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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid ART group | Experimental | Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biktarvy 50Mg-200Mg-25Mg Tablet | Drug | Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV Viral Load Suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV Viral Load Suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | 1 month |
| Percentage of Participants With HIV Viral Load Suppression |
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Inclusion Criteria:
Exclusion Criteria:
1) Any other comorbidities at the discretion of the investigator
self-representation
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| Name | Affiliation | Role |
|---|---|---|
| Hansel Tookes, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rapid ART Group | Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic. Biktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months HIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapid ART Group | Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic. Biktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months HIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Participants With HIV Viral Load Suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | Data was not collected for those participants that were lost to follow-up or death due to COVID pandemic | Posted | Count of Participants | Participants | 6 months |
|
1 year
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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 | Rapid ART Group | Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic. Biktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months HIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hansel Tookes | University of Miami Miller School of Medicine | 3056897030 | hetookes@miami.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 | Apr 25, 2022 | Dec 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D040261 | Harm Reduction |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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| HIV care | Other | HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months. |
|
HIV viral load suppression is defined as <200 copies/ml in participants' blood
| 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants With HIV Viral Load Suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Percentage of Participants With HIV Viral Load Suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 3 |
| 27 |
| 3 |
| 27 |
| 0 |
| 27 |
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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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |