<?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>IRCT2015052722448N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-12</date_registration>
      <primary_sponsor>Vice Chancellor for research of Hamadan University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women attending drug addiction treatment center on their action to undergo the screening test</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effect of giving cervical cancer screening consultation using protection motivation theory to addicted women who consume Methadone on their action to undergo the screening test</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19349</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: The participants will be divided into control and experimental groups based on random permutation method, so that first patient of each group will be selected from drawing lots. Other members of the addicted women community are put in control and experimental groups alternately.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: cervical cancer. Condition 2: consulting. Condition 3: drug  addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The objectives of this study will be described by researcher at a session to the participants courteously and friendly. The meeting time will be 45 until 60 minutes. Explaining the study purpose will be based on the GATHER counseling. The participants will be assured that their information will be published anonymously. After that, questionnaire will be completed. When questionnaire was be filled out by the participants, will be asked them about Pap test and their problems on this topic. Educational content that it is based on the structural model of motivation-protect, will be explained to experimental group individually. Educational content is as follow: brief description of the uterus anatomy and the cervix and genital emission, introduce groups who are at risk for cervical cancer (perceived vulnerability), the prevalence and the consequences of the disease (perceived severity), raise awareness about screening, to be referred a doctor at right time, the screening ways (perceived self-efficacy), benefits Pap test, the importance of early diagnosis (effective response) and anticipate problems and cost of the screening (the cost of the response). After that, the participants will be asked to talk about the issues and their problems. Advisor will explain the available solution. Advisor assists participant with help to decision making. If it be needed to more explanation, the benefits and costs of Pap test will be explained to participant. After consultation, questionnaire will be given to the participants again. We will request from participant for refer to us after one or two months in order to their behavior is examined. Intervention 2: Control group: Members of the control group will be selected in accordance with inclusion criteria. They will receive the questionnaire without any training.&#13;
Behavior of both groups will be assessed after one month. This assessment will be conducted in personal meeting by observation of the test sheet. The questionnaire will be given to member of the control group, again. After completion of the study, the control group will receive counseling service.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Fakouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati street, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 913 249 4556</telephone>
        <email>e.fakouri@edu.umsha.ac.ir; elhamf92@gmail.com; es.8818@yahoo.com</email>
        <affiliation>Nursing &amp; Midwifery Faculty; Hamadan University of Medical Sciences.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rafat Bakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 307, Fahmideh Street, Hamadan University of Medical sciences</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 81 3821 4468</telephone>
        <email>rbakht@yahoo.com</email>
        <affiliation>Nursing &amp; Midwifery Faculty; Hamadan Medical university of Iran.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The inclusion criteria for eligibility into the study are as follows, passing at least 3 years after the first sexual intercourse or married women above 21 years; not having had Pap test in the past three years; not to suffer cervical cancer and to consume Methadone. Also the participants will be studied with their consent. &#13;
Exclusion criteria: Exclusion criteria are unwillingness of the community members to continue participating in the study and formal training by other organizations during the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>100 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c53</hc_code>
      <hc_code>Z71.9</hc_code>
      <hc_code>F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri</hc_keyword>
      <hc_keyword>Counselling, unspecified</hc_keyword>
      <hc_keyword>Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The objectives of this study will be described by researcher at a session to the participants courteously and friendly. The meeting time will be 45 until 60 minutes. Explaining the study purpose will be based on the GATHER counseling. The participants will be assured that their information will be published anonymously. After that, questionnaire will be completed. When questionnaire was be filled out by the participants, will be asked them about Pap test and their problems on this topic. Educational content that it is based on the structural model of motivation-protect, will be explained to experimental group individually. Educational content is as follow: brief description of the uterus anatomy and the cervix and genital emission, introduce groups who are at risk for cervical cancer (perceived vulnerability), the prevalence and the consequences of the disease (perceived severity), raise awareness about screening, to be referred a doctor at right time, the screening ways (perceived self-efficacy), benefits Pap test, the importance of early diagnosis (effective response) and anticipate problems and cost of the screening (the cost of the response). After that, the participants will be asked to talk about the issues and their problems. Advisor will explain the available solution. Advisor assists participant with help to decision making. If it be needed to more explanation, the benefits and costs of Pap test will be explained to participant. After consultation, questionnaire will be given to the participants again. We will request from participant for refer to us after one or two months in order to their behavior is examined.</i_keyword>
      <i_keyword>Control group: Members of the control group will be selected in accordance with inclusion criteria. They will receive the questionnaire without any training.&#13;
Behavior of both groups will be assessed after one month. This assessment will be conducted in personal meeting by observation of the test sheet. The questionnaire will be given to member of the control group, again. After completion of the study, the control group will receive counseling service.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pap smear and cervical cancer awareness. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Self efficacy. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before the intervention, one to two months after the intervention. Method of measurement: Observed test papers.</prim_outcome>
      <prim_outcome>Response Efficacy. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Vulnerability Perceived. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Response costs. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Motivation. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Fear. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
      <prim_outcome>Perceived rewards. Timepoint: Before the intervention, immediately after the intervention, one to two months after the intervention. Method of measurement: Researcher made questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Vice Chancellor for research of Hamadan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-02-28</approval_date>
        <contact_name>Research Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
