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

Preventing Injection Initiation: The Change the Cycle Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Substance Abuse, Intravenous; HIV; Heroin Dependence; Opioid Dependence; Cocaine Dependence; Amphetamine Dependence
• Intervention / Treatment: Behavioral: Change the Cycle

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).

• Study Type: Interventional
• Enrollment (Actual): 979
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • San Francisco, California, United States, 94101
      • RTI International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: CTC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
People Initiated Into Injection Drug Use	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?"	6 months
Number of Request to Initiate Someone Into Drug Injection	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?"	6 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Institute on Drug Abuse (NIDA); University of Toronto; RTI International

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Longitudinal cohort study; injection drug use; people who inject drugs; Change the cycle; social learning theory; Information, Motivation, Behavior Skills Model
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Substance Abuse, Intravenous; Opioid-Related Disorders; Heroin Dependence; Cocaine-Related Disorders; Amphetamine-Related Disorders
• Other Study ID Numbers: HS-15-00243; R01DA038965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: June 2020
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF