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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates

Conditions
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Hepatitis C

Intervention / Treatment
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* Behavioral: Volitional Help Sheet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Volitional help sheet | Behavioral: Volitional Help Sheet<br>* 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).<br>|
| No Intervention: Control<br>Short Zimbardo's time perspective inventory (Orosz et al. 2017) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injecting Risk Behaviour | Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never) | 4 weeks | 
| 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to 4 weeks | 
| Social Connectedness | Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness) | Up to 8 weeks | 
| Group Identification | Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification). | Up to 8 weeks | 
| Depression | Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms) | 2 weeks | 
| Anxiety | Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms) | 2 weeks | 
| Post traumatic stress disorder | Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No. | 1 month | 
| 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). | Treatment duration (12 weeks) | 
| 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). | Up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural Medicine, Health Psychology, Psychosocial Intervention, People Who Inject Drugs