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CompletedNCT03293576ADAPTUpdated Aug 14, 2020

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

An interventional study of Volitional Help Sheet in Hepatitis C, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by University of Dundee · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hepatitis C

Keywords

  • Behavioural Medicine
  • Health Psychology
  • Psychosocial Intervention
  • People Who Inject Drugs
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Inability to provide informed consent;
  • Aggressive or violent behaviour;
  • Not currently receiving HCV treatment;
  • Inability to communicate in English.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Intervention

    Volitional help sheet

    Behavioral: Volitional Help Sheet

  • No intervention
    Control

    Short Zimbardo's time perspective inventory (Orosz et al. 2017)

Interventions

  • BehavioralVolitional 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).

05

What researchers measure

Primary outcomes

  1. Injecting Risk Behaviour

    Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)

    Time frame: 4 weeks

  2. Self-Efficacy

    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)

    Time frame: 4 weeks

Secondary outcomes

  1. Subjective Norms

    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).

    Time frame: Up to 4 weeks

  2. Social Connectedness

    Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)

    Time frame: Up to 8 weeks

  3. Group Identification

    Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).

    Time frame: Up to 8 weeks

  4. Depression

    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

    Time frame: 2 weeks

  5. Anxiety

    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

    Time frame: 2 weeks

  6. Post traumatic stress disorder

    Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.

    Time frame: 1 month

  7. Working alliance

    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).

    Time frame: Treatment duration (12 weeks)

  8. Illness perception

    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).

    Time frame: Up to 8 weeks

06

Study locations

1 site
  • Cairn Centre Needle Exchange
    Dundee, DD1 4NA, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03293576
Lead sponsor
University of Dundee
Collaborators
NHS Tayside
Responsible party
John Dillon (Professor, University of Dundee) — Principal investigator
First posted
Sep 26, 2017
Start date
Feb 22, 2018
Primary completion
Jan 3, 2020
Completion
Jan 3, 2020
Last update
Aug 14, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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