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

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ClinicalTrials.gov Identifier: NCT01632995
Recruitment Status : Completed
First Posted : July 4, 2012
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infections
Intervention Drug: FTC 200 mg/TDF 300 mg fixed-dose combination tablet
Enrollment 557
Recruitment Details 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 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.
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description

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.

Period Title: Pre-screening to Enrollment Period
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 Title: Main Study Follow-up Period
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
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 557
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 557 participants
33
(27 to 42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 557 participants
Female
0
   0.0%
Male
557
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 557 participants
White
266
  47.8%
Latino
192
  34.5%
Black
40
   7.2%
Asian
26
   4.7%
Other
32
   5.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 557 participants
557
1.Primary Outcome
Title Measurement of Acceptance Rate of PrEP
Hide Description [Not Specified]
Time Frame Measured through enrollment (Week 0)
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[Not Specified]
Arm/Group Title Participants Assessed for Participation
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All participants who were assessed for study participation
Overall Number of Participants Analyzed 1069
Measure Type: Count of Participants
Unit of Measure: Participants
Potentially eligible clients
921
  86.2%
Participants enrolled
557
  52.1%
2.Primary Outcome
Title Measurement of Refusal Rate of PrEP
Hide Description [Not Specified]
Time Frame Measured through enrollment (Week 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Assessed for Participation
Hide Arm/Group Description:
All participants who were assessed for study participation
Overall Number of Participants Analyzed 1069
Measure Type: Count of Participants
Unit of Measure: Participants
Potentially eligible clients
921
  86.2%
Declined participation
364
  34.1%
3.Primary Outcome
Title Duration of PrEP Use
Hide Description Number of study drug interruptions
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: interruptions
86
4.Primary Outcome
Title Duration of PrEP Use
Hide Description Mean duration of interruptions
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: Days
65
5.Primary Outcome
Title Measurement of Side Effects/Toxicities
Hide Description [Not Specified]
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: events
Serious adverse events 19
Creatinine elevations 23
6.Primary Outcome
Title Measurement of PrEP Adherence by TFV-DP Levels in DBS
Hide Description [Not Specified]
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
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DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample
Arm/Group Title Participants With DBS Testing
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All study participants who had at least 1 DBS result
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: Percent of Participants
% with protective TFV-DP levels at week 4 86
% with protective TFV-DP levels at week 12 85
% with protective TFV-DP levels at week 24 82
% with protective TFV-DP levels at week 36 85
% with protective TFV-DP levels at week 48 80
7.Primary Outcome
Title Number of Male Sexual Partners
Hide Description [Not Specified]
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Mean (Full Range)
Unit of Measure: partners
Mean Anal sex partners at baseline
10.9
(0 to 120)
Mean Anal sex partners at week 48
9.3
(0 to 240)
8.Primary Outcome
Title Measurement of PrEP Adherence by Medication Possession Ratio
Hide Description Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Mean PrEP adherence by medication possession ratio
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: percent
85.9
9.Secondary Outcome
Title Number of Participants Who Seroconvert
Hide Description [Not Specified]
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: participants
Acute HIV infection at baseline 3
HIV seroconversion during follow-up 2
10.Secondary Outcome
Title Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected
Hide Description [Not Specified]
Time Frame Participants were followed for 48 weeks, or up to the point of early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 557
Measure Type: Number
Unit of Measure: participant with acquired HIV resistance
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Hide Arm/Group Description

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.

All-Cause Mortality
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Affected / at Risk (%) # Events
Total   19/557 (3.41%)    
Cardiac disorders   
Atrial Fibrillation   1/557 (0.18%)  1
Gastrointestinal disorders   
Appendicitis   1/557 (0.18%)  1
colitis   1/557 (0.18%)  1
Diarrhea   1/557 (0.18%)  1
Large intestine perforation   1/557 (0.18%)  1
General disorders   
Hypertension / Hypertensive crisis   2/557 (0.36%)  2
Hepatobiliary disorders   
Cholecystitis   1/557 (0.18%)  1
Immune system disorders   
Food allergy   1/557 (0.18%)  1
Injury, poisoning and procedural complications   
Overdose   1/557 (0.18%)  1
Testicular torsion   1/557 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer   1/557 (0.18%)  1
Psychiatric disorders   
suicidal ideation and/or attempt, bipolar disorder, or anxiety  [1]  8/557 (1.44%)  8
Indicates events were collected by systematic assessment
[1]
Assessed as not related to study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Affected / at Risk (%) # Events
Total   25/557 (4.49%)    
Injury, poisoning and procedural complications   
Bone fracture   12/557 (2.15%)  12
Investigations   
Creatinine elevation   13/557 (2.33%)  23
Indicates events were collected by systematic assessment
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
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 )
First Submitted: June 29, 2012
First Posted: July 4, 2012
Results First Submitted: November 16, 2016
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017