<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/NCT03293576</url>
  </required_header>
  <id_info>
    <org_study_id>2017PZ04</org_study_id>
    <nct_id>NCT03293576</nct_id>
  </id_info>
  <brief_title>A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates</brief_title>
  <acronym>ADAPT</acronym>
  <official_title>Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Dundee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Tayside</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Dundee</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study evaluates the use of implementation intentions to increase self-efficacy and reduce&#xD;
      injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C&#xD;
      (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to&#xD;
      identify lower injecting risk behaviour scores in patients on treatment for hepatitis C&#xD;
      receiving the psychosocial intervention compared to the same patient group assigned to the&#xD;
      control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will entail completing a volitional help sheet.This will create&#xD;
      implementation intentions, which are self-regulatory strategies taking the form of &quot;if-then&quot;&#xD;
      plans (i.e. situation-solution plan).&#xD;
&#xD;
      Injecting risk behaviour scores and self-efficacy scores will be analysed for differences&#xD;
      between intervention and control groups.&#xD;
&#xD;
      To control for contact-time with the researchers, participants in the control group will&#xD;
      spend approximately 20 minutes with the researcher exploring Zimbardo's time perspective&#xD;
      constructs (ZTPI, Zimbardo &amp; Boyd, 1999) and completing the short Zimbardo's time perspective&#xD;
      inventory (Orosz et al. 2017). The inventory was selected because the cognitive processes&#xD;
      involved in accessing time constructs will also be activated in the intervention group for&#xD;
      the planning of coping strategies and goal achievement during future injecting risk&#xD;
      situations.&#xD;
&#xD;
      The study also aims:&#xD;
&#xD;
        -  To assess the variability in injecting risk behaviour as explained by subjective norms,&#xD;
           social connectedness and group identification constructs;&#xD;
&#xD;
        -  To assess the variability in intervention effectiveness as explained by changes in&#xD;
           mental health, illness perception subjective norms, social connectedness, and group&#xD;
           identification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2018</start_date>
  <completion_date type="Actual">January 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Injecting Risk Behaviour</measure>
    <time_frame>4 weeks</time_frame>
    <description>Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>4 weeks</time_frame>
    <description>Self-reported confidence in one's own ability to refuse sharing of injecting equipment and use of old injecting equipment. Fifteen items scored 1-7 (1 high confidence, 7 low confidence)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Norms</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Self-reported social norms of individual's injecting network. Four items scored 1-7 (1 strong acceptance of sharing equipment, 7 no acceptance of sharing equipment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Connectedness</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group Identification</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>2 weeks</time_frame>
    <description>Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>2 weeks</time_frame>
    <description>Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress disorder</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working alliance</measure>
    <time_frame>Treatment duration (12 weeks)</time_frame>
    <description>Self-reported therapeutic alliance with provider of hepatitis C treatment care over treatment duration. Eight items scored 1-5 (1 poor alliance, 5 excellent alliance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness perception</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Self-reported perception of hepatitis C as an illness. Eight items scored 1-10 (1 no impact on quality of life, 10 high impact on quality of life).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volitional help sheet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Short Zimbardo's time perspective inventory (Orosz et al. 2017)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volitional Help Sheet</intervention_name>
    <description>This brief intervention will last around 20 minutes. The participants and the researcher will read through the list of real-life solutions the participants might find applicable to them. They will then read through the list of situations one by one. The participant will draw a coloured line between the situation and the solution which seems more appropriate to them. The volitional help sheet helps create implementation intentions, which are self-regulatory strategies taking the form of &quot;if-then&quot; plans (i.e. situation-solution plan).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female. (Over 18 years of age);&#xD;
&#xD;
          -  Chronic HCV positive infection;&#xD;
&#xD;
          -  Current illicit drug use established through participants' self-report;&#xD;
&#xD;
          -  Current HCV treatment provided by the NHS;&#xD;
&#xD;
          -  Informed consent, agreeing to study and monitoring criteria;&#xD;
&#xD;
          -  English-speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent;&#xD;
&#xD;
          -  Aggressive or violent behaviour;&#xD;
&#xD;
          -  Not currently receiving HCV treatment;&#xD;
&#xD;
          -  Inability to communicate in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairn Centre Needle Exchange</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 4NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Dundee</investigator_affiliation>
    <investigator_full_name>John Dillon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Behavioural Medicine</keyword>
  <keyword>Health Psychology</keyword>
  <keyword>Psychosocial Intervention</keyword>
  <keyword>People Who Inject Drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Reinfection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03293576
org study id: 2017PZ04
nct id: NCT03293576
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study evaluates the use of implementation intentions to increase self-efficacy and reduce
      injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C
      (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to
      identify lower injecting risk behaviour scores in patients on treatment for hepatitis C
      receiving the psychosocial intervention compared to the same patient group assigned to the
      control group.
The intervention will entail completing a volitional help sheet.This will create
      implementation intentions, which are self-regulatory strategies taking the form of "if-then"
      plans (i.e. situation-solution plan).

      Injecting risk behaviour scores and self-efficacy scores will be analysed for differences
      between intervention and control groups.

      To control for contact-time with the researchers, participants in the control group will
      spend approximately 20 minutes with the researcher exploring Zimbardo's time perspective
      constructs (ZTPI, Zimbardo & Boyd, 1999) and completing the short Zimbardo's time perspective
      inventory (Orosz et al. 2017). The inventory was selected because the cognitive processes
      involved in accessing time constructs will also be activated in the intervention group for
      the planning of coping strategies and goal achievement during future injecting risk
      situations.

      The study also aims:

        -  To assess the variability in injecting risk behaviour as explained by subjective norms,
           social connectedness and group identification constructs;

        -  To assess the variability in intervention effectiveness as explained by changes in
           mental health, illness perception subjective norms, social connectedness, and group
           identification.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Injecting Risk Behaviour
time frame: 4 weeks
description: Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)
measure: Self-Efficacy
time frame: 4 weeks
description: Self-reported confidence in one's own ability to refuse sharing of injecting equipment and use of old injecting equipment. Fifteen items scored 1-7 (1 high confidence, 7 low confidence)
measure: Subjective Norms
time frame: Up to 4 weeks
description: Self-reported social norms of individual's injecting network. Four items scored 1-7 (1 strong acceptance of sharing equipment, 7 no acceptance of sharing equipment).
measure: Social Connectedness
time frame: Up to 8 weeks
description: Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)
measure: Group Identification
time frame: Up to 8 weeks
description: Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).
measure: Depression
time frame: 2 weeks
description: Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
measure: Anxiety
time frame: 2 weeks
description: Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
measure: Post traumatic stress disorder
time frame: 1 month
description: Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.
measure: Working alliance
time frame: Treatment duration (12 weeks)
description: Self-reported therapeutic alliance with provider of hepatitis C treatment care over treatment duration. Eight items scored 1-5 (1 poor alliance, 5 excellent alliance).
measure: Illness perception
time frame: Up to 8 weeks
description: Self-reported perception of hepatitis C as an illness. Eight items scored 1-10 (1 no impact on quality of life, 10 high impact on quality of life).
arm group label: Intervention
arm group type: Experimental
description: Volitional help sheet
arm group label: Control
arm group type: No Intervention
description: Short Zimbardo's time perspective inventory (Orosz et al. 2017)
intervention type: Behavioral
intervention name: Volitional Help Sheet
description: This brief intervention will last around 20 minutes. The participants and the researcher will read through the list of real-life solutions the participants might find applicable to them. They will then read through the list of situations one by one. The participant will draw a coloured line between the situation and the solution which seems more appropriate to them. The volitional help sheet helps create implementation intentions, which are self-regulatory strategies taking the form of "if-then" plans (i.e. situation-solution plan).
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Dundee
investigator full name: John Dillon
investigator title: Professor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Reinfection
sharing ipd: No