Sustainable Healthcenter Implementation PrEP Pilot Study

HIV Preexposure Prophylaxis Clinical Trial

— SHIPP  

Official title:

Sustainable Healthcenter Implementation PrEP Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074891
• Other study ID #: CDC-NCHHSTP-6511
• Status: Completed
• Start date: October 2014
• Est. completion date: November 2018

Study information

• Verified date: February 2016
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1420
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Chemoprophylaxis
• HIV Preexposure Prophylaxis

Intervention

Drug:
• coformulated TDF/FTC
Daily oral dose of coformulated TDF/FTC

Locations

Country	Name	City	State
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	Strawberry Mansion Health Center	Philadelphia	Pennsylvania
United States	Whitman Walker Health	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	CDC Foundation, Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Costs	Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP	Up to 3 years
Secondary	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

External Links

•   Link to CDC information about preexposure prophylaxis