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| Name | Class |
|---|---|
| CDC Foundation | OTHER |
| Gilead Sciences | INDUSTRY |
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A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons prescribed PrEP | adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coformulated TDF/FTC | Drug | Daily oral dose of coformulated TDF/FTC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety | Side effects, rates of renal adverse events, rates of atraumatic bone fractures, HIV infections with/without virus with mutations associated with TDF or FTC resistance, documented at clinical visits while prescribed PrEP | Every 3 months up to 36 months |
| Medication adherence | Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP | Every 3 months up to 36 months |
| Behavioral Responses | Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP | Every 3 months up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Costs | Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP | Up to 3 years |
| Clinical practice variation | Variation in clinical practices at each clinic visit for PrEP-related care relative to PHS PrEP guidelines, and the relationship of clinical practices to patient outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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1200 adult men who have sex with men, injection drug users, and heterosexually-active men and women who are at substantial risk of acquiring HIV infection and initiate the use of daily oral antiretroviral preexposure prophylaxis (PrEP) with TDF/FTC
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| Name | Affiliation | Role |
|---|---|---|
| Dawn K Smith, MD, MS, MPH | Centers for Disease Control and Prevention | Study Chair |
| Rebecca Cook, MPH | CDC Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whitman Walker Health | Washington D.C. | District of Columbia | 20009 | United States | ||
| Access Community Health Network - Grand Boulevard Health and Specialty Center |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068698 | Tenofovir |
| C075889 | Racivir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
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Dried blood spots
| Every 3 months up to 36 months |
| Chicago |
| Illinois |
| 60609 |
| United States |
| Howard Brown Community Health Center | Chicago | Illinois | 60613 | United States |
| Open Arms Healthcare Center | Jackson | Mississippi | 39216 | United States |
| Strawberry Mansion Health Center | Philadelphia | Pennsylvania | 19132 | United States |
| D003841 |
| Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |