<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043352</url>
  </required_header>
  <id_info>
    <org_study_id>3276-Ped-ERC-14</org_study_id>
    <nct_id>NCT03043352</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effectiveness and Impact of Community Case Management of Severe Acute Malnutrition</brief_title>
  <official_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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Action Contre la Faim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      HYPOTHESIS:&#xD;
&#xD;
      Investigators hypothesize that by provision of care at household level in a community through&#xD;
      lady health workers will as effective (recovery rate, burden of SAM, cost effective,&#xD;
      coverage) as through health care providers at facility level. OBJECTIVES&#xD;
&#xD;
        1. To evaluate the effectiveness (rate of recovery, burden &amp; coverage), of SAM standard&#xD;
           management of children 06-59 months delivered at household level by first level health&#xD;
           care providers (Lady health workers) compared with the standard CMAM program delivered&#xD;
           at health facility by Govt./ACF staff.&#xD;
&#xD;
        2. To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community&#xD;
           level versus treatment delivered at health facility by Govt/ACF staff.&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      Cluster randomized controlled trial&#xD;
&#xD;
      SAMPLE SIZE &amp; RANDOMIZATION:&#xD;
&#xD;
      Investigators took 6% prevalence to calculate the sample size with an expected reduction of&#xD;
      20%. A sample size of 3 clusters per group with 150 individuals per cluster is needed. STUDY&#xD;
      METHODOLOGY Intervention (Group A): LHWs will identify and treat all cases of severe acute&#xD;
      malnutrition (SAM) as per the study eligibility criteria (MUAC &lt; 11.5 cm) and manage all&#xD;
      cases of SAM without complications at home following the national CMAM guidelines. Control&#xD;
      (Group B): LHWs will identify SAM as per the CMAM guidelines (MUAC &lt; 11.5 cm) and will refer&#xD;
      all cases to the health facility (ACF) for further management and counselling by health&#xD;
      workers at facility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION &amp; RATIONALE:&#xD;
&#xD;
      There is good evidence of the success of CMAM programs for treating SAM in emergencies and&#xD;
      humanitarian crises [1], but little regarding the most cost effective mechanisms to deliver&#xD;
      it or of the added value of integrating treatment of acute malnutrition with treatment of&#xD;
      common childhood illness and/or extensive communitybased nutritional program.&#xD;
&#xD;
      HYPOTHESIS:&#xD;
&#xD;
      Provision of SAM treatment at household level in a community through lady health workers will&#xD;
      be as effective (recovery rate, survival, cost effectiveness, coverage) as treatment provided&#xD;
      at facility level.&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Will SAM treatment delivered through LHW at household level be as effective as SAM treatment&#xD;
      delivered at facility level by health center staff?&#xD;
&#xD;
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      To evaluate the effectiveness (rate of recovery, relapse &amp; coverage), of SAM treatment of&#xD;
      children 6-59 months delivered at household level by first level health care providers (Lady&#xD;
      health workers) compared with the standard CMAM program delivered at health facility by&#xD;
      Government and ACF staff. To evaluate the cost effectiveness of treatment of SAM provided by&#xD;
      LHWs at community level versus treatment delivered at health facility by Government and ACF&#xD;
      staff.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      To evaluate the characterization of the breast feeding and complementary feeding practices in&#xD;
      both study arms. To identify the main socio-economic characteristics of the households in&#xD;
      both study arms.&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      The study will be a 2-armed cluster randomized controlled trial targeting children 60-59&#xD;
      months and their mothers for the treatment and prevention of acute severe malnutrition in&#xD;
      children. Each cluster will be allocated to intervention group A, or control group B.&#xD;
&#xD;
      Cost-effectiveness analysis:&#xD;
&#xD;
      Cost effectiveness will be calculated to reflect the full range of resources required by&#xD;
      service providers and households. A societal perspective will be taken with data collected on&#xD;
      household costs incurred for participation in community and facility based activities. The&#xD;
      approach will capture all resources used regardless of who incurs them, as used for cost&#xD;
      analysis of other similar programs. Costs will be calculated with a combination of accounting&#xD;
      records and estimates derived with an &quot;ingredients&quot; approach, using unit costs and quantities&#xD;
      of inputs. Institutional costs will be estimated via accounting records. Costs which are&#xD;
      known to be incurred by the program but which are not reflected in the accounting records&#xD;
      (e.g. staff whose salaries are on different budgets, storage space which was not planned for&#xD;
      in the original budget, etc.) will be estimated after identifying these costs through&#xD;
      discussion with staff and document review. This data will be supplemented with costs&#xD;
      calculated via an ingredients approach. Key informant interviews will be held with all key&#xD;
      implementing staff to estimate their time allocation to project activities, in order to&#xD;
      perform an activity based cost analysis.&#xD;
&#xD;
      Coverage assessment:&#xD;
&#xD;
      Coverage Assessments will be implemented in the two areas at the start the study, at six&#xD;
      months of the study beginning and at the end of the study. SQUEAC methodology will be used.&#xD;
      Coverage assessments are of particular interest in order to access the population that is not&#xD;
      accessing treatment and understand its barriers to access. These assessments will be carried&#xD;
      out by trained ACF staff.&#xD;
&#xD;
      MAIN STUDY OUTCOMES:&#xD;
&#xD;
      The key indicators to be captured are:&#xD;
&#xD;
        1. Effectiveness - recovery rate (proportion of cured children among SAM enrolled),&#xD;
           supplement compliance rate, defaulter rate, relapse rate, Length of stay, average weight&#xD;
           gain, hospital admission, and complications&#xD;
&#xD;
        2. Coverage rates and barriers to access (estimated using the SQUEAC methodology)&#xD;
&#xD;
        3. Health &amp; Nutrition status of children (prevalence of malnutrition etc.)&#xD;
&#xD;
        4. Cost-effectiveness&#xD;
&#xD;
        5. Descriptive analysis to assess the distribution of various factors within and between&#xD;
           groups, cluster-adjusted analyses will compare SAM rates (recovery, survival, relapse,&#xD;
           default) observed in the different arms. Kaplan Meier statistics will be used for the&#xD;
           comparison of post-treatment survival.&#xD;
&#xD;
      SAMPLE SIZE &amp; RANDOMIZATION:&#xD;
&#xD;
      Investigators have calculated the sample size on the basis of SAM as the primary indicator;&#xD;
      Investigators took 6% prevalence to calculate the sample size with an expected reduction of&#xD;
      20%. A sample size of 3 clusters per group with 150 individuals per cluster achieves 98%&#xD;
      power to detect a difference of 0.200 between the group means when the standard deviation is&#xD;
      0.500 and the intracluster correlation is 0.00100 using a Two-Sided T-test with a&#xD;
      significance level of 0.05000.&#xD;
&#xD;
      Definition of cluster:&#xD;
&#xD;
      A union council has been defined as the CLUSTER for the trial, a union council is the&#xD;
      smallest administrative unit in the district which usually have a population of about 25000&#xD;
      to 30000, and this population has about 2500-3000 under five children, if Investigators&#xD;
      consider the national rates of SAM in Pakistan which is about 6% Investigators will find more&#xD;
      than 150 cases of SAM from each union council during the study period which will be enough&#xD;
      sample to achieve the objectives of the trial. One union council has usually one health&#xD;
      facility Basic health Unit (BHU) or Rural Health Center.&#xD;
&#xD;
      STUDY SITE:&#xD;
&#xD;
      The study will be carried out in Dadu district, a rural district of Sindh province of&#xD;
      Pakistan. This district has been selected due to the high global acute malnutrition (GAM)&#xD;
      rates, being affected by emergencies. Currently in Sindh, SAM treatment is delivered at&#xD;
      health facility level.&#xD;
&#xD;
      BENEFICIARIES:&#xD;
&#xD;
      Main target beneficiaries would be children 6- 59 months of age fulfilling the case&#xD;
      definition of severe malnutrition and their mothers.&#xD;
&#xD;
      DELIVERY OF INTERVENTION:&#xD;
&#xD;
      Intervention Arm (A): Lady Health Workers operating at field level in study arm A will be&#xD;
      trained at the start of the study. The same training package will be delivered to all LHWs&#xD;
      involved in the study regardless of their previous training and the trainings will be&#xD;
      delivered by the Department of Health (once officially agreed), by ACF &amp; AKU. All eligible&#xD;
      children in the LHW´s catchment area will be identified and registered by the LHWs as part of&#xD;
      their routine activities. In Pakistan national guidelines, SAM treatment admission criteria&#xD;
      is MUAC &lt;11.5 cm. Children 6- 59 months, with MUAC less than 11.5 cm and meeting eligibility&#xD;
      criteria will be enrolled after obtaining consent and provide treatment of SAM at home and&#xD;
      IYCF counseling and follow up till recovery. Children 60-59 months in the criteria for&#xD;
      stabilization care will also be referred by the LHW.&#xD;
&#xD;
      The LHW will visit fortnightly to follow up all recruited children with SAM and receiving&#xD;
      RUTF in their catchment population. If the child gets severely ill or having any complication&#xD;
      the LHW will immediately refer that child to the nearest health facility for hospital based&#xD;
      care. The LHW will record MUAC measurements on fortnightly follow up visits and weight and&#xD;
      height will be recorded by the data collectors. Control Arm (B): Lady Health Workers&#xD;
      operating at field level in study arm B will perform monthly home visit and will recruit and&#xD;
      register all eligible children in their catchment area as part of their routine activities.&#xD;
      The LHW will identify cases of SAM as per national CMAM guidelines through MUAC measurements&#xD;
      and refer them to the nearest health facility where ACF staff will provide treatment in the&#xD;
      facility as per standard CMAM guidelines.&#xD;
&#xD;
      DATA COLLECTION:&#xD;
&#xD;
      Data will be collected by an independent team, and not by LHWs. Data collection team will&#xD;
      consist of 2 data collectors and a team leader. Data collectors and team leaders will be&#xD;
      hired and trained to collect data by the study team.The team will visit identified households&#xD;
      and the data will cross validate the LHW activities. The study team will collect information&#xD;
