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The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP) (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327651
Recruitment Status : Completed
First Posted : April 1, 2011
Results First Posted : May 12, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
HIV Prevention Trials Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Daily dosing
Drug: Time-driven dosing
Drug: Event-driven dosing
Enrollment 622
Recruitment Details The study enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014
Pre-assignment Details Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Period Title: Self-administered Dosing Period
Started [1] 60 59 60 60 59 59 59 60 60
Week 10 59 58 60 60 59 59 57 57 56
Week 14 59 55 57 60 58 59 54 51 54
Week 18 57 56 56 60 57 59 53 49 53
Week 22 59 56 55 58 56 59 50 50 51
Week 26 58 56 53 57 56 58 50 51 49
Completed [2] 56 56 56 57 56 59 49 50 49
Not Completed 4 3 4 3 3 0 10 10 11
Reason Not Completed
Lost to Follow-up             3             2             4             2             3             0             8             9             10
Ineligible (retrospective result)             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             1             0             0             2             1             1
[1]
Week 6 (Randomization visit)
[2]
Week 30
Period Title: Post Study Follow-up
Started [1] 56 56 56 57 56 59 49 50 49
Completed [2] 56 55 55 57 56 59 45 49 47
Not Completed 0 1 1 0 0 0 4 1 2
Reason Not Completed
Lost to Follow-up             0             1             1             0             0             0             4             1             2
[1]
Week 30
[2]
Week 34
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem Total
Hide Arm/Group Description

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Total of all reporting groups
Overall Number of Baseline Participants 59 59 60 60 59 59 59 60 60 535
Hide Baseline Analysis Population Description
For daily dosing arm in Cape Town, we dropped one participant from analysis, since retrospective test of HIV infection in central lab shows that this participant was seroconverted on week 6(randomization week), so she was not eligible to be randomized. Because of this, total baseline population dropped from 536 to 535.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
25
(21 to 37)
26
(21 to 33)
25
(21 to 37)
31
(28 to 34)
28
(25 to 35)
31
(27 to 34)
28
(23 to 43)
31
(24 to 41)
32
(24 to 46)
29
(24 to 37)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
18-24 years
26
  44.1%
24
  40.7%
26
  43.3%
8
  13.3%
12
  20.3%
8
  13.6%
19
  32.2%
17
  28.3%
17
  28.3%
157
  29.3%
25-29 years
14
  23.7%
15
  25.4%
8
  13.3%
13
  21.7%
19
  32.2%
16
  27.1%
13
  22.0%
11
  18.3%
8
  13.3%
117
  21.9%
30-39 years
10
  16.9%
11
  18.6%
16
  26.7%
36
  60.0%
23
  39.0%
28
  47.5%
11
  18.6%
12
  20.0%
14
  23.3%
161
  30.1%
40+ years
9
  15.3%
9
  15.3%
10
  16.7%
3
   5.0%
5
   8.5%
7
  11.9%
16
  27.1%
20
  33.3%
21
  35.0%
100
  18.7%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
Female
59
 100.0%
59
 100.0%
60
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
178
  33.3%
Male
0
   0.0%
0
   0.0%
0
   0.0%
59
  98.3%
58
  98.3%
59
 100.0%
57
  96.6%
59
  98.3%
58
  96.7%
350
  65.4%
Transgender woman
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
0
   0.0%
2
   3.4%
0
   0.0%
1
   1.7%
5
   0.9%
Gender queer
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
2
   0.4%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
Less than secondary
38
  64.4%
39
  66.1%
39
  65.0%
0
   0.0%
1
   1.7%
1
   1.7%
16
  27.1%
18
  30.0%
7
  11.7%
159
  29.7%
Secondary and above
21
  35.6%
20
  33.9%
21
  35.0%
60
 100.0%
58
  98.3%
58
  98.3%
43
  72.9%
42
  70.0%
53
  88.3%
376
  70.3%
Number of sex partners in the past 3 months   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Sex partners
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
1
(1 to 1)
1
(1 to 1)
1
(1 to 1)
3
(2 to 10)
3
(1 to 10)
3
(2 to 5)
3
(2 to 5)
3
(2 to 6)
4
(2 to 7)
2
(1 to 5)
[1]
Measure Description: Median number of sex partners in the past 3 months, measured at baseline
Number of anal intercourse without a condom  
Median (Inter-Quartile Range)
Unit of measure:  Anal intercourse
Number Analyzed 59 participants 59 participants 60 participants 60 participants 59 participants 59 participants 59 participants 60 participants 60 participants 535 participants
2
(0 to 7)
2
(0 to 5)
1
(0 to 4)
0
(0 to 5)
0
(0 to 3)
0
(0 to 0)
3
(0 to 5)
3
(1 to 10)
5
(1 to 9)
1
(0 to 5)
1.Primary Outcome
Title Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
Hide Description Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm.
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Sexual exposures
1952 1074 1542 1485 1337 1018 1081 1311 1502
Measure Type: Number
Unit of Measure: percentage of sexual exposures
% completely covered 75 56 52 85 84 74 66 47 52
% pre-exposure coverage 21 30 33 11 12 19 24 30 29
% post-exposure coverage 1 9 8 1 3 5 2 8 6
% uncovered 3 5 7 3 1 3 8 15 13
2.Primary Outcome
Title The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
Hide Description Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are “covered”; Note: sex act is considered as “covered” if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Overall Number of Units Analyzed
Type of Units Analyzed: Sexual exposure
1952 1074 1542 1485 1337 1018 1081 1311 1502
Measure Type: Number
Unit of Measure: Number of pills needed for 100% coverage
2097 1552 1906 1746 1573 1268 1244 1390 1582
3.Primary Outcome
Title The Total Pills Actually Used Over the Follow-up Period
Hide Description The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Number
Unit of Measure: Number of pills actually used
7349 2852 2000 8285 3713 2157 5507 2468 2356
4.Primary Outcome
Title Self-reported Side Effect or Symptom Scores
Hide Description The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Number
Unit of Measure: percent of visits between week 6 to 30
Neurologic side effect 12.4 6.0 7.8 14.2 14.3 13.3 6.1 3.3 4.5
Gastrointestinal side effects 10.6 8.8 5.4 13.1 8.5 10.5 8 5.8 7.1
5.Secondary Outcome
Title Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Hide Description Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week
Time Frame week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
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Hide Analysis Population Description
Note: Not all participants were available to be analyzed at each visits below, this could be due to missed visit, drug concentration was missing, or participants did not report to have any sex in the last 7 days
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Week 10 Number Analyzed 40 participants 23 participants 37 participants 31 participants 29 participants 30 participants 23 participants 23 participants 27 participants
33
  82.5%
16
  69.6%
25
  67.6%
31
 100.0%
29
 100.0%
30
 100.0%
13
  56.5%
8
  34.8%
5
  18.5%
Week 18 Number Analyzed 39 participants 25 participants 30 participants 29 participants 30 participants 26 participants 27 participants 27 participants 21 participants
29
  74.4%
16
  64.0%
10
  33.3%
28
  96.6%
30
 100.0%
24
  92.3%
11
  40.7%
10
  37.0%
3
  14.3%
Week 30 Number Analyzed 29 participants 24 participants 31 participants 23 participants 19 participants 14 participants 18 participants 18 participants 18 participants
19
  65.5%
13
  54.2%
12
  38.7%
22
  95.7%
18
  94.7%
13
  92.9%
9
  50.0%
3
  16.7%
3
  16.7%
6.Secondary Outcome
Title A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hide Description Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Blood and lymphatic system disorders : Mild Mild
1
   1.7%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.4%
2
   3.3%
1
   1.7%
Moderate
1
   1.7%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
57
  96.6%
57
  96.6%
59
  98.3%
60
 100.0%
59
 100.0%
59
 100.0%
57
  96.6%
58
  96.7%
58
  96.7%
Cardiac disorders Mild
0
   0.0%
0
   0.0%
1
   1.7%
2
   3.3%
1
   1.7%
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
59
 100.0%
59
 100.0%
59
  98.3%
58
  96.7%
58
  98.3%
58
  98.3%
58
  98.3%
60
 100.0%
60
 100.0%
Ear and labyrinth disorders Mild
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
0
   0.0%
1
   1.7%
Moderate
1
   1.7%
2
   3.4%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
58
  98.3%
56
  94.9%
60
 100.0%
59
  98.3%
59
 100.0%
58
  98.3%
58
  98.3%
60
 100.0%
59
  98.3%
Eye disorders Mild
2
   3.4%
1
   1.7%
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
2
   3.3%
Moderate
2
   3.4%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
55
  93.2%
57
  96.6%
59
  98.3%
59
  98.3%
59
 100.0%
59
 100.0%
57
  96.6%
60
 100.0%
58
  96.7%
Gastrointestinal disorders Mild
18
  30.5%
17
  28.8%
18
  30.0%
24
  40.0%
22
  37.3%
23
  39.0%
28
  47.5%
27
  45.0%
28
  46.7%
Moderate
8
  13.6%
9
  15.3%
10
  16.7%
6
  10.0%
1
   1.7%
3
   5.1%
1
   1.7%
2
   3.3%
1
   1.7%
Severe
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
33
  55.9%
32
  54.2%
32
  53.3%
30
  50.0%
35
  59.3%
32
  54.2%
30
  50.8%
31
  51.7%
31
  51.7%
General disorders and administration site conditio Mild
9
  15.3%
5
   8.5%
7
  11.7%
10
  16.7%
16
  27.1%
11
  18.6%
10
  16.9%
10
  16.7%
8
  13.3%
Moderate
0
   0.0%
2
   3.4%
5
   8.3%
0
   0.0%
0
   0.0%
1
   1.7%
2
   3.4%
1
   1.7%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
50
  84.7%
52
  88.1%
48
  80.0%
50
  83.3%
43
  72.9%
47
  79.7%
46
  78.0%
49
  81.7%
52
  86.7%
Hepatobiliary disorders Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
59
 100.0%
58
  98.3%
60
 100.0%
60
 100.0%
58
  98.3%
59
 100.0%
59
 100.0%
60
 100.0%
60
 100.0%
Immune system disorders Mild
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
59
 100.0%
59
 100.0%
58
  96.7%
60
 100.0%
59
 100.0%
59
 100.0%
59
 100.0%
59
  98.3%
59
  98.3%
Infections and infestations Mild
11
  18.6%
10
  16.9%
15
  25.0%
22
  36.7%
33
  55.9%
28
  47.5%
22
  37.3%
21
  35.0%
21
  35.0%
Moderate
25
  42.4%
25
  42.4%
21
  35.0%
8
  13.3%
6
  10.2%
10
  16.9%
0
   0.0%
0
   0.0%
1
   1.7%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.0%
1
   1.7%
2
   3.4%
0
   0.0%
0
   0.0%
1
   1.7%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
23
  39.0%
24
  40.7%
24
  40.0%
27
  45.0%
19
  32.2%
19
  32.2%
37
  62.7%
39
  65.0%
37
  61.7%
Injury, poisoning and procedural complications Mild
7
  11.9%
5
   8.5%
11
  18.3%
16
  26.7%
15
  25.4%
14
  23.7%
17
  28.8%
18
  30.0%
14
  23.3%
Moderate
3
   5.1%
2
   3.4%
1
   1.7%
0
   0.0%
2
   3.4%
1
   1.7%
2
   3.4%
1
   1.7%
0
   0.0%
Severe
0
   0.0%
1
   1.7%
2
   3.3%
0
   0.0%
1
   1.7%
0
   0.0%
2
   3.4%
0
   0.0%
1
   1.7%
Potentically Life Threatening
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
48
  81.4%
51
  86.4%
46
  76.7%
44
  73.3%
41
  69.5%
44
  74.6%
38
  64.4%
41
  68.3%
45
  75.0%
Investigations Mild
13
  22.0%
15
  25.4%
13
  21.7%
18
  30.0%
9
  15.3%
7
  11.9%
8
  13.6%
6
  10.0%
6
  10.0%
Moderate
5
   8.5%
6
  10.2%
3
   5.0%
5
   8.3%
2
   3.4%
3
   5.1%
1
   1.7%
2
   3.3%
2
   3.3%
Severe
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
1
   1.7%
1
   1.7%
0
   0.0%
2
   3.3%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
41
  69.5%
38
  64.4%
43
  71.7%
35
  58.3%
47
  79.7%
48
  81.4%
50
  84.7%
50
  83.3%
52
  86.7%
Metabolism and nutrition disorders Mild
0
   0.0%
3
   5.1%
7
  11.7%
0
   0.0%
1
   1.7%
0
   0.0%
3
   5.1%
4
   6.7%
5
   8.3%
Moderate
6
  10.2%
5
   8.5%
10
  16.7%
0
   0.0%
0
   0.0%
1
   1.7%
2
   3.4%
3
   5.0%
4
   6.7%
Severe
3
   5.1%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.4%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
50
  84.7%
49
  83.1%
43
  71.7%
60
 100.0%
58
  98.3%
58
  98.3%
52
  88.1%
53
  88.3%
51
  85.0%
Musculoskeletal and connective tissue disorders Mild
6
  10.2%
6
  10.2%
9
  15.0%
13
  21.7%
15
  25.4%
13
  22.0%
13
  22.0%
11
  18.3%
9
  15.0%
Moderate
3
   5.1%
2
   3.4%
1
   1.7%
4
   6.7%
1
   1.7%
2
   3.4%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
50
  84.7%
51
  86.4%
50
  83.3%
43
  71.7%
43
  72.9%
44
  74.6%
46
  78.0%
49
  81.7%
51
  85.0%
Nervous system disorders Mild
17
  28.8%
14
  23.7%
19
  31.7%
17
  28.3%
18
  30.5%
22
  37.3%
16
  27.1%
10
  16.7%
17
  28.3%
Moderate
15
  25.4%
11
  18.6%
12
  20.0%
3
   5.0%
0
   0.0%
1
   1.7%
1
   1.7%
2
   3.3%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
27
  45.8%
34
  57.6%
29
  48.3%
39
  65.0%
41
  69.5%
36
  61.0%
42
  71.2%
47
  78.3%
43
  71.7%
Pregnancy, puerperium and perinatal conditions Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
58
  98.3%
59
 100.0%
60
 100.0%
60
 100.0%
59
 100.0%
59
 100.0%
59
 100.0%
60
 100.0%
60
 100.0%
Psychiatric disorders Mild
1
   1.7%
3
   5.1%
2
   3.3%
8
  13.3%
10
  16.9%
8
  13.6%
10
  16.9%
9
  15.0%
7
  11.7%
Moderate
2
   3.4%
0
   0.0%
2
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
1
   1.7%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.4%
1
   1.7%
0
   0.0%
Potentically Life Threatening
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.3%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
55
  93.2%
56
  94.9%
56
  93.3%
52
  86.7%
49
  83.1%
51
  86.4%
46
  78.0%
48
  80.0%
52
  86.7%
Renal and urinary disorders Mild
10
  16.9%
11
  18.6%
11
  18.3%
1
   1.7%
3
   5.1%
2
   3.4%
12
  20.3%
6
  10.0%
7
  11.7%
Moderate
4
   6.8%
2
   3.4%
3
   5.0%
0
   0.0%
1
   1.7%
1
   1.7%
0
   0.0%
4
   6.7%
1
   1.7%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
45
  76.3%
46
  78.0%
46
  76.7%
59
  98.3%
55
  93.2%
56
  94.9%
47
  79.7%
50
  83.3%
52
  86.7%
Reproductive system and breast disorders Mild
13
  22.0%
17
  28.8%
17
  28.3%
0
   0.0%
0
   0.0%
1
   1.7%
1
   1.7%
2
   3.3%
3
   5.0%
Moderate
7
  11.9%
8
  13.6%
8
  13.3%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
39
  66.1%
34
  57.6%
34
  56.7%
60
 100.0%
59
 100.0%
57
  96.6%
58
  98.3%
58
  96.7%
57
  95.0%
Respiratory, thoracic and mediastinal disorders Mild
5
   8.5%
5
   8.5%
9
  15.0%
36
  60.0%
23
  39.0%
29
  49.2%
18
  30.5%
19
  31.7%
18
  30.0%
Moderate
5
   8.5%
2
   3.4%
1
   1.7%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
49
  83.1%
52
  88.1%
50
  83.3%
24
  40.0%
36
  61.0%
29
  49.2%
41
  69.5%
41
  68.3%
42
  70.0%
Skin and subcutaneous tissue disorders Mild
6
  10.2%
8
  13.6%
8
  13.3%
8
  13.3%
15
  25.4%
10
  16.9%
8
  13.6%
5
   8.3%
5
   8.3%
Moderate
3
   5.1%
3
   5.1%
4
   6.7%
2
   3.3%
0
   0.0%
3
   5.1%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
49
  83.1%
48
  81.4%
48
  80.0%
50
  83.3%
44
  74.6%
46
  78.0%
51
  86.4%
55
  91.7%
55
  91.7%
Social circumstances Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
58
  98.3%
59
 100.0%
60
 100.0%
60
 100.0%
59
 100.0%
59
 100.0%
59
 100.0%
60
 100.0%
60
 100.0%
Vascular disorders Mild
2
   3.4%
3
   5.1%
1
   1.7%
0
   0.0%
0
   0.0%
1
   1.7%
2
   3.4%
0
   0.0%
0
   0.0%
Moderate
1
   1.7%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
56
  94.9%
55
  93.2%
59
  98.3%
60
 100.0%
59
 100.0%
58
  98.3%
57
  96.6%
60
 100.0%
60
 100.0%
Neoplasms benign, malignant, and unspecified Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potentically Life Threatening
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
59
 100.0%
59
 100.0%
60
 100.0%
60
 100.0%
59
 100.0%
58
  98.3%
59
 100.0%
60
 100.0%
60
 100.0%
7.Secondary Outcome
Title A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Hide Description Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study.
Time Frame From enrollment to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data is collected for plasma HIV RNA levels among all participants who seroconvert while on study, but this secondary analysis has not been carried out yet, so no outcome measure is presented here
Arm/Group Title Cape Town, South Africa Bangkok, Thailand Harlem, United States
Hide Arm/Group Description:
The University of Cape Town in Cape Town is the IRB of record for the Cape Town site
The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site
Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.
Overall Number of Participants Analyzed 191 193 238
Measure Type: Count of Participants
Unit of Measure: Participants
Before Randomization Number Analyzed 191 participants 193 participants 238 participants
Drug Resistance
1
   0.5%
0
   0.0%
1
   0.4%
No Drug Resistance
190
  99.5%
193
 100.0%
237
  99.6%
After Randomization (Daily dosing) Number Analyzed 59 participants 60 participants 59 participants
Drug Resistance
0
   0.0%
0
   0.0%
0
   0.0%
No Drug Resistance
59
 100.0%
60
 100.0%
59
 100.0%
After Randomization (Time-driven dosing) Number Analyzed 59 participants 59 participants 60 participants
Drug Resistance
1
   1.7%
0
   0.0%
0
   0.0%
No Drug Resistance
58
  98.3%
59
 100.0%
60
 100.0%
After Randomization (Event-driven dosing) Number Analyzed 60 participants 59 participants 60 participants
Drug Resistance
0
   0.0%
0
   0.0%
0
   0.0%
No Drug Resistance
60
 100.0%
59
 100.0%
60
 100.0%
8.Secondary Outcome
Title The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
Hide Description [Not Specified]
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Number
Unit of Measure: % of Correctly Timed Adherence
75 65 53 85 79 65 65 47 41
9.Secondary Outcome
Title The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews
Hide Description [Not Specified]
Time Frame From Week 6 to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants had product hold or product discontinuation log
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:
Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 7 7 8 12 3 5 2 7 2
Measure Type: Count of Participants
Unit of Measure: Participants
Pregnancy
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HIV−positive result
0
   0.0%
2
  28.6%
1
  12.5%
1
   8.3%
0
   0.0%
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
Other adverse experience
6
  85.7%
3
  42.9%
5
  62.5%
6
  50.0%
2
  66.7%
1
  20.0%
1
  50.0%
3
  42.9%
0
   0.0%
Other
1
  14.3%
2
  28.6%
1
  12.5%
5
  41.7%
1
  33.3%
4
  80.0%
0
   0.0%
4
  57.1%
2
 100.0%
10.Secondary Outcome
Title A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Hide Description Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.
Time Frame From week 6 (randomization week) to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Below "Number analyzed" population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product
Arm/Group Title Daily Dosing, Cape Town Time-driven Dosing, Cape Town Event-driven Dosing, Cape Town Daily Dosing, Bangkok Time-driven Dosing, Bangkok Event-driven Dosing, Bangkok Daily Dosing, Harlem Time-driven Dosing, Harlem Event-driven Dosing, Harlem
Hide Arm/Group Description:

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Overall Number of Participants Analyzed 59 59 60 60 59 59 59 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Blood and lymphatic system disorders Number Analyzed 2 participants 2 participants 1 participants 0 participants 0 participants 0 participants 2 participants 2 participants 2 participants
0
   0.0%
2
 100.0%
0
   0.0%
0 0 0
0
   0.0%
2
 100.0%
1
  50.0%
Cardiac disorders Number Analyzed 0 participants 0 participants 1 participants 2 participants 1 participants 1 participants 1 participants 0 participants 0 participants
0 0
0
   0.0%
1
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Ear and labyrinth disorders Number Analyzed 1 participants 3 participants 0 participants 1 participants 0 participants 1 participants 1 participants 0 participants 1 participants
0
   0.0%
0
   0.0%
0
0
   0.0%
0
0
   0.0%
0
   0.0%
0
0
   0.0%
Eye disorders Number Analyzed 4 participants 2 participants 1 participants 1 participants 0 participants 0 participants 2 participants 0 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0 0
0
   0.0%
0
0
   0.0%
Gastrointestinal disorders Number Analyzed 26 participants 27 participants 28 participants 30 participants 24 participants 27 participants 29 participants 29 participants 29 participants
18
  69.2%
17
  63.0%
24
  85.7%
9
  30.0%
1
   4.2%
2
   7.4%
13
  44.8%
13
  44.8%
16
  55.2%
General disorders and administration site conditio Number Analyzed 9 participants 7 participants 12 participants 10 participants 16 participants 12 participants 13 participants 11 participants 8 participants
4
  44.4%
1
  14.3%
6
  50.0%
1
  10.0%
1
   6.3%
0
   0.0%
3
  23.1%
9
  81.8%
4
  50.0%
Hepatobiliary disorders Number Analyzed 0 participants 1 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
0
   0.0%
0 0
1
 100.0%
0 0 0 0
Immune system disorders Number Analyzed 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
0 0
1
  50.0%
0 0 0 0
0
   0.0%
0
   0.0%
Infections and infestations Number Analyzed 36 participants 35 participants 36 participants 33 participants 40 participants 40 participants 22 participants 21 participants 23 participants
1
   2.8%
0
   0.0%
2
   5.6%
0
   0.0%
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
0
   0.0%
Injury, poisoning and procedural complications Number Analyzed 11 participants 8 participants 14 participants 16 participants 18 participants 15 participants 21 participants 19 participants 15 participants
3
  27.3%
4
  50.0%
7
  50.0%
10
  62.5%
7
  38.9%
10
  66.7%
13
  61.9%
16
  84.2%
10
  66.7%
Investigations Number Analyzed 18 participants 21 participants 17 participants 25 participants 12 participants 11 participants 9 participants 10 participants 8 participants
10
  55.6%
13
  61.9%
12
  70.6%
23
  92.0%
12
 100.0%
10
  90.9%
9
 100.0%
9
  90.0%
7
  87.5%
Metabolism and nutrition disorders Number Analyzed 9 participants 10 participants 17 participants 0 participants 1 participants 1 participants 7 participants 7 participants 9 participants
2
  22.2%
5
  50.0%
6
  35.3%
0
1
 100.0%
1
 100.0%
4
  57.1%
5
  71.4%
5
  55.6%
Musculoskeletal and connective tissue disorders Number Analyzed 9 participants 8 participants 10 participants 17 participants 16 participants 15 participants 13 participants 11 participants 9 participants
1
  11.1%
0
   0.0%
0
   0.0%
2
  11.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  33.3%
Neoplasms benign, malignant, and unspecified Number Analyzed 59 participants 59 participants 60 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
0 0 0
Nervous system disorders Number Analyzed 32 participants 25 participants 31 participants 21 participants 18 participants 23 participants 17 participants 13 participants 17 participants
17
  53.1%
17
  68.0%
21
  67.7%
3
  14.3%
2
  11.1%
1
   4.3%
7
  41.2%
4
  30.8%
5
  29.4%
Pregnancy, puerperium and perinatal conditions Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
0 0 0 0 0 0 0 0
Psychiatric disorders Number Analyzed 4 participants 3 participants 4 participants 8 participants 10 participants 8 participants 13 participants 12 participants 8 participants
3
  75.0%
1
  33.3%
1
  25.0%
1
  12.5%
0
   0.0%
0
   0.0%
2
  15.4%
2
  16.7%
3
  37.5%
Renal and urinary disorders Number Analyzed 14 participants 13 participants 14 participants 1 participants 4 participants 3 participants 12 participants 10 participants 8 participants
10
  71.4%
5
  38.5%
10
  71.4%
0
   0.0%
1
  25.0%
2
  66.7%
8
  66.7%
9
  90.0%
4
  50.0%
Reproductive system and breast disorders Number Analyzed 20 participants 25 participants 26 participants 0 participants 0 participants 2 participants 1 participants 2 participants 3 participants
1
   5.0%
0
   0.0%
1
   3.8%
0 0
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Respiratory, thoracic and mediastinal disorders Number Analyzed 10 participants 7 participants 10 participants 36 participants 23 participants 30 participants 18 participants 19 participants 18 participants
2
  20.0%
1
  14.3%
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
0
   0.0%
Skin and subcutaneous tissue disorders Number Analyzed 10 participants 11 participants 12 participants 10 participants 15 participants 13 participants 8 participants 5 participants 5 participants
4
  40.0%
5
  45.5%
3
  25.0%
2
  20.0%
0
   0.0%
2
  15.4%
1
  12.5%
2
  40.0%
0
   0.0%
Social circumstances Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
0 0 0 0 0 0 0 0
Vascular disorders Number Analyzed 3 participants 4 participants 1 participants 0 participants 0 participants 1 participants 2 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0 0
0
   0.0%
1
  50.0%
0 0
11.Secondary Outcome
Title A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Hide Description Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.
