Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
This study is currently recruiting participants.
Verified December 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
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: December 10, 2012
Last verified: December 2012
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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 in the United States.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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) ] [ Designated as safety issue: No ]
- Measurement of refusal rate of PrEP [ Time Frame: Measured through enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by participant race/ethnicity [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by participant race/ethnicity [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Duration of PrEP use [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of side effects [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: Yes ]
- Measurement of PrEP adherence by net pill number per day [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Number of male sexual partners [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Number of episodes of anal sex [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of toxicities [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: Yes ]
- Measurement of PrEP adherence by medication possession ratio [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of PrEP adherence by adherence patterns [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of PrEP adherence by detectability in biological specimens [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by participant age [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by participant education [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by participant risk group (MSM and transgender females) [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by study site [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of acceptance of PrEP by participant risk practices [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by participant age [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by participant education [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by participant risk group (MSM and transgender females) [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by study site [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Measurement of refusal of PrEP by participant risk practices [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measurement of participants' knowledge of PrEP [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Reasons for choosing PrEP [ Time Frame: Measured though enrollment (Week 0) ] [ Designated as safety issue: No ]
- Reasons for declining PrEP [ Time Frame: Measured through enrollment (Week 0) ] [ Designated as safety issue: No ]
- Number of participants who seroconvert [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of HIV drug resistance patterns among participants who become infected [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of self-reported diversion (selling or sharing) or PrEP medication [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
- Measurement of space/staff needs [ Time Frame: Measured through participant's post-drug discontinuation visit (4 weeks after stopping drug) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2012 |
| 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 500 HIV-uninfected MSM and transgender females at two STD clinics.
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 |
| Genders 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: antiretroviral therapy (ART) including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632995
Locations
| United States, California | |
| SF City Clinic CRS | Recruiting |
| San Francisco, California, United States, 94103 | |
| Contact: Robert Blue 415-487-5518 robert.blue@sfdph.org | |
| United States, Florida | |
| Miami PrEP CRS | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Yannine Estrada, PhD 305-243-6614 yestrada@med.miami.edu | |
Sponsors and Collaborators
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 |
| Study First Received: | June 29, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Infection Genital Diseases, Male |
Genital Diseases, Female Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 14, 2013
