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Change the Cycle: An RCT to Prevent Injection Initiation

Preventing Injection Initiation: The Change the Cycle Randomized Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02774954
Acronym
CTC
Enrollment
979
Registered
2016-05-17
Start date
2016-06-30
Completion date
2019-11-30
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amphetamine Dependence, Cocaine Dependence, Heroin Dependence, HIV, Opioid Dependence, Substance Abuse, Intravenous

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

BEHAVIORALChange the Cycle

See previous response

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
RTI International
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
People Initiated Into Injection Drug Use6 monthsThis 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 Injection6 monthsThis 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

ArmCount
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
Total979

Baseline characteristics

CharacteristicChange the CycleNutritionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
15 Participants13 Participants28 Participants
Age, Categorical
Between 18 and 65 years
467 Participants484 Participants951 Participants
Age, Continuous42.44 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 Participants120 Participants245 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
357 Participants377 Participants734 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Number of people who asked to be initiated in the last 6 months11.09 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 months5.14 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 Participants33 Participants61 Participants
Race (NIH/OMB)
Asian
3 Participants5 Participants8 Participants
Race (NIH/OMB)
Black or African American
94 Participants106 Participants200 Participants
Race (NIH/OMB)
More than one race
22 Participants27 Participants49 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
332 Participants326 Participants658 Participants
Region of Enrollment
United States
482 participants497 participants979 participants
Sex: Female, Male
Female
105 Participants118 Participants223 Participants
Sex: Female, Male
Male
377 Participants379 Participants756 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
17 / 48217 / 497
other
Total, other adverse events
0 / 4820 / 497
serious
Total, serious adverse events
0 / 4820 / 497

Outcome results

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?

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.

ArmMeasureValue (MEAN)Dispersion
Change the CycleNumber of Request to Initiate Someone Into Drug Injection6.42 Initiation requestStandard Deviation 25.48
NutritionNumber of Request to Initiate Someone Into Drug Injection4.06 Initiation requestStandard Deviation 5.56
p-value: 0.35ANOVA
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?

Time frame: 6 months

Population: Participants in the study are people who inject drugs.

ArmMeasureValue (MEAN)Dispersion
Change the CyclePeople Initiated Into Injection Drug Use2.05 People initiatedStandard Deviation 1.43
NutritionPeople Initiated Into Injection Drug Use3.26 People initiatedStandard Deviation 5.43
p-value: 0.35ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026