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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCC Behavioral Intervention Group | Experimental | PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCC | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. | Baseline, Week 48 |
| Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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;
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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sybil Hosek, PhD | Stroger Hospital of Cook County | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| University of Colorado - The Children's Hospital of Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28873128 | Result | 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. | |
| 31179503 |
| Label | URL |
|---|---|
| ATN website | View source |
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This research was conducted at 6 clinical sites. Accrual was open between 7/16/2013 and 9/30/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | PCC Behavioral Intervention Group | PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Emtricitabine/tenofovir (FTC/TDF (Truvada®)) | Drug | All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. |
|
|
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.
| 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. | 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. | 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. | 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. | 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) | Week 4, Week 12, Week 24, Week 36, Week 48 |
| 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. | 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: | 48 weeks |
| Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. | 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. | 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. | 48 weeks |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Fenway Institute | Boston | Massachusetts | 02215 | United States |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Derived |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PCC Behavioral Intervention Group | PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Modified binary variable for race, distinguishing only those who identified as Black/African-American from those who did not. | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Derived variable combining information on race and ethnicity. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Lumbar spine bone mineral density (BMD) | Subjects with DXA data at baseline. | Mean | Standard Deviation | g/cm2 |
| ||||||||||||||||
| Femoral neck bone mineral density (BMD) | Subjects with DXA data at baseline. | Mean | Standard Deviation | g/cm2 |
| ||||||||||||||||
| Total body bone mineral density (BMD) | Subjects with DXA data at baseline. | Mean | Standard Deviation | g/cm2 |
| ||||||||||||||||
| Total hip bone mineral density (BMD) | Subjects with DXA data at baseline. | Mean | Standard Deviation | g/cm2 |
| ||||||||||||||||
| Number of participants reporting unprotected sex with a male partner in the past month | From the participant ACASI question referring to male partners in the past month: "Of these males, how many did you have unprotected oral or anal sex with in the past month?" An event is defined as an answer of greater than 0. | Participants who provided a response to this question on the ACASI survey. | Count of Participants | Participants |
| ||||||||||||||||
| Number of male sexual partners in the last month | From the participant ACASI question: "During the past month, how many male partners have you had sexual contact with (oral or anal)?" | Participants who provided a response to this question on the ACASI survey. | Mean | Standard Deviation | male sexual partners |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 48 weeks |
|
|
| |||||||||||||||||||||||||||
| Primary | 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. | Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Subjects with DXA data at both baseline and Week 48. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Subjects with DXA data at both baseline and Week 48. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Subjects with DXA data at both baseline and Week 48. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Enrolled subjects with DXA results for baseline and Week 48 | Posted | Count of Participants | Participants | 48 weeks |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Participants providing data for this question at Week 48. | Posted | Count of Participants | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Participants providing data for this question at Week 48. | Posted | Mean | Standard Deviation | male sexual partners | Week 48 |
|
| ||||||||||||||||||||||||||
| Primary | 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. | Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question) | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Primary | 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) | Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week. | Posted | Count of Participants | Participants | Week 4, Week 12, Week 24, Week 36, Week 48 |
| ||||||||||||||||||||||||||||
| Secondary | 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) | Data not collected; only one type of risk reduction intervention was ultimately implemented. | Posted | 48 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Using Text Messaging Reminders | This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders. | The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders. | Posted | Count of Participants | Participants | Baseline through Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | 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: | Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question. | Posted | Count of Participants | Participants | 48 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. | Data were not collected. | Posted | 48 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Quantitative data were not collected for this outcome. | Posted | 48 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Data were not collected. | Posted | 48 weeks |
|
|
Adverse event data was collected over the duration of the study, from the start of enrollment on 7/16/2013 until the completion of subject follow-up on 8/18/2016 (approximately 3 years).
Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation Form and reported here.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCC Behavioral Intervention Group | PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP 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. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP | 0 | 78 | 3 | 78 | 6 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA SOC | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA SOC | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA SOC | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA SOC | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA SOC | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight Decreased | Investigations | MedDRA SOC | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA SOC | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA SOC | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA SOC | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA SOC | Systematic Assessment |
|
The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications, and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bob Harris | Westat | 301-251-1500 | bobharris@westat.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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| Unknown or Not Reported |
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| Non-Black/African-American |
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| Black/African American |
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| White |
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| White/Hispanic |
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| Other/Mixed Race |
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| Units | Counts |
|---|---|
| Participants |
|
| Liked a lot |
|
| Liked a lot |
|
| Liked a lot |
|
| Liked a lot |
|
| Liked a lot |
|
|
| Liked a lot |
|
|
| Liked a lot |
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| Liked a lot |
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| Liked a lot |
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|
| 4 days |
|
| Daily |
|
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| 4 days |
|
| Daily |
|
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| 4 days |
|
| Daily |
|
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| 4 days |
|
| Daily |
|
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| 4 days |
|
| Daily |
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| Often |
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| Often |
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| Often |
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| Often |
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| Often |
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| Often |
|