Sustainable Healthcenter Implementation PrEP Pilot Study

N/ACompletedNCT02074891

Centers for Disease Control and Prevention1,420 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,420

Conditions

HIV Chemoprophylaxis HIV Preexposure Prophylaxis

Interventions

coformulated TDF/FTCDRUG

Daily oral dose of coformulated TDF/FTC

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (5)

Whitman Walker Health

Washington D.C., District of Columbia, United States

Access Community Health Network - Grand Boulevard Health and Specialty Center

Chicago, Illinois, United States

Howard Brown Community Health Center

Chicago, Illinois, United States

Open Arms Healthcare Center

Jackson, Mississippi, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Every 3 months up to 36 months

Secondary Outcomes

Costs

Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP

Time frame: 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

Time frame: Every 3 months up to 36 months

Data from ClinicalTrials.gov

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