NCT02074891

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 28, 2024

Status Verified

February 1, 2016

Enrollment Period

4.1 years

First QC Date

February 24, 2014

Last Update Submit

May 24, 2024

Conditions

HIV ChemoprophylaxisHIV Preexposure Prophylaxis

Keywords

preexposure prophylaxisPrEPHIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Costs

    Up to 3 years

  • Clinical practice variation

    Every 3 months up to 36 months

Study Arms (1)

Persons prescribed PrEP

adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition.

Drug: coformulated TDF/FTC

Interventions

coformulated TDF/FTCDRUG

Daily oral dose of coformulated TDF/FTC

Also known as: Truvada, Tenofovir disoproxil fumarate (TDF), Emtracitabine (FTC)
Persons prescribed PrEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \<18 years of age
  • documented HIV infection (acute or established)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Whitman Walker Health

Washington D.C., District of Columbia, 20009, United States

Location

Access Community Health Network - Grand Boulevard Health and Specialty Center

Chicago, Illinois, 60609, United States

Location

Howard Brown Community Health Center

Chicago, Illinois, 60613, United States

Location

Open Arms Healthcare Center

Jackson, Mississippi, 39216, United States

Location

Strawberry Mansion Health Center

Philadelphia, Pennsylvania, 19132, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofovirRacivir

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Dawn K Smith, MD, MS, MPH

    Centers for Disease Control and Prevention

    STUDY CHAIR

  • Rebecca Cook, MPH

    CDC Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead, Prevention Research Team

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 28, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

May 28, 2024

Record last verified: 2016-02

Locations

US(5)