Trial Outcomes & Findings for Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics (NCT NCT01632995)
NCT ID: NCT01632995
Last Updated: 2021-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
557 participants
Primary outcome timeframe
Measured through enrollment (Week 0)
Results posted on
2021-11-05
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Pre-screening to Enrollment Period
STARTED
|
1069
|
|
Pre-screening to Enrollment Period
COMPLETED
|
557
|
|
Pre-screening to Enrollment Period
NOT COMPLETED
|
512
|
|
Main Study Follow-up Period
STARTED
|
557
|
|
Main Study Follow-up Period
COMPLETED
|
437
|
|
Main Study Follow-up Period
NOT COMPLETED
|
120
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics
Baseline characteristics by cohort
| Measure |
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
n=557 Participants
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.
|
|---|---|
|
Age, Continuous
|
33 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
557 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
266 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Latino
|
192 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
40 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
32 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
557 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Measured through enrollment (Week 0)Outcome measures
| Measure |
Participants Assessed for Participation
n=1069 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of Acceptance Rate of PrEP
Potentially eligible clients
|
921 Participants
|
|
Measurement of Acceptance Rate of PrEP
Participants enrolled
|
557 Participants
|
PRIMARY outcome
Timeframe: Measured through enrollment (Week 0)Outcome measures
| Measure |
Participants Assessed for Participation
n=1069 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of Refusal Rate of PrEP
Potentially eligible clients
|
921 Participants
|
|
Measurement of Refusal Rate of PrEP
Declined participation
|
364 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationNumber of study drug interruptions
Outcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Duration of PrEP Use
|
86 interruptions
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationMean duration of interruptions
Outcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Duration of PrEP Use
|
65 Days
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationOutcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of Side Effects/Toxicities
Serious adverse events
|
19 events
|
|
Measurement of Side Effects/Toxicities
Creatinine elevations
|
23 events
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationPopulation: 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
Outcome measures
| Measure |
Participants Assessed for Participation
n=294 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of PrEP Adherence by TFV-DP Levels in DBS
% with protective TFV-DP levels at week 4
|
86 Percent of Participants
|
|
Measurement of PrEP Adherence by TFV-DP Levels in DBS
% with protective TFV-DP levels at week 12
|
85 Percent of Participants
|
|
Measurement of PrEP Adherence by TFV-DP Levels in DBS
% with protective TFV-DP levels at week 24
|
82 Percent of Participants
|
|
Measurement of PrEP Adherence by TFV-DP Levels in DBS
% with protective TFV-DP levels at week 36
|
85 Percent of Participants
|
|
Measurement of PrEP Adherence by TFV-DP Levels in DBS
% with protective TFV-DP levels at week 48
|
80 Percent of Participants
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationOutcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Number of Male Sexual Partners
Mean Anal sex partners at baseline
|
10.9 partners
Interval 0.0 to 120.0
|
|
Number of Male Sexual Partners
Mean Anal sex partners at week 48
|
9.3 partners
Interval 0.0 to 240.0
|
PRIMARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationPopulation: Mean 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
Outcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of PrEP Adherence by Medication Possession Ratio
|
85.9 percent
|
SECONDARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationOutcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Number of Participants Who Seroconvert
Acute HIV infection at baseline
|
3 participants
|
|
Number of Participants Who Seroconvert
HIV seroconversion during follow-up
|
2 participants
|
SECONDARY outcome
Timeframe: Participants were followed for 48 weeks, or up to the point of early terminationOutcome measures
| Measure |
Participants Assessed for Participation
n=557 Participants
All participants who were assessed for study participation
|
|---|---|
|
Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected
|
1 participant with acquired HIV resistance
|
Adverse Events
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
Serious events: 19 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
n=557 participants at risk
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.
|
|---|---|
|
Psychiatric disorders
suicidal ideation and/or attempt, bipolar disorder, or anxiety
|
1.4%
8/557 • Number of events 8
|
|
General disorders
Hypertension / Hypertensive crisis
|
0.36%
2/557 • Number of events 2
|
|
Gastrointestinal disorders
Appendicitis
|
0.18%
1/557 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
0.18%
1/557 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
1/557 • Number of events 1
|
|
Gastrointestinal disorders
colitis
|
0.18%
1/557 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.18%
1/557 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.18%
1/557 • Number of events 1
|
|
Injury, poisoning and procedural complications
Testicular torsion
|
0.18%
1/557 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.18%
1/557 • Number of events 1
|
|
Immune system disorders
Food allergy
|
0.18%
1/557 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.18%
1/557 • Number of events 1
|
Other adverse events
| Measure |
Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)
n=557 participants at risk
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.
|
|---|---|
|
Investigations
Creatinine elevation
|
2.3%
13/557 • Number of events 23
|
|
Injury, poisoning and procedural complications
Bone fracture
|
2.2%
12/557 • Number of events 12
|
Additional Information
Dr. Albert Liu, Clinical Research Director
Bridge HIV, San Francisco Department of Public Health
Phone: 415-437-7408
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place