Newborn community health advancements among Ethiopian Orthodox Christian women in North Gondar, Ethiopia: community-based randomised trial protocol

Abstract

Introduction

Despite significant progress over past decades, neonatal and infant morbidity and mortality remain unacceptably high in Ethiopia. Simple interventions have been shown to improve the health of children and reduce mortality. These include promotion of exclusive breast feeding for the first 6 months of life, immunisation and utilisation of available newborn healthcare services, which are proven to improve newborn survival. This study aims to determine the impact of a behaviour change intervention that partners Orthodox priests with volunteer community health workers, known in Ethiopia as the Health Development Army and trains them to conduct newborn health outreach to improve care seeking, uptake of key interventions and identification of sick infants.

Methods

The study designed is a community-randomised trial conducted in the Central Gondar area. The behaviour change intervention pairs trained Orthodox priests with members of the Health Development Army to conduct community health outreach by identifying near-term pregnant women in their communities and educating them on the topics of exclusive breast feeding, immunisation, nutrition and uptake of available child healthcare services. The evaluation of the intervention will enrol up to 150 newborn–mother pairs from communities receiving the behaviour change intervention and another 150 pairs enrolled from control communities. The quantitative analysis will be done by comparing data between the intervention and control groups related to breast feeding, anthropometry, immunisation status and uptake of child health services. The primary outcomes are exclusive breastfeeding through 6 months, mid-upper arm circumference, completion of vaccinations and infant hospitalisation.

Ethics and dissemination

Ethical approval has been obtained from the University of Washington (STUDY00006942) and the University of Gondar (No.V/P/RCS/05/2523/2019) Institutional Review Boards. Oral consent was obtained for the formative study, whereas written consent (or witnessed thumbprint) will be obtained from all enrolled mothers. Results will be communicated to community members, relevant government agencies and other stakeholders.

Trial registration number

NCT05111899.

Correspondence to Dr Brandon L Guthrie; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• The pragmatic community-randomised design will produce an effect estimate that is closer to the real-world effectiveness of the intervention than an individually randomised design.

• The trial communities are representative of target populations and trial implementation is being conducted in conjunction with implementation science work to speed eventual implementation and scale-up within existing Ethiopian health programmes.

• Community randomisation is more susceptible to confounding at the individual and community level.

• The follow-up period is limited to 6 months, which may miss the long-term impacts of the intervention.

Introduction

Background and rationale

One in every 15 Ethiopian children dies before their fifth birthday and 7 in 10 of those deaths occur during infancy.¹ While there has been great progress in under-5 mortality, the progress in reducing newborn deaths has been slower, pointing to challenges and complexities in changing behaviours and practices around identifying illness and delivering newborn care.¹ For children who do survive, poor nutrition and its impacts on growth and development are widely observed. An estimated 7% of children in Ethiopia suffer from acute malnutrition (wasting), according to the 2019 Ethiopian Demographic and Health Survey.² Perhaps more importantly, in Ethiopia, 37% of children under 5 are estimated to be stunted, a sign of chronic undernutrition.^{2 3} Stunting is associated with significantly higher rates of mortality, cognitive and developmental delays, and lower-income earning potential.⁴ In the Amhara region where Strengthening Care Opportunities through Partnership in Ethiopia currently operates, stunting rates are the highest in the country, with almost half (46%) of all children stunted. This represents an important intervention opportunity to improve survival, development and productivity.⁵ Exclusive breast feeding in the first 6 months of life has the potential to dramatically improve growth and survival. However, cultural and social pressures often result in the cessation of exclusive breast feeding at younger ages, with significant impacts on future growth and development.⁶ Improvements in infant and young child survival and well-being are a priority focus area in Ethiopia.^{7 8} There is a clear need to improve access to care, health-seeking behaviour and recognition of ill children to reach current targets for neonatal and infant outcomes in the country.

Community health volunteers are critical to achieving improved health, especially in lower-income countries where there is increasing demand for healthcare services and a shortage of formal healthcare providers.⁹ Partnerships with faith leaders may provide a culturally relevant platform for accessing women and infants, increasing uptake of infant health and development of best practices, and providing support for women in the postnatal period. Faith leaders are a trusted group of counsellors for their parishioners and influence the behaviours of the community. The Central Gondar zone located in the Amhara state is characterised by its religious tradition with 84% of the population belonging to the Ethiopian Orthodox Church (EOC) faith tradition and the Church plays a large role in the daily lives of its followers.¹⁰ In this area, religious leaders of the EOC also have the potential to be strong advocates or hindrances to the effort to improve public health. A previous study pairing Orthodox priests with community health volunteers in health outreach and education demonstrated improvement in maternal health outcomes such as uptake of antenatal care and facility deliveries.¹¹

Objectives

This study aims to explore how linking religious leaders with front-line health workers may catalyse and empower local communities to improve health outcomes for newborns. The intervention involves pairing faith leaders with members of the Health Development Army (HDA), training them on infant and child healthcare and deploying them for community outreach to bring about behaviour change on infant and child health-related issues in the North Gondar area.

The primary aim of the study is to determine the impact of a behaviour change intervention that partners Orthodox priests with members of the HDA and trains them to conduct newborn health outreach to increase rates of early initiation of and exclusive breast feeding through 6 months, improve nutritional status (measured by mid-upper arm circumference (MUAC)) and increase immunisation coverage at 6 months. Secondary objectives of the study are to determine the impact of the intervention on infant growth at 6 months (based on height and weight), earlier identification of newborn illness and health-seeking behaviour of the mothers.

Trial design

The study will use a community-randomised parallel trial design with 1:1 allocation of communities, defined by church catchment areas, into the intervention and control arms. The unit of analysis will be at the individual level with up to 150 newborn–mother pairs enrolled from communities receiving the behaviour change intervention and 150 newborn–mother pairs enrolled from control communities. The trial aims to evaluate the effectiveness and implementation considerations of the LAUNCH (Leading Advancements in the Uptake of Newborn Community Health) intervention for newborn and maternal health in Ethiopia. We hypothesise that the LAUNCH intervention will result in better newborn health in intervention sites compared with those in control sites. The design of the intervention is intended to be readily integrated into a national maternal and child health policy and become a routine activity in a way that is feasible and acceptable for both the government and the community if it is shown to be effective in this trial setting.

Methods: participants, interventions and outcomes

Study setting

The study will be conducted in Gondar Zuria Woreda in the Central Gondar Zone of the Amhara Region of Ethiopia. The Minziro area of Gondar Zuria Woreda was selected as the project site after discussions with zonal and woreda health officials and with the North Gondar Zone Diocese. These discussions included a thorough analysis of all the woredas in the zone concerning child health status, the need for child health community interventions, the presence of similar health projects, transportation difficulties and security issues. The individual churches within the study area that were included in this study were selected because their catchment areas did not overlap with other study or non-study churches. They were also selected such that they were sufficiently geographically separated from each other to avoid contamination between intervention and control churches.

The Minziro area is a rural setting with an estimated total population of over 20 000 people living in 7 administrative kebeles. The majority of the population are followers of the EOC and, according to their tradition, each family has a soul father who serves as a trusted advisor to the family.

The lowest level in the Ethiopian health system is a primary healthcare unit, comprising one health centre and five satellite health posts. A health post is an operational centre for two Health Extension Workers (HEWs).¹² On average, a health post serves approximately 1000 households or 5000 people. The HEWs are specially trained health professionals on maternal and child health and hygiene and sanitation required to spend 75% of their time conducting outreach activities by going from house to house.¹² A total of 21 (HEWs) and 192 members of the HDA are assigned to the area by the regional health bureau to do routine health-related outreach activities.

Eligibility criteria

Church eligibility: Individual churches are the unit of randomisation for this study. To be eligible for inclusion, the church must of members of the EOC, located in the Minziro area of Gondar Zuria Woreda, have a catchment area where a majority of the population are members of the church and have a church leadership and priests who are willing to participate in the study. Churches were further selected such that their catchment areas do not overlap with another study or non-study church and are sufficiently geographically separated from each other to avoid contamination between study arms.

Participant eligibility: The inclusion criteria for newborn–mother pairs include: newborns delivered at least 1 month after the start of the intervention period, newborn–mother pairs who are EOC parishioners, mothers who have lived in the study area for at least 6 months and mothers who give written informed consent for themselves and their newborn. Exclusion criteria are newborns with gross developmental abnormalities that would make anthropometric measurements and interpretations difficult, newborns whose mothers have died by the time of recruitment, newborn whose family plans to relocate away from the study site in less than 6 months and newborns with known health issues (identified before the recruitment time) likely to affect growth, maturation and ability to breastfeed (eg, newborns with congenital heart disease, newborns born to known HIV-positive mothers, newborns with cleft lip and/or palate). If newborns are twins, only the first-born child will be included. In the analysis, a sensitivity analysis will be conducted excluding twins.

Interventions

The LAUNCH intervention is a behavioural intervention using priest-HDA pairs to provide outreach, information and support to pregnant and newborn mothers. The intervention will be implemented at the community level by pairs of trained EOC priests and members of the HDA recruited from the catchment areas of the churches in the intervention group. The intervention will have two components: the first will be a scheduled home visit of the paired priest and HDA members. The second component will be mass health education at churches, religious events and community gatherings. The intervention team will not be involved in enrollment and follow-up of mothers–child pairs into the research component that will evaluate the impact of the community intervention.

To inform the intervention, first, a formative assessment of the existing maternal and newborn child health landscape in Minziro area will be done using focus group discussions (FGDs) and key informant interviews (KIIs) with women, their partners, religious leaders and health professionals recruited from the Woreda. Thematic debrief reports of the FGDs and KIIs will be used to prepare a summary report of the major findings of the formative study, which will then be used to inform components of the intervention.

All the priests and HDA members in the catchment areas of the churches in the intervention group will be identified and given training on newborn health and components of the intervention. They will then be sent to their communities to do the intervention outreach activities. An initial 5-day training will be given to priests and HDA members in the intervention team. The training will focus on newborn health topics including early initiation of and exclusive breast feeding, maternal nutrition, immunisation, childhood illnesses and child healthcare services. At the end of the training, action plans will be prepared by the training organisers, priests and HDA. Priests and HDAs will be asked to identify near-term pregnant women (≥32 weeks of gestation) in their communities and arrange times for the delivery of health messages. In partnership with the HDAs, priests will be asked to integrate the health messages and education into their routine family visits done in structured intervals: during the last month of pregnancy, shortly after delivery and baptism of the newborn (approximately 40 days and 80 days after birth for boys and girls, respectively). During the intervention time, the primary activities will be the identification of near-term pregnant and newly delivered women, providing health education to their families during the follow-up visits and enabling newborn–mother pairs to access child healthcare services. In addition, priests will provide health education during religious events and community gatherings. These encounters will be used to educate pregnant and postpartum women and their families on newborn health. These community-based activities will be monitored by the University of Gondar (UoG) study team through regular monthly follow-up discussions with priests and HDA members.

Those living in the catchment area of churches assigned to the control arm will receive the standard of care related to antenatal and infant care services, including services normally provided by the HDA through the Government’s community health volunteer programme. Priests active in the control group may still be influential community figures but will not receive newborn health training or be mobilised alongside community health volunteers to share newborn health messages.

To implement the trial, we have distinct teams that are separated into the implementation team which is responsible for delivering the actual intervention and is designed to be representative of the types of teams that would deliver the intervention in future scale-up, and the evaluation team that is part of the research trial evaluation of the intervention. In parallel with this trial, we are conducting implementation science research to understand how this intervention can be scaled up and generalised to other settings.¹³ The first team, referred to as the intervention team consists of pairs of priests and HDA members who will conduct the intervention activities through interactions with households in their catchment area that experience the birth of a child during the trial period (refer to the Intervention Components and Procedure section for additional details). The intervention team will attempt to reach and provide the intervention package for all households with a new child and will act independently of the research team. The structure and functioning of the intervention team are intended to mirror what would be implemented if the intervention were to be scaled up and become part of routine public health practice. The second team, referred to as the evaluation team will be responsible for enrolling participants to evaluate the impact of the intervention. The evaluation team will enrol participants into the study until the sample size is reached. The evaluation team will attempt to sequentially enrol all eligible participants in the catchment areas independent of whether they were reached by the intervention team (refer to the Study enrolment and prospective follow-up section for additional details). This design will allow the study to evaluate the coverage of the intervention as well as its impact at the population level, rather than just at the level of those who actually received the intervention.

Outcomes

The primary outcome variables that will be assessed in the trial are the infant’s MUAC and exclusive breast feeding, both of which will be assessed at the follow-up visit. MUAC will be measured using a MUAC tape by a trained research assistant. Exclusive breast feeding will be measured based on self-reporting on a questionnaire administered by a research assistant. Secondary outcomes, all measured at the follow-up visit, include infant immunisation status measured by review of immunisation card, incidence of acute illness measured by self-report and hospitalisation measured by self-report. Additional covariates including maternal age, sex of the child, place of birth, attendance of antenatal and postnatal visits, maternal level of education, family economic status, and family size will be included.

Participant timeline

All newborn–mother pairs from both intervention and control groups will be recruited between 11 and 20 days after delivery as reported by HEWs and invited to participate in the study. The period of 11–20 days after delivery for the enrolment window was chosen to balance the cultural and logistical difficulty of accessing newborns in the days immediately following delivery against the desire to collect data (eg, initiation of exclusive breastfeeding) and anthropometric measurements (eg, weight and length) close to birth to establish baseline values for these variables. Recruitment will start 1 month following the start of the intervention and all reported newborn–mother pairs who meet the screening criteria will be invited to enrol in the study until the target sample size in each arm is reached. Enrolment will continue contemporaneously for both arms until the minimum target sample size is reached in both arms. HEW’s routine registers of new deliveries will be used to trace, recruit and screen study participants. Newborn–mother pairs who fulfil the initial screening criteria will be reported to the study team at the UoG which will travel to the study site regularly for recruitment of study participants and data collection. Newborn–mother pairs will be reported to the UoG study team both through phone calls made by HEWs and in person at the time of regular onsite visits by the team.

Eligible newborn–mother pairs will be visited by a member of the Evaluation Team at their home or at an appointed meeting location in their community to complete the written informed consent process. Those pairs who are recruited from the catchment areas of the intervention churches will be assigned to the intervention arm, and those from the catchment areas of the control churches will be assigned to the control arm. Initial baseline data will then be collected and follow-up visit schedules arranged with the evaluation team.

Sample size

A total of 300 newborn–mother pairs will be included in the study (150 pairs from the intervention churches and 150 pairs from the control churches). The sample size of 150 newborn–mother pairs from each arm is based on identifying a statistically significant difference in MUAC in infants between the study arms, with the inclusion of an additional 15% of participants to account for potential lost to follow-up. Using a global SD of MUAC among 5–6 months of 1 cm, based on WHO standard grow curves, with 150 infants in each group, using a two-sided t-test with α=0.05, we will have 80% power to detect a ≥0.4 cm difference in MUAC between groups, accounting for a 15% loss to follow-up. Assuming a smaller SD of MUAC of 0.5 cm in this more heterogeneous population, we will have 80% power to detect a ≥0.2 cm difference in MUAC between groups. Sample size calculations account for correlation within clusters assuming an intraclass correlation coefficient of 0.02 with 16 participants per cluster, resulting in a design effect of 1.3.¹³ We will also have 80% power to detect a significant difference of 50% exclusive breastfeeding at 6 months in the control group vs 70% in the intervention group, based on a χ² test with α=0.05.¹⁴ The effect sizes for the sample size calculations were selected based on the investigators’ judgement of the minimum detectable effect size that would be considered meaningfully relevant to justify the scale-up of the intervention.

