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

NCT03293576 | Completed DMC

• 1 other identifier: 2017PZ04
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Behavioural Medicine; Health Psychology; Psychosocial Intervention; People Who Inject Drugs

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Subjective Norms

  Up to 4 weeks

• Social Connectedness

  Up to 8 weeks

• Group Identification

  Up to 8 weeks

• Depression

  2 weeks

• Anxiety

  2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Volitional help sheet

Behavioral: Volitional Help Sheet

Control

NO INTERVENTION

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

Interventions

Volitional Help Sheet 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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Dundee: lead
• NHS Tayside: collaborator

Study Sites (1)

Cairn Centre Needle Exchange

Dundee, DD1 4NA, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 26, 2017
• Study Start: February 22, 2018
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)