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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Behavioral: Volitional Help Sheet

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Volitional help sheet	Behavioral: 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).
No Intervention: Control; Short Zimbardo's time perspective inventory (Orosz et al. 2017)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: NHS Tayside

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): January 3, 2020
• Study Completion (Actual): January 3, 2020

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Health Psychology; Psychosocial Intervention; Behavioural Medicine; People Who Inject Drugs
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Recurrence; Hepatitis; Hepatitis A; Hepatitis C; Reinfection
• Other Study ID Numbers: 2017PZ04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No