- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01772823
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado - The Children's Hospital of Denver
-
-
Florida
-
Miami, Florida, United States, 33101
- University of Miami
-
Tampa, Florida, United States, 33606
- University of South Florida
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Stroger Hospital and the CORE Center
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Fenway Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Childrens Research Hospital
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCC Behavioral Intervention Group
PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP
|
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
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 Names:
|
Experimental: 3MV Behavioral Intervention Group
3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP
|
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
48 Weeks
|
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. |
48 weeks
|
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. |
Baseline, Week 48
|
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. |
Baseline, Week 48
|
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. |
Baseline, Week 48
|
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. |
Baseline, Week 48
|
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. |
Baseline and 48 weeks
|
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?" |
Baseline and 48 weeks
|
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. |
Week 12
|
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. |
Week 12
|
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. |
Week 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. |
Week 12
|
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. |
Week 12
|
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. |
Week 12
|
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 |
Week 12
|
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 |
Week 12
|
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 |
Week 12
|
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). |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
|
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.
|
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
|
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. |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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" |
48 weeks
|
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" |
48 weeks
|
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" |
48 weeks
|
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" |
48 weeks
|
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" |
48 weeks
|
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" |
48 weeks
|
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" |
48 weeks
|
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." |
48 weeks
|
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." |
48 weeks
|
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." |
48 weeks
|
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. |
48 weeks
|
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
|
48 weeks
|
|
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) |
48 weeks
|
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) |
48 weeks
|
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) |
48 weeks
|
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. |
48 weeks
|
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) |
48 weeks
|
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?" |
48 weeks
|
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
|
48 weeks
|
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
|
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
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?" |
48 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Sybil Hosek, PhD, Cook County Health & Hospitals System
Publications and helpful links
General Publications
- Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.
- Havens PL, Perumean-Chaney SE, Patki A, Cofield SS, Wilson CM, Liu N, Anderson PL, Landovitz RJ, Kapogiannis BG, Hosek SG, Mulligan K. Changes in Bone Mass After Discontinuation of Preexposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine in Young Men Who Have Sex With Men: Extension Phase Results of Adolescent Trials Network Protocols 110 and 113. Clin Infect Dis. 2020 Feb 3;70(4):687-691. doi: 10.1093/cid/ciz486.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Other Study ID Numbers
- ATN 110 Version 3.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV-1 Infection | HIV Antibodies | Neutralizing Antibody | Viral Load | Monoclonal AntibodyUnited States
Clinical Trials on Emtricitabine/tenofovir (FTC/TDF (Truvada®))
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompleted
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompletedHIV InfectionsSouth Africa, Uganda, Zimbabwe
-
University of WashingtonBill and Melinda Gates FoundationCompletedHIV Infections | HIV-1 InfectionsKenya, Uganda
-
Merck Sharp & Dohme LLCCompletedHIV Preexposure ProphylaxisUnited States, Brazil, France, Japan, South Africa, Thailand, Peru
-
Merck Sharp & Dohme LLCActive, not recruitingProphylaxis | Human Immunodeficiency Virus Type 1 | HIV-IUnited States, South Africa, Uganda
-
Johns Hopkins UniversityWithdrawnPregnancy | HIV-1-infection
-
Gilead SciencesCompletedHepatitis BCanada, Germany, Turkey, United States, Greece, New Zealand, Hungary, Romania, Bulgaria, Serbia, Austria, Poland, Czech Republic, Spain
-
Gilead SciencesCompletedHIV Infections | Acquired Immunodeficiency SyndromeUnited States, Thailand, France, Uganda, United Kingdom, Belgium, Portugal, Mexico, Dominican Republic, Italy, Puerto Rico, Russian Federation
-
Gilead SciencesCompletedChronic Hepatitis BUnited States, Canada, Spain, Singapore, Turkey, Germany, France, Taiwan, Greece, Italy, Poland