<?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>IRCT20181205041861N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-26</date_registration>
      <primary_sponsor>Faculty of Medical Sciences, Tarbiat Modares University</primary_sponsor>
      <public_title>The effect of mobile application-based educational intervention on promoting cervical cancer prevention behaviors</public_title>
      <acronym></acronym>
      <scientific_title>Design, implementation, and evaluation of a theory-based  educational intervention based on the mobile app to promote cervical cancer prevention behaviors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57157</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Educational intervention in the field of promoting cervical cancer prevention behaviors through smart mobile application software, 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 their 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 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Educational content on preventive behaviours on cervical cancer is prepared based on the effective structures of I-Change theory, which will be obtained from the qualitative and review phase. The educational content designed in the form of an educational application is installed in the smartphones of the intervention group (women 18-49 years old). Educational content through online group teaching methods, Q&amp;A and collaborative learning, problem-solving, talking about positive experiences, posters, brochures, photos, videos and educational slides, retelling memories, etc. in the context of the mobile application will be provided. Intervention 2: Intervention group 2: This group will receive the educational intervention in accordance with the conceptual framework resulting from the influential structures of I-Change theory in digital form. Intervention 3: Control group: After evaluating and comparing the two educational interventions, based on ethical principles, this group will also receive the desired interventions.</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:
Part of the data on the main consequences can be shared.

When:
Access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions.

Conditions:
Repeated measurement analysis to evaluate the duration of training 6 months after the last intervention

Where to obtain:
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir

How to obtain:
One week after sending the email by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</zip>
        <telephone>+98 21 8288 4546</telephone>
        <email>sara.kazemi@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>Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115111</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 of childbearing age 18-49 (having married at least once regardless of their current marital status)
Resident of Ramsar
Having a smartphone and knowing how to use it
Has not received training before the intervention
literate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Opt out of study
Patients with learning disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Educational content on preventive behaviours on cervical cancer is prepared based on the effective structures of I-Change theory, which will be obtained from the qualitative and review phase. The educational content designed in the form of an educational application is installed in the smartphones of the intervention group (women 18-49 years old). Educational content through online group teaching methods, Q&amp;A and collaborative learning, problem-solving, talking about positive experiences, posters, brochures, photos, videos and educational slides, retelling memories, etc. in the context of the mobile application will be provided.</i_keyword>
      <i_keyword>Intervention group 2: This group will receive the educational intervention in accordance with the conceptual framework resulting from the influential structures of I-Change theory in digital form.</i_keyword>
      <i_keyword>Control group: After evaluating and comparing the two educational interventions, based on ethical principles, this group will also receive the desired interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Preventive measures for cervical cancer. Timepoint: Measurement of behavior before intervention,Immediately after intervention, and 3 months after intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</prim_outcome>
      <prim_outcome>Knowledge about the preventive behaviors of cervical cancer. Timepoint: Measurement of awareness before intervention, Immediately after intervention, and 3 months after the intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</prim_outcome>
      <prim_outcome>Motivation for preventive behaviors of cervical cancer. Timepoint: Measurement of motivation before the intervention, Immediately after the intervention, and 3 months after the intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</prim_outcome>
      <prim_outcome>Behavioral intention to prevent cervical cancer. Timepoint: Measurement of action to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</prim_outcome>
      <prim_outcome>Information Factors Related to Cervical Cancer Preventive Behaviors. Timepoint: Measurement of Information factors to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</prim_outcome>
      <prim_outcome>Predisposing factors cervical cancer preventive behaviors. Timepoint: Measurement of predisposing factors to preventive bahavior before the intervention, Immediately after the intervention, and 3 months after the intervention. Method of measurement: Use of preventive behaviors questionnaire to promote cervical cancer.</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>2021-05-24</approval_date>
        <contact_name>Trabiat Modares University</contact_name>
        <contact_address>Jalal Al-Ahmad St., Nasr Bridge, Tarbiat Modares University, School of Medicine Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
