antenatal care (ANC) among pregnant women is associated with poor maternal outcomes including birth complications and maternal death. (Mekonnen et al., 2019). A study conducted in Kenya observed that almost 40% of neonatal mortalities can be prevented by adherence to ANC appointments (Arunda et al., 2017). In 2016, the World Health Organization (WHO) revised its recommendation from a minimum of four ANC visits to eight contacts (WHO, 2016). Only half (54%) of pregnant women in SSA receive four or more clinical antenatal contacts (UNICEF, 2023). An analysis of a multi-country study found that the pooled prevalence of eight or more ANC contacts was 13% in the 15 studied countries (Ekholuenetale, 2021). In Kenya, no data are yet available on coverage of eight or more ANC contacts, but only 66% of pregnant women had at least four ANC contacts (Kenya National Bureau of Statistics, 2022).

In 2022, the Ministry of Health (MoH) of Kenya adopted the 2016 WHO ANC model with eight contacts in its updated national obstetrics and perinatal care guidelines (Liverpool School of Tropical Medicine, 2023). The Kenya MoH also included Group Antenatal Care (G-ANC) in the 2020 guidelines update based on a cluster randomized control trial (cRCT) in Kenya (2016–2018) that found G-ANC to be associated with increased ANC service utilization, improved quality of care, and higher levels of maternal satisfaction compared to individual ANC (Grenier et al., 2019). G-ANC is a transformative service delivery model provided by qualified healthcare providers to groups of pregnant women of similar gestational ages. WHO recommends G-ANC as an alternative to individual ANC for pregnant women in the context of rigorous research (WHO, 2016). Available evidence on G-ANC in low- and middle income countries (LMICs) indicate it is effective, acceptable, feasible, and demonstrates fidelity (Adaji et al., 2019; Grenier et al., 2022; Harsha Bangura et al., 2020; Patil et al., 2017; Singh et al., 2023). Most studies on G-ANC were conducted in research settings where conditions are controlled. Despite the growing interest in understanding how to scale and sustain G-ANC, no studies or evaluations of G-ANC implementation at scale in LMIC settings have been published.

G-ANC as the predominant service delivery model refers to G-ANC becoming the “default” standard of care for routine ANC. The predominant model was developed in Machakos County, Kenya, by Ekalakala Health Centre staff who participated in the cRCT and adopted G-ANC as the standard of care post-study. The Machakos County Health Management Team (CHMT) became interested in scaling up this model to ensure that as many women as possible could participate in G-ANC by increasing the number of facilities that provide G-ANC as the predominant model to maximize G-ANC coverage.

International Centre for Reproductive Health (ICRHK) and Jhpiego conducted this implementation research (IR) study to assess the feasibility, acceptability, effectiveness, and sustainability of adopting G-ANC as the predominant ANC model. Facilities were selected and categorized by ANC1 caseload. Facilities with smaller monthly ANC1 caseloads were chosen to fully transition to the predominant model (i.e., predominant model facilities [PMFs]). Higher volume facilities (HVFs) such as Level 4 and 5 hospitals were selected to maximize G-ANC coverage. It was hypothesized that HVFs would not be able to transition completely, due to fewer staff and higher ANC client volumes. Scale-up was explored at: 1) the facility level as G-ANC was adopted as the predominant model and sustained it over time; and 2) at the sub-national health system level to explore what inputs are needed to scale up and sustain G-ANC. It was designed collaboratively with the Machakos CHMT to ensure the results would support future health programs. The study objectives and research questions are described in Table 1.

Table 1. Study objectives and research questions.

Objective (IR
Domain)
Research questions
Health Facility Level
Feasibility•   What is the pace and coverage of G-ANC scale-up? What factors affect the facility’s ability to enroll
and serve a high proportion of ANC clients through G-ANC? What factors enable facilities to adopt
G-ANC as the predominant service delivery model?
Acceptability•   What is the level of satisfaction of G-ANC among pregnant women when G-ANC is implemented at
scale, particularly where it is the predominant service delivery model?
Effectiveness•   What is the level of retention of pregnant women in ANC through G-ANC (ANC4, ANC8)?
Fidelity•   How much process fidelity to highly participatory facilitation skills is observed in the G-ANC meetings?

