<?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>IRCT20181205041861N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-20</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>Mobile Phone Applications Education In STIs</public_title>
      <acronym></acronym>
      <scientific_title>Designing and evaluating a theory-based educational intervention using mobile app for promoting preventive behaviors of sexually transmitted infections in women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35768</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was used to randomize the samples.
Envelopes will be ready, printed and embedded in the envelope by a member of the research team and random numbers on the Randomaize.com site. The envelopes will be closed and its contents will not be visible. 
Then the researcher explains the purpose of the study by phone for people who were eligible to enter the study. If the person is willing to participate in the study, she will be required to submit the informed consent form by the email or the contact number registered on one of the social networks, such as Telegram and WhatsApp.
Then the applicant is allowed to the researcher to open an envelope on his behalf. The researcher then unpacks the envelope and, based on the contents of the envelope, the applicant will be categorized for the intervention or control group, Blinding description: -.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Promoting preventive behaviors of sexually transmitted infections (STIs).</hc_freetext>
      <i_freetext>Intervention 1: First, after receiving the ethics code from the Ethics Committee of the Vice-Chancellor of Research in Tarbiat Modares University, an online call for participating to a mobile based educational program designed and requited women at reproductive aged which had eligibility for the study. After initial phone re-checking the inclusion criteria the main researcher had simple randomized allocation for categorizing the participants in two separate intervention and control groups. Moreover, the researcher explained about the study goal and asked them for a contact way such as email or phone number for sending the consonant form and the pre-test questionnaire for both intervention and control groups as the same time. After receiving the completed pre-test questionnaire from both groups, the intervention group was announced for receiving an application download link via e-mail or a registered number on one of the online social networks. After receiving and installing the application (HESTIA), they can use the educational contents about preventive behavior of STIs one month. The educational content of this app was in various appearances, including games, flashcards, and animated short films, quiz questions, and texts. Theoretically, the content has been developed based on the principles of protected motivation theory. Furthermore, the educational content was based on the latest national and international (CDC) guidelines for the prevention of sexually transmitted diseases. After one month of the first download, HESTIA will be deactivated automatically and users will not have access to educational content through the app. The first post-test immediately after the end of the intervention will start by sending the online questionnaire, then the second post-test one month after the zero tests. The last but third post-test will be done three months after the end of the intervention. The measurement and evaluation tool is the same at all stages before and after the intervention. Intervention 2: Control group: The control group will not receive intervention and at the end of the study to follow the ethics, a training booklet will be placed in the control 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic information is confidential, but information about the outcome of the people's knowledge, attitude and behavior is shareable.

When:
A week after receiving the request via email to the corresponding researcher

To whom:
Researchers in academic institutions

Conditions:
Deputies of health in Medical Universities

Where to obtain:
Contact with Dr.Fatemeh Zarei as the corresponding researcher  via email: f.zarei@modares.ac.ir

How to obtain:
A week after receiving the request via email the corresponding researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran ,Jalal Ale Ahmad ,Nasr, Tarbiat Modares University</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>Faculty of Medical Sciences, Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University</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>Married women (once married)

living in Tehran
At least 18 years old
Having a smartphone and the ability to use it</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A50-A64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Infections with a predominantly sexual mode of transmission</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First, after receiving the ethics code from the Ethics Committee of the Vice-Chancellor of Research in Tarbiat Modares University, an online call for participating to a mobile based educational program designed and requited women at reproductive aged which had eligibility for the study. After initial phone re-checking the inclusion criteria the main researcher had simple randomized allocation for categorizing the participants in two separate intervention and control groups. Moreover, the researcher explained about the study goal and asked them for a contact way such as email or phone number for sending the consonant form and the pre-test questionnaire for both intervention and control groups as the same time. After receiving the completed pre-test questionnaire from both groups, the intervention group was announced for receiving an application download link via e-mail or a registered number on one of the online social networks. After receiving and installing the application (HESTIA), they can use the educational contents about preventive behavior of STIs one month. The educational content of this app was in various appearances, including games, flashcards, and animated short films, quiz questions, and texts. Theoretically, the content has been developed based on the principles of protected motivation theory. Furthermore, the educational content was based on the latest national and international (CDC) guidelines for the prevention of sexually transmitted diseases. After one month of the first download, HESTIA will be deactivated automatically and users will not have access to educational content through the app. The first post-test immediately after the end of the intervention will start by sending the online questionnaire, then the second post-test one month after the zero tests. The last but third post-test will be done three months after the end of the intervention. The measurement and evaluation tool is the same at all stages before and after the intervention.</i_keyword>
      <i_keyword>Control group: The control group will not receive intervention and at the end of the study to follow the ethics, a training booklet will be placed in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive behaviors of sexually transmitted diseases. Timepoint: Measurement of behavior before intervention,Immediately after intervention, and 3 months after intervention. Method of measurement: Use of preventive behaviors questionnaire for sexually transmitted diseases.</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>2018-11-18</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modares University of Medical Sciences</contact_name>
        <contact_address>Tehran , Jalal Ale Ahmad , Nasr, 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>
