<?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>IRCT201311124076N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-09</date_registration>
      <primary_sponsor>Resaerch Deputy tehran university of medical sciences</primary_sponsor>
      <public_title>Efficacy of peer education on HIV-related high risk behaviors</public_title>
      <acronym>Efficacy of peer education on HIV-related high risk behaviors</acronym>
      <scientific_title>Efficacy of peer education on HIV-related high risk behaviors among girls from dysfunctional family</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4257</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>HIV AIDS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:&#13;
 HIV/AIDS prevention education is of prominent importance. The study venues are all care centers for orphaned or mal-adapted girls in Tehran. Eighty young girls from malfunctioning families meeting inclusion criteria, selected through convenience sampling, will participate in the study after informed consent. Consulting institute managers, ten students will be evaluated to select four peer educators who will be trained by experienced staff in 5 to 10 sessions; thereafter they will educate their peers in the case group.  Case and control groups are going to be of two different centers to prevent bias and they will be investigated to eliminate con-founder effects. Data collection will proceed through structured, valid and reliable questionnaires in pre and post-test format; from peer educators and subsequently from trainees of these educators to evaluate the efficacy of intervention. in control group we dont have any intervention.only after the end of project we give them educational package. Intervention 2: Control Group:&#13;
There is no intervention for this group.&#13;
We will complete pre test post test questionnaire( same as intervention group).</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>Minoo Mohraz MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1583</telephone>
        <email>ircha@tums.ac.ir ircha.tums.ac.ir</email>
        <affiliation>Iranian research Center for HIV AIDS (IRCHA)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Mohraz MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian research center for HIV AIDS, Imam Hospital, Keshavarz BLVd , Valiasr Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1583</telephone>
        <email>ircha@tums.ac.ir ircha.tums.ac.ir</email>
        <affiliation>Iranian research center for HIV AIDS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age between 15- 25 years old; home residents; being care center participants for at least 6 months; informed consent to take part in the study.&#13;
Exclusion criteria: girls who expect graduation in the upcoming 3 months; those who have been in similar educational programs in the field of HIV/AIDS prevention; missing more than 2 sessions.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Human immunodeficiency virus [HIV] disease</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:&#13;
 HIV/AIDS prevention education is of prominent importance. The study venues are all care centers for orphaned or mal-adapted girls in Tehran. Eighty young girls from malfunctioning families meeting inclusion criteria, selected through convenience sampling, will participate in the study after informed consent. Consulting institute managers, ten students will be evaluated to select four peer educators who will be trained by experienced staff in 5 to 10 sessions; thereafter they will educate their peers in the case group.  Case and control groups are going to be of two different centers to prevent bias and they will be investigated to eliminate con-founder effects. Data collection will proceed through structured, valid and reliable questionnaires in pre and post-test format; from peer educators and subsequently from trainees of these educators to evaluate the efficacy of intervention. in control group we dont have any intervention.only after the end of project we give them educational package.</i_keyword>
      <i_keyword>Control Group:&#13;
There is no intervention for this group.&#13;
We will complete pre test post test questionnaire( same as intervention group)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HIV-related high risk behaviors. Timepoint: Exactly after intervention ( Time 0),45 days after intervention (1.5 Months) and 90 days after intervention (3 months). Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knowledge, attitudes, practice. Timepoint: Exactly after intervention ( Time 0),45 days after intervention (1.5 Months) and 90 days after intervention (3 months). 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>Resaerch Deputy tehran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-11-22</approval_date>
        <contact_name>Iranian Research Center for HIV/AIDS</contact_name>
        <contact_address>Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
