Seeing Is Believing: Screening Anemia to Make Risks Salient

Last registered on September 20, 2023

Pre-Trial

Trial Information

General Information

Title
Seeing Is Believing: Screening Anemia to Make Risks Salient
RCT ID
AEARCTR-0012048
Initial registration date
September 17, 2023

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
September 20, 2023, 10:59 AM EDT

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

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Primary Investigator

Affiliation
Sao Paulo School of Economics - FGV

Other Primary Investigator(s)

PI Affiliation
Inter-American Development Bank

Additional Trial Information

Status
On going
Start date
2021-06-01
End date
2024-04-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Anemia is a condition that affects 45 percent of children less than five in low- and middle-income countries (WHO, 2016). In El Salvador approximately one out of every two children 6- to 23-month-old in the poorest municipalities, has some anemia. If untreated, anemia can reduce cognitive capacity, increase the risk of infections, and, in the long term, cause permanent loss of productive capacity (Hass and Brownlie, 2001; Horton and Ross, 2003). According to the WHO, iron deficiency is the most common cause of anemia, and estimates indicate that about half of anemia cases worldwide could be due to this cause (Ezzati et al 2014). Most cases of iron deficiency anemia can be effectively prevented and treated in several ways (De-Regil et al, 2011; WHO, 2016b): increasing the intake of foods with high and easily absorbed iron content (mostly those from animal original such as beef, poultry, fish, among others), or with iron supplementation. Typical forms of supplementation are ferrous sulphate or micronutrient powders, which combine iron with other basic nutrients. In low-income settings, supplementation for prevention and treatment is the most common approach as there might be limited availability of iron-rich foods in households in these settings.

In 2014, El Salvador's government introduced micronutrient supplementation as a preventive treatment for anemia among children 6 to 23 months old. The program involved providing micronutrients free of charge to children aged 6 to 23 months old during child well-visits, developing a social marketing campaign to inform the population of the benefits of micronutrients, educating caregivers on strategies to improve diet and provide supplementation, providing tools to track adherence, and following-up and monitoring adherence through home visits of community health workers (CHW). Although there was a high take-up of micronutrient powders, the program fell short of increasing substantially treatment adherence (Bernal et al., 2020). Treatment adherence can be challenging at scale. In the case of micronutrients, it involves providing them daily for 60 days straight every six months. Other common forms of iron supplementation, such as ferrous sulfate require daily doses non-stop. A correct adherence is crucial for the effectiveness of the program but is challenging from a behavioral perspective. Several biases could prevent caregivers to fully adhere to the treatment (limited attention, mistaken beliefs about anemia or the treatment, among others). A qualitative study by Bernal et al. (2020) showed that in the case of El Salvador, caregivers do not make a correct assessment of the cost-benefit analysis of an adequate adherence to treatment, mostly since anemia symptoms can go easily unnoticed, and benefits of treatment are mostly long-term.

Given the high anemia rate in rural El Salvador, the guidelines for doctors are to prescribe micronutrients to every child between certain ages without testing. Given that there are no relevant side effects of micronutrients even for healthy children and that the probability of having anemia in low-income setting is high, common practice indicates that is that it would not be cost-effective to make anemia screening part of child well visits. As a result, anemia ends up being less salient that other potential diseases and caregivers tend to underscore the risk of their children developing anemia.

This paper studies a relatively low-cost intervention to increase the salience of anemia in order to adjust the caregivers' beliefs related to the probability of their children developing anemia. The intervention involved the introduction of non-invasive anemia screening for children under five years old in primary care units of the Ministry of Health as part of previously established child preventive visits. The main hypothesis behind the intervention is that increasing the saliency of anemia through the non-invasive screening will influence adherence to treatment for this condition. Screening in the treatment group took place during preventive checkups of children at ages 12, 18, 24, 36, 48, and 60 months old. During the screening, health workers explained to caregivers the purpose of the screening and its results using communications materials developed for the intervention. In addition, they provided information and counseling to caregivers regarding the adequate treatment established in clinical guidelines based on the screening result (no anemia, mild, moderate, or severe anemia). In the case of no anemia (even if in the margin), health workers encouraged caregivers to continue with the preventive treatment to keep their children healthy. The intervention was jointly developed with the Ministry of Health with support from technical experts in nutrition. The device used for non-invasive screening will be Massimo’s Rad-67, whose technology has been previously used in clinical settings (Parker et al, 2018) and population-level studies (Shamah Levy et al, 2017). The intervention started in April 2022 and is expected to end in December 2023.
External Link(s)

Registration Citation

Citation
Ajzenman, Nicolas and Pedro Bernal. 2023. "Seeing Is Believing: Screening Anemia to Make Risks Salient." AEA RCT Registry. September 20. https://doi.org/10.1257/rct.12048-1.0
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Experimental Details

