<?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>IRCT20120414009463N65</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-15</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>effect of comprehensive sex education on promoting safe sexual behavior</public_title>
      <acronym></acronym>
      <scientific_title>The effect of comprehensive sex education on promoting safe sexual behavior of HIV-positive youth</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>27</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60302</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By throwing the dice, people are divided into control and intervention groups. In this case, in case of even numbers (2, 4 or 6), people would enter the intervention group and in case of odd numbers (1, 3 or 5), people would enter the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>HIV/AIDS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: All HIV-positive 15- to 24-year-olds eligible to enter the study entered the study consciously after receiving a full explanation of the purpose of the study and obtaining written consent.Training sessions will be held for two groups of 15-19 years old and 20-24 years old. This classification was taken from the protocol of "Adolescent and Youth Health and Counseling Club" of the Ministry of Health of the Islamic Republic of Iran.Meetings are in groups of 4-6 people. The first introductory session was held between the instructor and the participants, stating the goals, reproductive and sexual health issues and the Charter of Citizenship Rights with emphasis on reproductive and sexual rights. In the second session, the anatomy and hormonal and physical changes of puberty were taught, and at the end, people explain their experiences during puberty. In the third session, sexually transmitted diseases and methods of preventing unwanted pregnancies were taught. The fourth and fifth sessions will discuss safe sex, high-risk sexual behaviors, and accountability. Sessions are about 120 minutes. Before and two months after the last intervention session, the Safe Sexual Behavior Questionnaire is examined in both groups. Intervention 2: Control group: The routine procedures of the Behavioral Diseases Counseling Center will be performed.</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 Because the information of HIV patients is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Asadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>asadi.midwife@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Behboodi Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Tehran University of Medical Sciences, East Nosrat Avenue,Towhid square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 8826 7483</telephone>
        <email>Behboodi@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>HIV-positive young people aged 15-24 who were aware of their disease.
Literate reading and writing</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of awareness of the status of the disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B20.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>HIV disease resulting in other viral infections</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: All HIV-positive 15- to 24-year-olds eligible to enter the study entered the study consciously after receiving a full explanation of the purpose of the study and obtaining written consent.Training sessions will be held for two groups of 15-19 years old and 20-24 years old. This classification was taken from the protocol of "Adolescent and Youth Health and Counseling Club" of the Ministry of Health of the Islamic Republic of Iran.Meetings are in groups of 4-6 people. The first introductory session was held between the instructor and the participants, stating the goals, reproductive and sexual health issues and the Charter of Citizenship Rights with emphasis on reproductive and sexual rights. In the second session, the anatomy and hormonal and physical changes of puberty were taught, and at the end, people explain their experiences during puberty. In the third session, sexually transmitted diseases and methods of preventing unwanted pregnancies were taught. The fourth and fifth sessions will discuss safe sex, high-risk sexual behaviors, and accountability. Sessions are about 120 minutes. Before and two months after the last intervention session, the Safe Sexual Behavior Questionnaire is examined in both groups.</i_keyword>
      <i_keyword>Control group: The routine procedures of the Behavioral Diseases Counseling Center will be performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Safe sexual behavior. Timepoint: Before the intervention and  two months  after intervention. Method of measurement: Use of safe sexual behavior questionnaire (SSBQ).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-12</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>The 6th floor of The central organization of Tehran University of Medical Sciences, at the corner of Qods Street , Keshavarz street. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
