A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates (ADAPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03293576|
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Behavioral: Volitional Help Sheet||Not Applicable|
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;
- To determine the difference in therapeutic alliance between care pathways and to establish its mediating role on injecting risk behaviour, SVR rates and HCV reinfection rates.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Integrating Health Psychology Into Hepatitis c Treatment: a Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates|
|Actual Study Start Date :||February 22, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
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)
- 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)
- 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)
- 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).
- 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)
- 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).
- 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)
- 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)
- Post traumatic stress disorder [ Time Frame: 1 month ]Self-reported trauma-induced stress symptoms over the past month. Five items scored Yes/No.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293576
|Contact: Amy Malagutiemail@example.com|
|Contact: John F. Dillonfirstname.lastname@example.org|
|Cairn Centre Needle Exchange||Recruiting|
|Dundee, United Kingdom, DD1 4NA|
|Contact: Daniel Kelly +441382 200532|
|Principal Investigator: Amy Malaguti|