<?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>IRCT20251127068127N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Assessing of an Intervention Based on 'Risk Communication and Community Engagement'(RCCE) for Enhancement of Framework Constructs and Preventing the Spread and Expansion of the Invasive Aedes Mosquito</public_title>
      <acronym></acronym>
      <scientific_title>Assessing of an Intervention Based on 'Risk Communication and Community Engagement'(RCCE) for Enhancement of Framework Constructs and Preventing the Spread and Expansion of the Invasive Aedes Mosquito</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>800</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88656</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: In this research urban neighborhoods (mahallas) function as both the randomization units and the study's cluster boundaries. The study areas consist of 20 distinct clusters which create geographic boundaries that enable researchers to study them without interference from other study areas. The study included 20 clusters which consisted of 10 clusters from Kheybar Health Center and 10 clusters from Qods Health Center. The study used random allocation to assign clusters to the two study arms at a 1:1 ratio between intervention and control groups. The research study will invite all eligible households from the chosen clusters to participate in the research study, Blinding description: Clusters will be randomly assigned to either the intervention arm or the usual care arm using a computer-generated random sequence. An independent statistician who has no role in participant recruitment and intervention delivery will perform the randomization process. Allocation concealment will be ensured at the cluster level. The allocation sequence will be kept in sealed, opaque envelopes and will not be disclosed until clusters have been enrolled.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Educational intervention using risk communication and social motivation framework to prevent the spread and spread of invasive Aedes mosquitoes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention will establish a community-based program which depends on the Risk Communication and Community Engagement (RCCE) framework as its foundational element. The program will run for 2 months and it will include these program components: 1.Risk communication: Delivery of culturally tailored messages addressing Aedes mosquito risks, dengue and other Aedes-borne diseases, modes of transmission, symptoms, and prevention strategies.  2.Community engagement: The community leaders together with health volunteers and local organizations will actively work to create a situation where people will join together to share accountability. 3.Behavioral motivation: The manual offers people practical steps which will help them remove mosquito breeding areas that include stagnant water near their homes while teaching them how to continue their preventive practices. 4.Communication channels: The program will use household visits and group sessions together with printed educational materials and digital and social media platforms which are suitable for the local community. The program will provide all activities through trained community health workers CHWs and primary health care staff who will implement activities according to standardized manuals and supervision protocols. Intervention 2: Control group: The usual care group will receive ongoing standard vector control and health education services which the local health system provides. The health centers use passive information delivery to their customers together with standard environmental health methods which do not include community engagement and do not use RCCE framework for their environmental health work.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Despite of anonymity of the obtained consent from participants, we assured them that their personal information would not be made public.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Ashourkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Tehran University of Medical Sciences, Poursina street, Ghods street, Enqelab Avenue, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>Ashoorkhani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Ashourkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Public Health, Tehran University of Medical Sciences, Poursina street, Ghods street, Enqelab Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417613151</zip>
        <telephone>+98 21 4293 3333</telephone>
        <email>ashoorkhani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be over 18 years of age.
They must reside in the intervention neighborhood.
The individual or their household must have a smartphone and virtual messengers.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those who cannot give informed consent
Individuals who have severe cognitive impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention will establish a community-based program which depends on the Risk Communication and Community Engagement (RCCE) framework as its foundational element. The program will run for 2 months and it will include these program components: 1.Risk communication: Delivery of culturally tailored messages addressing Aedes mosquito risks, dengue and other Aedes-borne diseases, modes of transmission, symptoms, and prevention strategies.  2.Community engagement: The community leaders together with health volunteers and local organizations will actively work to create a situation where people will join together to share accountability. 3.Behavioral motivation: The manual offers people practical steps which will help them remove mosquito breeding areas that include stagnant water near their homes while teaching them how to continue their preventive practices. 4.Communication channels: The program will use household visits and group sessions together with printed educational materials and digital and social media platforms which are suitable for the local community. The program will provide all activities through trained community health workers CHWs and primary health care staff who will implement activities according to standardized manuals and supervision protocols.</i_keyword>
      <i_keyword>Control group: The usual care group will receive ongoing standard vector control and health education services which the local health system provides. The health centers use passive information delivery to their customers together with standard environmental health methods which do not include community engagement and do not use RCCE framework for their environmental health work.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of receipt of appropriate communication and information (information demand, information access, information satisfaction, information trust, and infodemic risk) for promoting framework structures and preventing the spread and spread of invasive Aedes mosquitoes in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The level of knowledge and awareness of study participants for upgrading framework structures and preventing the spread and spread of invasive Aedes mosquitoes in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The risk perception of study participants for upgrading framework structures and preventing the spread and spread of invasive Aedes mosquitoes in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The performance of study participants to improve framework structures and prevent the spread and spread of invasive Aedes mosquitoes in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The level of social factors of the target community (stigma, social norms, social motivation) for promoting framework structures and preventing the spread and expansion of the invasive Aedes mosquito in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>The level of structural factors of the target community for improving framework structures and preventing the spread and expansion of the invasive Aedes mosquito in the intervention and control groups. Timepoint: Beginning and end of the study. Method of measurement: Researcher-made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Container Index (CI). Timepoint: Beginning and end of the study. Method of measurement: Standardized observational checklists and entomological inspection tools.</sec_outcome>
      <sec_outcome>Breteau Index (BI). Timepoint: Beginning and end of the study. Method of measurement: Standardized observational checklists and entomological inspection tools.</sec_outcome>
      <sec_outcome>House Index (HI). Timepoint: Beginning and end of the study. Method of measurement: Standardized observational checklists and entomological inspection tools.</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>Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-10</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Floor 6, Headquarters of Tehran University of Medical Sciences, Streetcorner of Quds Ave, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
