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Background: Universal Health Coverage ensures access to quality health services for all, with no financial hardship when accessing the needed services. Nevertheless, access to quality health services is marred by substantial resource shortages creating service delivery gaps in low-and middle-income countries, including Kenya. The Innovative Partnership for Universal Sustainable Healthcare (i-PUSH) program, developed by AMREF Health Africa and PharmAccess Foundation (PAF), aims to empower low-income women of reproductive age and their families through innovative digital tools. This study aims to evaluate the impact of i-PUSH on maternal and child health care utilization, women’s health including their knowledge, behavior, and uptake of respective services, as well as women’s empowerment and financial protection. It also aims to evaluate the impact of the LEAP training tool on empowering and enhancing community health volunteers’ health literacy and to evaluate the impact of the M-TIBA health wallet on savings for health and health insurance uptake. Methods: This is a study protocol for a cluster randomized controlled trial (RCT) study that uses a four-pronged approach—including year-long weekly financial and health diaries interviews, baseline and endline surveys, a qualitative study, and behavioral lab-in-the-field experiments—in Kakemega County, Kenya. In total, 240 households from 24 villages in Kakamega will be followed to capture their health, health knowledge, health-seeking behavior, health expenditures, and enrolment in health insurance over time. Half of the households live in villages randomly assigned to the treatment group where i-PUSH will be implemented after the baseline, while the other half of the households live in control village where i-PUSH will not be implemented until after the endline. The study protocol was reviewed and approved by the AMREF Ethical and Scientific Review Board. Research permits were obtained from the National Commission for Science, Technology and Innovation agency of Kenya. Discussion: People in low-and middle-income countries often suffer from high out-of-pocket healthcare expenditures, which, in turn, impede access to quality health services. Saving for healthcare as well as enrolment in health insurance can improve access to healthcare by building capacities at all levels—individuals, families, and communities. Notably, i-PUSH fosters savings for health care through the mobile-phone based “health wallet,” it enhances enrolment in subsidized health insurance through the mobile platform—M-TIBA—developed by PAF, and it seeks to improve health knowledge and behavior through community health volunteers (CHVs) who are trained using the LEAP tool—AMREF’s mHealth platform. The findings will inform stakeholders to formulate better strategies to ensure access to Universal Health Coverage in general, and for a highly vulnerable segment of the population in particular, including low-income mothers and their children. Trial registration: Registered with Protocol Registration and Results System (protocol ID: AfricanPHRC; trial ID: NCT04068571: AEARCTR-0006089; date: 29 August 2019) and The American Economic Association’s registry for randomized controlled trials (trial ID: AEARCTR-0006089; date: 26 June 2020).
i-PUSH has been ongoing in parts of Kakamega County since 2017. The study is being carried out in Khwisero Sub-county—one of the sub-counties in Kakamega County, where the i-PUSH program has expanded after the baseline survey. The implementing partners selected two health clinics that were considered to be included in the expansion of the i-PUSH program. Twenty-four (24) villages located in the catchment areas of these two clinics were randomly selected from a list of all eligible villages (N = 239) in the catchment areas. The list of villages was provided by the Sub-county government jointly with the i-PUSH program area manager. Random selection was done by the research team using a computer program to generate a short list of villages from the longlist, to be randomly assigned to either the treatment or the control group. Villages cover on average about 100 households. Each village is served by one unique CHV. The survey design is a longitudinal cluster randomized controlled trial (RCT). Randomization occurs at the level of villages in Khwisero Sub-county in Kenya. The “treatment” and “control” groups are constructed, comparing villages where i-PUSH has been rolled out after the baseline with villages where i-PUSH would not roll out until after the endline. The research team used community-level socio-demographic and infrastructure indicators (including number of households, village-level access to basic amenities and public services, adult literacy rate, women literacy rate, perceived health status, and healthcare utilization indicators) from baseline data to form pairs of similar villages and determine the exact matching indicators. In keeping with robustness of the cluster RCT, the procedure hence followed four steps for matching of the “treatment” and “control” villages: (i) purposive selection of the Sub-county (Khwisero) where the intervention rolled out, (ii) random selection of 24 villages, (iii) pair-matching of villages based on relevant background characteristics and baseline outcomes of interest, and (iv) randomization of treatment and control villages within each pair of villages by flipping a coin. Pairing villages before randomization reduces the risk of a bad draw during the randomization process. Randomization without pairing would, in expectation, also lead to similar control and treatment groups, but it was also possible that the random draw produces a control and treatment group with very different characteristics by chance [6]. This risk was reduced through pairing. We used the Euclidean distance for our matching process, which corresponds to the absolute difference between the standardized values of all of the covariates for a possible pair of matches. We conducted the matching within each of the four originally selected health clinic catchment areas separately. Thus, each village was matched with one of the other five villages in the vicinity of the health clinic. This was done to ensure that each health clinic had an equal number of treatment and control villages