Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project
2 other identifiers
interventional
557
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Oct 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 21, 2017
CompletedNovember 5, 2021
July 1, 2016
2.3 years
June 29, 2012
November 16, 2016
November 3, 2021
Conditions
Outcome Measures
Primary Outcomes (8)
Measurement of Acceptance Rate of PrEP
Measured through enrollment (Week 0)
Measurement of Refusal Rate of PrEP
Measured through enrollment (Week 0)
Duration of PrEP Use
Number of study drug interruptions
Participants were followed for 48 weeks, or up to the point of early termination
Duration of PrEP Use
Mean duration of interruptions
Participants were followed for 48 weeks, or up to the point of early termination
Measurement of Side Effects/Toxicities
Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by TFV-DP Levels in DBS
Participants were followed for 48 weeks, or up to the point of early termination
Number of Male Sexual Partners
Participants were followed for 48 weeks, or up to the point of early termination
Measurement of PrEP Adherence by Medication Possession Ratio
Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits
Participants were followed for 48 weeks, or up to the point of early termination
Secondary Outcomes (2)
Number of Participants Who Seroconvert
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
Participants were followed for 48 weeks, or up to the point of early termination
Study Arms (1)
Emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
EXPERIMENTALAll study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.
Interventions
Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
SF City Clinic Non-Network CRS
San Francisco, California, 94103, United States
Whitman Walker Non-network CRS
Washington D.C., District of Columbia, 20009, United States
Miami PrEP Non-Network CRS
Miami, Florida, 33136, United States
Related Publications (1)
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PMID: 21091279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Albert Liu, Clinical Research Director
- Organization
- Bridge HIV, San Francisco Department of Public Health
Study Officials
- STUDY CHAIR
Albert Liu, MD, MPH
San Francisco Department of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 4, 2012
Study Start
October 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 5, 2021
Results First Posted
March 21, 2017
Record last verified: 2016-07