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

NCT ID: NCT03293576

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2020-01-03

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Volitional help sheet

Group Type: EXPERIMENTAL

Volitional Help Sheet

Intervention Type: BEHAVIORAL

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).

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Tayside

OTHER_GOV

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

John Dillon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairn Centre Needle Exchange

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

2017PZ04

Identifier Type: -

Identifier Source: org_study_id