Skip to main content
OpenTrials
Completed

NCT Number: NCT02074891

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Chemoprophylaxis HIV Preexposure Prophylaxis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Whitman Walker Health, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

coformulated TDF/FTC

Drug

Daily oral dose of coformulated TDF/FTC

Other names: Truvada, Tenofovir disoproxil fumarate (TDF), Emtracitabine (FTC)

Primary outcomes

  1. Clinical safety

    Time frame: 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

  2. Medication adherence

    Time frame: 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

  3. Behavioral Responses

    Time frame: 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

Secondary outcomes

  1. Costs

    Time frame: Up to 3 years

    Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP

  2. Clinical practice variation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • CDC Foundation
  • Gilead Sciences

Registry information

Acronym: SHIPP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2014
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.