Clinical trial NCT02774954: Change the Cycle: An RCT to Prevent Injection Initiation
Official title: Preventing Injection Initiation: The Change the Cycle Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: RTI International
name: University of Toronto
First posted: 2016-05-17
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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).

Eligibility 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.

Primary outcomes:
measure: People Initiated Into Injection Drug Use
timeFrame: 6 months
measure: Number of Request to Initiate Someone Into Drug Injection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: RTI International
state: California
Study officials:
affiliation: University of Southern California
name: Ricky Bluthenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References: