Change the Cycle: An RCT to Prevent Injection Initiation

NCT02774954 | Completed Results DMC

• 2 other identifiers: HS-15-00243R01DA038965
• Study Type: interventional
• Target: 979
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Abuse, Intravenous; HIV; Heroin Dependence; Opioid Dependence; Cocaine Dependence; Amphetamine Dependence

Keywords

Change the cycle; social learning theory; people who inject drugs; injection drug use; Information, Motivation, Behavior Skills Model; Longitudinal cohort study

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Change the cycle

EXPERIMENTAL

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

Nutrition

ACTIVE COMPARATOR

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

Interventions

Change the Cycle BEHAVIORAL

See previous response

Also known as: CTC

Change the cycle; Nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Drug Abuse (NIDA): collaborator
• RTI International: collaborator
• University of Toronto: collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

RTI International

San Francisco, California, 94101, United States

Location

MeSH Terms

Conditions

Substance Abuse, Intravenous; Heroin Dependence; Opioid-Related Disorders; Cocaine-Related Disorders; Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Limitations and Caveats

Our chief limitation was loss-to-follow-up. Our rate of recapture at 6 month was 62% while are recapture rate between 6 month and 12 month interview was 89%.

Results Point of Contact

• Title: Ricky Bluthenthal
• Organization: USCalifornia

rbluthen@usc.edu

3234428236

Study Officials

• Ricky Bluthenthal, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician who is conducting the data analysis will not know the content of the intervention assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study compares 2 active listening, information-motivation-behavior skills interventions aimed at improving health behaviors among very low-income, drug using participants.

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 17, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: June 2020

Locations

US (2)