We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : December 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). The behavioral intervention will be assigned at the level of the site, which include Many Men, Many Voices (3MV) and Personalized Cognitive Counseling (PCC). Subjects will first complete the behavioral intervention offered at their respective site and then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as PrEP. Behavioral and biomedical data will be collected at baseline and 0, 4, 8, 12, 24, 36 and 48 weeks. Any subjects who become HIV infected during the course of the study will be discontinued from the study agent and followed for an additional 24 weeks after the study visit at which HIV infection is confirmed. Those subjects who meet specific bone or renal criteria at the Week 48 visit or the 24-Week HIV Seropositive visit will be followed for an additional 48 weeks in the Extension Phase to monitor longer-term outcomes of potential concerns.

Condition or disease Intervention/treatment Phase
HIV Infection Behavioral: 3MV Behavioral: PCC Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®)) Phase 2

Detailed Description:
The primary objectives of the study are to provide additional safety data regarding FTC/TDF (Truvada®) use as PrEP in YMSM, to examine acceptability, patterns of use, rates of adherence, measure levels of drug exposure and patterns of risk behavior when YMSM are provided open label FTC/TDF (Truvada®). The study will also examine information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP from prior studies.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States
Study Start Date : November 2012
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 3MV Behavioral Intervention Group
3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP
Behavioral: 3MV
Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 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 other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
Other Name: Many Men, Many Voices
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
  • FTC/TDF
  • Truvada®
  • Emtricitabine/tenofovir
  • PrEP
Experimental: PCC Behavioral Intervention Group
PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP
Behavioral: PCC
Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
Other Name: Personalized Cognitive Counseling
Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
  • FTC/TDF
  • Truvada®
  • Emtricitabine/tenofovir
  • PrEP


Outcome Measures

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

    This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM

    Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal.


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

    This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM."

    The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48.


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

    This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

    Bone mineral density at Baseline and Week 48: data reported below for lumbar spine.


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

    This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

    Bone mineral density at Baseline and Week 48: data reported below for femoral neck.


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

    This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

    Bone mineral density at Baseline and Week 48: data reported below for total body.


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

    This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

    Bone mineral density at Baseline and Week 48: data reported below for total hip.


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

    This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

    Responses to the participant ACASI question referring to male partners in the past month/since the last survey:

    "Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month?" (Baseline), or "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?" (Week 48) An event is defined as an answer of greater than 0.


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

    This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

    Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:

    "During the past month, how many male partners have you had sexual contact with (oral or anal)?" (Baseline), or "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" (Week 48)

    And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:

    "Of those you had unprotected sex with, how many did you know were HIV positive?"


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

    This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill.


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

    This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

    This specific outcome focuses on the question of how participants felt about the taste of the pill.


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

    This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

    This specific outcome focuses on the question of how participants felt about the color of the pill.


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

    This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

    This specific outcome focuses on the question of how participants felt about taking the pill every day.


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

    This outcome addresses the objective "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

    This specific outcome focuses on the question of how participants felt about taking part in the study.


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

    This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit.


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

    This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit


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

    This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit


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

    This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

    Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor


  18. 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 ]

    This outcome addresses the objective: "Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

    PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily).


  19. 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 ]
    PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.

  20. 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 ]

    This outcome addresses the objective: "Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

    PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations.



Secondary Outcome Measures :
  1. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 1 of 10: "I learned a lot from this workshop/session"


  2. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 2 of 10: "I will be able to apply what I learned from this workshop/session in my life"


  3. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 3 of 10: "I was given an opportunity to participate and discuss information with others"


  4. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 4 of 10: "The workshop/session was well organized"


  5. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 5 of 10: "The topic of this workshop/session was interesting"


  6. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 6 of 10: "The presenter(s) stimulated my interest in the material"


  7. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 7 of 10: "The topic of this workshop/session was relevant to my life"


  8. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 8 of 10: "The workshop/session was enjoyable."


  9. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 9 of 10: "I would recommend this workshop/session to others."


  10. 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 ]

    Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

    Item 10 of 10: "I felt comfortable participating in this workshop/session."


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

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's age at enrollment.


  12. 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 ]
  13. Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) [ Time Frame: 48 weeks ]

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's race (5 categories)


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

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's race (2 categories)


  15. 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 ]

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)


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

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's BMI (kg/m2), assessed categorically.


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

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)


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

    Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

    PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

    This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"


  19. Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders [ Time Frame: 48 weeks ]
    Total number of subjects who signed up for text message reminders

  20. Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders [ Time Frame: 48 weeks ]
    Number of subjects who discontinued receiving text message reminders while they were still on the study agent

  21. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Were away from home?"


  22. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Were too busy with other things?"


  23. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Simply forgot?"


  24. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Had too many study pills to take?"


  25. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Wanted to avoid side effects?"


  26. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Did not want others to notice you taking meds?"


  27. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Had a change in daily routine?"


  28. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Felt like the study pill was toxic/harmful?"


  29. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Fell asleep/slept through dose time?"


  30. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Felt sick or ill?"


  31. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Felt depressed/overwhelmed?"


  32. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Ran out of study pills?"


  33. 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 ]

    Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

    Question: In the past month, how often have you missed taking your study pills because you:

    "Didn't think you needed it because you weren't having risk sex?"



Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 22 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent;
  • Male gender at birth;
  • Age 18 years and 0 days through 22 years and 364 days, inclusive, at the time of signed informed consent;
  • Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

    • At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;
    • Anal intercourse with 3 or more male sex partners during the last 6 months;
    • Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;
    • Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;
    • Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or
    • At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;
  • Tests HIV antibody negative at time of screening;
  • Willing to provide locator information to study staff;
  • Willing to take pre-exposure prophylaxis (PrEP);
  • Willing to participate in behavioral intervention;
  • Reports intention not to relocate out of the Adolescent Medicine Trial Unit (AMTU) study area during the course of the study; and
  • Does not have a job or other obligations that would require long absences from the AMTU study area (greater than 4 weeks at a time).

Exclusion Criteria:

  • Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;
  • Intoxicated or under the influence of alcohol or other drugs at the time of consent;
  • Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 Protocol Team if they are having difficulty making the judgment.);
  • History of bone fractures not explained by trauma;
  • Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;
  • Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min, or serum creatinine ≥ upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
  • Confirmed ≥ Grade 2 hypophosphatemia at time of screening;
  • Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;
  • Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;
  • Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio(UP/C);
  • UP/C > 0.37 g/g at time of screening, regardless of urine dipstick protein result;
  • Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (<120 mg/dL) at time of screening;
  • A confirmed Grade ≥ 3 toxicity on any screening evaluations;
  • Known allergy/sensitivity to the study agent or its components;
  • Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;
  • Use of disallowed medications ; or
  • Inability to understand spoken English.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772823


Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33101
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Stroger Hospital and the CORE Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fenway Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Westat
Investigators
Study Chair: Sybil Hosek, PhD Cook County Health & Hospitals System
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Westat
ClinicalTrials.gov Identifier: NCT01772823     History of Changes
Other Study ID Numbers: ATN 110 Version 3.0
First Posted: January 21, 2013    Key Record Dates
Results First Posted: December 21, 2017
Last Update Posted: December 21, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Westat:
HIV, PrEP, FTC/TDF, Truvada®

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents