HIV Chemoprophylaxis, HIV Preexposure Prophylaxis
Conditions
Keywords
preexposure prophylaxis, PrEP, HIV
Brief summary
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.
Interventions
DRUGcoformulated TDF/FTC
Daily oral dose of coformulated TDF/FTC
Sponsors
CDC Foundation
Gilead Sciences
Centers for Disease Control and Prevention
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult * documented without HIV infection (acute or established) * report sexual behaviors that indicate substantial risk of HIV acquisition * report injection-related behaviors that indicate substantial risk of HIV acquisition
Exclusion criteria
* \<18 years of age * documented HIV infection (acute or established)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical safety | Every 3 months up to 36 months | 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 |
| Medication adherence | Every 3 months up to 36 months | Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP |
| Behavioral Responses | Every 3 months up to 36 months | Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs | Up to 3 years | Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP |
| Clinical practice variation | Every 3 months up to 36 months | 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 |
Countries
United States
Outcome results
None listed