<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230814059147N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-06</date_registration>
      <primary_sponsor>Office of Research Innovation and Commercialization (ORIC) National University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of a Multi-Component School-Based Educational Intervention on Improving Water, Sanitation, and Hygiene (WASH) Practices among Primary School Children in Rawalpindi</public_title>
      <acronym>SWIFT Trial</acronym>
      <scientific_title>Effectiveness of a Multi-Component School-Based Educational Intervention on Improving Water, Sanitation, and Hygiene (WASH) Practices among Primary School Children in Rawalpindi: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>188</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91402</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple cluster randomization method with a 1:1 allocation ratio was used, with the school serving as the unit of randomization to minimize contamination between students within the same institution. Eligible public primary schools from the selected peri-urban areas of Rawalpindi were assigned unique identification numbers, and an independent researcher generated the random allocation sequence using a computer-generated random number function in Microsoft Excel. No stratification was applied because all participating schools had comparable geographical and administrative characteristics. Allocation concealment was maintained until completion of baseline data collection by restricting access to the allocation sequence to the independent researcher. Owing to the nature of the intervention, blinding of participants and school staff was not feasible; however, outcome assessors remained blinded to group allocation during data collection to minimize observer bias, Blinding description: Owing to the nature of the multi-component school-based intervention, blinding of participants, teachers, and intervention providers was not feasible. However, outcome assessors were blinded to group allocation during baseline, post-intervention, and follow-up data collection to minimize observer bias. Thus, the study employed an assessor-blinded (single-blind) design.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Poor hand hygiene (inadequate handwashing practices) among primary school children. Condition 2: Acute upper respiratory infection,.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group received a 4-week multi-component school-based Water, Sanitation and Hygiene (WASH) intervention comprising four integrated components: (1) four weekly 45-minute interactive hygiene education sessions delivered by trained investigators using age-appropriate presentations, demonstrations, storytelling, discussions, and practical handwashing exercises; (2) continuous provision of commercially available hand soap at designated school handwashing stations throughout the intervention period; (3) environmental behavioural nudges, including painted footprints leading from toilets to handwashing stations and mirrors installed above the stations to encourage handwashing with soap; and (4) establishment of student-led WASH committees supervised by teachers to reinforce hygiene practices, promote peer support, monitor soap availability, and encourage maintenance of handwashing facilities. Intervention 2: Control group: Participants in the control group continued their routine educational activities according to the standard government primary school curriculum throughout the 4-week study period. No additional WASH-specific intervention, including interactive hygiene education sessions, continuous soap provision, environmental behavioural nudges (painted footprints and mirrors), or student-led WASH committees, was introduced. Schools maintained their usual water, sanitation, and hygiene facilities and practices without modification.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
De-identified Individual Participant Dataset (IPD) and Study Documents

De-identified individual participant data underlying the published results, including the study protocol, statistical analysis plan, data dictionary, informed consent forms, and study instruments (WASH KAP questionnaire and Structured Non-Intrusive Observation checklist), will be made available upon reasonable request to the corresponding investigator. Data will be shared after publication of the primary study findings for researchers with a methodologically sound proposal, following approval by the principal investigator and institutional ethics requirements. Participant confidentiality will be protected by removing all personal identifiers.

When:
By December 2026

To whom:
All the people related to public health

Conditions:
For public health issues related to hand hygiene

Where to obtain:
by emailing the Dr Paaras Suleman : 
Dr Paaras Suleman 
sulemanpaaras@gmail.com
0334-3931815

How to obtain:
Researchers requesting access to study data or documents should submit a written request to the corresponding investigator describing the research objectives, intended use of the data, and analysis plan. Requests will be reviewed by the principal investigator and, where required, the institutional ethics committee to ensure scientific merit and protection of participant confidentiality. Approved applicants may be required to sign a data-sharing agreement before receiving de-identified data and study documents. Data will normally be made available within 4–8 weeks of approval.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Paaras Suleman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Rd, Rawalpindi,</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 334 3931815</telephone>
        <email>sulemanpaaras@gmail.com</email>
        <affiliation>Armed Forces Post Graduate Medical Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Paaras Suleman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH Rd, Rawalpindi,</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 334 3931815</telephone>
        <email>sulemanpaaras@gmail.com</email>
        <affiliation>Armed Forces Post Graduate Medical Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Male and female students enrolled in grades 2 through 5.
Written informed consent from parents and administrative approval from the school head
Student assent provided following a child-friendly explanation of the study procedures</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Documented cognitive or sensory impairments that would have significantly hindered comprehension of the interactive educational sessions.
Students with more than 50% absenteeism during the baseline month or the active intervention phase, as this prevented the child from receiving the minimum "intervention dosage" required for habit formation.
Students who joined the school after the randomization process was completed.
Non-eligible Age/Grade Profile: Students who did not fall within the target age bracket of 6–12 years or were not officially enrolled in grades 2 through 5 at the time of the baseline assessment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A09</hc_code>
      <hc_code>J06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Infectious gastroenteritis and colitis, unspecified</hc_keyword>
      <hc_keyword>Acute upper respiratory infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group received a 4-week multi-component school-based Water, Sanitation and Hygiene (WASH) intervention comprising four integrated components: (1) four weekly 45-minute interactive hygiene education sessions delivered by trained investigators using age-appropriate presentations, demonstrations, storytelling, discussions, and practical handwashing exercises; (2) continuous provision of commercially available hand soap at designated school handwashing stations throughout the intervention period; (3) environmental behavioural nudges, including painted footprints leading from toilets to handwashing stations and mirrors installed above the stations to encourage handwashing with soap; and (4) establishment of student-led WASH committees supervised by teachers to reinforce hygiene practices, promote peer support, monitor soap availability, and encourage maintenance of handwashing facilities.</i_keyword>
      <i_keyword>Control group: Participants in the control group continued their routine educational activities according to the standard government primary school curriculum throughout the 4-week study period. No additional WASH-specific intervention, including interactive hygiene education sessions, continuous soap provision, environmental behavioural nudges (painted footprints and mirrors), or student-led WASH committees, was introduced. Schools maintained their usual water, sanitation, and hygiene facilities and practices without modification.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Observed handwashing with soap (HWWS). Timepoint: At baseline, post-intervention (4 weeks), and 3-month follow-up. Method of measurement: measured using a Structured Non-Intrusive Observation (SNIO).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>WASH Knowledge, Attitude and Practice (KAP) score. Timepoint: Baseline, immediately after the 4-week intervention, and 3-month follow-up. Method of measurement: Validated 73-item WASH KAP questionnaire (composite KAP score).</sec_outcome>
      <sec_outcome>Illness-related absenteeism. Timepoint: Throughout the study and at 3-month follow-up. Method of measurement: School attendance registers cross-verified with parental illness reports.</sec_outcome>
      <sec_outcome>Sustainability of handwashing behavior (behavioral slippage). Timepoint: 3-month follow-up. Method of measurement: Structured Non-Intrusive Observation (SNIO).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Office of Research Innovation and Commercialization (ORIC) National University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-25</approval_date>
        <contact_name>Armed Forces Post Graduate Medical Institute Ethical Review Committe</contact_name>
        <contact_address>CMH Rd, Rawalpindi, Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
