A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates (ADAPT)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Volitional Help Sheet
Sponsored by

About this trial
This is an interventional prevention trial for Hepatitis C focused on measuring Behavioural Medicine, Health Psychology, Psychosocial Intervention, People Who Inject Drugs
Eligibility 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.
Sites / Locations
- Cairn Centre Needle Exchange
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Volitional help sheet
Short Zimbardo's time perspective inventory (Orosz et al. 2017)
Outcomes
Primary Outcome Measures
Injecting Risk Behaviour
Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)
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)
Secondary Outcome Measures
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).
Social Connectedness
Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)
Group Identification
Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).
Depression
Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Anxiety
Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Post traumatic stress disorder
Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.
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).
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).
Full Information
NCT ID
NCT03293576
First Posted
September 5, 2017
Last Updated
August 12, 2020
Sponsor
University of Dundee
Collaborators
NHS Tayside
1. Study Identification
Unique Protocol Identification Number
NCT03293576
Brief Title
A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
Acronym
ADAPT
Official Title
Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
Collaborators
NHS Tayside
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Behavioural Medicine, Health Psychology, Psychosocial Intervention, People Who Inject Drugs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Volitional help sheet
Arm Title
Control
Arm Type
No Intervention
Arm Description
Short Zimbardo's time perspective inventory (Orosz et al. 2017)
Intervention Type
Behavioral
Intervention Name(s)
Volitional Help Sheet
Intervention 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).
Primary Outcome Measure Information:
Title
Injecting Risk Behaviour
Description
Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)
Time Frame
4 weeks
Title
Self-Efficacy
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Subjective Norms
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).
Time Frame
Up to 4 weeks
Title
Social Connectedness
Description
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
Title
Group Identification
Description
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
Title
Depression
Description
Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Time Frame
2 weeks
Title
Anxiety
Description
Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)
Time Frame
2 weeks
Title
Post traumatic stress disorder
Description
Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.
Time Frame
1 month
Title
Working alliance
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).
Time Frame
Treatment duration (12 weeks)
Title
Illness perception
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).
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cairn Centre Needle Exchange
City
Dundee
ZIP/Postal Code
DD1 4NA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
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