Impact of the ACCESO program on food security and water quality - A cluster randomized controlled trial in rural Guatemala

Last registered on December 06, 2023

Pre-Trial

Trial Information

General Information

Title
Impact of the ACCESO program on food security and water quality - A cluster randomized controlled trial in rural Guatemala
RCT ID
AEARCTR-0012647
Initial registration date
December 03, 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
December 06, 2023, 8:51 AM EST

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

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Primary Investigator

Affiliation
World Vision

Other Primary Investigator(s)

PI Affiliation
World Vision Guatemala
PI Affiliation
World Vision US

Additional Trial Information

Status
On going
Start date
2023-07-01
End date
2026-12-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
The Assistance for Change and Economic Growth for Food Security (Asistencia para el Cambio y Crecimiento Econ├│mico por la Seguridad Alimentaria, ACCESO) program is an emergency food security intervention program implemented by World Vision Guatemala. Prior to the start of any intervention activities, in 3 of ACCESO's operational departamentos, 50 villages were randomly allocated to intervention (n=19) or control (n=31). Two villages' leadership refused participation in the intervention program, resulting in a total of 48 villages within this cluster RCT. In the first year of the intervention program, vulnerable households will receive four monthly cash transfers of $110 each (Q860) in July, August, September, and October 2023. They will additionally receive a ceramic water filter (Ecofiltro) and a handwashing station with soap. Households in both intervention and control communities will be screened and enrolled into this cluster RCT research study starting on 4December 2023, using vulnerability criteria utilized by the intervention implementer to enroll houses into the intervention program April-June 2023. Primary outcomes will be 1) reported moderate or severe hunger in September of 2023 (according to Household Hunger Score, with modified extended recall period to specific month of September), and 2) household drinking water quality (E. coli >0 colony forming units/100mL). Analysis will be intention to treat, and secondary analyses will be per-protocol based on households that received the ACCESO intervention. Secondary outcomes will include other indicators of food security including Food Consumption Score (last 7 days, binary "acceptable" or not, as well as continuous), Reduced Coping Strategies Index (last 7 days, continuous), and Household Hunger Score in previous 30 days (binary, moderate/severe hunger or not), and reported respiratory illness or diarrhea among children <5yrs of age within the previous 7 days.
External Link(s)

Registration Citation

Citation
Casselberry, Ila , Miles Kirby and Hector S. Pena. 2023. "Impact of the ACCESO program on food security and water quality - A cluster randomized controlled trial in rural Guatemala." AEA RCT Registry. December 06. https://doi.org/10.1257/rct.12647-1.0
Experimental Details

Interventions

Intervention(s)
In the first year of the intervention program, vulnerable households will receive four monthly unconditional multipurpose (though labeled for food) cash transfers of $110 each (Q860) in July, August, September, and October 2023. They will additionally receive in October-November 2023 a ceramic water filter (Ecofiltro) and a handwashing station with soap. Additional intervention components and programmatic support will be provided later in 2024 and 2025, including additional cash transfers targeted to the most vulnerable 30% in April 2024.
Intervention Start Date
2023-07-01
Intervention End Date
2025-12-31

Primary Outcomes

Primary Outcomes (end points)
Primary outcomes will be 1) reported moderate or severe hunger in September of 2023 (according to Household Hunger Score, with modified extended recall period to specific month of September, asked in December 2023-January 2024), and 2) household drinking water quality in May-June 2024 (E. coli >0 colony forming units/100mL).
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary outcomes measured in first survey round December 2023-January 2024:
-Food Consumption Score (last 7 days, binary "acceptable" or not, as well as continuous)
-Reduced Coping Strategies Index (last 7 days, continuous)
-Household Hunger Score in September 2023 (binary, severe hunger or not)
-Household Hunger Score in previous 30 days (binary, moderate/severe hunger or not; severe hunger or not)
-Reported respiratory illness among children <5yrs of age within the previous 7 days, and reported care-seeking.
-Reported diarrhea among children <5yrs of age within the previous 7 days, and reported care-seeking.
-Household drinking water quality: E. coli >0 colony forming units/100mL
-Household drinking water quality: High risk (E. coli >10 colony forming units/100mL)
-Household drinking water quality: Very high risk (E. coli >100 colony forming units/100mL).
-Presence of soap and water at handwashing location
-Reported usual treatment of household drinking water

Secondary outcomes measured in second survey round (estimated May-June 2024):
-Food Consumption Score (last 7 days, binary "acceptable" or not, as well as continuous)
-Reduced Coping Strategies Index (last 7 days, continuous)
-Household Hunger Score in previous 30 days (binary, moderate/severe hunger or not; severe hunger or not)
-Above FCS, rCSI, and HHS indicators among most vulnerable 30% of houses
-Reported respiratory illness among children <5yrs of age within the previous 7 days, and reported care-seeking.
-Reported diarrhea among children <5yrs of age within the previous 7 days, and reported care-seeking.
-Household drinking water quality: High risk (E. coli >10 colony forming units/100mL)
-Household drinking water quality: Very high risk (E. coli >100 colony forming units/100mL).
-Presence of soap and water at handwashing location
-Reported usual treatment of household drinking water
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Within three regions (Alta Verapaz, San Marcos, and Totonicapán departamentos) and six sub-regions (municipios), a master list of 50 villages was compiled, which contained villages determined to meet basic eligibility criteria according to pre-established implementer criteria and available data including poverty, health status, and lack of other intervention activities. Within each of the 6 municipios, the number of study villages ranges from 5-14 villages (avg 8). In each municipio, the implementer (World Vision) identified a fixed number of intervention villages to be randomly selected as intervention, ranging from 1-4 per municipio, based on programmatic requirements. Using R, randomization was conducted for each municpio, resulting in a total of 19 intervention villages and 31 control villages randomly allocated. Two villages' leadership refused to participate in the intervention program, resulting in 17 intervention villages and 31 control villages for the cluster randomized trial.

In the first year of the intervention program, vulnerable households will receive four monthly multipurpose cash transfers of $110 each (Q860) in July, August, September, and October 2023, labeled for food. They will additionally receive in October-November 2023 a ceramic water filter (Ecofiltro) and a handwashing station with soap. Additional intervention components and programmatic support will be provided later in 2024 and 2025, including additional cash transfers targeted to the most vulnerable 30% in April 2024.

Households in intervention and control villages will be enrolled into the study starting on 4December 2023. A household is eligible for the study if it is within the selected village, has a single-parent, has a vulnerable child under 5, is headed by a woman, has any members with a partial or total disability, has any adults over 75 years of age, does not currently participate in other food assistance projects (other than ACCESO), had a deficient diet between the months of April and June 2023, had a high rate of implementation of coping strategies in the face of food shortages, or had had moderate/severe hunger between the months of April and June 2023. Additionally, an adult 18 years of age or older must be home and able and willing to provide informed consent and answer the survey questions.

Outcomes will be assessed in two surveys (December 2023-January 2024 and May-June 2024), with the possibility of additional follow-ups pending funding to assess longer-term impacts of the various intervention components.
Experimental Design Details
Not available
Randomization Method
Clusters were block randomized by sub-region (municipio) in office by a computer, using the randomizr package in R (version 4.2.2, 2022-10-31 ucrt -- "Innocent and Trusting").
Randomization Unit
Village
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
48 villages
Sample size: planned number of observations
1200 households, with two follow-up rounds
Sample size (or number of clusters) by treatment arms
31 control villages and 17 intervention villages, with enrollment aim of 25 households enrolled per village.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Save the Children Ethics & Evidence Generation
IRB Approval Date
2023-11-27
IRB Approval Number
SC-EEG-FY2023-241