Change the Cycle: An RCT to Prevent Injection Initiation

HIV Clinical Trial

— CTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774954
• Other study ID #: HS-15-00243
• Secondary ID: R01DA038965
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: November 2019

Study information

• Verified date: February 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 979
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Change the Cycle
See previous response

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	RTI International	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Drug Abuse (NIDA), RTI International, University of Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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