Optimal Design for Scaling Childhood Immunization Bracelets: Experimental evidence from Sierra Leone

Last registered on August 28, 2024

Pre-Trial

Trial Information

General Information

Title
Optimal Design for Scaling Childhood Immunization Bracelets: Experimental evidence from Sierra Leone
RCT ID
AEARCTR-0014239
Initial registration date
August 21, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
August 28, 2024, 3:08 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
University of Chicago

Other Primary Investigator(s)

PI Affiliation
University of Chicago
PI Affiliation
Ministry of Health Sierra Leone
PI Affiliation
Innovations for Poverty Action

Additional Trial Information

Status
On going
Start date
2024-06-20
End date
2027-03-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
In collaboration with the Government of Sierra Leone, we are scaling social signaling incentives, specifically colored bracelets, across 20% of the country’s public clinics. We are evaluating their impact on routine immunization uptake, including the new malaria vaccine, under two different designs that vary the number of vaccination points at which parents receive a signal. In both treatments, we replicate the design tested in Karing (2024), where children receive an initial bracelet at the first vaccine visit and a signal at nine months. To test the potential for signaling incentives to reduce the drop-off in later vaccines, we also add a signal at the final malaria vaccine visit at 18 months. The two treatments differ in whether a bracelet is also provided at the first malaria dose. A signal at more frequent decision points might offer less of an opportunity to stand out as a good parent, potentially reducing the bracelet’s signaling effect. Conversely, frequent signals could offset unexpected costs, acting as insurance. Beyond social image concerns, making the new vaccine visible may impact vaccination uptake by accelerating learning about its availability, safety, and schedule. We will shed light on the role of the social signaling and information channels through surveys with caregivers across control and treatment clinics.

External Link(s)

Registration Citation

Citation
Warren, Shana et al. 2024. "Optimal Design for Scaling Childhood Immunization Bracelets: Experimental evidence from Sierra Leone ." AEA RCT Registry. August 28. https://doi.org/10.1257/rct.14239-1.0
Sponsors & Partners

Sponsors

Partner

Experimental Details

Interventions

Intervention(s)
Context: With the introduction of a malaria vaccine in April 2024 in all districts except Freetown (Western Urban district), the vast majority of children in Sierra Leone are now due for 10 immunization visits: at birth (BCG, oral polio), 6 weeks (Penta 1+), 10 weeks (Penta 2+), 14 weeks (Penta 3+), 6-months (Malaria 1), 7-months (Malaria 2), 8-months (Malaria 3), 9-months (Measles 1, Yellow Fever), 15-months (Measles 2), and 18 months (Malaria 4). As of June 2024, children residing in Western Area Urban (Freetown) are not eligible for the malaria vaccine. These children continue to have a six-visit immunization schedule. Given the recent introduction of the malaria vaccine, there is uncertainty around if and when the malaria vaccine may be offered to children in Freetown.

Intervention: We will provide children with colorful bracelets that indicate their progress through the immunization schedule. These colorful bracelets serve as social signals. They may also provide information about the new vaccine’s availability and take-up in their community. In both bracelet treatments children will receive a first bracelet at their first vaccine visit, a signaling bracelet for timely completion of all vaccines up to Measles 1, and a final bracelet for timely completion of all immunizations through Malaria 4, the last of the new ten-visit schedule. In one of the bracelet treatments, we will also incentivize the first malaria vaccine dose at 6 months with an additional bracelet.

Nurses-in-charge of each study clinic will be invited to a district-level training introducing them to the bracelets and study. They will subsequently receive comprehensive training on the implementation of the bracelets at their clinic. Community Health Workers (CHWs) assigned to each clinic will receive cascade training from their supervisor to disseminate information about the bracelets and their meaning as part of their door-to-door activities in their communities.

Innovations for Poverty Action field staff will visit the clinic to monitor the quality of the implementation a couple of weeks after the clinic-based training, and approximately every three to four months thereafter.
Intervention Start Date
2024-06-20
Intervention End Date
2026-12-31

Primary Outcomes

Primary Outcomes (end points)
1. Number of vaccines received on time, defined as coming within 2 months of each vaccine’s due date.
2. Number of vaccines by 20 months* independent of timeliness.
3. Number of malaria doses received by 20 months.

*We will extend this window to 24 months if we secure additional funding. Twenty-four months is the ideal timeframe to capture the possible convergence between the control and treatment groups.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
1. Vaccination outcomes:
- Number of measles doses by 20 months.
- Share of children completing malaria and measles vaccines on time, on time, defined as coming within 2 months of a vaccine’s due date, for the following vaccines: BCG due at birth; Penta 1, 2 and 3 due at 1.5, 2.5 and 3.5 months; Malaria 1, 2 and 3 due at 6, 7 and 8 months; Measles 1 and 2 due at 9 and 15 months; Malaria 4 due at 18 months.
- Share of children completing malaria and measles vaccines by the time they are 20 months old, for the following vaccines.

2. Other vaccine-related outcomes:
- Knowledge about the malaria vaccine’s availability, schedule, eligibility criteria.
- Social norms around completion of the malaria vaccine (views about caregivers who complete the malaria vaccine visits timely versus not).
- Perception of the malaria vaccine’s importance and safety.
- Frequency and intensity of vaccination outreach activities at the clinic level.

3. Other non-vaccine related outcomes:
- Vitamin-A supplementation (VAS) timeliness at 6, 12 and 18 months.
- Non-vaccine-related malaria prevention behavior (e.g. use of bed net).
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Government clinics in the selected districts will be randomly assigned into one of three study arms:

1) Three-bracelet arm: Clinic staff distribute three differently colored bracelets. A yellow bracelet is given at the 1st immunization visit. The yellow bracelet will be exchanged for a purple bracelet when a child comes for all visits up until the first dose of measles on time. The bracelet will be exchanged for a multicolor bracelet if the child comes for all visits up until the last malaria dose on time. The bracelets show whether a child has completed the 8 required immunization visits within one year on time, and completed all visits required within two years on time.

2) Four-bracelet arm: Clinic staff distribute four differently colored bracelets. A yellow bracelet is given at the 1st immunization visit. The yellow bracelet will be exchanged for an orange bracelet when the child comes for the first malaria vaccine visit. The orange bracelet will be exchanged for a purple bracelet when a child comes for all subsequent malaria vaccine visits and the first dose of measles on time. The bracelet will be exchanged for a multicolor bracelet if the child comes for all visits up until the last malaria dose on time. The bracelets show whether a child has initiated the malaria vaccine series, completed the 8 required immunization visits within one year on time, and completed all visits required within two years on time.

3) Control group: No bracelets are given.

If the malaria vaccine is rolled out in Freetown, we will introduce the signaling bracelets in a random set of clinics in Western Area districts. We randomly assigned a set of clinics in these districts to the three-bracelet treatment or the control.
Experimental Design Details
Not available
Randomization Method
Randomization done by a computer.

Randomization is performed at the level of Peripheral Health Units (PHUs, a.k.a health clinics) and stratified by district, clinic type and size. Specifically, we stratify the randomization by whether a clinic is i) a Community Health Center, ii) any other PHU type with a population larger than the 70th percentile of clinics, iii) any other PHU type with a population lower or equal to the 70th percentile of clinics.
Randomization Unit
Primary health unit (PHU)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
255 PHUs (clinics)
Sample size: planned number of observations
We will capture immunization data for 12 monthly cohorts of children in each of our study clinics. For the latest vaccine, we will capture outcomes for 3 cohorts who will be old enough to have received the malaria 4 vaccine and be assessed for completion of the full immunization schedule. Maximum sample - full immunization rate under one year and timeliness for vaccines 1-8: N = 255 (clinics) x 12 (monthly birth cohorts) x 15 (average birth cohort size) = 45,900 caregivers. Minimum sample - full immunization rate under two years and timeliness for vaccines 9 and 10: N = 255 x 3 x 15 = 11,475 caregivers.
Sample size (or number of clusters) by treatment arms
85 health clinics control, 85 health clinics 3-bracelet treatment, 85 health clinics 4-bracelet treatment.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Innovations for Poverty Action IRB
IRB Approval Date
2024-06-04
IRB Approval Number
IRB#-4661
IRB Name
Sierra Leone Ethics and Scientific Review Committee
IRB Approval Date
2024-03-27
IRB Approval Number
N/A