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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA038965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| RTI International | OTHER |
| University of Toronto | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Change the cycle | Experimental | 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. |
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| Nutrition | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change the Cycle | Behavioral | See previous response |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricky Bluthenthal, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| RTI International |
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.
June 2020
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A total of 984 participants were recruited of whom 979 complete baseline study requirements and are considered in the trial.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 6 Month Follow-up |
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| 12 Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Participants in the study are people who inject drugs. | Posted | Mean | Standard Deviation | People initiated | 6 months |
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Adverse events were tracked for the participants time in the study which could have extended up to 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Our chief limitation was loss-to-follow-up. Our rate of recapture at 6 month was 62% while are recapture rate between 6 month and 12 month interview was 89%.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricky Bluthenthal | USCalifornia | 3234428236 | rbluthen@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2018 | Apr 8, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015819 | Substance Abuse, Intravenous |
| D006556 | Heroin Dependence |
| D009293 | Opioid-Related Disorders |
| D019970 | Cocaine-Related Disorders |
| D019969 | Amphetamine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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This study compares 2 active listening, information-motivation-behavior skills interventions aimed at improving health behaviors among very low-income, drug using participants.
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The statistician who is conducting the data analysis will not know the content of the intervention assignment.
| San Francisco |
| California |
| 94101 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| People helped inject for the first time in the last 6 months | Mean | Standard Deviation | Number of people |
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| Number of people who asked to be initiated in the last 6 months | Mean | Standard Deviation | Number of people |
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| OG001 | 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 |
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| Primary | 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?" | 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. | Posted | Mean | Standard Deviation | Initiation request | 6 months |
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| 17 |
| 482 |
| 0 |
| 482 |
| 0 |
| 482 |
| EG001 | 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 | 17 | 497 | 0 | 497 | 0 | 497 |
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