Change the Cycle: An RCT to Prevent Injection Initiation

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).

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.