Interventions

Intervention(s)
This paper studies a relatively low-cost intervention to increase the salience of anemia in order to adjust the caregivers' beliefs related to the probability of their children developing anemia. The intervention involved the introduction of non-invasive anemia screening for children under five years old in primary care units of the Ministry of Health as part of previously established child preventive visits. The main hypothesis behind the intervention is that increasing the saliency of anemia through the non-invasive screening will influence adherence to treatment for this condition. Screening in the treatment group took place during preventive checkups of children at ages 12, 18, 24, 36, 48, and 60 months old. During the screening, health workers explained to caregivers the purpose of the screening and its results using communications materials developed for the intervention. In addition, they provided information and counseling to caregivers regarding the adequate treatment established in clinical guidelines based on the screening result (no anemia, mild, moderate, or severe anemia). In the case of no anemia (even if in the margin), health workers encouraged caregivers to continue with the preventive treatment to keep their children healthy. The intervention was jointly developed with the Ministry of Health with support from technical experts in nutrition. The device used for non-invasive screening will be Massimo’s Rad-67, whose technology has been previously used in clinical settings (Parker et al, 2018) and population-level studies (Shamah Levy et al, 2017). The intervention started in April 2022 and is expected to end in December 2023.
Intervention Start Date
2023-04-01
Intervention End Date
2023-12-31

Primary Outcomes

Primary Outcomes (end points)
1) Adherence to anemia treatment : shared of days in which micronutrients or ferrous sulfate was consumed relative to the recommended schedule among children 12 to 60 months old
Primary Outcomes (explanation)
The outcomes come from a household survey that was implemented for this project. It is self-reported by the main caregiver of the child (usually the mother). The indicators is based on the number of days in which micronutrients or ferrous sulfate was consumed by the child in the last six months, relative to the recommended schedule for each treatment.

Secondary Outcomes

Secondary Outcomes (end points)
(1) Anemia prevalence among children 12 to 59 months old
(2) Anemia screening among children 12 to 59 months old
(3) Iron-rich diet among children 12 to 59 months old

Importantly: we measured some behavioral traits and time preferences in a baseline survey. We will test if there are heterogeneous effects by the pre-treatment levels of them (for instance, high versus low level of pre-treatment patience)
Secondary Outcomes (explanation)
(1) Anemia prevalence is based on a non-invasive hemoglobin measurement obtained with Maximo's Rad-67 on all children 12 to 59 months old from the household survey.
(2) Anemia screening is based on the caregiver's response to a question on whether the child received an anemia screening in the last six months
(3) Iron-rich diet is constructed based on a series of questions about what the child ate during the last day. Iron-rich refers to consumption of animal-based foods, eggs, iron-fortified foods and/or beans or lentils among others.

Experimental Design

Experimental Design
To estimate the effect of the intervention, a clustered randomized controlled trial was designed. From a total of 75 primary care units 38 were randomly assigned to a treatment group and the rest to control. The intervention was implemented in those units assigned to treatment, whereas those in the control will continue to operate as usual. That is, in the control units, children in well-visits will continue receiving the usual clinical examination and preventive treatment for anemia. Block randomization was used in the assignment process, with blocks formed based on region and available data on adherence to micronutrient treatment prior to the start of the intervention. Block randomization helps increase the likelihood of a balance of observable and unobservable characteristics within each block and increases precision (List, Sadoff & Wagner, 2010). The evaluation design allows us to estimate the effect of introducing non-invasive anemia screening and to understand whether it adds value in relationship with the routine activities performed for prevention and treatment at the primary care level. The intent-to-treat (ITT) and treatment on the treated (TT) parameters will be estimated. The former (ITT) will inform the overall population effect of the intervention regardless of the reach of the anemia screening achieved in the population. The latter (TT) will allow us to understand the effect of the intervention among those children who received an anemia screening. The evaluation results could inform a cost-benefit analysis to determine whether the benefits of introducing this type of screening outweigh its costs.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer. The randomization was done live via Teams in the presence of representatives of the Ministry of Health.
Randomization Unit
Clusters: primary care units.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
75
Sample size: planned number of observations
2250
Sample size (or number of clusters) by treatment arms
Power estimates were obtained using previously available data on adherence and anemia prevalence a power of 80% and a 95% confidence level, a cluster size of 30. Considering a baseline level of adherence of 15% and an intra-cluster correlation (ICC) of 0.11, the minimum detectable effect (MDE) will be of around 10 percentage points. With respect to anemia, considering a baseline level of anemia of 37% and an ICC of 0.08, the MDE will be also of close to 10 percentage points. These power estimates are conservative since they do not account for gains in precision that can be obtained with the block randomization as well as from adding covariates and baseline level measures. Additional gains in precision could be obtained by including covariates and baseline level measures. The MDE for adherence is adequate considering the low baseline. With regards to anemia, while the MDE could seem somewhat large, we consider it adequate from a policy standpoint, since the intervention will need to prove quite effective to justify the introduction of this type of screening in these settings.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Around 10 percentage points for adherence to treatment (days)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number