xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014671</url>
    </required_header>
    <id_info>
      <org_study_id>CHS/54/2014</org_study_id>
      <nct_id>NCT06014671</nct_id>
    </id_info>
    <brief_title>The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS</brief_title>
    <official_title>The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS at Mettu Karl Referral and Bedele Hospital, Southwest Ethiopia, 2022: A Quasi-experimental Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mattu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mattu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Quality of life (QOL) is a significant importance for people living with HIV/AIDS by&#xD;
        modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia,&#xD;
        interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for&#xD;
        quality of life. The objective of the study was to assess the effects of interpersonal&#xD;
        psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital,&#xD;
        southwest Ethiopia, 2022.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">May 30, 2022</completion_date>
    <primary_completion_date type="Actual">May 30, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of Interpersonal Psychotherapy on quality of life among people living with HIVAIDS</measure>
      <time_frame>two months</time_frame>
      <description>Quality of Life measured by World Health Organization Health Related Quality of Life (WHOQOL- BREF).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">128</enrollment>
    <condition>Breif Description: Patients' Quality of Life of</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intervention group were took interpersonal psychotherapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>control group didn't took interpersonal psychotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Interpersonal Psychotherapy</intervention_name>
      <description>Intervention Group were took interpersonal psychotherapy</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PLWHA who were 18 years of age or above were included in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  PLWHA who are either currently or previously used IPT and acute physical or mental&#xD;
               disturbances will be excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mattu University</name>
        <address>
          <city>Addis Ababa</city>
          <state>Oromia</state>
          <zip>318 (mattu)</zip>
          <country>Ethiopia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Ethiopia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mattu University</investigator_affiliation>
      <investigator_full_name>Zakir Abdu</investigator_full_name>
      <investigator_title>Assistant Professor of Psychiatry</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>researchers need information could get it</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>at any time</ipd_time_frame>
      <ipd_access_criteria>with formal letter and justification</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014671
  org study id: CHS/54/2014
  nct id: NCT06014671
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Quality of life (QOL) is a significant importance for people living with HIV/AIDS by
        modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia,
        interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for
        quality of life. The objective of the study was to assess the effects of interpersonal
        psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital,
        southwest Ethiopia, 2022.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The effect of Interpersonal Psychotherapy on quality of life among people living with HIVAIDS
  time frame: two months
  description: Quality of Life measured by World Health Organization Health Related Quality of Life (WHOQOL- BREF).
  arm group label: Intervention group
  arm group type: Experimental
  description: intervention group were took interpersonal psychotherapy
  arm group label: Control group
  arm group type: Experimental
  description: control group didn't took interpersonal psychotherapy
  intervention type: Behavioral
  intervention name: Interpersonal Psychotherapy
  description: Intervention Group were took interpersonal psychotherapy
  arm group label: Control group
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Ethiopia
  responsible party type: Principal Investigator
  investigator affiliation: Mattu University
  investigator full name: Zakir Abdu
  investigator title: Assistant Professor of Psychiatry
  sharing ipd: Yes
  ipd description: researchers need information could get it
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: at any time
  ipd access criteria: with formal letter and justification