HIV InfectionPhase 2NCT01769456
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)
A Phase 2 study testing PCC and Emtricitabine/tenofovir (FTC/TDF (Truvada®)) in people with HIV Infection, run by University of North Carolina, Chapel Hill at 6 sites in United States.
Trial summary
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Read more about this study
- Who is it for?
- Ages 15 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- PCC and Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2013to Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Willing and able to provide written informed consent;
- Male gender at birth;
- Age 15 years and 0 days through 17 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;
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- 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 PrEP;
- Willing to participate in behavioral intervention;
- Reports intention not to relocate out of AMTU study area during the course of the study; and
- Does not have a job or other obligations that would require long absences from AMTU study area (greater than 4 weeks at a time).
Who cannot join
- 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) 113 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 calculated based on bedside Schwartz formula: Glomerular filtration rate (GFR) = (0.413 x (height in centimeters)) / (serum creatinine in mg/dl)), or serum creatinine > upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado - The Children's Hospital of Denver
Aurora, Colorado, 80045
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Tulane Medical Center
New Orleans, Louisiana, 70112
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Project PrEPare - 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) in the United States
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during the course of the study will be discontinued from the study agent and be 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.
Read the detailed description
The aims of the study are to obtain additional data on the safety of FTC/TDF (Truvada®) and to evaluate acceptability, patterns of use, rates of adherence, and measured levels of drug exposure when YMSM are provided with open label FTC/TDF (Truvada®) and information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP based on prior studies in adults. The study will also examine patterns of sexual risk behavior among HIV-uninfected YMSM in the U.S. at high risk of acquiring HIV infection who are provided with open label FTC/TDF (Truvada®) as PrEP. The study will also explore the feasibility and acceptability of implementing an efficacious risk reduction behavioral intervention prior to the provision of PrEP- PCC. The inclusion of a behavioral intervention in this project not only addresses the ethical responsibility of providing at least the minimum risk reduction education to all subjects given the high HIV risk of the study population, but also builds behavioral skills to assist subjects in reducing their risk when not taking PrEP. Furthermore, the study will evaluate the process of protocol implementation to better understand how to best implement PrEP research and program practice at adolescent medicine sites, including an evaluation of consent procedures and the acceptability/feasibility of allowing youth minors to consent for their own participation in HIV prevention intervention, to the extent allowable by local laws and regulations, and to allow youth minor participation in a clinical trial without requiring disclosure of their sexual orientation and risk behaviors to their parents or legal guardians.
- Conditions
- HIV Infection
- Being tested
- PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
- Keywords
- HIV, PrEP, FTC/TDF, Truvada®
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCCBehavioural
Also called Personalized Cognitive Counseling
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 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.
Emtricitabine/tenofovir (FTC/TDF (Truvada®))Drug
Also called FTC/TDF, Truvada®, Emtricitabine/tenofovir, PrEP
All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PCC Behavioral Intervention Group | Experimental | PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP Receives: Behavioral: PCC; Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
Measured: 48 weeks
Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:
Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Baseline, Week 48
Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:
Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Baseline, Week 48
Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
The percent change in total body BMD from baseline measurement to Week 48 is calculated as:
Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Baseline, Week 48
Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:
Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Baseline, Week 48
Number of Participants With Decrease in Bone Mineral Density
The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: 48 weeks
Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:
"Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0.
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Week 48
Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:
"Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?"
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Measured: Week 48
Acceptability of PrEP Regimen and Study Visits
This represents one of the indicators associated with 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.
Measured: Week 12
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
This outcome addresses the objective: 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.
Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.
The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).
The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)
Measured: Week 4, Week 12, Week 24, Week 36, Week 48
Secondary outcomes (6)
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation
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 session interesting, was it relevant to their life, and did they learn from the session)
Measured: 48 weeks
Number of Participants Using Text Messaging Reminders
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.
Measured: Baseline through Week 48
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.
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:
Measured: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.
Measured: 48 weeks
Evaluation of the Process of Protocol Implementation
Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.
NOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:
Gilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9.
Measured: 48 weeks
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sybil Hosek, PhD, Study chair, Stroger Hospital of Cook County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769456
- Sponsor's protocol ID
- ATN 113 Version 2.0
- Status last verified
- Nov 2017
- First submitted
- 14 Jan 2013
- Last updated
- 17 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hosek SG, Landovitz RJ, Kapogiannis B, Siberry GK, Rudy B, Rutledge B, Liu N, Harris DR, Mulligan K, Zimet G, Mayer KH, Anderson P, Kiser JJ, Lally M, Brothers J, Bojan K, Rooney J, Wilson CM. Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017 Nov 1;171(11):1063-1071. doi: 10.1001/jamapediatrics.2017.2007.
PubMed 28873128Havens 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.
