An interventional study of Change the Cycle in Substance Abuse, Intravenous, HIV and Heroin Dependence, sponsored by University of Southern California. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by University of Southern California · Not applicable, Interventional, and Prevention
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.
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).
29 studies on the registry are indexed under Substance Abuse, Intravenous; 1 is open to participants now.
This study's enrollment of 979 is above the median of 117 across 21 interventional studies indexed under Substance Abuse, Intravenous.
Browse Substance Abuse, Intravenous studies →University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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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
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
See previous response
Also known as: CTC
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
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
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.
| Milestone | Change the Cycle | Nutrition |
|---|---|---|
| Started | 482 | 497 |
| Completed baseline interview and intervention | 482 | 497 |
| Completed | 482 | 497 |
| Not completed | 0 | 0 |
| Milestone | Change the Cycle | Nutrition |
|---|---|---|
| Started | 482 | 497 |
| Completed | 286 | 313 |
| Not completed | 196 | 184 |
| Milestone | Change the Cycle | Nutrition |
|---|---|---|
| Started | 286 | 313 |
| Completed | 253 | 279 |
| Not completed | 33 | 34 |
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?"
| People initiated | Change the Cycle | Nutrition |
|---|---|---|
| People Initiated Into Injection Drug Use | 2.05 ± 1.43 | 3.26 ± 5.43 |
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?"
| Initiation request | Change the Cycle | Nutrition |
|---|---|---|
| Number of Request to Initiate Someone Into Drug Injection | 6.42 ± 25.48 | 4.06 ± 5.56 |
Collected over Adverse events were tracked for the participants time in the study which could have extended up to 18 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Change the Cycle | 17/482 (3.5%) | 0/482 (0%) | 0/482 (0%) |
| Nutrition | 17/497 (3.4%) | 0/497 (0%) | 0/497 (0%) |
| Age, Categorical(Participants) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 467 | 484 | 951 |
| >=65 years | 15 | 13 | 28 |
| Age, Continuous(Years) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Mean | 42.44 ± 12.22 | 42.17 ± 12.12 | 42.30 ± 12.17 |
| Sex: Female, Male(Participants) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Female | 105 | 118 | 223 |
| Male | 377 | 379 | 756 |
| Ethnicity (NIH/OMB)(Participants) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Hispanic or Latino | 125 | 120 | 245 |
| Not Hispanic or Latino | 357 | 377 | 734 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 28 | 33 | 61 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 3 | 0 | 3 |
| Black or African American | 94 | 106 | 200 |
| White | 332 | 326 | 658 |
| More than one race | 22 | 27 | 49 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| United States | 482 | 497 | 979 |
| People helped inject for the first time in the last 6 months(Number of people) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Mean | 5.14 ± 13.65 | 6.72 ± 25.00 | 5.94 ± 20.13 |
| Number of people who asked to be initiated in the last 6 months(Number of people) | Change the Cycle | Nutrition | Total |
|---|---|---|---|
| Mean | 11.09 ± 13.65 | 10.45 ± 41.50 | 10.77 ± 36.93 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Using the National Addiction and HIV Data Archive program (NAHDAP), we will provide our datasets and codebooks to researchers in a format that facilitates data-sharing. After the completion of the study, the dataset will be de-identified and made available for secondary analysis on the NAHDAP website (http://www.icpsr.umich.edu/icpsrweb/NAHDAP/). Researchers who request access will be given a password to access the data, documentation, and surveys. As part of the registration process, researchers will sign an agreement to adhere to the data coding guidelines that were developed for the project, will state their intentions for use, and will agree to inform the original investigators of their findings and publications for tracking purposes with acknowledgments to the granting agency. Because the respondents will be identified only by ID codes in the datasets, it will be impossible to identify individuals from the datasets.
Supporting information: Study protocol, Informed consent form
Time frame: June 2020
Ran from Jun 2016 to primary completion in Nov 2018, 29 months.
Results were first posted in Mar 2023, 4 years 4 months after primary completion.
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