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

Hepatitis C Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293576
• Other study ID #: 2017PZ04
• Status: Completed
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: January 3, 2020

Study information

• Verified date: August 2020
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Cairn Centre Needle Exchange	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injecting Risk Behaviour	Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)	4 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	Depression	Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)	2 weeks
Secondary	Anxiety	Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)	2 weeks
Secondary	Post traumatic stress disorder	Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.	1 month
Secondary	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)
Secondary	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