Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition Through Lady Health Workers As Compared To a Facility Based Program: A Cluster Randomized Controlled Trial
Brief Summary: HYPOTHESIS:

Investigators hypothesize that by provision of care at household level in a community through lady health workers will as effective (recovery rate, burden of SAM, cost effective, coverage) as through health care providers at facility level. OBJECTIVES

1. To evaluate the effectiveness (rate of recovery, burden \& coverage), of SAM standard management of children 06-59 months delivered at household level by first level health care providers (Lady health workers) compared with the standard CMAM program delivered at health facility by Govt./ACF staff.
2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt/ACF staff.

STUDY DESIGN:

Cluster randomized controlled trial

SAMPLE SIZE \& RANDOMIZATION:

Investigators took 6% prevalence to calculate the sample size with an expected reduction of 20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute malnutrition (SAM) as per the study eligibility criteria (MUAC \< 11.5 cm) and manage all cases of SAM without complications at home following the national CMAM guidelines. Control (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC \< 11.5 cm) and will refer all cases to the health facility (ACF) for further management and counselling by health workers at facility.


Options:
A: Inclusion Criteria:

* Born in the study area
* Presence of severe acute malnutrition (SAM).
* Ability of the parents or guardians to provide informed consent.

Exclusion Criteria:

* Presence of chronic debilitating illness.
* Residence outside of study areas.
* Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.
* Internally displaced population
B: Inclusion Criteria:

* Women living in intervention and comparison villages
* Mother to at least one child under 59 months old

Exclusion Criteria:

-No living child
C: Households in one of the two study arms will be eligible for inclusion if they meet all of the following citeria:

* Provide informed consent
* Households with women of reproductive age and with at least one child under the age of 36 months (10 years for spillover households to ascertain the secondary outcomes of extent of spillover).
* Household has access to plot of land or containers where vegetables could be grown
* Households that speak and understand English or Swahili

Exclusion Criteria:

* Do not provide informed consent
* Households without a woman of reproductive age or a child under the age of 36 months (10 years for spillover households).
* Households without access to plot of land or containers where vegetables could be grown.
* Households that do not speak and understand English or Swahili.
D: Inclusion Criteria:

* children aged 06-59 months at the time of the study
* children who live in a village in the health district participating in the study

Exclusion Criteria:

* children whose legal guardian refuses to participate in the study

Answer: A