Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2022-02-01
2024-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
Interventions
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Descovy 200Mg 25Mg Tablet
daily Descovy tab by mouth
PrEP
PrEP will be provided in a community setting by community-based harm reduction program.
Eligibility Criteria
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Inclusion Criteria
2. speak either English or Spanish
3. ability to provide informed consent
4. currently enrolled in the syringe services program
5. have a negative HIV rapid test result
6. estimated creatinine clearance \> 30 ml/minute
Exclusion Criteria
2. decline to participate
3. test positive for HIV via rapid test
4. are pregnant or plan on becoming pregnant
5. have symptoms acute HIV.
6. Any other comorbidities that at the discretion of the investigator would prevent the participant from participating in the study.
18 Years
ALL
Yes
Sponsors
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Gilead Sciences
INDUSTRY
University of Miami
OTHER
Responsible Party
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Hansel Tookes
Professor of Medicine
Principal Investigators
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Hansel Tookes
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20210017
Identifier Type: -
Identifier Source: org_study_id