Recruitment

Source and study populations: The source population will be all women of EOC families in the age range 15–49 years living in the Central Gondar Zone of the Amhara Region who have just delivered a live neonate. The study population includes those women who live in the Minziro area of the Gondar Zuria Woreda and who have delivered a live neonate during the participant recruitment time.

Study enrolment and prospective follow-up: All deliveries taking place in the catchment areas of the intervention churches will be included in the study under the intervention arm, and all deliveries that take place in the catchment areas of the control churches will be included under the control arm. The primary analysis will be by intention-to-treat and study participants will be enrolled regardless of whether or not they actually received the intervention and will be analysed according to the community they lived in. All newborn–mother pairs to be included in the study will be blinded in such a way that they will not be told about the presence of intervention and a comparison group. Questionnaires administered at study visits will include items to determine if, and to what degree, participants were exposed to the intervention, regardless of whether they live in an intervention or control catchment area.

Teams of research assistants will work with the zonal HEWs to identify all births occurring in the study area. Mothers will be invited to participate in the study, and each participating newborn–mother pair will be followed up by the study team for up to 6 months after enrolment, with a total of two study visits (enrolment and follow-up). The study was intentionally designed to minimise additional study contact with participants to limit the impact of such contact on care seeking or other behaviours.

Independent of the intervention team, members of the evaluation team will attempt to contact all newborn–mother pairs between 11 and 20 days after birth for the enrolment visit. Most contacts will occur at home, but contact may be made at other locations (eg, health facility and church). The follow-up visit will be conducted between 5 and 6 months after birth, with the timing of the follow-up visit scheduled to coincide with the period immediately before the recommendation to transition from exclusive breast feeding to mixed feeding. This will allow for the assessment of exclusive breast feeding through 6 months without relying on recall of past breastfeeding behaviours at a time point after the recommended feeding transition.

Methods: assignment of interventions

Allocation

Sequence generation: The randomisation sequence will be generated using simple randomisation and will be conducted by an independent statistician who is not involved with the study. The unit of randomisation will be the catchment area of churches. A list of all 22 EOC churches around the Minziro area will be obtained from the Woreda Diocese, and a map of their distribution will be prepared. The churches will then be randomly allocated to the intervention group and the control group with a 1:1 ratio.

Allocation concealment mechanism: All study catchment areas will be simultaneously allocated to the intervention or control arm, which then determines the composition and training of Intervention team. Therefore, there is no need for concealment of allocation.

Implementation: The allocation sequence will be generated by an independent statistician who is not involved with the study. They will provide a list of the churches assigned to the intervention and control arms to the study investigators. The study investigators will then notify the intervention churches, identify all of the priests associated with these churches and HDA members in the intervention community and provide training to the newly formed intervention team. A separate evaluation team will enrol study participants in the intervention and control catchment areas.

Blinding

Study participants will be blinded as to which study arm their community was assigned to, but it will not be possible to blind the investigators, the intervention team or the evaluation team.

Methods: data collection, management and analysis

Data collection methods

The evaluation team will collect individual-level data from each participating newborn–mother pair in the trial to measure exclusive breast feeding, vaccination coverage, anthropometry, community engagement (eg, church attendance and participation in community activities), and other indicators of maternal and child health. This information will be collected through investigator-administered questionnaires, a review of vaccination records and anthropometric measurements. Each newborn–mother pair will receive two visits by the evaluation team during their sixth-month study period. The evaluation team will use Open DataKit (ODK), an electronic data collection system to record data on tablets. The evaluation team will upload the collected data to a secured central web-based server on return to the UoG campus. The overall processes of recruitment and subsequent data collection activities will be supervised by an on-site study manager. The evaluation team will rely heavily on predesigned standard operating procedures that contain detailed, step-by-step instructions for collecting and handling data.

Standard questions from WHO’s Infant and Young Child Feeding indicators documents will be used to assess breastfeeding and nutritional characteristics of the newborns.^{15 16} Anthropometric measurements of both mothers and newborns such as MUAC, weight, and length of the baby, and MUAC of the mother will be taken by the evaluation team on routine visits using a measuring tape (MUAC), portable digital scale (weight) and ShorrBoards (infant length/height). The data collectors will be given detailed training, hands-on practice and undergo validation on anthropometric measurement skills before the data collection. Detailed contact and locator information, including home location, will be collected from participants to promote retention in the study and complete follow-up. Home visits will be conducted to improve retention and minimise the burden of participation.

Data management

Study data will be collected and stored electronically using mobile tablets. The study team will use ODK, an electronic data collection system to record and store data. The study team will upload the collected data to a secured central web-based server on return to the study headquarters following all fieldwork. The overall processes of recruitment and subsequent data collection activities will be supervised by an on-site study manager. The study team and study manager will rely on standard operating procedures that contain detailed, step-by-step instructions for collecting and handling data.

Statistical methods

Infant outcomes will be compared between children from intervention communities and those in control communities, regardless of whether or not they were actually exposed to the intervention. We will use logistic regression to compare dichotomous outcomes (eg, exclusive breast feeding through 6 months, completion of vaccinations, infant hospitalisation) and linear regression for continuous outcomes (eg, MUAC). We will account for correlation within church communities by adjusting the variance for the effect of clustering. The primary analysis will be an intention-to-treat comparison between intervention and control communities based on location of residence without adjustment for covariates or consideration of whether participants actually received the intervention or not. Exploratory secondary analyses will include adjustments for potential confounders and subgroup analyses based on actual exposure to the intervention. The trial is not powered for subgroup analyses, and therefore, these analyses are only intended to inform future refinement of the intervention if we detect a signal of differential efficacy. A sensitivity analysis will also be conducted excluding twins. Participants who are lost to follow-up or missing outcome measurements will be excluded from the primary analyses, with sensitivity analyses conducted to determine the potential bias due to censoring.

Methods: monitoring

Data monitoring

There is no formal data monitoring committee for this trial. A data monitoring committee was not required by the study funder or ethical review committees. The study was judged to be no more than minimal risk to subjects and the intervention does not involve activities that are outside of regular public health practice.

Harms

The study team will collect information related to adverse outcomes among infants and mothers involved in the study. All adverse outcomes will be reviewed by the study investigators. All serious adverse events judged to be related to the study activities will be reported to the institutional review boards that oversee this trial.

Auditing

There are no formal auditing procedures for this trial. Data quality monitoring and adherence to study protocols is overseen for the study investigators.

Patient and public involvement

The research question addressed by the LAUNCH study was informed by formative work with members of the community and through active collaboration with members of the EOC and members of the HDA. As the active implementers of the intervention, these members of the community were integrally involved with the research. In addition, potential participants were involved with the design of the intervention and planning of the trial design. On completion of the trial and its analysis, findings will be presented at community presentations.

Ethics and dissemination

Research ethics approval

Ethical approval has been obtained from both the University of Washington (STUDY00006942) and the UoG (No. V/P/RCS/05/2523/2019) Institutional Review Boards. Permission from the Zonal and Woreda Health Offices will be obtained before the recruitment of study participants. Participants who have been recruited for the FGDs and KIIs will individually be explained the purpose of the study and verbal consent will be taken.

Newborn–mother pairs who have been recruited to participate in the study will meet with a member of the evaluation team in a private setting. The study team member will read the written consent script to the potential subject. Any misunderstandings will be clarified. They will be offered a printed copy of the consent script. Those willing to participate will sign the written informed consent and the registration interview will proceed.

Protocol amendments

Relevant protocol modifications will be reported to the IRBs with oversight of this trial. Modifications will not be implemented until they are approved by the IRBs. These modifications will also be recorded on the trial registration through ClinicalTrials.gov.

Consent and assent

Newborn–mother pairs who have been recruited to participate in the study will meet with a member of the evaluation team in a private setting either at home or in other private settings. The evaluation team member will read the consent/assent form to the potential subject. At the end, the potential subject will be given an opportunity to ask questions about the study procedures and their rights as research subjects. They will be offered a printed copy of the consent/assent form. The study team member conducting the consent/assent process will ask the potential subject some questions related to the voluntary nature of participation to assess their understanding of their rights as research subjects. Any misunderstandings will be clarified. If they are not interested in participating in the research, they will be thanked for their time. Those willing to participate will give their written documentation of consent/assent and the enrolment interview will proceed. Participants unable to write their signature will document their consent/assent by placing a thumbprint on the consent/assent form.

Confidentiality

All study information will remain in confidential, secure files accessible only to the investigators and authorised study staff. All questionnaires and other study-related material will be labeled with an identification number, not with participant names or other identifiers. Data will be kept on a secure, password-protected computer behind a firewall that is located in a locked office at the UoG or in a password-protected secure online database hosted on a cloud server. Data stored in the online database will not include personal identifiers. All study staff will undergo training on protecting the confidentiality of study subjects.

Declaration of interests

The investigators declare no financial or other competing interests.

Access to data

The study investigators will have full access to all study records and data. Requests for access to the study data should be sent to the study’s principal investigators. Access to a deidentified dataset may be granted to appropriate applicants.

Ancillary and post-trial care

None.

Dissemination policy

The results of the study will be communicated to relevant government agencies, members and leadership of the EOC, priests and HDA members who implemented the intervention, community members from the participating communities and other relevant stakeholders. We have made arrangements with the Federal Ministry of Health on the consumption of the study findings and recommendations for possible policy impacts and scale up of the intervention. Findings will also be communicated to the zonal health office and the Amhara Regional Health Bureau.

The LAUNCH trial, under the Strengthening Care Opportunities through Partnership in Ethiopia (SCOPE) initiative (website: https://scopehealth.org/), will be implemented in collaboration with a diverse group of stakeholders. We would like to express our sincere gratitude to the SCOPE partners, including leadership and priests under the North Gondar Diocese of the Ethiopian Orthodox Church, University Presbyterian Church, health extension workers, and members of the Health Development Army. Their invaluable contributions and unwavering support throughout this research project are deeply appreciated. We are also grateful to the Frankel Family Foundation for their generous funding, which has made this study possible. Furthermore, we would like to acknowledge the Stewardship Foundation (website: https://stewardshipfdn.org/) for their support in funding the LAUNCH clinical trial. We express our deepest gratitude to each and every one of them for their significant contributions and commitment.

Ethics statements

Patient consent for publication

Not applicable.

Footnote

Contributors GAA and BLG are principal investigators. DGB, GAA, BLG, JW, LMW, DH and KCR drafted the initial protocol and supervised trial protocol development. GAT was responsible for coordination of study activities. All authors critically revised, read and approved the final manuscript.

Funding This work was generously funded by the Frankel Family Foundation and the Stewardship Foundation (website: https://stewardshipfdn.org/). The funding was provided as an award gift and does not have an associated award/grant number.

Disclaimer The funder has no role in study design, data collection and analysis. Frankel Family Foundation and the Stewardship Foundation approved the initial study proposal at the time of funding. These funders were not and will not be involved in subsequent study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication.

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

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