      regarding children with SAM at baseline survey and during the study from LHWs and health&#xD;
      facilities staff. A trained community health worker will visit the household having child&#xD;
      with SAM and will take informed consent and recruit the child in the study.&#xD;
&#xD;
      Baseline Cross Sectional Survey :&#xD;
&#xD;
      A cross sectional survey will be conducted at household level in both arms&#xD;
&#xD;
      Fortnightly follow-up visits :&#xD;
&#xD;
      A fortnightly follow up of children will be carried out by the community health worker until&#xD;
      the recovery of child this may takes up to 3-6 months during the first 3 months of the study&#xD;
      , the purpose of this follow up is to collect the information regarding, acceptability,&#xD;
      compliance, concurrent morbidities if any and record anthropometry (only weight &amp; MUAC).&#xD;
&#xD;
      Monthly follow-up visits:&#xD;
&#xD;
      Monthly follow ups will be done by data collectors to capture the information on recovery,&#xD;
      feeding practices, child's nutritional status morbidities &amp; mortality. These follow ups will&#xD;
      be continued for 6 months from the time of recruitment. Complete anthropometry (MUAC, Height&#xD;
      and Weight) will be carried out during monthly follow ups.&#xD;
&#xD;
      Household cost survey:&#xD;
&#xD;
      Towards the end of the intervention, a household survey will be implemented on a random&#xD;
      sample of program beneficiaries in both study areas to collect information on the direct and&#xD;
      indirect costs they incurred in participating in the program. This will include information&#xD;
      on cost of transportation, foods and medicines purchased, and time spent in accessing care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2015</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate rate of recovery</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate the rate of recovery of SAM treatment of children 6-59 months old 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 and ACF staff.&#xD;
Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of malnutrition</measure>
    <time_frame>18 months</time_frame>
    <description>It will be estimated through cross sectional surveys.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the cost effectiveness of treatment.</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt and ACF staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse from severe acute malnutrition</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate the relapse of SAM treatment of children 6-59 months old 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 and ACF staff.&#xD;
Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Default cases of SAM</measure>
    <time_frame>18 months</time_frame>
    <description>Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">762</enrollment>
  <condition>Severe Malnutrition</condition>
  <arm_group>
    <arm_group_label>Group A (intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Management of SAM at home' LHWs will identify and treat all cases of severe acute malnutrition (SAM) as per the study eligibility criteria (MUAC &lt; 11.5 cm) and manage all cases of SAM without complications at home with 'Standard CMAM program'. The LHWs will also identify SAM with complications for further assessment to the BHU Doctor and subsequent referral to the stabilization center . They will also provide one to one health and Infant and Young Child Feeding (IYCF) counselling to care takers of children in their catchment area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>'Management of SAM at facility' LHWs will identify SAM as per 'Standard CMAM program' (MUAC &lt; 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Management of SAM at home</intervention_name>
    <description>LHWs will identify and treat all cases of severe acute malnutrition (SAM) in children under-five years at household level compared with the standard CMAM program</description>
    <arm_group_label>Group A (intervention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Management of SAM at facility</intervention_name>
    <description>LHWs will identify SAM as per 'Standard CMAM program' (MUAC &lt; 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.</description>
    <arm_group_label>Group B (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in the study area&#xD;
&#xD;
          -  Presence of severe acute malnutrition (SAM).&#xD;
&#xD;
          -  Ability of the parents or guardians to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic debilitating illness.&#xD;
&#xD;
          -  Residence outside of study areas.&#xD;
&#xD;
          -  Inability or refusal of the parents or guardians to give informed consent, or refusal&#xD;
             of assessment.&#xD;
&#xD;
          -  Internally displaced population&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sajid Soofi, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University Project Office</name>
      <address>
        <city>Khairpur Nathan Shah</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.</citation>
    <PMID>23746776</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 11, 2015</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr Sajid Bashir Soofi</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>SAM</keyword>
  <keyword>Malnutrition</keyword>
  <keyword>LHW</keyword>
  <keyword>CMAM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
    <mesh_term>Severe Acute Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043352
org study id: 3276-Ped-ERC-14
nct id: NCT03043352
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
INTRODUCTION & RATIONALE:

      There is good evidence of the success of CMAM programs for treating SAM in emergencies and
      humanitarian crises [1], but little regarding the most cost effective mechanisms to deliver
      it or of the added value of integrating treatment of acute malnutrition with treatment of
      common childhood illness and/or extensive communitybased nutritional program.

      HYPOTHESIS:

      Provision of SAM treatment at household level in a community through lady health workers will
      be as effective (recovery rate, survival, cost effectiveness, coverage) as treatment provided
      at facility level.

      RESEARCH QUESTION:

      Will SAM treatment delivered through LHW at household level be as effective as SAM treatment
      delivered at facility level by health center staff?

      PRIMARY OBJECTIVES:

      To evaluate the effectiveness (rate of recovery, relapse & coverage), of SAM treatment of
      children 6-59 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
      Government and ACF staff. To evaluate the cost effectiveness of treatment of SAM provided by
      LHWs at community level versus treatment delivered at health facility by Government and ACF
      staff.

      SECONDARY OBJECTIVES:

      To evaluate the characterization of the breast feeding and complementary feeding practices in
      both study arms. To identify the main socio-economic characteristics of the households in
      both study arms.

      STUDY DESIGN:

      The study will be a 2-armed cluster randomized controlled trial targeting children 60-59
      months and their mothers for the treatment and prevention of acute severe malnutrition in
      children. Each cluster will be allocated to intervention group A, or control group B.

