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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
Results First Received: November 16, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: HIV Infections
Intervention: Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were screened and enrolled at 3 sites in the US (San Francisco, Miami, Washington DC). Enrollment began on October 1, 2012 and ended February 10, 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
As this PrEP Demonstration project assessed acceptance of PrEP, all participants assessed for participation are included in the "start" category, and those who enrolled and initiated PrEP are indicated as a separate milestone.

Reporting Groups
  Description
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.

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.


Participant Flow for 2 periods

Period 1:   Pre-screening to Enrollment Period
    Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
STARTED [1]   1069 
COMPLETED [2]   557 
NOT COMPLETED   512 
[1] All participants who were assessed for study participation
[2] All participants who enrolled in study

Period 2:   Main Study Follow-up Period
    Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
STARTED [1]   557 
COMPLETED [2]   437 
NOT COMPLETED   120 
[1] Participants who enrolled and initiated PrEP
[2] Participants who completed 48 weeks of follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.


Baseline Measures
   Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) 
Overall Participants Analyzed 
[Units: Participants]
 557 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 33 
 (27 to 42) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      557 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
White   266 
Latino   192 
Black   40 
Asian   26 
Other   32 
Region of Enrollment 
[Units: Participants]
 
United States   557 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Measurement of Acceptance Rate of PrEP   [ Time Frame: Measured through enrollment (Week 0) ]

2.  Primary:   Measurement of Refusal Rate of PrEP   [ Time Frame: Measured through enrollment (Week 0) ]

3.  Primary:   Duration of PrEP Use   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

4.  Primary:   Duration of PrEP Use   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

5.  Primary:   Measurement of Side Effects/Toxicities   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

6.  Primary:   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 ]

7.  Primary:   Number of Male Sexual Partners   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

8.  Primary:   Measurement of PrEP Adherence by Medication Possession Ratio   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

9.  Secondary:   Number of Participants Who Seroconvert   [ Time Frame: Participants were followed for 48 weeks, or up to the point of early termination ]

10.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Albert Liu, Clinical Research Director
Organization: Bridge HIV, San Francisco Department of Public Health
phone: 415-437-7408
e-mail: albert.liu@sfdph.org


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