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Change the Cycle: An RCT to Prevent Injection Initiation (CTC)

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ClinicalTrials.gov Identifier: NCT02774954
Recruitment Status : Active, not recruiting
First Posted : May 17, 2016
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
RTI International
University of Toronto
Information provided by (Responsible Party):
Ricky Bluthenthal, University of Southern California

Brief Summary:
The study will test the efficacy of a hour long, one-on-one, active listening counseling session (called Change the Cycle or CTC) aimed at reducing behaviors among active people who inject drugs (PWID) that research has found to facilitate uptake of injection drug use among non-injectors. The study will involve ~1,100 PWID who will be randomized to CTC or an equal attention control intervention on improving nutrition. Participants will be recruited in Los Angeles and San Francisco, California and followed up at 6 and 12 months to determine changes in direct and indirect facilitation of injection initiation among non-injectors.

Condition or disease Intervention/treatment Phase
Substance Abuse, Intravenous HIV Heroin Dependence Opioid Dependence Cocaine Dependence Amphetamine Dependence Behavioral: Change the Cycle Phase 3

Detailed Description:

The study goal is to conduct a large-scale randomized controlled trial (RCT) of the "Change the Cycle" (CTC) intervention. CTC is an hour long, single-session, one-on-one intervention that aims to reduce injection initiation by encouraging active PWID to not promote drug injection, model injection behavior, describe how to inject, or assist in injection initiations of non-injectors. CTC uses the Information-Motivation-Behavioral skills (IMB) model to achieve changes among active PWID through seven short modules. Information and motivational domains are addressed in guided conversations about (1) their own first injection episode and consequences, (2) past experiences initiating injection-naive people and consequences, (3) health, legal, and social risks related to injection drugs, (4) health, legal, social risks of initiating people, and (5) identifying their own behaviors that might promote injection among others. The behavioral skills are addressed through (6) skill-building discussions and consideration of common initiation scenarios, and (7) safer injection education.

Aim 1: To test the efficacy of CTC on reducing the number of non-injectors initiated into injection (counts) by PWID. Hypothesis 1: PWID who receive CTC will report initiating fewer non-injectors into drug injection at 6 and 12 months as compared with PWID in the control condition.

Aim 2: To test the efficacy of CTC on reducing the number of times PWID are asked to initiate (counts) someone into injection. Hypothesis 2: PWID who receive CTC will report having been asked fewer times to initiate someone into drug injection at 6 and 12 months as compared with PWID in the control condition.

Aim 3: To test whether injection initiation social learning risks (injecting in front of, describing injection to, and speaking positively about injection to non-injectors) act as mediational mechanisms for the efficacy of the CTC intervention on initiation and request-to-initiate outcomes. Hypothesis 3: Social learning variables will significantly mediate the association between the CTC intervention and episodes of initiating and being requested to initiate someone into drug injection at 6 and 12 months.

To achieve these aims, active PWID (N=1,076) will be randomly assigned to receive CTC or an equal attention control condition in Los Angeles (LA) and San Francisco (SF), CA. Injection initiation and injection initiation social learning variables will be collected at baseline, 6 months, and 12 months using computer-assisted personal-interviewing (CAPI). The equal attention control condition will focus on improving nutrition, specifically increasing fresh water intake and protein consumption, and will replicate CTC in length, theoretical foundation (IMB), and modality (1 on 1 personal session).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 972 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study compares 2 active listening, information-motivation-behavior skills interventions aimed at improving health behaviors among very low-income, drug using participants.
Masking: Single (Outcomes Assessor)
Masking Description: The statistician who is conducting the data analysis will not know the content of the intervention assignment.
Primary Purpose: Prevention
Official Title: Preventing Injection Initiation: The Change the Cycle Randomized Controlled Trial.
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Change the cycle
CTC uses the Information-Motivation-Behavioral skills (IMB) model to achieve changes among active PWID through seven short modules. Information and motivational domains are addressed in guided conversations about (1) their own first injection episode and consequences, (2) past experiences initiating injection-naive people and consequences, (3) health, legal, and social risks related to injection drugs, (4) health, legal, social risks of initiating people, and (5) identifying their own behaviors that might promote injection among others. The behavioral skills domain is addressed through a (6) skill-building discussion and rehearsal of responses to possible initiation scenarios, and (7) safer injection education.
Behavioral: Change the Cycle
See previous response
Other Name: CTC

Active Comparator: Nutrition
The nutrition equal attention control intervention is a single-session, 60- minute Information-Motivation-Behavioral (IMB) skills-based intervention addressing healthy eating. The healthy eating intervention uses a one-on-one guided conversation between the interventionist and the participant. The intervention addresses (1) information about current eating patterns and recommendations for healthy alternatives (20 minutes), (2) motivations for improving healthy eating by providing feedback to participants on personal responsibility, a menu of alternative change options, a decision balance exercise, and eating goal setting (10 minutes), and (3) Behavioral Self-Management Component (30 minutes) that covers eating scenarios, participant responses, and healthy alternatives to the scenario and the participants feedback.
Behavioral: Change the Cycle
See previous response
Other Name: CTC




Primary Outcome Measures :
  1. Number of non-injectors initiated into drug injection [ Time Frame: 6 months ]
    This data is collected based on responses to the following question: "In the last 6 months, how many people have you helped injected for the first time?"

  2. Number of request to initiate someone into drug injection [ Time Frame: 6 months ]
    This data is collected based on responses to the following question: "In the last 6 months, has anyone ASKED you to help them inject an illicit drug for the first time?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-reported Injection an illicit drug in the last 30 days,
  • visible evidence of injection such as track mark or stigmata,
  • at least 18 years of age

Exclusion Criteria:

  • Under 18 years of age,
  • no self-reported drug injection in the last 30 days,
  • no physical evidence of recent drug injection.

Information from the National Library of Medicine

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): NCT02774954


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
RTI International
San Francisco, California, United States, 94101
Sponsors and Collaborators
University of Southern California
National Institute on Drug Abuse (NIDA)
RTI International
University of Toronto
Investigators
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Principal Investigator: Ricky Bluthenthal, PhD University of Southern California

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Responsible Party: Ricky Bluthenthal, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02774954     History of Changes
Other Study ID Numbers: HS-15-00243
R01DA038965 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Using the National Addiction and HIV Data Archive program (NAHDAP), we will provide our datasets and codebooks to researchers in a format that facilitates data-sharing. After the completion of the study, the dataset will be de-identified and made available for secondary analysis on the NAHDAP website (http://www.icpsr.umich.edu/icpsrweb/NAHDAP/). Researchers who request access will be given a password to access the data, documentation, and surveys. As part of the registration process, researchers will sign an agreement to adhere to the data coding guidelines that were developed for the project, will state their intentions for use, and will agree to inform the original investigators of their findings and publications for tracking purposes with acknowledgments to the granting agency. Because the respondents will be identified only by ID codes in the datasets, it will be impossible to identify individuals from the datasets.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: June 2020
Keywords provided by Ricky Bluthenthal, University of Southern California:
Change the cycle
social learning theory
people who inject drugs
injection drug use
Information, Motivation, Behavior Skills Model
Longitudinal cohort study
Additional relevant MeSH terms:
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Substance-Related Disorders
Cocaine-Related Disorders
Opioid-Related Disorders
Heroin Dependence
Amphetamine-Related Disorders
Substance Abuse, Intravenous
Chemically-Induced Disorders
Mental Disorders