Change the Cycle: An RCT to Prevent Injection Initiation

Study Overview
=================
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).

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

Conditions
-----------------
Opioid Dependence, Cocaine Dependence, Amphetamine Dependence, HIV, Substance Abuse, Intravenous, Heroin Dependence

Intervention / Treatment
-----------------
* Behavioral: Change the Cycle


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Change the cycle<br>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<br>* See previous response<br>* Other names: CTC;|
| Active Comparator: Nutrition<br>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<br>* See previous response<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Change the cycle, social learning theory, people who inject drugs, injection drug use, Information, Motivation, Behavior Skills Model, Longitudinal cohort study