Trial Outcomes & Findings for Change the Cycle: An RCT to Prevent Injection Initiation (NCT NCT02774954)
NCT ID: NCT02774954
Last Updated: 2023-03-20
Results Overview
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?"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
979 participants
Primary outcome timeframe
6 months
Results posted on
2023-03-20
Participant Flow
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.
A total of 984 participants were recruited of whom 979 complete baseline study requirements and are considered in the trial.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Baseline
STARTED
|
482
|
497
|
|
Baseline
Completed Baseline Interview and Intervention
|
482
|
497
|
|
Baseline
COMPLETED
|
482
|
497
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
6 Month Follow-up
STARTED
|
482
|
497
|
|
6 Month Follow-up
COMPLETED
|
286
|
313
|
|
6 Month Follow-up
NOT COMPLETED
|
196
|
184
|
|
12 Month Follow-up
STARTED
|
286
|
313
|
|
12 Month Follow-up
COMPLETED
|
253
|
279
|
|
12 Month Follow-up
NOT COMPLETED
|
33
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Change the Cycle: An RCT to Prevent Injection Initiation
Baseline characteristics by cohort
| Measure |
Change the Cycle
n=482 Participants
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
|
Nutrition
n=497 Participants
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
|
Total
n=979 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
467 Participants
n=99 Participants
|
484 Participants
n=107 Participants
|
951 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Continuous
|
42.44 Years
STANDARD_DEVIATION 12.22 • n=99 Participants
|
42.17 Years
STANDARD_DEVIATION 12.12 • n=107 Participants
|
42.30 Years
STANDARD_DEVIATION 12.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
377 Participants
n=99 Participants
|
379 Participants
n=107 Participants
|
756 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
125 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
357 Participants
n=99 Participants
|
377 Participants
n=107 Participants
|
734 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
94 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
332 Participants
n=99 Participants
|
326 Participants
n=107 Participants
|
658 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
482 participants
n=99 Participants
|
497 participants
n=107 Participants
|
979 participants
n=206 Participants
|
|
People helped inject for the first time in the last 6 months
|
5.14 Number of people
STANDARD_DEVIATION 13.65 • n=99 Participants
|
6.72 Number of people
STANDARD_DEVIATION 25.00 • n=107 Participants
|
5.94 Number of people
STANDARD_DEVIATION 20.13 • n=206 Participants
|
|
Number of people who asked to be initiated in the last 6 months
|
11.09 Number of people
STANDARD_DEVIATION 13.65 • n=99 Participants
|
10.45 Number of people
STANDARD_DEVIATION 41.50 • n=107 Participants
|
10.77 Number of people
STANDARD_DEVIATION 36.93 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants in the study are people who inject drugs.
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?"
Outcome measures
| Measure |
Change the Cycle
n=253 Participants
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
|
Nutrition
n=279 Participants
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
|
|---|---|---|
|
People Initiated Into Injection Drug Use
|
2.05 People initiated
Standard Deviation 1.43
|
3.26 People initiated
Standard Deviation 5.43
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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?"
Outcome measures
| Measure |
Change the Cycle
n=253 Participants
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
|
Nutrition
n=279 Participants
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
|
|---|---|---|
|
Number of Request to Initiate Someone Into Drug Injection
|
6.42 Initiation request
Standard Deviation 25.48
|
4.06 Initiation request
Standard Deviation 5.56
|
Adverse Events
Change the Cycle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
Nutrition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 17 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place