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An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

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: NCT01772823
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : December 21, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV Infection
Interventions: Behavioral: 3MV
Behavioral: PCC
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))

  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 12 clinical sites. Accrual was open between July 2012 and September 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
3MV Behavioral Intervention Group 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

Participant Flow for 3 periods

Period 1:   Behavioral Intervention (BL -3MV or PCC)
    3MV Behavioral Intervention Group   PCC Behavioral Intervention Group
STARTED   128   72 
COMPLETED   116   70 
NOT COMPLETED   12   2 
Lost to Follow-up                1                0 
Withdrawal by Subject                1                1 
Inadvertent enrollment                1                0 
Inelligible at rescreen                2                1 
Wk 0 not completed, 30 days of baseline                6                0 
Moved out of area                1                0 

Period 2:   Treatment Phase (Week 0- Week 48)
    3MV Behavioral Intervention Group   PCC Behavioral Intervention Group
STARTED   116   70 
COMPLETED   88   52 
NOT COMPLETED   28   18 
Lost to Follow-up                15                13 
Withdrawal by Subject                6                1 
Moved out of area                4                3 
Incarcerated                1                0 
Suicide gesture/disruptive behavior                1                0 
Wk 0 not completed, 30 days of baseline                1                1 

Period 3:   Extension Phase (Visits 24,48wks Post tx
    3MV Behavioral Intervention Group   PCC Behavioral Intervention Group
STARTED   63 [1]   42 [2] 
COMPLETED   53   33 
NOT COMPLETED   10   9 
Lost to Follow-up                6                5 
Withdrawal by Subject                1                2 
Moved out of area                2                2 
Became unavailable for study visits                1                0 
[1] 25 of the 88 subjects that completed the Treatment Phase were not eligible for the Extension Phase
[2] 10 of the 52 subjects that completed the Treatment Phase were not eligible for the Extension Phase



  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
3MV Behavioral Intervention Group 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Total Total of all reporting groups

Baseline Measures
   3MV Behavioral Intervention Group   PCC Behavioral Intervention Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   72   200 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.14  (1.40)   20.25  (1.23)   20.18  (1.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      128 100.0%      72 100.0%      200 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race/ethnicity       
Asian/Pacific Islander      2   1.6%      0   0.0%      2   1.0% 
Black/African American      55  43.0%      38  52.8%      93  46.5% 
White      26  20.3%      16  22.2%      42  21.0% 
White/Hispanic      15  11.7%      6   8.3%      21  10.5% 
Other/Mixed Race      30  23.4%      12  16.7%      42  21.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic Ethnicity       
Hispanic      39  30.5%      14  19.4%      53  26.5% 
Non-Hispanic      89  69.5%      56  77.8%      145  72.5% 
Refused      0   0.0%      2   2.8%      2   1.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   128   72   200 
BMI 
[Units: Participants]
Count of Participants
     
Underweight (<18.5 kg/m^2)      3   2.3%      6   8.3%      9   4.5% 
Normal (18.5-<25 kg/m^2)      71  55.5%      38  52.8%      109  54.5% 
Overweight (25.0-<30 kg/m^2)      25  19.5%      18  25.0%      43  21.5% 
Obese (=>30 kg/m^2)      29  22.7%      10  13.9%      39  19.5% 


  Outcome Measures

1.  Primary:   Number of Participants With Serum Creatinine Event of Grade 1 or Higher   [ Time Frame: 48 Weeks ]

2.  Primary:   Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48   [ Time Frame: 48 weeks ]

3.  Primary:   Lumbar Spine Bone Mineral Density at Baseline and at Week 48   [ Time Frame: Baseline, Week 48 ]

4.  Primary:   Femoral Neck Bone Mineral Density at Baseline and at Week 48   [ Time Frame: Baseline, Week 48 ]

5.  Primary:   Total Body Bone Mineral Density at Baseline and at Week 48   [ Time Frame: Baseline, Week 48 ]

6.  Primary:   Total Hip Bone Mineral Density at Baseline and at Week 48   [ Time Frame: Baseline, Week 48 ]

7.  Primary:   Number of Participants With Unprotected Sex Acts   [ Time Frame: Baseline and 48 weeks ]

8.  Primary:   Number of Sex Partners   [ Time Frame: Baseline and 48 weeks ]

9.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill   [ Time Frame: Week 12 ]

10.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill   [ Time Frame: Week 12 ]

11.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill   [ Time Frame: Week 12 ]

12.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day   [ Time Frame: Week 12 ]

13.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study   [ Time Frame: Week 12 ]

14.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit   [ Time Frame: Week 12 ]

15.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit   [ Time Frame: Week 12 ]

16.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior   [ Time Frame: Week 12 ]

17.  Primary:   Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam   [ Time Frame: Week 12 ]

18.  Primary:   Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 ]

19.  Primary:   Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 ]

20.  Primary:   Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)   [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 ]

21.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session."   [ Time Frame: 48 weeks ]

22.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life."   [ Time Frame: 48 weeks ]

23.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others."   [ Time Frame: 48 weeks ]

24.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized."   [ Time Frame: 48 weeks ]

25.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting."   [ Time Frame: 48 weeks ]

26.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material."   [ Time Frame: 48 weeks ]

27.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life."   [ Time Frame: 48 weeks ]

28.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable."   [ Time Frame: 48 weeks ]

29.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others."   [ Time Frame: 48 weeks ]

30.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session."   [ Time Frame: 48 weeks ]

31.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)   [ Time Frame: 48 weeks ]

32.  Secondary:   Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.   [ Time Frame: 48 weeks ]

33.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)   [ Time Frame: 48 weeks ]

34.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)   [ Time Frame: 48 weeks ]

35.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)   [ Time Frame: 48 weeks ]

36.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)   [ Time Frame: 48 weeks ]

37.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)   [ Time Frame: 48 weeks ]

38.  Secondary:   Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)   [ Time Frame: 48 weeks ]

39.  Secondary:   Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders   [ Time Frame: 48 weeks ]

40.  Secondary:   Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders   [ Time Frame: 48 weeks ]

41.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)   [ Time Frame: 48 weeks ]

42.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)   [ Time Frame: 48 weeks ]

43.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)   [ Time Frame: 48 weeks ]

44.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)   [ Time Frame: 48 weeks ]

45.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)   [ Time Frame: 48 weeks ]

46.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)   [ Time Frame: 48 weeks ]

47.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)   [ Time Frame: 48 weeks ]

48.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)   [ Time Frame: 48 weeks ]

49.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)   [ Time Frame: 48 weeks ]

50.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)   [ Time Frame: 48 weeks ]

51.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)   [ Time Frame: 48 weeks ]

52.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)   [ Time Frame: 48 weeks ]

53.  Secondary:   Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01772823     History of Changes
Other Study ID Numbers: ATN 110 Version 3.0
First Submitted: December 21, 2012
First Posted: January 21, 2013
Results First Submitted: October 13, 2017
Results First Posted: December 21, 2017
Last Update Posted: January 17, 2018