Time Frame From Enrollment to week 30 (end of self-administered dosing)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented
Arm/Group Title Cape Town, South Africa, Seroconverted Participant #1 Cape Town, South Africa, Seroconverted Participant #2 Cape Town, South Africa, Seroconverted Participant #3 Cape Town, South Africa, Seroconverted Participant #4 Cape Town, South Africa, Seroconverted Participant #5 Cape Town, South Africa, Seroconverted Participant #6 Cape Town, South Africa, Seroconverted Participant #7 Cape Town, South Africa, Seroconverted Participant #8 Bangkok, Thailand, Seroconverted Participant #1 Bangkok, Thailand, Seroconverted Participant #2 Harlem, United States, Seroconverted Participant #1 Harlem, United States, Seroconverted Participant #2
Hide Arm/Group Description:
#1 seroconverted participants in Cape Town, South Africa, not randomized
#2 seroconverted participants in Cape Town, South Africa, not randomized
#3 seroconverted participants in Cape Town, South Africa, not randomized
#4 seroconverted participants in Cape Town, South Africa, daily arm
#5 seroconverted participants in Cape Town, South Africa, time-driven arm
#6 seroconverted participants in Cape Town, South Africa, time-driven arm
#7 seroconverted participants in Cape Town, South Africa, event-driven arm
#8 seroconverted participants in Cape Town, South Africa, event-driven arm
#1 seroconverted participants in Bangkok, Thailand, not randomized
#2 seroconverted participants in Bangkok, Thailand, not randomized
#1 seroconverted participants in Harlem, United States, not randomized
#2 seroconverted participants in Harlem, United States, daily arm
Overall Number of Participants Analyzed 1 1 1 1 1 1 1 1 1 1 1 1
Measure Type: Number
Unit of Measure: viral load
Enrollment Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
20
Day 3 Number Analyzed 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 1 participants 0 participants
400 400 40 78450 400
Week 4 Number Analyzed 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 1 participants 0 participants
3460 3667690 749590 710 40900
Week 5 Number Analyzed 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
5732050 3938670 1570
Week 6 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 1 participants 0 participants
400 92960 5070 83260
Week 10 Number Analyzed 1 participants 1 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
416070 93040 400 1799950
Week 14 Number Analyzed 0 participants 1 participants 0 participants 1 participants 0 participants 1 participants 0 participants 0 participants 1 participants 0 participants 0 participants 1 participants
93660 400 2100 119720 1567040
Week 18 Number Analyzed 0 participants 1 participants 0 participants 1 participants 0 participants 1 participants 1 participants 0 participants 1 participants 0 participants 0 participants 1 participants
114520 650 3710 83010 127330 73030
Week 22 Number Analyzed 0 participants 1 participants 0 participants 1 participants 1 participants 1 participants 1 participants 0 participants 1 participants 0 participants 0 participants 0 participants
178210 400 5887760 127480 136310 178070
Week 26 Number Analyzed 0 participants 1 participants 1 participants 0 participants 0 participants 1 participants 1 participants 1 participants 1 participants 0 participants 0 participants 0 participants