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Completed

NCT Number: NCT03293576

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairn Centre Needle Exchange

Dundee, DD1 4NA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Injecting Risk Behaviour

    Time frame: 4 weeks

    Self-reported injecting risk behaviour over the past 4 weeks. Seventeen items scored 1-4 (1 frequently, 4 never)

  2. Self-Efficacy

    Time frame: 4 weeks

    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)

Secondary outcomes

  1. Subjective Norms

    Time frame: Up to 4 weeks

    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).

  2. Social Connectedness

    Time frame: Up to 8 weeks

    Self-reported perceived social connectedness to general society. Eight items scored 1-6 (1 low connectedness, 6 high connectedness)

  3. Group Identification

    Time frame: Up to 8 weeks

    Self-reported perceived identification with family group and injecting group. Eight items scored 1-7 (1 high identification, 7 low identification).

  4. Depression

    Time frame: 2 weeks

    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

  5. Anxiety

    Time frame: 2 weeks

    Self-reported depressive symptoms over the past 2 weeks. Nine items scored 0-3 (0 no symptoms, 3 depressive symptoms)

  6. Post traumatic stress disorder

    Time frame: 1 month

    Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.

  7. Working alliance

    Time frame: Treatment duration (12 weeks)

    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).

  8. Illness perception

    Time frame: Up to 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • NHS Tayside

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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