Sustainable Healthcenter Implementation PrEP Pilot Study (SHIPP)

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 Overview

• Status: Unknown
• Conditions: HIV Preexposure Prophylaxis; HIV Chemoprophylaxis
• Intervention / Treatment: Drug: coformulated TDF/FTC

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20009
      • Recruiting
      • Whitman Walker Health
      • Contact: Megan Coleman, FNP; Phone Number: 202-797-3577; Email: MColeman@whitman-walker.org
      • Principal Investigator: Megan Coleman, FNP
  • Illinois
    • Chicago, Illinois, United States, 60609
      • Recruiting
      • Access Community Health Network - Grand Boulevard Health and Specialty Center
      • Contact: Danielle Lazar; Phone Number: 312-526-2070; Email: danielle.lazar@accesscommunityhealth.net
    • Chicago, Illinois, United States, 60613
      • Recruiting
      • Howard Brown Community Health Center
      • Contact: Magda Houlberg, MD; Phone Number: 773-388-8933; Email: MagdaH@howardbrown.org
      • Principal Investigator: Magda Houlberg, MD
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • Open Arms Healthcare Center
      • Contact: Leandro Mena, MD, MPH; Phone Number: 601-815-3885; Email: lmena@umc.edu
      • Principal Investigator: Leandro Mena, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19132
      • Recruiting
      • Strawberry Mansion Health Center
      • Contact: Helena Kwakwa, MD, MPH; Phone Number: 215-685-6769; Email: hkwakwa@aol.com
      • Principal Investigator: Helena Kwakwa, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1200 adult men who have sex with men, injection drug users, and heterosexually-active men and women who are at substantial risk of acquiring HIV infection and initiate the use of daily oral antiretroviral preexposure prophylaxis (PrEP) with TDF/FTC

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons prescribed PrEP; adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition.	Drug: coformulated TDF/FTC; Daily oral dose of coformulated TDF/FTC; Other Names: Truvada; Tenofovir disoproxil fumarate (TDF); 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

Collaborators and Investigators

• Sponsor: CDC Foundation
• Collaborators: Gilead Sciences
• Investigators: Study Chair: Dawn K Smith, MD, MS, MPH, Centers for Disease Control and Prevention; Study Director: Rebecca Cook, MPH, CDC Foundation

Publications and helpful links

Helpful Links

• Link to CDC information about preexposure prophylaxis

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: February 26, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 2, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: HIV; PrEP; preexposure prophylaxis
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: CDC-NCHHSTP-6511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No