<?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>IRCT20200602047638N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-22</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>Educational program promoting preventive behaviors of sexually transmitted infections</public_title>
      <acronym></acronym>
      <scientific_title>Design and assessment of a preventive behavioral training program for Sexual Transmited Infections among women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55632</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Random permutation block design of two treatments with quadruple blocks: Thus, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards as follows: BBAA,BABA,BAAB,ABAB,ABBA,AABB ,We then randomly select a digit from digits 1 to 6 (by someone other than the researcher). For example, if the number 2 is selected, it means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group, and we continue this operation until the sample size reaches the quorum.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexually transmitted infections (STIs).</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": After receiving the code of ethics of the Ethics Committee of the Research Department at the Faculty of Medical Sciences, Tarbiat Modarres University and approved the proposal initially achieved both by phone and by sending invitations through cyberspace, all interested women eligible to participate in the Educational program are invited will do.In the intervention group, the educational content will be presented based on the learning objectives pre-formulated in the second phase of the study in the form of mini lecture, group discussions, film screening, and infographic display.The place of training sessions in the classes of the city will be under the supervision of the Women Empowerment Headquarters of Tehran Municipality. Evaluation of the effect of post-test training intervention will be done in three time periods immediately, 1 month and three months after the end of the training intervention. Assessment tools at all stages of the same before and after the intervention. Intervention 2: Control group: In the control group, no educational intervention is performed, but at the end of the study, a booklet containing information about sexually transmitted diseases will be given as a gift to the participants.</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:
In this study, data can be shared after people are unrecognizable

When:
Access to study documentation will begin 6 months after the results are published

To whom:
Study documentation will be available to researchers in academic and scientific institutions

Conditions:
The use of data is allowed with the permission of the ethics committee of Tarbiat Modares University of Tehran

Where to obtain:
1- Dr. Fatemeh Zarei, Assistant Professor of Health Education and health promotion, Tarbiat Modares University, f.zarei@modares.ac.ir
2- Afsaneh Karami Joyani, PhD student in health education and health promotion 
K.Afsaneh@modares.ac.ir

How to obtain:
A week after receiving the request via email the corresponding researcher. (f.zarei@modares.ac.ir)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shamsuddin Niknami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modarres University,Jalal Al-Ahmad ,Bridge Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141173116</zip>
        <telephone>+98 21 8288 3549</telephone>
        <email>niknamis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran ,Jalal Ale Ahmad , Nasr Bridge  , Tarbiat Modares University  City Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>f.zarei@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Living in Tehran
without any chronic debilitating diseases such as (cancer, MS, acute heart disease)
age 18 to 48 years
having a minimum literacy and ability to answer questions and discuss in training classes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>48 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mental disorders
drug dependence and addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A50.0-A51.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Early congenital syphilis, symptomatic-Early syphilis</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": After receiving the code of ethics of the Ethics Committee of the Research Department at the Faculty of Medical Sciences, Tarbiat Modarres University and approved the proposal initially achieved both by phone and by sending invitations through cyberspace, all interested women eligible to participate in the Educational program are invited will do.In the intervention group, the educational content will be presented based on the learning objectives pre-formulated in the second phase of the study in the form of mini lecture, group discussions, film screening, and infographic display.The place of training sessions in the classes of the city will be under the supervision of the Women Empowerment Headquarters of Tehran Municipality. Evaluation of the effect of post-test training intervention will be done in three time periods immediately, 1 month and three months after the end of the training intervention. Assessment tools at all stages of the same before and after the intervention.</i_keyword>
      <i_keyword>Control group: In the control group, no educational intervention is performed, but at the end of the study, a booklet containing information about sexually transmitted diseases will be given as a gift to the participants.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive behaviors of sexually transmitted diseases. Timepoint: it will be performed in three time periods immediately, 1 month and three months after the end of the educational intervention. Method of measurement: Quarterly Scale Questionnaire for Measuring Preventive Behaviors from Sexually Transmitted Infections.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Faculty of Medical Sciences, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-22</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University</contact_name>
        <contact_address>Tehran ,Jalal Ale Ahmad , Nasr Bridge  , Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
