Amphetamine Dependence, Cocaine Dependence, Heroin Dependence, HIV, Opioid Dependence, Substance Abuse, Intravenous
Conditions
Keywords
Change the cycle, social learning theory, people who inject drugs, injection drug use, Information, Motivation, Behavior Skills Model, Longitudinal cohort study
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).
Interventions
See previous response
Sponsors
Study design
Masking description
The statistician who is conducting the data analysis will not know the content of the intervention assignment.
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| People Initiated Into Injection Drug Use | 6 months | 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? |
| Number of Request to Initiate Someone Into Drug Injection | 6 months | 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? |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in community settings using targeted sampling approach. The first participant was recruited on June 20, 2016 and the last participant was recruited on October 1, 2017.
Pre-assignment details
A total of 984 participants were recruited of whom 979 complete baseline study requirements and are considered in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Change the Cycle 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.
Change the Cycle: See previous response | 482 |
| Nutrition 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.
Change the Cycle: See previous response | 497 |
| Total | 979 |
Baseline characteristics
| Characteristic | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 13 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 467 Participants | 484 Participants | 951 Participants |
| Age, Continuous | 42.44 Years STANDARD_DEVIATION 12.22 | 42.17 Years STANDARD_DEVIATION 12.12 | 42.30 Years STANDARD_DEVIATION 12.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 125 Participants | 120 Participants | 245 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 357 Participants | 377 Participants | 734 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of people who asked to be initiated in the last 6 months | 11.09 Number of people STANDARD_DEVIATION 13.65 | 10.45 Number of people STANDARD_DEVIATION 41.5 | 10.77 Number of people STANDARD_DEVIATION 36.93 |
| People helped inject for the first time in the last 6 months | 5.14 Number of people STANDARD_DEVIATION 13.65 | 6.72 Number of people STANDARD_DEVIATION 25 | 5.94 Number of people STANDARD_DEVIATION 20.13 |
| Race (NIH/OMB) American Indian or Alaska Native | 28 Participants | 33 Participants | 61 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 94 Participants | 106 Participants | 200 Participants |
| Race (NIH/OMB) More than one race | 22 Participants | 27 Participants | 49 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 332 Participants | 326 Participants | 658 Participants |
| Region of Enrollment United States | 482 participants | 497 participants | 979 participants |
| Sex: Female, Male Female | 105 Participants | 118 Participants | 223 Participants |
| Sex: Female, Male Male | 377 Participants | 379 Participants | 756 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 482 | 17 / 497 |
| other Total, other adverse events | 0 / 482 | 0 / 497 |
| serious Total, serious adverse events | 0 / 482 | 0 / 497 |
Outcome results
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?
Time frame: 6 months
Population: Participants are people who inject drugs. The outcomes variable is the number of people who requested that participants help them with their first injection drug use. Study participants could receive multiple request.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change the Cycle | Number of Request to Initiate Someone Into Drug Injection | 6.42 Initiation request | Standard Deviation 25.48 |
| Nutrition | Number of Request to Initiate Someone Into Drug Injection | 4.06 Initiation request | Standard Deviation 5.56 |
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?
Time frame: 6 months
Population: Participants in the study are people who inject drugs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Change the Cycle | People Initiated Into Injection Drug Use | 2.05 People initiated | Standard Deviation 1.43 |
| Nutrition | People Initiated Into Injection Drug Use | 3.26 People initiated | Standard Deviation 5.43 |