<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/NCT02972606</url>
  </required_header>
  <id_info>
    <org_study_id>205949</org_study_id>
    <nct_id>NCT02972606</nct_id>
  </id_info>
  <brief_title>OPEN Study: Pain Management Treatment Needs Interviews</brief_title>
  <official_title>Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chelsea and Westminster NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Presently, there are few options for medically managing HIV-related painful peripheral&#xD;
      sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural&#xD;
      Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN.&#xD;
      However, there is a scarcity of research on psychological treatment approaches for pain&#xD;
      management in people with HIV. This study will use in-depth semi-structured interviews to&#xD;
      examine the needs of people with painful HIV-SN for a psychologically-based pain management&#xD;
      treatment that may be delivered over the Internet. Interview questions will examine&#xD;
      participants' needs in terms of treatment content and delivery format. Men and women, ethnic&#xD;
      minorities, and people who use recreational drugs will be sampled to ensure that interview&#xD;
      responses reflect the views of people most commonly suffering from this condition.&#xD;
      Approximately 30 people will be recruited for the study. The interviews will be audio&#xD;
      recorded, transcribed verbatim, and coded to identify themes. The interview responses will be&#xD;
      used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that&#xD;
      tailoring the treatment based on the qualitative interview responses will increase the&#xD;
      acceptability of the treatment and will improve treatment adherence rates for a future study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This report is independent research supported by the National Institute for Health Research&#xD;
      (NIHR Post Doctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in&#xD;
      this publication are those of the authors and not necessarily those of the NHS, the National&#xD;
      Institute for Health Research or the Department of Health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed a Semi-Structure Interview</measure>
    <time_frame>Day 1</time_frame>
    <description>Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.</description>
  </primary_outcome>
  <enrollment type="Actual">26</enrollment>
  <condition>HIV</condition>
  <condition>Peripheral Neuropathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        People with HIV and painful peripheral neuropathy. We will purposively sample men, women,&#xD;
        ethnic minorities, and people who use recreational drugs .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years or older.&#xD;
&#xD;
          -  Living with HIV.&#xD;
&#xD;
          -  A positive screen for peripheral sensory neuropathy, as indicated by: presence of&#xD;
             self-reported bilateral foot pain and/or numbness in a symmetrical distribution.&#xD;
&#xD;
          -  Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score&#xD;
             of greater than or equal to 3 on the patient reported outcomes section of the&#xD;
             Neuropathic Pain Interview.&#xD;
&#xD;
          -  Pain in the feet present most days for at least 3 months.&#xD;
&#xD;
          -  Average pain intensity of greater than or equal to 4/10.&#xD;
&#xD;
          -  Average interference of pain with daily activities is greater than or equal to 4/10.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency,&#xD;
             diabetes, exposure to isoniazid or chemotherapy drug treatment, or a known history of&#xD;
             a neuropathy due to a cause other than HIV or antiretroviral treatment&#xD;
&#xD;
          -  Unable to conduct interview in English.&#xD;
&#xD;
          -  Current diagnosis of dementia or learning disability.&#xD;
&#xD;
          -  Unwilling to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Whitney Scott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea &amp; Westminster Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://journals.lww.com/pain/Abstract/publishahead/A_qualitative_study_of_the_experience_and_impact.98522.aspx</url>
    <description>Published peer-reviewed paper</description>
  </link>
  <reference>
    <citation>Scott W, Garcia Calderon Mendoza Del Solar M, Kemp H, McCracken LM, C de C Williams A, Rice ASC. A qualitative study of the experience and impact of neuropathic pain in people living with HIV. Pain. 2020 May;161(5):970-978. doi: 10.1097/j.pain.0000000000001783.</citation>
    <PMID>31855944</PMID>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>September 15, 2021</results_first_submitted>
  <results_first_submitted_qc>April 13, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2023</results_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Peripheral Neuropathy</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Qualitative Research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02972606/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Participants With HIV and Neuropathy</title>
          <description>Participants with HIV and Neuropathy (this was a qualitative study and participants were not assigned to arms).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants were included in the analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants With HIV and Neuropathy</title>
          <description>Participants with HIV and Neuropathy who completed semi-structured interviews.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.7" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White British/European</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black British/African</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed a Semi-Structure Interview</title>
        <description>Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.</description>
        <time_frame>Day 1</time_frame>
        <population>All participants were analysed</population>
        <group_list>
          <group group_id="O1">
            <title>Not Applicable</title>
            <description>Not applicable as this is a qualitative study</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed a Semi-Structure Interview</title>
          <description>Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.</description>
          <population>All participants were analysed</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not recorded. There was a risk management procedure that involved contacting the participants' GP if clinically meaningful distress or other symptoms were identified during the qualitative interviews. However, the frequency of contacting GPs to manage this risk was not systematically recorded as this was not an intervention study.</time_frame>
      <desc>All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not recorded. There was a risk management procedure that involved contacting the participants' GP if clinically meaningful distress or other symptoms were identified during the qualitative interviews. However, the frequency of contacting GPs to manage this risk was not systematically recorded as this was not an intervention study.</desc>
      <group_list>
        <group group_id="E1">
          <description>Not applicable. This is a qualitative study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Whitney Scott</name_or_title>
      <organization>King's College London</organization>
      <phone>02071885421</phone>
      <email>whitney.scott@kcl.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT02972606
org study id: 205949
nct id: NCT02972606
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Presently, there are few options for medically managing HIV-related painful peripheral
      sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural
      Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN.
      However, there is a scarcity of research on psychological treatment approaches for pain
      management in people with HIV. This study will use in-depth semi-structured interviews to
      examine the needs of people with painful HIV-SN for a psychologically-based pain management
      treatment that may be delivered over the Internet. Interview questions will examine
      participants' needs in terms of treatment content and delivery format. Men and women, ethnic
      minorities, and people who use recreational drugs will be sampled to ensure that interview
      responses reflect the views of people most commonly suffering from this condition.
      Approximately 30 people will be recruited for the study. The interviews will be audio
      recorded, transcribed verbatim, and coded to identify themes. The interview responses will be
      used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that
      tailoring the treatment based on the qualitative interview responses will increase the
      acceptability of the treatment and will improve treatment adherence rates for a future study.
This report is independent research supported by the National Institute for Health Research
      (NIHR Post Doctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in
      this publication are those of the authors and not necessarily those of the NHS, the National
      Institute for Health Research or the Department of Health.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Number of Participants Who Completed a Semi-Structure Interview
time frame: Day 1
description: Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Whitney Scott, PhD
role: Principal Investigator
affiliation: King's College London
facility: 
facility: 
country: United Kingdom
url: https://journals.lww.com/pain/Abstract/publishahead/A_qualitative_study_of_the_experience_and_impact.98522.aspx
description: Published peer-reviewed paper
citation: Scott W, Garcia Calderon Mendoza Del Solar M, Kemp H, McCracken LM, C de C Williams A, Rice ASC. A qualitative study of the experience and impact of neuropathic pain in people living with HIV. Pain. 2020 May;161(5):970-978. doi: 10.1097/j.pain.0000000000001783.
PMID: 31855944
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 