<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/NCT03822611</url>
  </required_header>
  <id_info>
    <org_study_id>WASHPaLS Subsidy Study</org_study_id>
    <nct_id>NCT03822611</nct_id>
  </id_info>
  <brief_title>Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities</brief_title>
  <official_title>Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Aquaya Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tetratech</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Aquaya Institute</source>
  <oversight_info>
    <has_dmc>No</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>
      This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure&#xD;
      and behaviours in communities that have reached Open Defecation Free (ODF) status after a&#xD;
      Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that&#xD;
      sanitation subsidies targeted at the most vulnerable households within ODF communities will&#xD;
      increase and help sustain latrine coverage, quality, and use amongst the targeted households,&#xD;
      and through a spill-over effect, amongst the rest of the community. Half of participating&#xD;
      communities will receive the targeted subsidy, while the other half will not receive any&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Community-Led Total Sanitation (CLTS) is a widely used approach to eradicate open defecation&#xD;
      in rural communities in developing countries. Using emotional triggers, CLTS promotes&#xD;
      community self-help to build household latrines. In Ghana, where CLTS is part of the&#xD;
      government's official sanitation strategy, a community is declared &quot;Open Defecation Free&quot;&#xD;
      (ODF) when 80 percent of households own a latrine.&#xD;
&#xD;
      There is however evidence that open defecation persists in so-called &quot;ODF&quot; communities,&#xD;
      especially as the most vulnerable households (the poorest of the poor) cannot afford to&#xD;
      construct or maintain durable latrines. As a result, subsidies for these vulnerable&#xD;
      households have been proposed as a strategy to promote the construction of durable latrines&#xD;
      and help sustain safe sanitation behaviours in communities having received CLTS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>
    <intervention_model_description>cluster Randomized controlled trial (c-RCT)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of households owning an individual, functional latrine with full superstructure</measure>
    <time_frame>Approximately 18 months</time_frame>
    <description>Household ownership (yes/no) of a latrine that is i) not shared with other households (&quot;individual&quot;), ii) whose pit is not collapsed and not full (&quot;functional&quot;), and iii) with four walls (or circular walls) and a roof of any materials (&quot;full superstructure&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of households reporting practicing open defecation</measure>
    <time_frame>Approximately 18 months</time_frame>
    <description>Self report by the respondent of not always using a toilet to defecate when at home.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of households owning an individual, functional latrine with full superstructure and durable superstructure</measure>
    <time_frame>Approximately 18 months</time_frame>
    <description>Household ownership (yes/no) of a latrine that is i) not shared with other households (&quot;individual&quot;), ii) whose pit is not collapsed and not full (&quot;functional&quot;), iii) with four walls (or circular walls) and a roof of any materials (&quot;full superstructure&quot;), iv) with a concrete/plastic slab and pit lining with plastic/rocks/bricks/concrete (&quot;durable substructure&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of households reporting satisfaction with latrine</measure>
    <time_frame>Approximately 18 months</time_frame>
    <description>Self report by the respondent of being satisfied with the latrine (s)he uses for defecation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5615</enrollment>
  <condition>Sanitation</condition>
  <arm_group>
    <arm_group_label>Targeted Subsidy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In these communities, households identified as vulnerable receive a voucher for a free latrine sub-structure (slab + pit lining), redeemable with local sanitation suppliers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No subsidy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In these communities, no household receives a voucher.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Targeted Subsidy</intervention_name>
    <description>Voucher</description>
    <arm_group_label>Targeted Subsidy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        This study is a cluster randomized controlled trial that will enroll entire communities.&#xD;
        Within a community, only specific households will be selected to receive sanitation subsidy&#xD;
        vouchers. Outcomes will be measured both for voucher recipients and for the rest of the&#xD;
        community.&#xD;
&#xD;
        Inclusion Criteria (for Communities):&#xD;
&#xD;
          -  Community was targeted by UNICEF's Community-Led Total Sanitation (CLTS) program in&#xD;
             Tatale, Yendi, and Kpandai districts in Ghana.&#xD;
&#xD;
          -  Community has Open Defecation Free (ODF) status according to local authorities.&#xD;
&#xD;
          -  Community has more than 15 and less than 100 households.&#xD;
&#xD;
        Exclusion Criteria (for Communities):&#xD;
&#xD;
          -  Community is located less than 2 kilometers away from a community in the opposite&#xD;
             treatment arm.&#xD;
&#xD;
        Inclusion Criteria (for voucher recipients within study communities):&#xD;
&#xD;
          -  Household is extremely poor, as identified through community consultation and/or the&#xD;
             government's Livelihood Empowerment Against Poverty (LEAP) program.&#xD;
&#xD;
          -  Household has at least one vulnerable person, i.e. who meets one of the following&#xD;
             criteria: i) older than 65 years old, ii) person with a disability, iii) orphan or&#xD;
             vulnerable child, iv) female head of household, v) widow(er), vi) terminally-ill&#xD;
             persons, vii) unemployed, viii) outcast groups.&#xD;
&#xD;
        Exclusion Criteria (for voucher recipients within study communities):&#xD;
&#xD;
          -  Household owns a functional, individual (non-shared) latrine with durable&#xD;
             sub-structure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Peletz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Aquaya Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Districts of Tatale and Kpandai, Northern Region</name>
      <address>
        <city>Tamale</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 1, 2021</last_update_submitted>
  <last_update_submitted_qc>October 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for the primary and all secondary outcome measures as well as key confounders (demographics, wealth index, community characteristics) will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be available within 9 months of study completion.</ipd_time_frame>
  </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/NCT03822611
org study id: WASHPaLS Subsidy Study
nct id: NCT03822611
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure
      and behaviours in communities that have reached Open Defecation Free (ODF) status after a
      Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that
      sanitation subsidies targeted at the most vulnerable households within ODF communities will
      increase and help sustain latrine coverage, quality, and use amongst the targeted households,
      and through a spill-over effect, amongst the rest of the community. Half of participating
      communities will receive the targeted subsidy, while the other half will not receive any
      treatment.
Community-Led Total Sanitation (CLTS) is a widely used approach to eradicate open defecation
      in rural communities in developing countries. Using emotional triggers, CLTS promotes
      community self-help to build household latrines. In Ghana, where CLTS is part of the
      government's official sanitation strategy, a community is declared "Open Defecation Free"
      (ODF) when 80 percent of households own a latrine.

      There is however evidence that open defecation persists in so-called "ODF" communities,
      especially as the most vulnerable households (the poorest of the poor) cannot afford to
      construct or maintain durable latrines. As a result, subsidies for these vulnerable
      households have been proposed as a strategy to promote the construction of durable latrines
      and help sustain safe sanitation behaviours in communities having received CLTS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: cluster Randomized controlled trial (c-RCT)
primary purpose: Other
masking: None (Open Label)
measure: Percentage of households owning an individual, functional latrine with full superstructure
time frame: Approximately 18 months
description: Household ownership (yes/no) of a latrine that is i) not shared with other households ("individual"), ii) whose pit is not collapsed and not full ("functional"), and iii) with four walls (or circular walls) and a roof of any materials ("full superstructure").
measure: Percentage of households reporting practicing open defecation
time frame: Approximately 18 months
description: Self report by the respondent of not always using a toilet to defecate when at home.
measure: Percentage of households owning an individual, functional latrine with full superstructure and durable superstructure
time frame: Approximately 18 months
description: Household ownership (yes/no) of a latrine that is i) not shared with other households ("individual"), ii) whose pit is not collapsed and not full ("functional"), iii) with four walls (or circular walls) and a roof of any materials ("full superstructure"), iv) with a concrete/plastic slab and pit lining with plastic/rocks/bricks/concrete ("durable substructure").
measure: Percentage of households reporting satisfaction with latrine
time frame: Approximately 18 months
description: Self report by the respondent of being satisfied with the latrine (s)he uses for defecation.
arm group label: Targeted Subsidy
arm group type: Experimental
description: In these communities, households identified as vulnerable receive a voucher for a free latrine sub-structure (slab + pit lining), redeemable with local sanitation suppliers.
arm group label: No subsidy
arm group type: No Intervention
description: In these communities, no household receives a voucher.
intervention type: Behavioral
intervention name: Targeted Subsidy
description: Voucher
arm group label: Targeted Subsidy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Peletz, PhD
role: Principal Investigator
affiliation: The Aquaya Institute
facility: 
country: Ghana
responsible party type: Sponsor
sharing ipd: Yes
ipd description: De-identified individual participant data for the primary and all secondary outcome measures as well as key confounders (demographics, wealth index, community characteristics) will be made available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be available within 9 months of study completion.