in their catchment area. Hence, we computed this distance measure between each village and all other villages within the same health clinic catchment area; “pair” the two villages with the minimum distance and remove them from the list; repeat the distance calculation excluding the pair made; and continue until all villages were paired. After the matching process, the randomization assignment was carried out in the presence of key stakeholders including PAF, local liaison persons and village representatives, upon explaining all steps. Consent for the procedures was obtained from local government officials before the random assignment. The following steps were followed: papers with paired village names were folded and put in a bag; and two village representatives from each paired village discussed on whom to pick the paper and after the other group members verified that the names could not be seen, one paper was picked. A Kenya Shilling 10 coin was used to decide which group the picked village belonged to by flipping the coin. The village representatives had decided that the head of the coin should represent the control group, justifying that Kenyatta (1st president of Kenya) was a “controlling village” and the shield to represent the intervention group. The process of choosing the folded paper and flipping of the coin was repeated for all paired villages. The treatment group thus consists of the target population living in the randomly assigned 12 treatment villages. i-PUSH roll out in the treatment villages includes training of their CHVs with the LEAP tool, who subsequently introduced the health wallet to eligible women living in the treatment villages they serve, and offer them the subsidized insurance scheme on their mobile phone. The CHVs working in the control villages (as well as the remaining non-sampled villages on the longlist) have not received training on the LEAP tool until endline, nor were women in the control villages offered the health wallet and subsidized insurance on their mobile phone. We randomized at the village level because (1) villages are served by one CHV each, who are either trained or not trained on LEAP (hence, the LEAP intervention cannot be varied within villages); (2) to avoid contamination between households within the same villages regarding health-related knowledge and behavior; and, (3) moreover, it was deemed politically unfeasible to offer the health wallet and subsidized health insurance to some eligible households in a village but not to other eligible households in that same village. Upon roll out of the subsidized health services, eligible households were encouraged to use the services, though they were given the right to opt out at any time. The study population consists of eligible households living in the selected study villages. Eligible households included those with at least one woman of reproductive age (WRA) (18–49) who (a) had at least one child below 4 years living with her at baseline or (b) was pregnant at baseline. Data on all household members are also collected from these eligible households. Selected CHVs and PAF’s area manager provided the full list of households and other necessary information within the work area of each CHV. Based on the household demographics and pregnancy information, eligible households were identified. Initially, the study sought a 50-50 allocation between households with a pregnant woman and households with a child under 4 years old. After the household listing exercise, it became clear that there were too few pregnant women in each village to fulfill this criterion. We then decided to include all pregnant women in our sample and randomly sample additional households with children under 4 years old until the cluster size (10 households per village) was achieved. The research team did a random selection as follows: all eligible households with children under 4 years old were entered in a spreadsheet and receive a randomly assigned number. The team ordered the households per CHV based on this random number, and the first 10 households per CHV in each village were included in the study sample. Additional eligible households per CHV were over-sampled to serve as replacement households for dropouts. Sample size calculation followed Hemming et al. [7]’s study by fixing the number of clusters per arm to be 12 clusters, and then estimated the cluster size and total sample size. In the current study, it was assumed that the i-PUSH program could yield an effect size of 0.4 standard deviation in terms of health care utilization with an intracluster correlation (ICC) of ρ = 0.014. The estimates of the ICC were derived from Geng et al. [8]’s, study conducted in Nandi County which used high-frequency data on diaries on health-seeking behaviors and financial expenditures over 1 year (October 2012–October 2013). The calculation of the ICC was based on health care utilization measured as visits to any formal health provider, unconditional on reported health symptoms. It hypothesized a confidence interval of 95%, a margin-of-error of 5%, and a power of 80%. With a cluster size per arm of 12 clusters, and a total number of women per cluster of 10, the total sample size was 120 households per arm and 240 households for the full study. To keep sample size at par, households that dropped out of the study before the start of the intervention were replaced with new eligible households on a rolling basis for a maximum period of six months, or until the program started. i-PUSH is a comprehensive intervention that ultimately aims to improve the utilization of Reproductive and Maternal and Child Health (RMNCH) services among WRA and their young children in Kakamega and Nairobi Counties, by increasing knowledge about and (financial) access to RMNCH services as well as improving the quality of care of RMNCH services. In the original i-PUSH program that is the focus of this evaluation, households receive the first year of health insurance premium for free, while they are stimulated and supported to save for a 50% co-payment in the second year, and a 100% premium payment thereafter. The free provision in year one is expected to show the benefits of insurance to the selected households. The support for savings during the first year for a 50% co-payment in the second year is expected to install a habit of savings.1 The i-PUSH