<?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>IRCT2016121131346N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-01</date_registration>
      <primary_sponsor>Research Deputy school of Nursing and Midwifery of Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education on protective behaviors of Human Papillomavirus</public_title>
      <acronym></acronym>
      <scientific_title>Effect of education based on Health Belief Model on protective behaviors against Human Papillomavirus in vulnerable women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24686</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Humanpapillomavirus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: In this group, intervention is protective behavior of papillomavirus education base on Health Belief model structures. The number of meetings and training content will be determined after needs assessment  and includes  condom use  in  sex with a partner who has high risk behaviors, Having sex within marriage, Not having oral and anal sex and not smoking and  recognition virus signs in partner. Intervention 2: Control group:&#13;
The control group only receive Routine training of centers which they will be referred.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shokoohi Maryam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr st, Rashidyasemi st, School of Nursing &amp; Midwifery Iran University ofMedical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 218888288586</telephone>
        <email>shokoohi.m@tak.iums.ac.ir؛shokoohi_maryam52@yahoo.com</email>
        <affiliation>School of Nursing &amp; Midwifery Iran University ofMedical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamshidimanesh Mansoureh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr st, Rashid Yasemi St, School of Nursing &amp; Midwifery Iran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 218888288586</telephone>
        <email>jamshidimanesh@yahoo.commjamshidimanesh@gmail.com</email>
        <affiliation>School of Nursing &amp; Midwifery Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1.Minimum age of 18&#13;
2.Substance abuse disorder&#13;
3.Sexually active&#13;
4. Absence of warts on the genitals and anus in women based on self-reported or register file&#13;
5.Be able to read and write&#13;
Exclusion criteria:&#13;
1. Being absent more than one session in a training class</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B07</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Viral infections characterized by skin and mucous membrane lesions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: In this group, intervention is protective behavior of papillomavirus education base on Health Belief model structures. The number of meetings and training content will be determined after needs assessment  and includes  condom use  in  sex with a partner who has high risk behaviors, Having sex within marriage, Not having oral and anal sex and not smoking and  recognition virus signs in partner.</i_keyword>
      <i_keyword>Control group:&#13;
The control group only receive Routine training of centers which they will be referred.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Susceptibility. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Perceived Severity. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Perceived Benefits. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Perceived Barriers. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Cues to Action. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Self Efficacy. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 items Likert scale.</prim_outcome>
      <prim_outcome>Protective Behavior of Human Papillomavirus. Timepoint: Before the intervention, 4 weeks and 12 weeks after the intervention. Method of measurement: Researcher made tools with the 5 item Likert scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of Safe Sex. Timepoint: Before, 4 weeks ,12 weeks after intervention. Method of measurement: Questionary.</sec_outcome>
      <sec_outcome>Number of partner. Timepoint: Before, 4 weeks ,12 weeks After intervention. Method of measurement: Questionary.</sec_outcome>
      <sec_outcome>Number of  sexual relationship types. Timepoint: Before, 4 weeks ,12 weeks After intervention. Method of measurement: Questionary.</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>Research Deputy school of Nursing and Midwifery of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-08</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Tehran, Shahid Hemmat Highway, next Milad tower, Iran University of Medical Sciences Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
