This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Pre-Exposure Prophylaxis in YMSM

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01033942
First received: December 16, 2009
Last updated: April 14, 2017
Last verified: February 2017
Results First Received: October 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Prevention
Condition: HIV
Interventions: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Drug: Placebo
Behavioral: Many Men, Many Voices (3MV)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.

Reporting Groups
  Description
FTC/TDF as PrEP

Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Placebo Pill Control

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

No Pill Control

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.


Participant Flow:   Overall Study
    FTC/TDF as PrEP   Placebo Pill Control   No Pill Control
STARTED   20   19   19 
COMPLETED   18   15   18 
NOT COMPLETED   2   4   1 
Withdrawal by Subject                1                1                1 
Lost to Follow-up                1                0                0 
Enrolled in Extension Study                0                3                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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

Reporting Groups
  Description
FTC/TDF as PrEP

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Placebo Pill Control

Blinded administration of placebo pill; HIV behavioral intervention

Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

No Pill Control

Subjects receive HIV behavioral intervention but no pill.

Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

Total Total of all reporting groups

Baseline Measures
   FTC/TDF as PrEP   Placebo Pill Control   No Pill Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   19   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 19.8  (1.44)   20.26  (1.45)   19.84  (0.96)   19.97  (1.30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      20 100.0%      19 100.0%      19 100.0%      58 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      7  35.0%      6  31.6%      10  52.6%      23  39.7% 
Not Hispanic or Latino      13  65.0%      13  68.4%      9  47.4%      35  60.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   5.0%      0   0.0%      0   0.0%      1   1.7% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      10  50.0%      12  63.2%      9  47.4%      31  53.4% 
White      1   5.0%      1   5.3%      2  10.5%      4   6.9% 
More than one race      8  40.0%      6  31.6%      8  42.1%      22  37.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   20   19   19   58 
Education [1] 
[Units: Participants]
       
Eighth Grade of Less   0   0   1   1 
GED   0   1   1   2 
Highschool Diploma   10   3   5   18 
Some College   8   14   8   30 
[1] Not all participants answered every question.
Current Employment 
[Units: Participants]
       
Unemployed   12   11   9   32 
Full Time   2   2   2   6 
Part Time   6   6   8   20 
Housing Experience (Responded YES) [1] 
[Units: Participants]
       
Kicked out of House Due to Sexual Orientation   4   2   3   9 
Spent at least 1 Night in Shelter S   5   6   8   19 
Have Exchanged Sex for Money or Place to Stay   2   3   5   10 
[1] Not all participants answered every question
Unprotected Anal Sex with Man in Past 30 Days 
[Units: Participants]
       
Yes   9   7   8   24 
No   11   12   11   34 
Unprotected Anal or Vaginal Sex with Woman 
[Units: Participants]
       
Yes   0   2   1   3 
No   20   17   18   55 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Actual Number of Study Visits Completed by 24 Weeks   [ Time Frame: 24 weeks ]

2.  Primary:   Acceptability of Size of Pill   [ Time Frame: Week 24 ]

3.  Primary:   Acceptability of the Taste of the Pill   [ Time Frame: Week 24 ]

4.  Primary:   Acceptability of the Color of the Pill   [ Time Frame: Week 24 ]

5.  Primary:   Acceptability of Taking the Pill Everyday   [ Time Frame: Week 24 ]

6.  Primary:   Acceptability of Taking Part in the Study   [ Time Frame: Week 24 ]

7.  Primary:   Acceptability of Participating in Group Sessions   [ Time Frame: Week 24 ]

8.  Primary:   Acceptability of Being Randomly Assigned to a Group   [ Time Frame: Week 24 ]

9.  Primary:   Acceptability of Having an HIV Test at Every Visit   [ Time Frame: Week 24 ]

10.  Primary:   Acceptability of Risk Reduction Counseling at Every Visit   [ Time Frame: Week 24 ]

11.  Primary:   Acceptability of Questions About Sexual Behavior at Every Visit   [ Time Frame: Week 24 ]

12.  Primary:   Acceptability of Being Contacted by the Research Team in Between Visits   [ Time Frame: Week 24 ]

13.  Primary:   Acceptability of Physical Examination by a Doctor   [ Time Frame: Week 24 ]

14.  Primary:   Acceptability of Health Clinic for Study Visits   [ Time Frame: Week 24 ]

15.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 4   [ Time Frame: 4 weeks ]

16.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 8   [ Time Frame: Week 8 ]

17.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 12   [ Time Frame: Week 12 ]

18.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 16   [ Time Frame: Week 16 ]

19.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 20   [ Time Frame: Week 20 ]

20.  Primary:   Number of Missed Doses Based on Self-Report Calendar Data-Week 24   [ Time Frame: Week 24 ]

21.  Primary:   Number of Missed Doses Over Time Based on Self-Report Calendar Data   [ Time Frame: 24 weeks ]

22.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Week 4   [ Time Frame: Week 4 ]

23.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Week 8   [ Time Frame: Week 8 ]

24.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Week 12   [ Time Frame: Week 12 ]

25.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Week 16   [ Time Frame: Week 16 ]

26.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Week 20   [ Time Frame: Week 20 ]

27.  Primary:   Number of Missed Doses Based on Medication Refill Dates-Overall   [ Time Frame: 20 Weeks ]

28.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline   [ Time Frame: Baseline ]

29.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4   [ Time Frame: Week 4 ]

30.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8   [ Time Frame: Week 8 ]

31.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12   [ Time Frame: Week 12 ]

32.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16   [ Time Frame: Week 16 ]

33.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20   [ Time Frame: Week 20 ]

34.  Primary:   Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24   [ Time Frame: Week 24 ]

35.  Primary:   Frequency of Missing Study Pills Because Participant Was Away From Home   [ Time Frame: 24 Weeks ]

36.  Primary:   Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things   [ Time Frame: 24 Weeks ]

37.  Primary:   Frequency of Missing Study Pills Because Participant Simply Forgot   [ Time Frame: 24 Weeks ]

38.  Primary:   Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take   [ Time Frame: 24 weeks ]

39.  Primary:   Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects   [ Time Frame: 24 weeks ]

40.  Primary:   Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications   [ Time Frame: 24 weeks ]

41.  Primary:   Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine   [ Time Frame: 24 weeks ]

42.  Primary:   Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful   [ Time Frame: 24 weeks ]

43.  Primary:   Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time   [ Time Frame: 24 weeks ]

44.  Primary:   Frequency of Missing Study Pills Because Participant Felt Sick or Ill   [ Time Frame: 24 weeks ]

45.  Primary:   Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed   [ Time Frame: 24 weeks ]

46.  Primary:   Frequency of Missing Study Pills Because Participant Ran Out of Study Pills   [ Time Frame: 24 weeks ]

47.  Primary:   Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex   [ Time Frame: 24 weeks ]

48.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4   [ Time Frame: Week 4 ]

49.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8   [ Time Frame: Week 8 ]

50.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12   [ Time Frame: Week 12 ]

51.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16   [ Time Frame: Week 16 ]

52.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20   [ Time Frame: Week 20 ]

53.  Primary:   Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24   [ Time Frame: Week 24 ]

54.  Primary:   Perceived Risk of Becoming HIV Positive at Week 4   [ Time Frame: Week 4 ]

55.  Primary:   Perceived Risk of Becoming HIV Positive at Week 8   [ Time Frame: Week 8 ]

56.  Primary:   Perceived Risk of Becoming HIV Positive at Week 12   [ Time Frame: Week 12 ]

57.  Primary:   Perceived Risk of Becoming HIV Positive at Week 16   [ Time Frame: Week 16 ]

58.  Primary:   Perceived Risk of Becoming HIV Positive at Week 20   [ Time Frame: Week 20 ]

59.  Primary:   Perceived Risk of Becoming HIV Positive at Week 24   [ Time Frame: Week 24 ]

60.  Primary:   Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 4 ]

61.  Primary:   Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 8 ]

62.  Primary:   Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 12 ]

63.  Primary:   Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 16 ]

64.  Primary:   Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 20 ]

65.  Primary:   Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study   [ Time Frame: Week 24 ]

66.  Primary:   Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 4 ]

67.  Primary:   Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 8 ]

68.  Primary:   Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 12 ]

69.  Primary:   Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 16 ]

70.  Primary:   Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 20 ]

71.  Primary:   Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex   [ Time Frame: Week 24 ]

72.  Primary:   Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 4 ]

73.  Primary:   Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 8 ]

74.  Primary:   Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 12 ]

75.  Primary:   Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 16 ]

76.  Primary:   Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 20 ]

77.  Primary:   Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP   [ Time Frame: Week 24 ]

78.  Primary:   Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 4 ]

79.  Primary:   Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 8 ]

80.  Primary:   Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 12 ]

81.  Primary:   Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 16 ]

82.  Primary:   Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 20 ]

83.  Primary:   Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study   [ Time Frame: Week 24 ]

84.  Primary:   Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 4 ]

85.  Primary:   Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 8 ]

86.  Primary:   Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 12 ]

87.  Primary:   Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 16 ]

88.  Primary:   Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 20 ]

89.  Primary:   Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study   [ Time Frame: Week 24 ]

90.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline   [ Time Frame: Baseline ]

91.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4   [ Time Frame: Week 4 ]

92.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8   [ Time Frame: Week 8 ]

93.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12   [ Time Frame: Week 12 ]

94.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16   [ Time Frame: Week 16 ]

95.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20   [ Time Frame: Week 20 ]

96.  Secondary:   Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24   [ Time Frame: Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
After release of Pre-exposure Prophylaxis Initiative efficacy results, the Data and Safety Monitoring Board recommended that subjects be unblinded, enrollment stopped, all be offered option of PrEP, subjects on PrEP arm continued as scheduled.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Bob Harris
Organization: Westat
phone: 301-251-1500
e-mail: bobharris@westat.com



Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01033942     History of Changes
Other Study ID Numbers: ATN 082
Study First Received: December 16, 2009
Results First Received: October 28, 2014
Last Updated: April 14, 2017