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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to see if providing participants with pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid PrEP group | Experimental | Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descovy 200Mg 25Mg Tablet | Drug | daily Descovy tab by mouth |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up | Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PrEP Initiation Post Negative HIV Rapid Test | Number of days between receiving negative test result and initiating PrEP via self-report | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
self representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Hansel Tookes | 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 PrEP Group | Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. Descovy 200Mg 25Mg Tablet: daily Descovy tab by mouth PrEP: PrEP will be provided in a community setting by community-based harm reduction program. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rapid PrEP Group | Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. Descovy 200Mg 25Mg Tablet: daily Descovy tab by mouth PrEP: PrEP will be provided in a community setting by community-based harm reduction program. |
| 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 | Intracellular Level of Tenofovir Diphosphate Levels Via Dried Blood Spot at 6-month Follow-up | Tenofovir diphosphate levels will be quantified using a validated dried blood spot (DBS) assay. The outcome will be reported as the mean intracellular concentration (fmol/punch) at the 6-month follow-up visit. This measure reflects intracellular drug exposure and adherence. | Specimens were collected but none met laboratory acceptance criteria (insufficient punch volume and degradation). Therefore, no valid concentrations could be calculated. All values are reported as Not Analyzable. | Posted | Mean | Standard Deviation | fmol/punch | 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 PrEP Group | Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program. Descovy 200Mg 25Mg Tablet: daily Descovy tab by mouth PrEP: PrEP will be provided in a community setting by community-based harm reduction program. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hansel Tookes, Professor of Medicine | University of Miami | 305-689-7030 | 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 | May 5, 2022 | Oct 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000613801 | emtricitabine tenofovir alafenamide |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| PrEP |
| Behavioral |
PrEP will be provided in a community setting by community-based harm reduction program. |
|
| Participants |
|
| Sex: Female, Male | 4 participants consented and left before data was collected for baseline | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 4 participants consented and left before data was collected for baseline | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Time to PrEP Initiation Post Negative HIV Rapid Test | Number of days between receiving negative test result and initiating PrEP via self-report | All participants-initiated PrEP immediately following their negative test result. Because initiation occurred on the same day as the negative test (day 0), the calculated value for every participant was zero days | Posted | Number | days | up to 12 months |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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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 |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |