Sustainable Healthcenter Implementation PrEP Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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Conditions

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HIV Chemoprophylaxis HIV Preexposure Prophylaxis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Persons prescribed PrEP

adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition.

coformulated TDF/FTC

Intervention Type DRUG

Daily oral dose of coformulated TDF/FTC

Interventions

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coformulated TDF/FTC

Daily oral dose of coformulated TDF/FTC

Intervention Type DRUG

Other Intervention Names

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Truvada Tenofovir disoproxil fumarate (TDF) Emtracitabine (FTC)

Eligibility Criteria

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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