<?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>IRCT20191206045626N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-12</date_registration>
      <primary_sponsor>Tarbiat Modarres University, Vice Chancellor Research</primary_sponsor>
      <public_title>Design, Implementation and Evaluation of a Cervical Cancer Prevention Behavior Training Program for Women of Reproductive Age</public_title>
      <acronym></acronym>
      <scientific_title>Design, Implementation and Evaluation of a Cervical Cancer Prevention Behavior Training Program for Women of Reproductive Age 18-49 in Andimeshk in 1399-1998</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: This is a two-stage study; the first stage is a cross-sectional descriptive study with the aim of determining knowledge, attitude, self-efficacy and practice about cervical cancer of women of reproductive age 18-49 in Andimeshk. The second phase of an experimental study with a control group with the overall aim of evaluating a cervical cancer screening training (Pap smear) training program in women of reproductive age 18-49 years in Andimeshk. First, all women who met the inclusion criteria. After completing the questionnaire, the subjects will be divided into two intervention and control groups according to their evaluation and mean score, Randomization description: Randomization of the samples will be done in order to maintain equilibrium in the number of subjects belonging to the control and intervention groups and to obtain maximum power in the study using a randomized block design with 4 blocks. These duplicate random blocks will be performed for each cluster individually.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Screening for cervical cancer(Pap smear).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group in this study consisted of 42 people who scored less than average after the pre-test; the intervention in this study will be educational. After completing the first phase of the study (cross-sectional) and assessing the educational needs of the questionnaire, the educational content will be formulated in 4 constructs of knowledge, attitude, self-efficacy and performance. And will be delivered in 3 training sessions for one month. Intervention 2: Control group: The control group in this intervention consisted of 42 subjects who received a mean and higher score after the pre-test; no intervention for the control group. Post-test will be performed by Pap smear screening questionnaire from both intervention and control groups. This post-test will also be repeated 3 months after the end of training for both groups.</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:
In this study, data can be shared after people are unrecognizable.
Statistical analysis and intervention program reporting will also be shared.

When:
+Access to study documentation will begin 6 months after the results are published.

To whom:
Study documentation will be available to researchers working in academic and scientific institutions.

Conditions:
Study documentation will be available only to researchers working in academic and scientific institutions and will not be available to others.

Where to obtain:
1. Dr. Alireza Heidarnia, Professor of Health Education, Tarbiat Modares University
email: hidarnia@modares.ac.ir
2- Shahnaz Ghavavandi MSc Student of Health Education, Tarbiat Modarres University
email: ghalavandishahnaz@modares.ac.ir

How to obtain:
Writing the request clearly defines what part of the applicant's actual need is to study the documentation.
Submit request via email provided in the study.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Heidarnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3108</telephone>
        <email>ghalavandishahnaz@gmail.com</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Heidarnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al Ahmad Street, Nasr district, Tarbiat Modares University, Faculty of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3108</telephone>
        <email>ghalavandishahnaz@gmail.com</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 Andimeshk
Minimum literacy
Minimum 18 years and maximum 49 years
Written consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cervical cancer or other STDs                                                     2.Opt out of study                                                                 3.Inability to read and write</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group in this study consisted of 42 people who scored less than average after the pre-test; the intervention in this study will be educational. After completing the first phase of the study (cross-sectional) and assessing the educational needs of the questionnaire, the educational content will be formulated in 4 constructs of knowledge, attitude, self-efficacy and performance. And will be delivered in 3 training sessions for one month.</i_keyword>
      <i_keyword>Control group: The control group in this intervention consisted of 42 subjects who received a mean and higher score after the pre-test; no intervention for the control group. Post-test will be performed by Pap smear screening questionnaire from both intervention and control groups. This post-test will also be repeated 3 months after the end of training for both groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improve cervical cancer screening behavior. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: 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>Tarbiat Modarres University, Vice Chancellor Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-21</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modarres University</contact_name>
        <contact_address>Jalal Al Ahmad Street,district Nasr,Tarbiat Modares University,Faculty of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
