<?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>IRCT201612113034N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-31</date_registration>
      <primary_sponsor>Research Deputy school of Nursing and Midwifery of Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of peer education on preventive behaviors of HIV and hepatitis B</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of peer-based education on self-esteem , perceived vulnerability and performance towards prevention of  HIV and hepatitis B in women with substance use disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3028</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>Condition 1: HIV. Condition 2: Hepatitis B.</hc_freetext>
      <i_freetext>Intervention 1: Control: To control group, a training session based on the protocol Ministry of Health to prevent HIV infection in the mother and child will be held after filling out the questionnaire. Intervention 2: In this intervention peers education is the most important part of education. Researcher make a test, based on check list of intervention session and each peer who be able to get satisfaction score will select as a peer educator. Researcher will educate peers educators in 30 hours and education of intervention group will be in 6 session two days a week and each session is about 45 to 60 minutes. Educational content includes HIV and Hepatitis B disease definition and ways of prevention of them,save sexual behavior, use of condom, do HIV and Hepatitis B test, dialogue and assertiveness techniques with the partner and  problem solving. For control grope one session will hold according to the Ministry of Health protocol based on the prevention of HIV in mother and child after filling out questionnaire.It should be noted, researcher will monitor all stages of the intervention process.</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>Soheila Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr st, Rashidyasemi 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>soheila_ahmadi124@yahoo.com; catherine515124@gmail.com</email>
        <affiliation>School of Nursing &amp; Midwifery Iran University of Medical 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.com; mjamshidimanesh@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:Age over 18 years;When filling out the questionnaire and participate in the class have the ability to answer and dialogue;Having at least degree of knowledge;substance use at least for 3 months; sexually active;lack of HIV infection.exclusion criteria: do not participate in training class for more than one session;Happening unexpected events</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B20-B24</hc_code>
      <hc_code>B16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Human immunodeficiency virus [HIV] disease</hc_keyword>
      <hc_keyword>Acute hepatitis B</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control: To control group, a training session based on the protocol Ministry of Health to prevent HIV infection in the mother and child will be held after filling out the questionnaire.</i_keyword>
      <i_keyword>In this intervention peers education is the most important part of education. Researcher make a test, based on check list of intervention session and each peer who be able to get satisfaction score will select as a peer educator. Researcher will educate peers educators in 30 hours and education of intervention group will be in 6 session two days a week and each session is about 45 to 60 minutes. Educational content includes HIV and Hepatitis B disease definition and ways of prevention of them,save sexual behavior, use of condom, do HIV and Hepatitis B test, dialogue and assertiveness techniques with the partner and  problem solving. For control grope one session will hold according to the Ministry of Health protocol based on the prevention of HIV in mother and child after filling out questionnaire.It should be noted, researcher will monitor all stages of the intervention process.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-esteem. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Rosenberg Self-esteem Questionnaire.</prim_outcome>
      <prim_outcome>Perceived Vulnerability  to HIV. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Vulnerability to HIV  Questionnaire.</prim_outcome>
      <prim_outcome>Perceived Vulnerability to Hepatits b. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Vulnerability to Hepatitis B Questionnaire.</prim_outcome>
      <prim_outcome>Performance. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Condom use. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</sec_outcome>
      <sec_outcome>HIV test. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</sec_outcome>
      <sec_outcome>HBV TEST. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</sec_outcome>
      <sec_outcome>Type of sex. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</sec_outcome>
      <sec_outcome>Number of partner. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function questionnaire.</sec_outcome>
      <sec_outcome>Number of save sex. Timepoint: Before intervention, immedately, 4 weeks and 12 weeks after intervention. Method of measurement: Demographic, Sexual function 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>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>2017-04-05</approval_date>
        <contact_name>Iran University of Medical Science</contact_name>
        <contact_address>Iran University of Medical Science, Next to the Milad Tower, Shahid Hemat Highway, Tehran, Iran Teran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