Conceptual framework

Overall, it is hypothesized that facilities that can adapt the model to improve feasibility and maintain high intervention fidelity will have higher levels of satisfaction among pregnant women, leading to greater retention in ANC and increased institutional deliveries for better pregnancy outcomes among G-ANC participants. The most important intervention principles are group processes (i.e., the quality of highly participatory facilitation), group stability, and group size. Diluting these principles may adversely affect women’s comfort in the group, openness and freedom of the discussion, the validation of women’s experiences and needs, and the bonding and relationships between women and the providers.

We also hypothesized that: (i) G-ANC as the predominant ANC model can be implemented with high fidelity and deliver better quality ANC for women, particularly a more positive experience of care; (ii) facilities with smaller caseloads and more ANC staff will be able to transition and sustain G-ANC as the predominant ANC model; and (iii) facilities with fewer staff and higher caseloads, such as hospitals, will not be able to transition fully to G-ANC, leading to lower health care provider satisfaction with G-ANC and less likelihood that G-ANC at scale will be sustained over time. Figure 1 illustrates the G-ANC scale up theory of change.

dc1576fd-d8af-4145-987e-1d41be0fe26e_figure1.gif

Figure 1. G-ANC scale up Theory of Change.

Methods

Study design

This was a mixed-methods implementation research study that collected qualitative and quantitative data at baseline, during implementation, and at the end of the study period. The study team collected the required data and information using study instruments, process documentation, as well as the routine ANC register (MOH 405), a MoH tool used for routinely reporting clinical services for pregnant women. Process documentation also included observations of changes in the health facility (e.g., re-allocation of staff to ANC) and changes in the G-ANC model.

The study team abstracted pre-intervention quantitative data 12 months preceding G-ANC scale-up from facility ANC registers at study facilities, including any data available on previous G-ANC implementation. The same data were collected monthly from all facilities during the implementation period. The study team excluded personal identifiers and abstracted only aggregated descriptive information about each facility, such as total ANC clients. The study assessed fidelity through facility visits and meeting observations.

During implementation, a survey of women attending G-ANC was conducted. Every month the study team interviewed three pregnant women participating in G-ANC from each health facility, at the end of a G-ANC meeting. Women were allowed to participate in the survey only once. The study team conducted forty focus group discussions (FGDs) with pregnant women attending ANC at the mid-point (n=20) and at the end of the study (n=20).

Further, KIIs were conducted with health care providers engaged in G-ANC and ANC or health facility in-charges at the study’s mid-point (n=24) and end-line (n=24). At each point, they were purposively selected. Four health care providers were selected from each facility: two at midline and another two at the end line. Additionally, six county/sub-county health managers purposively selected participated in the KIIs. The study data and instruments are summarized in Table 2.

Table 2. Study data, study tools and frequency.

Data collection periodStudy toolsFrequency
QuantitativeQualitative
Pre-intervention
Pre-intervention facility data•   Baseline ANC register data
abstraction tool
•   Baseline G-ANC data abstraction
tool
•   Baseline facility monitoring tool
Once: 12 months
of data
Intervention period
Assessment of ANC services•   G-ANC facility monitoring tool Monthly, per facility
ANC attendance from facility
registers
•   ANC register data abstraction tool
•   ANC data abstraction from the
monthly summary form
Monthly, per facility
Data on G-ANC attendance from the
G-ANC Cohort Tracker
•   G-ANC data abstraction toolMonthly, per facility
G-ANC meeting observations•   G-ANC meeting fidelity tool Monthly, per facility
Interviews with a sample of pregnant
women attending G-ANC in each
facility
•   G-ANC questionnaireMonthly, per facility
Midline and endline
FGDs with pregnant women
attending G-ANC: FGDs will be
stratified by type of facility
•   FGD Guide: pregnant women
attending G-ANC at HVFs
•   FGD Guide: pregnant women
attending G-ANC at PMFs
Both time points
KIIs with health care providers,
including facility in-charges
•   KII Guide: health care
providers supporting G-ANC
at HVFs
•   KII Guide: health care
providers supporting G-ANC
at PMFs
Both time points
KIIs with sub county/county health
managers
•   KII GuideBoth time points

For iterative improvement, the study team conducted quarterly in-depth reviews to share data with facility teams and the sub-county and county health management teams (S/CHMTs), throughout the study to identify whether adjustments were needed in implementation.

