Abstract

Background Undernutrition underlies approximately 45% of global deaths among children less than five years old, making it one of the most concerning global child health issues. The PRObiotics and SYNbiotics in infants in Kenya (PROSYNK) trial is assessing whether supervised doses of pro/synbiotics daily for the first 10 days and then weekly to age 6 months (total of 32 doses), has a positive impact on gut health and thereby growth and nutrition. This study is an early-stage cost and implementation feasibility study defining unit costs for the PROSYNK trial and estimating programmatic cost and feasibility of delivering the intervention to infants in rural Kenya.

Methods This provider perspective costing study uses a combination of ingredients approach, activity-based costing and microcosting. First, an empirical cost analysis of the PROSYNK trial was conducted by review of trial documentation and time and motion observations. Next, semi-structured interviews with key informants informed a thematic analysis of implementation feasibility and the development of a theoretical programme structure which formed the basis for estimation of total economic programme costs.

Results The economic cost of delivering the full pro/synbiotics course under trial conditions was measured as $757.32 per participant. Experience gained during PROSYNK and discussions with key informants revealed that it was feasible for the Ministry of Health (MoH) to implement programmatic delivery of the pro/synbiotics, particularly through community-based delivery, without a cold chain and with pro/synbiotic administered directly into infant’s mouths. Incremental economic costs to the MoH of delivering the pro/synbiotic programmatically were estimated to be $9.15 per infant per full course under the base case scenario.

Conclusion Pro/synbiotic administration in early life may be feasible and bear similar costs to existing nutrition interventions. This study will provide policy makers and stakeholders with vital cost and feasibility information to inform effective programmatic implementation in Kenya and similar settings.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The PROSYNK trial is funded by the Childrens Investment Fund Foundation. No additional funding was available for this economic analysis.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval was granted by ethics committees at the Liverpool School of Tropical Medicine (LSTM; 20(09)) and Kenya Medical Research Institute (KEMRI; KEMRI/SERU/CGHR/320/3917)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

List of AbbreviationsABCActivity-based costingCHACommunity health assistantCHVCommunity health volunteerGBPGreat British PoundsKEMRIKenya Medical Research InstituteKESKenyan ShillingsLMICsLow- and middle-income countriesLSTMLiverpool School of Tropical MedicineMCHMaternal and Child HealthMoHMinistry of HealthPROSYNKPRObiotics and SYNbiotics in infants in KenyaSoCStandard of CareTAMTime and motionTIDCTrial intervention delivery costsTPSTheoretical programme structureTRCTrial research costsUSDUS DollarsWHOWorld Health OrganizationKEMSAKenya Medical Supplies Authority