program utilizes innovative digital tools developed by both partners to enhance access to affordable and quality health care to low-income WRA and their families. Through i-PUSH, selected clinics participate in the “SafeCare” quality improvement program. Women receive the National Health Insurance Fund (NHIF) SupaCover at subsidized premiums on their mobile phone, using PAF’s so-called “health wallet.” The “health wallet” runs on the digital platform M-TIBA, which registers health care utilization at participating clinics, connecting patients, providers, and payers on one platform. PAF is piloting several other tools on this platform in addition to the health wallet, such as Connected Diagnostics for Malaria in Kisumu County, the MomCare program for antenatal and postnatal care in Kisumu and Nairobi Counties, and socio-economic mapping for UHC support in Kisumu County. CHVs are the first point-of-contact for women in the program. They make use of AMREF’s Mjali (Mobile Jamii Afya Link) tool for digital registration of household information and the mobile phone-based LEAP tool for training. The LEAP tool employs a mobile learning approach to train and empower CHVs using their mobile devices operating from any phone [9]. This enables the CHVs to learn at their own pace, and with their own mobile devices while in the community, providing both interpersonal and community aspects of learning. This evaluation study will focus on two of these spheres of interest supported by mobile tools: knowledge on health and health behavior and (financial) access to healthcare services; the quality upgrades at the health facilities cannot be evaluated with our study design because all i-PUSH clinics in our study area were already upgraded at baseline. A rough sketch to the implementation of enrolment, intervention, and assessment of the program is indicated in Table Table1.1. The implementation of i-PUSH will not alter access to the usual health care services (including use of any medication) throughout the implementation of the program. Schedule of enrolment, interventions, and assessments Working with CHVs, i-PUSH will increase the knowledge on both RMNCH and on insurance/health financing among women and men in the treatment communities. To this end, CHVs receive additional training through the specially developed LEAP training tool (module) carried out by AMREF. This tool contains modules on specific health terrains of interest (notably, health promotion activities for children under 5, family planning, antenatal care (ANC), danger signs in pregnancy and after delivery, danger signs in children under 5, maternal and child health and nutrition, water safety, hygiene and sanitation) as well as on health savings and health insurance. The CHVs can follow this training on the smartphone that they will receive as part of their inclusion in the program. It complements the standard monthly training sessions of CHVs by AMREF. AMREF can currently assess whether LEAP improves the knowledge of its CHVs because at the end of each training module, CHVs can participate in a quiz on the tool that tests their newly gained knowledge. We will examine whether the LEAP training tool on top of the standard training activities of CHVs translate into improving women and men’s knowledge and behavior on pre-specified topics. We will also assess whether CHVs’ time spent on LEAP, number of training modules completed, and scores on the LEAP quizzes predict impact on women and men in the communities. The improved knowledge on health and health financing of women and men is also expected to translate into improved attitudes towards insurance and saving for health and insurance. To support these changes in knowledge and attitudes, WRA would receive the first year of their NHIF insurance premium at 100% subsidy and the second year at a 50% subsidy. The subsidies are expected to enhance initial enrolment in NHIF such that enrollees can experience first-hand the benefits of insurance. Moreover, this will allow women to be acquainted with regular savings for the insurance premium for the next year, such that they will get into the habit of recurrent savings and increasingly be able to frequently set aside small amounts of money. An integral component of the i-PUSH program is the so-called “health wallet” on M-TIBA (a mobile payment platform). Most WRA in the target population have limited access to formal financial services such as bank savings accounts. The widespread availability of M-PESA opens a new avenue of change in this respect. To alleviate this constraint, i-PUSH offers women the opportunity to set aside money in a commitment savings device on their mobile phone. The only requirement is that the mobile number is registered on their personal name. This will allow them (and other people such as spouses, relatives) to transfer funds into the wallet through M-PESA, which are subsequently “reserved” for direct payment of medical costs at M-TIBA-connected health providers or for future payment of the annual insurance co-premium. This feature of the health wallet is expected to support women in their financial planning—funds transferred into the wallet are kept safe and secure until they are needed for health-related purposes. Additional small-scale interventions are added to the program to enhance further savings, such as the provision of a savings calendar. Thus, this component of the program expects to increase savings for health as well as uptake and renewal of health insurance among the target population. Enrolment in health insurance is further facilitated through an additional feature of i-PUSH—CHVs can digitally enroll WRA and their household members (spouses, children, and other dependents) on the NHIF SupaCover as long as they have an ID or birth certificate available at the time of the CHV visit. The CHV uploads the required documents and takes care of the registration process on his or her smartphone (as provided by the i-PUSH program), saving the women from a lot of hassle in traveling back and forth to the insurance offices to hand over all the required documents and go through the administrative steps. In other words, i-PUSH is also expected to relieve logistical and time constraints to the uptake of insurance. Such a scheme enhances enrolment into insurance [9].
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