Clinical trial NCT03293576: A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates
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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Behavioural Medicine
Health Psychology
Psychosocial Intervention
People Who Inject Drugs
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2017-09-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Injecting Risk Behaviour
timeFrame: 4 weeks
measure: Self-Efficacy
timeFrame: 4 weeks
Secondary outcomes:
measure: Subjective Norms
timeFrame: Up to 4 weeks
measure: Social Connectedness
timeFrame: Up to 8 weeks
measure: Group Identification
timeFrame: Up to 8 weeks
measure: Depression
timeFrame: 2 weeks
measure: Anxiety
timeFrame: 2 weeks
measure: Post traumatic stress disorder
timeFrame: 1 month
measure: Working alliance
timeFrame: Treatment duration (12 weeks)
measure: Illness perception
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Cairn Centre Needle Exchange
Study officials:
References: