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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

February 24, 2014
October 23, 2014
October 2014
May 2017   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02074891 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Sustainable Healthcenter Implementation PrEP Pilot Study
Sustainable Healthcenter Implementation PrEP Pilot Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Dried blood spots

Non-Probability Sample

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

  • HIV Chemoprophylaxis
  • HIV Preexposure Prophylaxis
Drug: coformulated TDF/FTC
Daily oral dose of coformulated TDF/FTC
Other Names:
  • Truvada
  • Tenofovir disoproxil fumarate (TDF)
  • Emtracitabine (FTC)
Persons prescribed PrEP
adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition.
Intervention: Drug: coformulated TDF/FTC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
May 2017
May 2017   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact: Dawn K Smith, MD, MS, MPH 404-639-5166 dsmith1@cdc.gov
United States
 
NCT02074891
CDC-NCHHSTP-6511
No
Dawn Smith, Centers for Disease Control and Prevention
CDC Foundation
Gilead Sciences
Study Chair: Dawn K Smith, MD, MS, MPH Centers for Disease Control and Prevention
Study Director: Rebecca Hartz, MPH CDC Foundation
Centers for Disease Control and Prevention
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP