Sustainable Healthcenter Implementation PrEP Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Sustainable Healthcenter Implementation PrEP Pilot Study

Conditions
-----------------
HIV Chemoprophylaxis, HIV Preexposure Prophylaxis

Intervention / Treatment
-----------------
* Drug: coformulated TDF/FTC


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons prescribed PrEP<br>adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition. | Drug: coformulated TDF/FTC<br>* Daily oral dose of coformulated TDF/FTC<br>* Other names: Emtracitabine (FTC);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Every 3 months up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, preexposure prophylaxis, PrEP