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An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769456
First Posted: January 16, 2013
Last Update Posted: December 11, 2017
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.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Westat
Results First Submitted: October 6, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV Infection
Interventions: Behavioral: PCC
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))

  Participant Flow
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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 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.

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
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:   Overall Study
    PCC Behavioral Intervention Group
STARTED   78 [1] 
COMPLETED   41 
NOT COMPLETED   37 
Lost to Follow-up                19 
Withdrawal by Subject                3 
Did not receive PCC intervention                6 
Moved out of the area                3 
No wk 0 visit w/in 30 days of screening                5 
Parental request to youth to withdraw                1 
[1] 1 subject inadvertently enrolled, discontin'd after baseline, re-enrolled later and completed study



  Baseline Characteristics
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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
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.

Baseline Measures
   PCC Behavioral Intervention Group 
Overall Participants Analyzed 
[Units: Participants]
 78 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 78 
   16.52  (0.66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 78 
Female      0   0.0% 
Male      78 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 78 
Hispanic or Latino      35  44.9% 
Not Hispanic or Latino      42  53.8% 
Unknown or Not Reported      1   1.3% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
 
Black/African-American   
Participants Analyzed 
[Units: Participants]
 78 
Black/African-American      33  42.3% 
Non-Black/African-American      45  57.7% 
[1] Modified binary variable for race, distinguishing only those who identified as Black/African-American from those who did not.
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
 
Race/ethnicity   
Participants Analyzed 
[Units: Participants]
 78 
Asian/Pacific Islander      2   2.6% 
Black/African American      23  29.5% 
White      11  14.1% 
White/Hispanic      16  20.5% 
Other/Mixed Race      26  33.3% 
[1] Derived variable combining information on race and ethnicity.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 78 
United States   78 
Lumbar spine bone mineral density (BMD) [1] 
[Units: G/cm2]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 75 
   1.03  (0.15) 
[1] Subjects with DXA data at baseline.
Femoral neck bone mineral density (BMD) [1] 
[Units: G/cm2]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 75 
   0.99  (0.16) 
[1] Subjects with DXA data at baseline.
Total body bone mineral density (BMD) [1] 
[Units: G/cm2]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 75 
   1.15  (0.11) 
[1] Subjects with DXA data at baseline.
Total hip bone mineral density (BMD) [1] 
[Units: G/cm2]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 75 
   1.06  (0.15) 
[1] Subjects with DXA data at baseline.
Number of participants reporting unprotected sex with a male partner in the past month [1] [2] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 60 
   52 
[1]

From the participant ACASI question referring to male partners in the past month:

“Of these males, how many did you have unprotected oral or anal sex with in the past month?”

An event is defined as an answer of greater than 0.

[2] Participants who provided a response to this question on the ACASI survey.
Number of male sexual partners in the last month [1] [2] 
[Units: Male sexual partners]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 73 
   1.95  (2.15) 
[1]

From the participant ACASI question:

"During the past month, how many male partners have you had sexual contact with (oral or anal)?"

[2] Participants who provided a response to this question on the ACASI survey.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study   [ Time Frame: 48 weeks ]

2.  Primary:   Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48   [ Time Frame: Baseline, Week 48 ]

3.  Primary:   Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48   [ Time Frame: Baseline, Week 48 ]

4.  Primary:   Total Body Bone Mineral Density: Percent Change From Baseline to Week 48   [ Time Frame: Baseline, Week 48 ]

5.  Primary:   Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48   [ Time Frame: Baseline, Week 48 ]

6.  Primary:   Number of Participants With Decrease in Bone Mineral Density   [ Time Frame: 48 weeks ]

7.  Primary:   Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex   [ Time Frame: Week 48 ]

8.  Primary:   Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners   [ Time Frame: Week 48 ]

9.  Primary:   Acceptability of PrEP Regimen and Study Visits   [ Time Frame: Week 12 ]

10.  Primary:   Estimation of Medication Adherence by Dried Blood Spot (DBS) Results   [ Time Frame: Week 4, Week 12, Week 24, Week 36, Week 48 ]

11.  Secondary:   Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation   [ Time Frame: 48 weeks ]

12.  Secondary:   Number of Participants Using Text Messaging Reminders   [ Time Frame: Baseline through Week 48 ]

13.  Secondary:   Rating of the Reasons for Missing Medications on a 4-point Likert Scale.   [ Time Frame: 48 weeks ]

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

15.  Secondary:   Evaluation of the Process of Protocol Implementation   [ Time Frame: 48 weeks ]

16.  Secondary:   Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.   [ Time Frame: 48 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 of Results:

Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT01769456     History of Changes
Other Study ID Numbers: ATN 113 Version 2.0
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: October 6, 2017
Results First Posted: November 13, 2017
Last Update Posted: December 11, 2017