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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA030768 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| George Mason University | OTHER |
| Howard University | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.
Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.
STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone | Drug | 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD4 Count Absolute | CD4 Count Absolute | Baseline |
| CD4 Count Absolute | CD4 Count Absolute | 6 Months |
| CD4 Count Absolute | CD4 Count | 12 Months |
| CD4 Percent | CD4 Percent | Baseline |
| CD4 Percent | CD4 Percent | 6 Months |
| CD4 Percent | CD4 Percent | 12 Months |
| Viral Load | Viral Load | Baseline |
| Viral Load | Viral Load | 6 Months |
| Viral Load | Viral Load | 12 Months |
| Log Viral Load | Log Viral Load |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Opioid Treatment Outcomes | Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year. | baseline, 3 months, 9 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Altice, MD | Yale University School of Medicine/AIDS Program | Principal Investigator |
| Faye Taxman, PhD | George Mason University | Principal Investigator |
| William Lawson, MD | Howard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University | Washington D.C. | District of Columbia | 20060 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
| FG001 | Placebo | Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine | Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
| BG001 | Placebo | Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
| 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 | CD4 Count Absolute | CD4 Count Absolute | Participants with complete lab results. | Posted | Mean | Standard Deviation | cells/uL | Baseline |
|
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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 | Buprenorphine | Buprenorphine/naloxone: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frederick Altice, Principal Investigator | Yale University | 203-737-2883 | frederick.altice@yale.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Placebo Oral Tablet | Drug | 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. |
|
| Baseline |
| Log Viral Load | Log Viral Load | 6 Months |
| Log Viral Load | Log Viral Load | 12 Months |
| Improved Criminal Justice Outcomes |
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit. |
| baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | CD4 Count Absolute | CD4 Count Absolute | Participants with complete lab results. | Posted | Mean | Standard Deviation | cells/uL | 6 Months |
|
|
|
| Primary | CD4 Count Absolute | CD4 Count | Participants with complete lab results. | Posted | Mean | Standard Deviation | cells/uL | 12 Months |
|
|
|
| Primary | CD4 Percent | CD4 Percent | Participants with complete lab results. | Posted | Mean | Standard Deviation | CD4 Percent | Baseline |
|
|
|
| Primary | CD4 Percent | CD4 Percent | Participants with complete lab results. | Posted | Mean | Standard Deviation | CD4 Percent | 6 Months |
|
|
|
| Primary | CD4 Percent | CD4 Percent | Participants with complete lab results. | Posted | Mean | Standard Deviation | CD4 Percent | 12 Months |
|
|
|
| Primary | Viral Load | Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | IU/mL | Baseline |
|
|
|
| Primary | Viral Load | Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | IU/mL | 6 Months |
|
|
|
| Primary | Viral Load | Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | IU/mL | 12 Months |
|
|
|
| Primary | Log Viral Load | Log Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | log(IU/mL) | Baseline |
|
|
|
| Primary | Log Viral Load | Log Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | log(IU/mL) | 6 Months |
|
|
|
| Primary | Log Viral Load | Log Viral Load | Participants with complete lab results. | Posted | Mean | Standard Deviation | log(IU/mL) | 12 Months |
|
|
|
| Secondary | Improved Opioid Treatment Outcomes | Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year. | This outcome was not collected and analyzed due to the change in study design (see study description). | Posted | baseline, 3 months, 9 months, 12 months |
|
|
| Secondary | Improved Criminal Justice Outcomes | Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit. | These data were never collected and summarized due to the change in study design (see study description). | Posted | baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | Placebo Oral Tablet: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |