<?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>IRCT20250102064255N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-28</date_registration>
      <primary_sponsor>Dezfoul University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of application-based education on women's knowledge and attitudes about human papillomavirus infection and cervical cancer</public_title>
      <acronym>AEHPVS</acronym>
      <scientific_title>Comparing the effect of education on the prevention of human papillomavirus infection and cervical cancer on the components of the planned behavior model in women of reproductive age using two methods based on an application and a lecture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81792</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, each of the comprehensive urban health service centers of Dezful is considered as a cluster and 3 centers are randomly selected from them (cluster sampling). In the next step, based on household information in the integrated health system, eligible women will be identified and randomly invited to participate in the study. Then, samples from each center will be randomly assigned to three groups of mobile software intervention, lecture intervention, and control group using a random number table (simple randomization).</study_design>
      <phase>N/A</phase>
      <hc_freetext>human papilloma virus.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: In this group, a set of trainings will be provided to the user gradually through a designed mobile application. The trainings are in the areas of symptoms, risk factors, prevention methods, self-care, treatment, consequences of HPV infection, genital warts and cervical cancer. In this method, the trainings will be sent to the patients every 48 hours (every two days). To ensure that the educational content is received and studied by the patient, they will be contacted within 24 hours after the content is sent and the samples will be discussed about the content sent. Intervention 2: Second intervention group: For the lecture intervention group, four 30- to 45-minute training sessions will be held. The training will be delivered face-to-face in small groups (maximum 10 people). The sessions will be provided weekly (one session per week) for one month at selected comprehensive health service centers in Dezful. The educational content of the first session includes an explanation of the objectives of the study, completing a pre-test, and explaining the introduction of the disease, symptoms, and risk factors for HPV infection, genital warts, and cervical cancer. The second session will answer participants’ questions about the first session, transmission routes, the importance of prevention, and methods for preventing HPV infection, genital warts, and cervical cancer. The third session will answer participants’ questions about the content presented in the second session, ways to treat cervical cancer, HPV infection, and genital warts, and preventing their transmission to others. The fourth session will also include answers to participants' questions about the content presented in previous sessions, the complications and consequences of these diseases, and a review of the entire course content. Intervention 3: Control group: During the study, the control group will not receive any training (except for routine center training provided by center personnel). At the end of the study, in order to comply with ethical principles, educational content will be provided to the control group members.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 12, 6th Floor, Medis Building 17, Nobahar 8, Nobahar St., Shariati Boulevard</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461876545</zip>
        <telephone>+98 61 4242 2710</telephone>
        <email>s.hamedrahimi68@gmail.com</email>
        <affiliation>Dezfoul University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 12, 6th Floor, Medis Building 17, Nobahar 8, Nobahar St., Shariati Boulevard</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6461876545</zip>
        <telephone>+98 61 4242 2710</telephone>
        <email>s.hamedrahimi68@gmail.com</email>
        <affiliation>Dezfoul 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>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 15-49 years,
residing in Dezful city,
not a member of the treatment team,
literate,
having a phone equipped with Android system (software-based intervention group),
no history of neurological or psychiatric illness,
no history of hysterectomy or sexually transmitted disease,
no history of uterine cancer.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in similar training classes,
change of residence,
unwillingness to participating in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B97.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Papillomavirus as the cause of diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: In this group, a set of trainings will be provided to the user gradually through a designed mobile application. The trainings are in the areas of symptoms, risk factors, prevention methods, self-care, treatment, consequences of HPV infection, genital warts and cervical cancer. In this method, the trainings will be sent to the patients every 48 hours (every two days). To ensure that the educational content is received and studied by the patient, they will be contacted within 24 hours after the content is sent and the samples will be discussed about the content sent.</i_keyword>
      <i_keyword>Second intervention group: For the lecture intervention group, four 30- to 45-minute training sessions will be held. The training will be delivered face-to-face in small groups (maximum 10 people). The sessions will be provided weekly (one session per week) for one month at selected comprehensive health service centers in Dezful. The educational content of the first session includes an explanation of the objectives of the study, completing a pre-test, and explaining the introduction of the disease, symptoms, and risk factors for HPV infection, genital warts, and cervical cancer. The second session will answer participants’ questions about the first session, transmission routes, the importance of prevention, and methods for preventing HPV infection, genital warts, and cervical cancer. The third session will answer participants’ questions about the content presented in the second session, ways to treat cervical cancer, HPV infection, and genital warts, and preventing their transmission to others. The fourth session will also include answers to participants' questions about the content presented in previous sessions, the complications and consequences of these diseases, and a review of the entire course content.</i_keyword>
      <i_keyword>Control group: During the study, the control group will not receive any training (except for routine center training provided by center personnel). At the end of the study, in order to comply with ethical principles, educational content will be provided to the control group members.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean score of awareness. Timepoint: Measurement of awareness before the intervention, immediately after the intervention, and 2 months after the completion of the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Mean score of attitude. Timepoint: Measurement of attitude before the intervention, immediately after the intervention, and 2 months after the completion of the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Mean score of subjective norms. Timepoint: Measurement of subjective norms before the intervention, immediately after the intervention, and 2 months after the completion of the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Mean score of Perceived behavioral control. Timepoint: Measurement of Perceived behavioral control before the intervention, immediately after the intervention, and 2 months after the completion of the educational intervention. Method of measurement: Researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Mean score of behavioral intention. Timepoint: Measurement of behavioral intention before the intervention, immediately after the intervention, and 2 months after the completion of the educational intervention. Method of measurement: Researcher-made questionnaire.</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>Dezfoul University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-05</approval_date>
        <contact_name>Ethics committee of Dezful University of Medical Sciences</contact_name>
        <contact_address>Azadegan Blvd Dezful Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
