The study will be conducted in Kampala and Wakiso districts in the central region of Uganda, a low-income country . The study area was selected due to the high population density and varied housing patterns with urban, semi-urban, and rural areas. The population of the region is 3,504,498 (Kampala: 1,507,080; Wakiso: 1,997,418) . The region has 2047 health facilities (Kampala: 1458; Wakiso 589) and 74.3% coverage of mobile phone ownership .
We will conduct a randomized controlled trial (RCT) to test the effectiveness of the intervention comprised of a behaviorally informed mobile money health savings account on birth preparedness, maternal health service utilization, male involvement in maternal health, and savings amount towards healthcare costs. A dedicated mobile money health savings account will be provided by clinicPesa, a mobile money health savings company registered in Uganda. clinicPesa offers a commitment device for savings, where a client’s savings can only be spent on healthcare expenditures and not withdrawn for other purposes. The overall study flow chart is shown in Fig. 1. The schedule of the RCT is shown in the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) figure (Fig. 2). The SPIRIT checklist is provided in Additional file 1.
Sample size, eligibility, and recruitment
The minimum sample size for the RCT is 572 participants (286 in each arm). It was calculated using OpenEpi version 3. The power of the study was set at 80% and the significance level at 5%. A previous savings group research in a SSA region for maternal healthcare service utilization was used for assumptions . Considering an approximate 20% dropout rate and sampling unit rounding, 700 participants will be recruited (350 participants in each arm).
To be eligible for joining in this study, participants should have the following characteristics: (1) 18–49 years old, (2) between 12–35 gestational weeks (pregnant female) OR partner of someone who is (male), (3) own a mobile phone, (4) has a registered Mobile Telephone Network (MTN) mobile money account, (5) willingness to enroll in clinicPesa’s health savings mobile money account. Participants are ineligible if their partner is known to already be participating in the study to avoid duplicating results of savings amounts; only one member per household may participate in the study.
Participants will be recruited and enrolled in person by clinicPesa at 77 public and private health facilities where clinicPesa operates. Five trained research assistants will approach male and female clients at the maternity ward of selected health facilities. The clients at the health facility will be offered an opportunity to enroll in the study when they sign up to join clinicPesa. In the case of a COVID-19 lockdown on movement, participants will be recruited through a phone query from clinicPesa’s registered user base. Users who sign up for clinicPesa agree to terms and conditions set by clinicPesa, which include the possibility of being offered to join studies to improve the product offered by clinicPesa.
A person who is not involved with any other study procedure (including recruitment, implementation of the intervention, and data analysis) will share a computer-generated randomized allocation table with clinicPesa at the beginning of the recruitment period, which will not be shared with the study recruitment team . At the end of each recruiting day, the customer ID numbers of participants who agreed to join the study will be matched to the table to be assigned to either the control or the intervention group (1:1 randomization), and a study participant ID will be created to maintain participant anonymity within the study .
Participants will receive a description of the study during the informed consent process, but they will not be told which group they have been allocated to after enrollment. The study recruiters at the beginning of data collection and outcome assessors during final data collection will be blinded to the allocation. In addition, the data analyst will be blinded to the allocation of the participants until after the data analysis is complete.
The intervention consists of a basic mobile money health savings account as part of a Mamas Program offered by the local partner organization administering mobile money health savings accounts and additional behavioral designs to encourage savings for maternal health costs. The intervention was formulated using behavioral science approaches for promoting health savings towards the costs of maternal health care among pregnant women and their partners. The Mamas Program is a subset of the company’s clients that are registered as pregnant, and they receive additional reminders on ANC appointments, nutritional tips, and health tips about pregnancy. In the intervention group, participants receive the standard Mamas Program local company offering and messaging in addition to behavioral designs that encourage saving. The behavioral designs include “nudges” to encourage saving behavior; this will be done through reminder messages that sound like they are from their child, notifications about meeting their targets, and social norms notifications based on their savings rates and time in the intervention.
In the control group, participants receive the standard Mamas Program local company offering and messaging only. Both groups will have access to a mobile money health savings account as offered local company with the ability to deposit and withdraw health savings or set targets related to pregnancy for their savings goals, in addition to the Mamas Program messages for a healthy pregnancy.
