<?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>IRCT20111017007816N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Design, implementation and evaluation of cervical cancer screening education intervention among middle-aged women</public_title>
      <acronym></acronym>
      <scientific_title>"Design, implementation and evaluation of cervical cancer screening education intervention among middle-aged women served by the comprehensive health centers of Shiraz city: Integration of the  Extended  Parallel Process Model into the PRECEDE-PROCEED planning model"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>188</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83011</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: A multi-stage sampling procedure is used for this study. In the first stage, from the two health centers in Shiraz (Shohadaye Enghelab and Shohadaye Valfajr), Shohadaye Valfajr Health Center is selected as the primary sampling unit because it has easier access to the required research data. This health center oversees 20 comprehensive health centers across Shiraz, covering both urban and suburban areas (including Saadi, Sahlabad, Ghaleno, etc.). This study will focus specifically on the suburban areas.

In the second phase, four comprehensive health centers will be randomly selected in the suburban areas. These four centers will then be assigned to either the intervention group (two centers) or the control group (two centers), using block randomization to ensure a balanced distribution. This allocation process will take into account the appropriate geographical distance between centers to prevent information contamination between the intervention and control groups.

In the third phase, a list of individuals who meet the study's inclusion criteria is compiled by each comprehensive health center. A random number table will be used to select the required number of participants from each center. Participants will be assigned to either the intervention or control group based on the previously randomized assignment of their respective comprehensive health care center.

To calculate the sample size, we will use the formula for randomized cluster studies, taking into account the cluster design of the study, and include the design effect in our calculations.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cervical cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group Type of intervention: Educational programme based on the EPPM model for cervical cancer screening Intervention details: Number of sessions: Minimum of 6 sessions (may be modified based on pre-test results) Duration of each session: 60 minutes Mode of delivery: In-person and virtual Design basis: PRECEDE-PROCEED model (phase 3) + EPPM model Implementation process: Pretest: Assessment of knowledge, attitude, perceived sensitivity, perceived severity, self-efficacy and response effectiveness Identification of training needs based on the results of the pre-test Training content includes: Accurate information about cervical cancer and screening methods Changing negative attitudes and false beliefs Increasing perceived sensitivity and severity Strengthening self-efficacy and response effectiveness Educational methods: Lecture, group discussion, film screening, visual aids, questions and answers, presentation of successful experiences, multimedia materials. Intervention 2: Control group: Type of intervention: Usual treatment (control)Intervention details: During the study: Routine education by comprehensive health centres (no specific intervention)After the study: All educational resources of the intervention group will be made available to this group. Educational sessions will be held according to the intervention group. A 6-session training programme based on the EPPM model will be conductedEthical considerations: This approach ensures that the control group also benefits from the educational intervention.</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:
All potential data can be shared after non -identification.

When:
Starting an access period 6 months after printing results

To whom:
All members of the community to the journal in which the article is published.

Conditions:
Supervisor's opinion

Where to obtain:
Shiraz School of Health Promotion Department of Dr. Mahin Nazari

How to obtain:
It takes about a week to a month from the author responsible for the coordinator.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahin Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of health education &amp; promotion, School of health , Shiraz University of Medical Science</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 1725 1001</telephone>
        <email>manazari@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of health education &amp; promotion, School of health , Shiraz University of Medical Science</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71348-14336</zip>
        <telephone>+98 71 1725 1001</telephone>
        <email>manazari@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Iranian 30-59 years old• Eligible for Pap smear according to national guidelines• Married, divorced, widowed• Resident in the study area• Providing informed consent for participation• No history of cervical cancer diagnosis or treatment• Ability to participate in educational sessions• Ability to understand and communicate• Not pregnant• Not participating in similar studies</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C47.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of peripheral nerves of head, face and neck</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 Type of intervention: Educational programme based on the EPPM model for cervical cancer screening Intervention details: Number of sessions: Minimum of 6 sessions (may be modified based on pre-test results) Duration of each session: 60 minutes Mode of delivery: In-person and virtual Design basis: PRECEDE-PROCEED model (phase 3) + EPPM model Implementation process: Pretest: Assessment of knowledge, attitude, perceived sensitivity, perceived severity, self-efficacy and response effectiveness Identification of training needs based on the results of the pre-test Training content includes: Accurate information about cervical cancer and screening methods Changing negative attitudes and false beliefs Increasing perceived sensitivity and severity Strengthening self-efficacy and response effectiveness Educational methods: Lecture, group discussion, film screening, visual aids, questions and answers, presentation of successful experiences, multimedia materials</i_keyword>
      <i_keyword>Control group: Type of intervention: Usual treatment (control)Intervention details: During the study: Routine education by comprehensive health centres (no specific intervention)After the study: All educational resources of the intervention group will be made available to this group. Educational sessions will be held according to the intervention group. A 6-session training programme based on the EPPM model will be conductedEthical considerations: This approach ensures that the control group also benefits from the educational intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Attitude to screening - Attitude to Cervical Cancer - Screening BehaviorIntention to perform screening - threatening perception - perception of the effectiveness of actions-—perceived actions-—enabling of enabling-—reinforcing agents. Timepoint: Before the intervention - immediately after the intervention - 2 months after the intervention - 4 months after the intervention. Method of measurement: In this study, researcher-made questionnaires will be designed and formulated based on the theory of parallel development process and the model. These questionnaires are approved by the panel of specialists in order to evaluate the factors associated with cervical cancer screening behavior, according to the results of the early stages of the study.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-16</approval_date>
        <contact_name>Faculties of Health, Nutrition and Food Sciences, Shiraz University of Medical Sciences.</contact_name>
        <contact_address>Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran. shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
