Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sustainable Healthcenter Implementation PrEP Pilot Study (SHIPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Centers for Disease Control and Prevention
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Dawn Smith, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02074891
First received: February 24, 2014
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
HIV Chemoprophylaxis
HIV Preexposure Prophylaxis
Drug: coformulated TDF/FTC

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sustainable Healthcenter Implementation PrEP Pilot Study

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Clinical safety [ Time Frame: Every 3 months up to 36 months ] [ Designated as safety issue: Yes ]
    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

  • Medication adherence [ Time Frame: Every 3 months up to 36 months ] [ Designated as safety issue: Yes ]
    Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP

  • Behavioral Responses [ Time Frame: Every 3 months up to 36 months ] [ Designated as safety issue: Yes ]
    Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP


Secondary Outcome Measures:
  • Costs [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP

  • Clinical practice variation [ Time Frame: Every 3 months up to 36 months ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

Dried blood spots


Estimated Enrollment: 1200
Study Start Date: October 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074891

Contacts
Contact: Dawn K Smith, MD, MS, MPH 404-639-5166 dsmith1@cdc.gov

Locations
United States, Illinois
Access Community Health Network - Grand Boulevard Health and Specialty Center Recruiting
Chicago, Illinois, United States, 60609
Contact: Danielle Lazar    312-526-2070    danielle.lazar@accesscommunityhealth.net   
Principal Investigator: Danielle Lazar         
United States, New Jersey
Newark Community Health Centers - Ludlow St. Clinic Recruiting
Newark, New Jersey, United States, 07114
Contact: Ada Emuwa, MD, MPH    973-565-0355    Aemuwa@nchcfqhc.org   
Principal Investigator: Ada Emuwa, MD, MPH         
United States, Pennsylvania
Strawberry Mansion Health Center Recruiting
Philadelphia, Pennsylvania, United States, 19132
Contact: Helena Kwakwa, MD, MPH    215-685-6769    hkwakwa@aol.com   
Principal Investigator: Helena Kwakwa, MD, MPH         
United States, Texas
Central Care Community Health Centers - MLK Boulevard Clinic Recruiting
Houston, Texas, United States, 77033
Contact: Asha Freeman, MD    832-308-1071    afreeman@centralcarechc.org   
Principal Investigator: Asha Freeman, MD         
Sponsors and Collaborators
CDC Foundation
Gilead Sciences
Investigators
Study Chair: Dawn K Smith, MD, MS, MPH Centers for Disease Control and Prevention
Study Director: Rebecca Hartz, MPH CDC Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Dawn Smith, Biomedical Interventions Activity Lead, Epidemiology Branch, DHAP, NCHHSTP, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02074891     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-6511
Study First Received: February 24, 2014
Last Updated: October 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
preexposure prophylaxis
PrEP
HIV

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014