<?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>IRCT20200615047784N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-02</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of educational intervention on social cognitive theory in health ambassadors on the preventive behaviors of cutaneous leishmaniasis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational intervention based on social cognitive theory in health volunteers on preventive behaviors of cutaneous leishmaniosis in volunteers and covered households</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>220</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48974</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: With a multi-stage cluster method of comprehensive rural health service centers and health houses affiliated to Mashhad city health center number one, which consists of 51 rural centers and health houses in three clusters (clusters based on their geographical location relative to the city health center) Mashhad number one is considered) First, a cluster will be selected randomly by lottery method. Each health house will be given a number and by drawing a health house for the experimental group (individual number) and a health house It is assigned to the control group (even number). Then, in each of the selected health centers, the list of registered health ambassadors is extracted and according to the Word criteria, individuals are included in the study and sample size, Blinding description: In this study, the study analysts are kept blind to the information of the intervention and control groups by assigning an unspecified title (for example, by titles of groups 1 and 3).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Leishmaniasis.</hc_freetext>
      <i_freetext>Intervention 1: This study will be performed quasi-experimentally with a control group. First, a descriptive study is performed to determine the factors related to the preventive behaviors of leishmaniasis. In the second stage, intervention studies of before and after type are performed with a randomized control group. Based on the education of leishmaniasis and based on cognitive-social theory on preventive behaviors of leishmaniasis through health ambassadors will be performed on rural households in Mashhad 1. Training programs between 6 to 8 sessions; 2 face-to-face sessions (60 m) and other virtual sessions (via social media) will be held over a period of one month. The educational content will be in the form of pamphlets, tracts, educational videos, and slides. In 3 stages, the researcher-made questionnaire will be completed immediately after the training, immediately after the training, and 3 months after the training. The data will be analyzed with SPSS software. The teaching method should be measured. Intervention 2: Control group: Health ambassadors and members of their families do not receive training in the control group, but after the intervention, they will be given a training package.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Upon completion of the study, it will be provided to the applicant organizations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmoud Fakhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 16. Daneshghah street, Mashhad, Khorasan-Razavi. Postal Cod: 9137673119</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137673119</zip>
        <telephone>+98 51 3189 2206</telephone>
        <email>Fakharm2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrsadat Mahdizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.16, Daneshgah street, School of health, Mashhad, Khorasan razavi. Postal Cod: 9137673119</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137673119</zip>
        <telephone>+98 51 3854 4633</telephone>
        <email>Mahdizadehtm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Health ambassadors and their parents have informed consent.
Health ambassadors must be over 15 years old
Health ambassadors do not have a confirmed disability or physical disability.
Have not attended health ambassadors training classes.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not able to read and write.
Family members covered by health ambassadors must be over 40 years old.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B55.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cutaneous leishmaniasis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study will be performed quasi-experimentally with a control group. First, a descriptive study is performed to determine the factors related to the preventive behaviors of leishmaniasis. In the second stage, intervention studies of before and after type are performed with a randomized control group. Based on the education of leishmaniasis and based on cognitive-social theory on preventive behaviors of leishmaniasis through health ambassadors will be performed on rural households in Mashhad 1. Training programs between 6 to 8 sessions; 2 face-to-face sessions (60 m) and other virtual sessions (via social media) will be held over a period of one month. The educational content will be in the form of pamphlets, tracts, educational videos, and slides. In 3 stages, the researcher-made questionnaire will be completed immediately after the training, immediately after the training, and 3 months after the training. The data will be analyzed with SPSS software. The teaching method should be measured.</i_keyword>
      <i_keyword>Control group: Health ambassadors and members of their families do not receive training in the control group, but after the intervention, they will be given a training package.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of self-control. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of self-efficacy. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of social support. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of outcome expectations. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of  barrier self efficacy. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of environmental perception. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of emotional adjustment. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Scores of structures of outcome experiences. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Score of preventive behavior of leishmaniasis. Timepoint: Before the intervention - immediately after the intervention - 3 months after the intervention. Method of measurement: questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Demographic variables. Timepoint: At one stage, preferably 3 months after training. Method of measurement: questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-13</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>No. 16، Daneshgah Street، School of Health. Postal Code: 9137673119 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
