Study setting:
The city of Boa Vista has a population of approximately 330,000 people, with, 22,377 families (~30%) currently receiving or enrolled in social cash transfers under the bolsa familia program, very similar to the national average (35% of the population) [27]. According to the Municipality health secretariat, infant mortality rate is estimated at 14.2 per 1000 live births, with 21% of births by teenage mothers and 11% of infants born preterm[28].
Eligibility criteria:
Study eligibility is restricted both spatially and at the individual level. As mentioned in the Study Design section, the scale-up targets only vulnerable neighborhoods. Boa Vista social services classify all neighborhoods based on literacy rates, average per capita income (less than ¼ of the minimum wage), access to water, sanitation, sewage systems and electricity into A (low vulnerability), B (medium vulnerability) and C (high vulnerability) areas. Out of the 55 neighborhoods in Boa Vista, 12 were classified as “high socioeconomic status (A), 14 were classified as “low vulnerability” (B) and 29 were classified as “high vulnerability” (C). The study was restricted to the 43 B and C areas.
Within all target areas, all pregnant women as well as women with children under the age of one are eligible for the program as long as they are either poor, were under the age of 20 at the time of conception or were ever exposed to domestic or sexual violence.
Interventions:
Home visit arm (Arm 1)
The intervention will be delivered during fortnightly home visits with the presence of the child and at least one of the main caregivers (the program focusses on the mother, but ideally with the father participation or any other family member that routinely spends time with the child). The home visiting curriculum is divided in 3 main modules: 1) pregnancy module: this module is designed to make mothers aware of pregnancy danger signs, to encourage adherence to antenatal care (attendance, performing exams and supplementation), to improve bonding and positive parental practices and to prepare women for breastfeeding. 2) Neonatal module: comprises 3 home visits during the baby’s first month of life. One visit during the first week, a second visit at 15 days and the third visit at 28 days. The primary focus of these visits is babies’ health, breastfeeding and bonding. 3) child module for ages 02–36 months. Each home visit has 3 or 4 play activities to address child development domains (gross motor, fine motor, language, cognitive development and social emotional development). A recycled materials toy kit is used to support these activities. Visits take in average 45 minutes; after demonstrating and practicing each activity with the caregiver, the visitor leaves the toys, and mother/caregiver is encouraged to play and interact with the child in the two-week interval between the visits. Activities are age-appropriate, and toys and learning materials are exchanged for a new set at each visit. Home visits will be conducted by newly hired and trained child development agents, who will be tasked to complete 60 home visits per month (3 visits per workday), supporting 30 families.
Group-meeting arm:
Group meetings are designed to deliver essentially the same content. Meetings are held fortnightly at the CRAS center (Social Services Centers) for groups of 8 mothers and their children, other members of the family can participate as well. Groups are formed with participants at a similar stage of gestation or with children of similar age. Group composition remains fixed to increase bonding over time. The only difference between the center and the home-based curriculums is the number of activities per session: due to the larger number of participants, the number of activities is reduced to 2 at centers. The neonatal module is also reduced to 1 or 2 sessions, since we do not expect mothers to attend the sessions during the first 2 weeks of babies’ life. Group moderators will be hired by the project and will be tasked to schedule 3 age-groups specific 1 hour and 30 min sessions each day.
Program teams will be based at the 7 regional social service units (CRAS) and will deliver the intervention according to the services coverage area. Group meetings will be held at the centers, where a meeting room will be fully dedicated to the project and are more easily accessed by mothers, since they are distributed within the more vulnerable areas.
Outcomes:
The primary study outcome is child development at age 2 as assessed by the PRIDI scale. The secondary study outcome is child survival, which will be assessed using data from the municipality’s vital registration system (SIM and SINASC). Maternal depression will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D Scale).
Intention to treat analysis will be used to compare outcomes across the 3 study arms.
Additional per-protocol analysis will be conducted using data on program compliance. Our primary measure of compliance in the home visiting arm will be the number of home visits completed. Our primary compliance measure in the center-based groups will be the number of sessions attended by the mother.
Randomization
Randomization of program rollout timing was based on a simple random number draw in Stata. The number of treated areas in phases 1 and 2 were determined based on logistical feasibility and an initial agreement between the municipality and the project team: in phase one, 9 areas were chosen for home visits and 2 for center-based programs. In phases 2 and 3, program reach was gradually increased to reach all communities as outlined in the Study Design section above. In phase I, 11 neighborhoods will receive the intervention; in phase II, 27; in phase III, all B and C neighborhoods will receive interventions. Figure 3 summarizes the neighborhood selection process and shows the random allocation of interventions by phase. Figure 4 shows the spatial location of areas chosen for each intervention phase.
Recruitment
Recruitment for this project will be implemented in close collaboration with the Municipality Secretariat for Social Wellbeing and Health (SSWH). The SSWH identifies eligible pregnant women each month, and links them to the project team. Each woman is then visited by study staff and, conditional on their consent, completes a baseline interview. According to the municipality of Boa Vista, there are approximately 600 new pregnancies per month. The baseline forms are then used to establish eligibility for the program. As stated above, the following three (non-mutually exclusive) groups of women are eligible for the program:
- Household classified as poor
- pregnant women under age 20 (teenage pregnancies)
- women with previous exposure to partner violence
In the first few years of the program, a small sample of women with children under age 1 will also be enrolled. This sample will be used to assess the relative impact of reduced exposure to the interventions.
Blinding: Given the nature of the intervention, blinding of participants is not possible. Endline interviewers will be blind to group assignment.
Sample size and power calculations
Based on the estimated number of births in the targeted B and C areas, we anticipate completing approximately 12,000 baselines (screening interviews) over the project period. Out of these mother-child dyads, we will randomly select 3000 for the endline assessment. We assume an average causal effect of 0.5SD on compliant mothers. With an anticipated average compliance rate of 50%, the study is powered to detect an intent-to-treat effect of 0.25SD with power 0.9 between each of the two intervention arms and the control arm, assuming an average sample of 120 households in each of the 11 neighborhoods treated in Phase 1, and an average sample of 60 households in each of the 28 control neighborhoods, assuming an intra-class correlation of 0.02.
In order to assess spillovers within households, we will also assess all older siblings under age 4 in households selected for endline. Based on the high fertility rates observed at baseline, we anticipate a sample of 750 older siblings. Assuming a uniform distribution of siblings across clusters, the study is powered to detect a 0.3SD change in PRIDI score with power 0.8.
In order to assess domain-specific changes in children’s development, we will also invite 80 mothers from each arm for a detailed assessment using the Bayley’s Scales for Infant and Toddler development. For these assessments, we will randomly select moms from the control group as well as compliant mothers from the two intervention arms.
Timeline
Baseline survey collection started in December 1 2017. Home visits team was trained in November 2017 and visits were launched shortly after initiation of baseline in Phase 1 home visiting areas; the first births within this group occurred in February 2018. Due to logistical challenges, center-based programs were started later; the two areas randomly selected for Phase 1 of the project were formally launched in July 2018. Phase II (both for home visits and center-based programs) was started in July 2019, with 10 neighborhoods added to home visiting programs, and 8 added to center-based programs.
Endline surveys are scheduled to start in March 2020 and will target children at age 2. With the targeted sample size of 3000 households we anticipate to complete endline by March 2021. BSID–3 assessments will start in July and should be completed within six months.
Data management:
Baseline and endline data will be collected in electronic format on tablets and storied on a secure server. The project leader will be responsible for the anonymization of the data system. A unique identifier will be used in the data system to preserve participant’s privacy and confidentiality.
Statistical methods:
For statistical analysis, standard regression models will be used for the continuous PRIDI outcome. Logistic regression models will be used for the secondary mortality outcome. All analysis will be conducted using the Stata 15 statistical software package. Primary analysis will be intent-to-treat. To assess the impact of partial compliance, we will also estimate average treatment effects on the treated (per-protocol analysis).
Ethical clearance:
The study was approved by the Researcher’s institution IRB under protocol number CAAE:73722917.4.0000.0076 in August 2017. Each participant signs the consent form at enrollment, during the baseline interview visit. Should the participant be a minor, the consent form is signed by the responsible adult.
Trial Status:
As of November 2019, trial enrollment is open and is scheduled to continue until July 2020. The present protocol is in its first version, since November 2017.