Sustainable Healthcenter Implementation PrEP Pilot Study

Completed

• Conditions: HIV Chemoprophylaxis; HIV Preexposure Prophylaxis
• Interventions: Drug: coformulated TDF/FTC

• Registration Number: NCT02074891
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2014-10
• Status Verified: 2016-02
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1420

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
Costs	Up to 3 years	Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP

Trial Locations

Locations (5)

Access Community Health Network - Grand Boulevard Health and Specialty Center; 🇺🇸 Chicago, Illinois, United States

Whitman Walker Health; 🇺🇸 Washington, District of Columbia, United States

Howard Brown Community Health Center; 🇺🇸 Chicago, Illinois, United States

Open Arms Healthcare Center; 🇺🇸 Jackson, Mississippi, United States

Strawberry Mansion Health Center; 🇺🇸 Philadelphia, Pennsylvania, United States