      Cost-effectiveness analysis:

      Cost effectiveness will be calculated to reflect the full range of resources required by
      service providers and households. A societal perspective will be taken with data collected on
      household costs incurred for participation in community and facility based activities. The
      approach will capture all resources used regardless of who incurs them, as used for cost
      analysis of other similar programs. Costs will be calculated with a combination of accounting
      records and estimates derived with an "ingredients" approach, using unit costs and quantities
      of inputs. Institutional costs will be estimated via accounting records. Costs which are
      known to be incurred by the program but which are not reflected in the accounting records
      (e.g. staff whose salaries are on different budgets, storage space which was not planned for
      in the original budget, etc.) will be estimated after identifying these costs through
      discussion with staff and document review. This data will be supplemented with costs
      calculated via an ingredients approach. Key informant interviews will be held with all key
      implementing staff to estimate their time allocation to project activities, in order to
      perform an activity based cost analysis.

      Coverage assessment:

      Coverage Assessments will be implemented in the two areas at the start the study, at six
      months of the study beginning and at the end of the study. SQUEAC methodology will be used.
      Coverage assessments are of particular interest in order to access the population that is not
      accessing treatment and understand its barriers to access. These assessments will be carried
      out by trained ACF staff.

      MAIN STUDY OUTCOMES:

      The key indicators to be captured are:

        1. Effectiveness - recovery rate (proportion of cured children among SAM enrolled),
           supplement compliance rate, defaulter rate, relapse rate, Length of stay, average weight
           gain, hospital admission, and complications

        2. Coverage rates and barriers to access (estimated using the SQUEAC methodology)

        3. Health & Nutrition status of children (prevalence of malnutrition etc.)

        4. Cost-effectiveness

        5. Descriptive analysis to assess the distribution of various factors within and between
           groups, cluster-adjusted analyses will compare SAM rates (recovery, survival, relapse,
           default) observed in the different arms. Kaplan Meier statistics will be used for the
           comparison of post-treatment survival.

      SAMPLE SIZE & RANDOMIZATION:

      Investigators have calculated the sample size on the basis of SAM as the primary indicator;
      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 achieves 98%
      power to detect a difference of 0.200 between the group means when the standard deviation is
      0.500 and the intracluster correlation is 0.00100 using a Two-Sided T-test with a
      significance level of 0.05000.

      Definition of cluster:

      A union council has been defined as the CLUSTER for the trial, a union council is the
      smallest administrative unit in the district which usually have a population of about 25000
      to 30000, and this population has about 2500-3000 under five children, if Investigators
      consider the national rates of SAM in Pakistan which is about 6% Investigators will find more
      than 150 cases of SAM from each union council during the study period which will be enough
      sample to achieve the objectives of the trial. One union council has usually one health
      facility Basic health Unit (BHU) or Rural Health Center.

      STUDY SITE:

      The study will be carried out in Dadu district, a rural district of Sindh province of
      Pakistan. This district has been selected due to the high global acute malnutrition (GAM)
      rates, being affected by emergencies. Currently in Sindh, SAM treatment is delivered at
      health facility level.

      BENEFICIARIES:

      Main target beneficiaries would be children 6- 59 months of age fulfilling the case
      definition of severe malnutrition and their mothers.

      DELIVERY OF INTERVENTION:

      Intervention Arm (A): Lady Health Workers operating at field level in study arm A will be
      trained at the start of the study. The same training package will be delivered to all LHWs
      involved in the study regardless of their previous training and the trainings will be
      delivered by the Department of Health (once officially agreed), by ACF & AKU. All eligible
      children in the LHW´s catchment area will be identified and registered by the LHWs as part of
      their routine activities. In Pakistan national guidelines, SAM treatment admission criteria
      is MUAC <11.5 cm. Children 6- 59 months, with MUAC less than 11.5 cm and meeting eligibility
      criteria will be enrolled after obtaining consent and provide treatment of SAM at home and
      IYCF counseling and follow up till recovery. Children 60-59 months in the criteria for
      stabilization care will also be referred by the LHW.

      The LHW will visit fortnightly to follow up all recruited children with SAM and receiving
      RUTF in their catchment population. If the child gets severely ill or having any complication
      the LHW will immediately refer that child to the nearest health facility for hospital based
      care. The LHW will record MUAC measurements on fortnightly follow up visits and weight and
      height will be recorded by the data collectors. Control Arm (B): Lady Health Workers
      operating at field level in study arm B will perform monthly home visit and will recruit and
      register all eligible children in their catchment area as part of their routine activities.
      The LHW will identify cases of SAM as per national CMAM guidelines through MUAC measurements
      and refer them to the nearest health facility where ACF staff will provide treatment in the
      facility as per standard CMAM guidelines.

      DATA COLLECTION:

      Data will be collected by an independent team, and not by LHWs. Data collection team will
      consist of 2 data collectors and a team leader. Data collectors and team leaders will be
      hired and trained to collect data by the study team.The team will visit identified households
      and the data will cross validate the LHW activities. The study team will collect information
      regarding children with SAM at baseline survey and during the study from LHWs and health
      facilities staff. A trained community health worker will visit the household having child
      with SAM and will take informed consent and recruit the child in the study.

      Baseline Cross Sectional Survey :

      A cross sectional survey will be conducted at household level in both arms

      Fortnightly follow-up visits :

      A fortnightly follow up of children will be carried out by the community health worker until
      the recovery of child this may takes up to 3-6 months during the first 3 months of the study
      , the purpose of this follow up is to collect the information regarding, acceptability,
      compliance, concurrent morbidities if any and record anthropometry (only weight & MUAC).

      Monthly follow-up visits:

      Monthly follow ups will be done by data collectors to capture the information on recovery,
      feeding practices, child's nutritional status morbidities & mortality. These follow ups will
      be continued for 6 months from the time of recruitment. Complete anthropometry (MUAC, Height
      and Weight) will be carried out during monthly follow ups.

      Household cost survey:

      Towards the end of the intervention, a household survey will be implemented on a random
      sample of program beneficiaries in both study areas to collect information on the direct and
      indirect costs they incurred in participating in the program. This will include information
      on cost of transportation, foods and medicines purchased, and time spent in accessing care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate rate of recovery
time frame: 18 months
description: To evaluate the rate of recovery of SAM treatment of children 6-59 months old 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 and ACF staff.
Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.
measure: Prevalence of malnutrition
time frame: 18 months
description: It will be estimated through cross sectional surveys.
measure: To evaluate the cost effectiveness of treatment.
time frame: 18 months
description: To evaluate the cost effectiveness of treatment of SAM provided by LHWs at community level versus treatment delivered at health facility by Govt and ACF staff.
measure: Relapse from severe acute malnutrition
time frame: 18 months
description: To evaluate the relapse of SAM treatment of children 6-59 months old 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 and ACF staff.
Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.
measure: Default cases of SAM
time frame: 18 months
description: Pakistan national guidelines for the community based management of acute malnutrition 2014 will be used to measure this outcome.
arm group label: Group A (intervention)
arm group type: Experimental
description: 'Management of SAM at home' 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 with 'Standard CMAM program'. The LHWs will also identify SAM with complications for further assessment to the BHU Doctor and subsequent referral to the stabilization center . They will also provide one to one health and Infant and Young Child Feeding (IYCF) counselling to care takers of children in their catchment area.
arm group label: Group B (Control)
arm group type: Active Comparator
description: 'Management of SAM at facility' LHWs will identify SAM as per 'Standard CMAM program' (MUAC < 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.
intervention type: Dietary Supplement
intervention name: Management of SAM at home
description: LHWs will identify and treat all cases of severe acute malnutrition (SAM) in children under-five years at household level compared with the standard CMAM program
arm group label: Group A (intervention)
intervention type: Dietary Supplement
intervention name: Management of SAM at facility
description: LHWs will identify SAM as per 'Standard CMAM program' (MUAC < 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.
arm group label: Group B (Control)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
healthy volunteers: No
last name: Sajid Soofi, FCPS
role: Principal Investigator
affiliation: Aga Khan University
facility: 
country: Pakistan
citation: Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 3;382(9890):396.
PMID: 23746776
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr Sajid Bashir Soofi
investigator title: Associate Professor
mesh term: Malnutrition
mesh term: Severe Acute Malnutrition
sharing ipd: Yes