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A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates (ADAPT)

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ClinicalTrials.gov Identifier: NCT03293576
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
John Dillon, University of Dundee

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: Volitional Help Sheet Not Applicable

Detailed Description:

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;
  • To determine the difference in therapeutic alliance between care pathways and to establish its mediating role on injecting risk behaviour, SVR rates and HCV reinfection rates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Volitional help sheet
Behavioral: Volitional Help Sheet
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).

No Intervention: Control
Short Zimbardo's time perspective inventory (Orosz et al. 2017)



Primary Outcome Measures :
  1. Injecting Risk Behaviour [ Time Frame: 4 weeks ]
    Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)

  2. Self-Efficacy [ Time Frame: 4 weeks ]
    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)


Secondary Outcome Measures :
  1. Subjective Norms [ Time Frame: Up to 4 weeks ]
    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).

  2. Social Connectedness [ Time Frame: Up to 8 weeks ]
    Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)

  3. Group Identification [ Time Frame: Up to 8 weeks ]
    Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).

  4. Depression [ Time Frame: 2 weeks ]
    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

  5. Anxiety [ Time Frame: 2 weeks ]
    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

  6. Post traumatic stress disorder [ Time Frame: 1 month ]
    Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.

  7. Working alliance [ Time Frame: Treatment duration (12 weeks) ]
    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).

  8. Illness perception [ Time Frame: Up to 8 weeks ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female. (Over 18 years of age);
  • Chronic HCV positive infection;
  • Current illicit drug use established through participants' self-report;
  • Current HCV treatment provided by the NHS;
  • Informed consent, agreeing to study and monitoring criteria;
  • English-speaking.

Exclusion Criteria:

  • Inability to provide informed consent;
  • Aggressive or violent behaviour;
  • Not currently receiving HCV treatment;
  • Inability to communicate in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293576


Contacts
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Contact: Amy Malaguti +441382346556 a.malaguti@dundee.ac.uk
Contact: John F. Dillon +441382383017 j.f.dillon@dundee.ac.uk

Locations
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United Kingdom
Cairn Centre Needle Exchange Recruiting
Dundee, United Kingdom, DD1 4NA
Contact: Daniel Kelly    +441382 200532      
Principal Investigator: Amy Malaguti         
Sponsors and Collaborators
University of Dundee
NHS Tayside

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Responsible Party: John Dillon, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT03293576     History of Changes
Other Study ID Numbers: 2017PZ04
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John Dillon, University of Dundee:
Behavioural Medicine
Health Psychology
Psychosocial Intervention
People Who Inject Drugs

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections