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The goal of this randomized control pilot study is to learn about a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The main question it aims to answer is how financial incentives for not using stimulants will impact stimulant use. Participants in the experimental group will have the opportunity to earn financial incentives for providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, along with health education on the health risks of stimulant use and substance injection. Researchers will compare the experimental group to the control group who will receive health education on the health risks of stimulants use and injection.
The investigators are proposing a two condition, parallel groups, randomized control pilot study to evaluate the efficacy of a financial incentives intervention among individuals who use stimulants and take part in a community-based syringe exchange program. The study design will include recruiting service recipients who already participate in programs offered by a syringe exchange program.The experimental group will have the opportunity to earn financial incentives contingent on providing a negative urine sample for stimulants using a point-of-care test, which indicates abstinence from stimulant use, in addition to health education on the health risks of stimulant use and substance injection. The control group will receive health education on the health risks of stimulants use and injection. All participants will participate in their syringe exchange services as usual. The investigators chose the health education as the control because participants across both conditions already receive the services provided by the syringe exchange program. Moreover, this control condition will help control for a potential type of between-groups variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Education | Other |
| |
| Health Education plus Incentives for Abstinence | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentives for Abstinence | Behavioral | Participants in the incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use. |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulant Free Urine Sample | all samples will be assessed using point-of-care test urine drug test conducted at the center | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard Center | Burlington | Vermont | 05401 | United States |
Inclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Education | The Health Education condition is based on a previous intervention used as a control in a number of other studies. Sessions consist of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
| FG001 | Health Education Plus Incentives for Abstinence | Participants in the health education plus incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use. Additionally, they also receive the health education provided in the Health Education condition, with sessions consisting of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Education | The Health Education condition is based on a previous intervention used as a control in a number of other studies. Sessions consist of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Stimulant Free Urine Sample | all samples will be assessed using point-of-care test urine drug test conducted at the center | Posted | Mean | Standard Error | % stimulant-negative urine drug test | 12 weeks | Urine drug test | Urine drug test |
|
From enrollment to study completion at 12 weeks
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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 | Health Education | The Health Education condition is based on a previous intervention used as a control in a number of other studies. Sessions consist of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
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This project was designed as a pilot study with a small sample size. As such, there are limitations of the statistical power due to the small sample size. Although the originally proposed sample size by condition was not met, the results are able to discern patterns of differences in the primary outcome by study condition.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Rawson | University of Vermont | +1 (310) 951-9091 | richard.rawson@uvm.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 | Aug 11, 2025 | Aug 12, 2025 | Prot_SAP_000.pdf |
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| Health Education | Behavioral | The Health Education condition is based on a previous intervention used as a control in a number of other studies. Sessions consist of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
|
| Health Education Plus Incentives for Abstinence |
Participants in the health education plus incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use. Additionally, they also receive the health education provided in the Health Education condition, with sessions consisting of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Health Education Plus Incentives for Abstinence | Participants in the health education plus incentives for abstinence condition will have the opportunity to earn financial incentives for abstaining from stimulant use. Additionally, they also receive the health education provided in the Health Education condition, with sessions consisting of an educational program addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness manual. | 0 | 14 | 0 | 14 | 0 | 14 |
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