Study setting

The study was conducted in Machakos County, with a population of 1.4 million, and adjacent to the capital, Nairobi. There were 275 facilities that reported ANC data in 2020, per the KHIS/DHIS2. Ten health facilities in Machakos County participated in the G-ANC cRCT.

Sample size

Purposive sampling in consultation with the CHMT was used to identify 12 health facilities for G-ANC scale-up. The selection was based on the geographical distribution (i.e., at least one facility in each of the eight sub-counties in Machakos) and number of clients who received ANC services per month. Five facilities were defined as high-volume (i.e., more than 70 ANC cases per month) and seven as low to moderate-volume (less than 70 ANC cases per month).

Data was collected from 12 health facilities in Machakos County (Table 3). Five facilities were considered high-volume based on the ANC1 monthly caseloads (>70–80/month) and seven facilities were considered low-to-moderate volume based on monthly ANC1 caseloads. The low-to-moderate volume facilities were also considered as the predominant model facilities where G-ANC was offered as the predominant model for ANC, although women also had the option to have personalized ANC visits. At least one facility was selected from each of the eight sub-counties in Machakos County, as per the recommendation from the Machakos CHMT. The 12 facilities served 4.5% of the total ANC1 clients reported in 2020.

Table 3. Study facilities by type.

Predominant model facilities (PMFs)High volume facilities (HVFs)
Ikombe Health CentreMachakos Level 5 Hospital
Kakuyuni Health CentreKangundo Level 4 Hospital
Kivaa Health CentreMatuu Level 4 Hospital
Mitaboni Health CentreMlolongo Health Centre
Mutituni Level 4 HospitalNguluni Health Centre
Muumandu Health Centre
Wamunyu Health Centre

In addition, the sample size calculation for this study was based on detecting client satisfaction among women attending ANC. The sample calculated was the minimum number of ANC clients that would be representative of the total number of clients attending G-ANC to determine the overall level of satisfaction with G-ANC, based on the question “Among women attending G-ANC, what is the level of client satisfaction with G-ANC?” The following parameters were used in the calculation: 1) the estimated population of pregnant women attending ANC 4 visits in the 12 facilities; 2) a confidence interval of 95%; 3) a margin of error of 5% and 4) power of 80%. To estimate the population of pregnant women attending the 4 ANC visits in the 12 health facilities, we considered the following:

  • In 2021, approximately 34,614 pregnant women attended the first ANC visits in Machakos County and 20,676 attended 4 ANC visits (about 60% ANC 4 attendance KHIS). Total ANC 1 visits for the 12 health facilities were 849 per month which amounts to approximately 10,188 per year. Assuming a 60% ANC 4 attendance, we estimated that there will be 6,113 women eligible to participate in the survey across all 12 facilities. The sample size of 362 pregnant women was estimated based on these calculations. Based on previous research we conducted in Kenya, we adjusted for data errors and incompleteness by 10%. A total of 398 pregnant women were included in the adjusted sample size for individual interviews with G-ANC participants. The sample sizes for different participant groups and data collection approaches are summarized in Table 4.

Table 4. Sample size.

Data collection methodNumber of timesNumber of
participants
Total
Interviews with pregnant women attending G-ANC in the 12 facilities (i.e., G-ANC
participants)
Individual interviews1 per selected
participant
398398
FGDs with pregnant women attending G-ANC in the 12 facilities (i.e., G-ANC participants)
FGDs41040
KIIs with health care providers involved in G-ANC in the study facilities: four providers,
either an in-charge, nurses or other health care providers providing G-ANC per facility, and
six county/sub-county health managers
KIIs: Health care providers including facilities in-
charge (2 per HF at midline; 2 others at endline)
1 interview per
selected key informant
4848
KIIs: county/sub-county health managers1 per selected key
informant
2 county, 4
sub-county
6
Total: KIIs54
Maximum number of participants492

Recruitment procedure

Participants were recruited from study health facilities: the health care providers, and women attending G-ANC. The women were informed about the survey by the G-ANC nurse-facilitator before the G-ANC meeting that day. Those who were interested were consented and interviewed by the research assistant. Those who took part in the survey were ineligible to take part in future surveys. County/sub-county health managers were recruited in coordination with CHMT for the KIIs. The recruitment is summarized in Table 5.

Table 5. Recruiting participants for the main study.

Study participantsRecruitment strategy
Pregnant women attending G-ANC to
participate in the monthly quantitative
interviews
398 women were to respond to the monthly quantitative interviews. Three women were
selected in each facility each month (36 women each month). Selection was random.
Pregnant women attending G-ANC to
participate in FGDs
Maternal and Neonatal Health nurses worked with the study team to identify women to
participate in the FGDs. The participants for the different groups were identified using
information from the G-ANC cohort trackers, ANC registers, and maternal and neonatal
child health booklets (i.e., information number of G-ANC meetings attended).
Health care providers (including in-
charges) to participate in KIIs
Health facility in-charges worked with the study team to identify staff supporting G-ANC.
Two health care providers were selected in each facility at midline, and two different health
care providers at endline. Where the facility had less than four health care providers
supporting G-ANC, this person was selected and the in-charge was also interviewed.
County/sub-county health managers
to participate in KIIs
CHMT officials worked with the study team to identify sub-county reproductive health
coordinators and county health managers supporting G-ANC.

Inclusion and exclusion criteria

Participant selection was purposive and based on the criteria described in the Table 6 below.

Table 6. Inclusion and exclusion criteria.

InclusionExclusion
Facilities
•   Trained and supplied/equipped to conduct G-ANC•   Do not provide maternal and child health services
Pregnant Women Attending ANC
•   Met Kenya’s definition of mature minors (under the age of 18)
•   By self-report, 18 years or older
•   Pregnant women attending G-ANC
•   Able and willing to provide written informed consent to
participate in the study
•   Pregnant women referred to the facility for evaluation
(not G-ANC)
•   Pregnant women attending individual ANC
Health Care Providers
•   Working in MNH departments involved in G-ANC
•   Able and willing to provide written informed consent to
participate in the study
•   Able and willing to participate in KIIs
•   Health care providers not involved in any G-ANC
related activities
Sub-county/County Health Managers
•   Working on/involved in G-ANC
•   Able and willing to provide written informed consent to
participate in the study
•   Able and willing to participate in KIIs
•   Working in sub-county/county role less than one year

Intervention description

Group ANC is an alternative ANC service delivery model that enrols pregnant women at their first ANC visit into groups (cohorts) with other women of similar gestational age (GA). These women are organized into cohorts and receive subsequent ANC during scheduled meetings together as a group.

The G-ANC eight-contact model includes the first individual visit (i.e., booking visit, intake visit, ANC1) plus seven G-ANC meetings (Figure 2). Facilities in Machakos County have been implementing the Jhpiego G-ANC eight-contact model since 2019. The intervention includes facilitated, participatory discussions on topics most relevant to the stage of pregnancy. Three main components of G-ANC were retained: building peer support; conducting clinical assessment including self-assessments; and using a participatory facilitated learning approach. The six principles in the G-ANC model define the intervention and are used to measure fidelity to the intervention (Grenier et al., 2020).

dc1576fd-d8af-4145-987e-1d41be0fe26e_figure2.gif

Figure 2. G-ANC eight-contact model.

Scale-up was informed by co-design workshops led by the Machakos CHMT in January 2022 which included staff from the 12 facilities and Jhpiego technical staff. Participants mapped available resources for G-ANC scale-up in the 12 health facilities and discussed adaptations to the model to make it more feasible at scale, particularly in facilities that will adopt G-ANC as the predominant model. The G-ANC model and materials were then updated in January 2022. Materials include the following: meeting guides for facilitators; illustrated picture cards for facilitated group discussions (5–6 cards per meeting); self-assessment cards (1 per women); take-action booklets used by women during meetings; and an implementation guide that includes guidance on preparing and implementing G-ANC at scale. The G-ANC cohort tracker was used to record attendance for each group, and a G-ANC meeting observation checklist was used to provide feedback on fidelity. The study team supplied all the G-ANC related materials, equipment and supplies, as well as some ANC equipment (e.g., automated blood pressure devices, weighing scales). Facilities that lacked appropriate and adequate meeting space were supplied with a tent.

Intervention training and mentoring

A series of trainings were conducted in February 2022 to: 1) standardize the county trainers and sub-county mentors on the revised materials and scale-up aims; 2) refresh previously-trained health care providers who have experience conducting G-ANC on the new materials and scale-up plans; and 3) train a fresh set of health care providers on G-ANC facilitation skills. The county trainers and mentors—mainly the county and sub-county Reproductive Health Coordinators—led the training activities, with support from Jhpiego. County trainers and mentors provided on-site mentoring and support as the 12 facilities scaled-up G-ANC. The Sub County Health Management Teams (SCHMTs) were responsible for G-ANC monitoring, including meeting observations, within their ongoing routine ANC/MNH supportive supervision responsibilities. As required, facilities mentored new staff on-the-job (OJT) to become competent G-ANC facilitators.

Implementation and scale-up

We assessed G-ANC implementation and scale-up in a routine setting where service provision and commodities were government administered, as opposed to prior studies where resources were externally supported. The intervention was fully implemented by staff at the study facilities who are health care providers employed by the government and routinely provide ANC services in accordance with standards of clinical care outlined in the national guidelines on ANC (Ministry of Health Kenya, 2016).

G-ANC was integrated into the 12 health facilities and the county's existing healthcare systems. The 12 facilities introduced the 2022 model in March/April 2022 at the scale the facility staff felt was feasible. Staff at each facility adopted G-ANC and contextualized the model, considering the G-ANC principles and scaled up G-ANC within their ANC services. The sub-county mentors and county trainers supervised and provided continuous mentorship for G-ANC services.

Data collection

Baseline quantitative data were collected for the period March 2021 to February 2022 from the 12 study facilities. Monthly data abstraction and quarterly surveys were conducted from the inception of the project in March 2022 until November 2023. Midline data were collected in April 2023, and endline data in December 2023 using KIIs and FGDs. Additionally, a quantitative sub-study was incorporated, focusing on exploring the determinants influencing the choice of place of delivery among women participating in G-ANC from the eight health centers of the 12 health study facilities.

The study team worked with experienced research assistants who had a minimum of a diploma certificate in a relevant health discipline including social sciences or equivalent. All research assistants were extensively trained before any data collection. Training was on the study objectives, collection of data through assessment tools, surveys, FGDs, KIIs, and in-depth interviews (IDIs), and moderating the sessions. To ensure language and translation accuracy, the research assistants were educated on the exact wording of each specific question. Additionally, all research assistants were trained on how to obtain informed consent from participants as well as responsible/ethical research conduct.

Data management and analysis

ICRHK was the local research partner and was responsible for leading data collection. For quantitative data, data quality checks for completeness and accuracy were done at different levels. ICRHK data collectors verified data before submitting it, and the data manager at ICRHK monitored data on an ongoing basis. For qualitative data, the study team closely monitored the data collection process, involved multiple analysts to check interpretation, and monitored personal values and ideas that may bias qualitative findings. Participant validation of the data was achieved through county/sub-county and facility quarterly review and feedback sessions in Machakos County.

The data was managed according to ICRHK, Jhpiego, and John Hopkins Biostatistics Centre (JHBC) data policies. Soft-copy data was de-identified of personal identifiers such as name, age, and residence. Data was stored on encrypted drives, and only authorized study staff had access to it.

Qualitative data was transcribed from audio to text. Findings were summarized and structured under key thematic areas related to the logical framework's outputs and outcomes. Analysis was done using the Dedoose Version 9.0.17, cloud application for managing, analyzing, and presenting qualitative and mixed method research data (2021). Los Angeles, CA: Socio-cultural Research Consultants. LLC www.dedoose.com. A free one month trial with all standard Dedoose features with no payment information required can be found on https://www.dedoose.com/signup.

Quantitative data will be analyzed and presented in the form of descriptive and inferential tables. Following this analysis, quantitative findings will be triangulated with qualitative results to compare and contrast findings, deepen the analysis of interesting or contradictory findings, discuss challenges, raise issues that needed further investigation, and suggest implications for the program implementation.

Ethical considerations

Ethical approval was obtained on July 13, 2022 from the African Medical and Research Foundation AMREF ESRC (ESRC P1219/2022) in Kenya and from the National Commission for Science, Technology and Innovation (License No: NACOSTI/P/22/19555) on the 22nd August 2022. Permission to conduct the research was obtained from the Government of Machakos County, Department of Health and Emergency Services in the office of the County Director of Medical Services (Ref No. MKS/DHES/RSCH/VOLI/233) on the 29th August 2022. In addition, IRB approval was obtained from the Johns Hopkins Bloomberg School of Public Health (JHSPH) Institutional Review Board (IRB No. 21094) on the 21st June 2022.

Written informed consents were obtained from all participants as per the United States (US), international, and local regulations, and ICRHK’s Informed Consent Process. The informed consent described the study objectives, procedures, voluntary participation, and the risks and benefits to the study subjects. Consent forms for the mothers were translated to the Kiswahili language. Consent forms for KIIs were not translated since health care providers are educated and work in the English language. Participation in the study was entirely voluntary. All eligible pregnant women, health care providers, and county/sub-county health managers who met the inclusion criteria were enrolled in the study. Confidentiality was observed throughout the study period.

Study status

Data collection is complete, and analysis underway. Baseline data was collected 29 August-2 September 2022 by trained research assistants for the period from March 2021 to Feb 2022 (considered the baseline period) in the 12 study health facilities. Implementation period ran from March 2022 to November 2023. Trained research assistants collected midline data between March-April 2023 and endline data in December 2023. The final study results will be ready for publication in September 2024.

Discussion

Machakos County and the MOH in Kenya will use the evidence generated from this study to inform the scale-up of G-ANC as the predominant model at the health facilities at the sub-national and national levels respectively. Findings will be disseminated in Machakos County, with national stakeholders including the MOH, and with stakeholders in other LMICs to inform G-ANC implementation in similar settings. The study team will hold dissemination meetings with relevant stakeholders to facilitate the integration of findings from the study into local-level and national-level policies. These meetings will be jointly organized with the local and national level health key decision makers.

Ethics and consent

Ethical approval was obtained from the African Medical and Research Foundation AMREF ESRC (ESRC P1219/2022) in Kenya and from the National Commission for Science, Technology and Innovation (License No: NACOSTI/P/22/19555). Permission to conduct the research was obtained from the Government of Machakos County, Department of Health and Emergency Services in the office of the County Director of Medical Services (Ref No. MKS/DHES/RSCH/VOLI/233). In addition, IRB approval was obtained from the Johns Hopkins Bloomberg School of Public Health (JHSPH) Institutional Review Board (IRB No. 21094).

Written informed consents were obtained from all participants as per the United States (US), international, and local regulations, and ICRHK’s Informed Consent Process. The informed consent described the study objectives, procedures, voluntary participation, and the risks and benefits to the study subjects. Consent forms for the mothers were translated to the Kiswahili language. Consent forms for KIIs were not translated since health care providers are educated and work in the English language. Participation in the study was entirely voluntary. All eligible pregnant women, health care providers, and county/sub-county health managers who met the inclusion criteria were enrolled in the study. Confidentiality was observed throughout the study period.

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Mwaisaka J, Owira P, Olum M et al. Maximizing Group Antenatal Care (G-ANC) coverage in health facilities: Study Protocol for an Implementation Research in Machakos County, Kenya [version 1; peer review: awaiting peer review]. Gates Open Res 2025, 9:34 (https://doi.org/10.12688/gatesopenres.16278.1)
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