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Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01632995
First received: June 29, 2012
Last updated: January 30, 2017
Last verified: July 2016
  Purpose
This study will assess the uptake, acceptability, safety, and feasibility of HIV pre-exposure prophylaxis (PrEP), consisting of a once-daily fixed-dose combination tablet of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), administered at sexually transmitted disease (STD) clinics and a community health center in the United States.

Condition Intervention
HIV Infections Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Measurement of Acceptance Rate of PrEP [ Time Frame: Measured through enrollment (Week 0) ]
  • Measurement of Refusal Rate of PrEP [ Time Frame: Measured through enrollment (Week 0) ]
  • Duration of PrEP Use [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
    Number of study drug interruptions

  • Duration of PrEP Use [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
    Mean duration of interruptions

  • Measurement of Side Effects/Toxicities [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
  • Measurement of PrEP Adherence by TFV-DP Levels in DBS [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
  • Number of Male Sexual Partners [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
  • Measurement of PrEP Adherence by Medication Possession Ratio [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
    Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits


Secondary Outcome Measures:
  • Number of Participants Who Seroconvert [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]
  • Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

Enrollment: 557
Study Start Date: October 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet
Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Other Name: Truvada

Detailed Description:

A previous study (iPrEx) showed that daily PrEP with FTC/TDF provided with a comprehensive package of prevention services is effective in preventing HIV infection among men who have sex with men (MSM). The PrEP administered in that study was given in the context of a research setting/controlled trial, but it is important to evaluate the acceptability, sustainability, and safety of PrEP in a "real world" setting. This study will evaluate PrEP administered to HIV-uninfected MSM and transgender females at two STD clinics and one community health center in the United States.

Each participant will receive PrEP for up to 1 year and will have up to 8 study visits. PrEP will consist of one fixed-dose FTC/TDF combination tablet orally each day. All participants will have study visits at screening, enrollment, and 4 weeks after enrollment; participants will continue to have visits at Weeks 12, 24, 36, 48, and 52 if they do not seroconvert. Participants who seroconvert will discontinue PrEP and will have a post-drug discontinuation visit 4 weeks after discontinuing PrEP. At most visits, participants will undergo blood, urine, and hair sample collection; give a medical history; undergo a physical exam; receive risk-reduction counseling and condoms; undergo testing for HIV and other STDs; receive study drugs; and undergo a pill count and adherence assessment (follow-up visits only). For participants who stop taking the study drug but remain in the study, urine, blood, and hair samples will not be collected at 12-week follow-up visits if all stop procedures have been completed and if there are no lab abnormalities that require additional follow-up. Participants will also answer questionnaires at screening, 12-week visits, and at study exit.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be either a man who has sex with men or a transgender female
  • Male sex (at birth)
  • Willing and able to provide written informed consent
  • HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening
  • No laboratory evidence of a detectable HIV viral load (San Francisco site only)
  • Evidence of risk of acquiring HIV-1 infection including any one of the following:

    (1) Condomless anal sex with two or more male or transgender female sex partners during the last 12 months; or (2) two or more episodes of anal sex with at least one HIV-positive partner during the last 12 months; or (3) sex with a male or transgender female partner and any of the following STDs diagnosed during the last 12 months or at screening: syphilis, rectal gonorrhea, or rectal chlamydia.

  • Able to provide a street address of residence or phone number for themselves or two personal contacts who would know their whereabouts during the period of the demonstration project
  • Adequate renal function: creatinine clearance of 60 ml/min or greater as estimated by the Cockcroft-Gault equation within 45 days of enrollment
  • A urine dipstick with a negative or trace result for protein within 45 days of enrollment
  • Fluent in English or in Spanish

Exclusion Criteria:

  • Signs or symptoms of acute HIV infection
  • Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment
  • Hepatitis B surface antigen (HBsAg) positive
  • History of pathological bone fractures not related to trauma
  • Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents
  • Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
  • At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
  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: NCT01632995

Locations
United States, California
SF City Clinic Non-Network CRS
San Francisco, California, United States, 94103
United States, District of Columbia
Whitman Walker Non-network CRS
Washington, District of Columbia, United States, 20009
United States, Florida
Miami PrEP Non-Network CRS
Miami, Florida, United States, 33136
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Albert Liu, MD, MPH San Francisco Department of Public Health
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01632995     History of Changes
Other Study ID Numbers: PrEP Demonstration Project
11879 ( Registry Identifier: DAIDS ES )
Study First Received: June 29, 2012
Results First Received: November 16, 2016
Last Updated: January 30, 2017

Additional relevant MeSH terms:
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2017