PubMed 31179503
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PrEPare - 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) in the United States
- ClinicalTrials.gov ID
- NCT01769456
- Acronym / sponsor ID
- ATN 113 Version 2.0
- Conditions
- HIV Infection
- Keywords
- HIV, PrEP, FTC/TDF, Truvada®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Gilead Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 13 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 100 HIV-uninfected YMSM at high risk of acquiring HIV infection, between the ages of 15 and 17 inclusive will be enrolled across all participating Adolescent Medicine Trial Units (AMTUs). Subjects will complete the behavioral intervention selected by all participating sites, Personalized Cognitive Counseling (PCC), and will then be provided with open label emtricitabine (FTC)/tenofovir (TDF) (Truvada®) as pre-exposure prophylaxis (PrEP). Behavioral and biomedical data will be collected at baseline and at 0, 4, 8, 12, 24, 36 and 48 weeks. Any subject who becomes HIV infected during the course of the study will be discontinued from the study agent and be 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.
Detailed description
The aims of the study are to obtain additional data on the safety of FTC/TDF (Truvada®) and to evaluate acceptability, patterns of use, rates of adherence, and measured levels of drug exposure when YMSM are provided with open label FTC/TDF (Truvada®) and information regarding safety and efficacy of FTC/TDF (Truvada®) as PrEP based on prior studies in adults. The study will also examine patterns of sexual risk behavior among HIV-uninfected YMSM in the U.S. at high risk of acquiring HIV infection who are provided with open label FTC/TDF (Truvada®) as PrEP. The study will also explore the feasibility and acceptability of implementing an efficacious risk reduction behavioral intervention prior to the provision of PrEP- PCC. The inclusion of a behavioral intervention in this project not only addresses the ethical responsibility of providing at least the minimum risk reduction education to all subjects given the high HIV risk of the study population, but also builds behavioral skills to assist subjects in reducing their risk when not taking PrEP. Furthermore, the study will evaluate the process of protocol implementation to better understand how to best implement PrEP research and program practice at adolescent medicine sites, including an evaluation of consent procedures and the acceptability/feasibility of allowing youth minors to consent for their own participation in HIV prevention intervention, to the extent allowable by local laws and regulations, and to allow youth minor participation in a clinical trial without requiring disclosure of their sexual orientation and risk behaviors to their parents or legal guardians.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCC Behavioral Intervention Group | Experimental | Behavioral: PCC, Drug: Emtricitabine/tenofovir (FTC/TDF (Truvada®))PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent;
- Male gender at birth;
- Age 15 years and 0 days through 17 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:
- Tests HIV antibody negative at time of screening;
Key exclusion criteria (17 listed)
- 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) 113 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCCAlso: Personalized Cognitive CounselingPersonalized 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 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. | Behavioural | PCC Behavioral Intervention Group |
| Emtricitabine/tenofovir (FTC/TDF (Truvada®))Also: FTC/TDF, Truvada®, Emtricitabine/tenofovir, PrEPAll subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | Drug | PCC Behavioral Intervention Group |
Primary outcome
Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
Time frame: 48 weeks
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM. Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
Time frame: Baseline, Week 48
The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as: Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
Time frame: Baseline, Week 48
The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as: Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
Time frame: Baseline, Week 48
The percent change in total body BMD from baseline measurement to Week 48 is calculated as: Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
Time frame: Baseline, Week 48
The percent change in total hip BMD from baseline measurement to Week 48 is calculated as: Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Number of Participants With Decrease in Bone Mineral Density
Time frame: 48 weeks
The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body). This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
Time frame: Week 48
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI: "Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0. This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
Time frame: Week 48
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI: "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Acceptability of PrEP Regimen and Study Visits
Time frame: Week 12
This represents one of the indicators associated with 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.
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
Time frame: Week 4, Week 12, Week 24, Week 36, Week 48
This outcome addresses the objective: 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. Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples. The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch). The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)
6 secondary outcomes
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation
Time frame: 48 weeks
Number of Participants Using Text Messaging Reminders
Time frame: Baseline through Week 48
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
Time frame: 48 weeks
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.
Time frame: 48 weeks
Evaluation of the Process of Protocol Implementation
Time frame: 48 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28873128Hosek SG, Landovitz RJ, Kapogiannis B, Siberry GK, Rudy B, Rutledge B, Liu N, Harris DR, Mulligan K, Zimet G, Mayer KH, Anderson P, Kiser JJ, Lally M, Brothers J, Bojan K, Rooney J, Wilson CM. Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017 Nov 1;171(11):1063-1071. doi: 10.1001/jamapediatrics.2017.2007.
- Derived from this study: PubMed 31179503Havens 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.
- ATN websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sybil Hosek, PhD study chair
Stroger Hospital of Cook County
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCC and Emtricitabine/tenofovir (FTC/TDF (Truvada®)) in people with HIV Infection, run by University of North Carolina, Chapel Hill at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study (time frame: 48 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.