It is assumed that the risk of contamination is low because participants are unlikely to share financial or account information with others, including any messages received from clinicPesa to an individual phone number. Participants can voluntarily withdraw from the study at any time.
The primary outcome is level of birth preparedness and usage of maternal health services, assessed by the number of birth kits or items within birth kits purchased, antenatal care visits, skilled birth attendance by a doctor, nurse, midwife, and/or medical assistant or clinical officer, and delivery at a health facility, all based on recall by the participant; the amount of validated expenditure in participants’ clinicPesa accounts from the day of enrollment during the intervention period will also be assessed. The primary outcome will be measured by asking the participant during the end-line survey about their pregnancy and delivery experience.
Secondary outcomes include male involvement in maternal healthcare, measured by financial support, attendance to ANC, assisting with planning the delivery, and providing perceived emotional support to the mother, as well as total savings for healthcare, assessed using the validated amount of savings accrued in participants’ clinicPesa accounts from the day of enrollment plus any withdrawals for healthcare expenditures during the intervention period. The withdrawals will also be coded to determine if they were used for maternal health service costs, including transport, or other healthcare costs, such as birth preparedness kits, baby materials, or others. Deposits into the account will be coded by whether it was the mobile money account owner or another mobile money account (for example, a different family member saving into the account).
Male involvement in maternal healthcare will be assessed by measuring whether they provided financial support for clinicPesa or otherwise, attendance to ANC, and assisting with planning of the delivery, measured by an ad-hoc male involvement index . Women will be queried about the perceived levels of involvement, and men will be queried about their level of involvement.
The following information will be collected during the baseline interviews to conduct sub-group analyses and to identify factors associated with savings for maternal healthcare and male involvement during pregnancy: age, education, employment, area of residence (rural or urban), pregnancy intention, joint decision making within a couple. Other information, such as feedback on the intervention, will be collected to inform future interventions, but this information will not be part of the analysis for this study.
On the day of enrollment after consenting to join the study, all participants will fill out an interviewer-administered survey conducted by research assistants to identify baseline characteristics, demographic information, savings intention and behavior, and knowledge of and involvement in maternal health. This information will be used to conduct descriptive statistics and sub-group analyses to identify factors associated with savings behavior: age, education, marital status, employment, rural/ urban status, estimated wealth quintile, pregnancy status, attitudes towards male involvement in pregnancy, attitudes of and behaviors towards saving money, pregnancy preparation intentions.
Once a woman delivers, data on the amount saved plus any expenditures during the period of the intervention will be pulled from clinicPesa’s database for registered participants [46, 47]. The participants will also be called for an end-line questionnaire two weeks after their estimated delivery date that collects the same information as baseline with additional items on how they used the clinicPesa platform, delivery experience, and perceived involvement of the male partner in maternal healthcare. A pre-test of the data collection tools will be conducted with 14 random participants users from clinicPesa’s user base.
Background characteristics will be analyzed to determine that both the control and intervention groups were balanced and randomization was done correctly. The primary outcome of birth preparedness and maternal health utilization will be compared between the intervention and control groups. The mean total savings amounts of participants (regardless of expenditure) will be compared between the intervention and the control groups using T-tests for mean savings. Mixed-effect regression analysis will be performed to assess the effect of the intervention on the following outcomes: amount of money saved across the study period (plus withdrawals), birth preparedness, maternal health service utilization, male involvement in maternal healthcare, and utilization of money for pregnancy-related health costs (delivery, preparation, transportation, or other, if applicable). Logistic regression will be used to control for potential cluster effects. Weighting approach will be used to control for variation in probability of participants being included in the study across study recruitment sites (large facilities vs small facilities).
It is expected that after a participant enrolls in the study and is randomized, final savings data can be collected remotely even if the participant does not engage with the platform (i.e., does not save any money after enrollment) or complete the end-line survey. In this case, savings outcome data can still be collected. Attrition rates and reasons for dropout will be logged if possible. An intention to treat (ITT) analysis will be conducted, and a sensitivity analysis will be conducted for any missing data [48, 49]. The significance level will be set at 5%, and Stata version 13.1 will be used for analysis of the data set.