| Primary | Number of Participants With Serum Creatinine Event of Grade 1 or Higher | 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. | Participants with visit data through 48 weeks. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | 48 Weeks | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
| | | Title | Denominators | Categories |
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| Primary | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 | 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. | Enrolled subjects with DXA results for Baseline and Week 48 The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Lumbar Spine Bone Mineral Density at Baseline and at 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. | Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | g/cm2 | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Femoral Neck Bone Mineral Density at Baseline and at 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. | Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | g/cm2 | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Total Body Bone Mineral Density at Baseline and at 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. | Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | g/cm2 | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Total Hip Bone Mineral Density at Baseline and at 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. | Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | g/cm2 | | Baseline, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Number of Participants With Unprotected Sex Acts | 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. | Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | Baseline and 48 weeks | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Number of Sex Partners | 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?" | Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | sexual partners | | Baseline and 48 weeks | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit | 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. | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit | 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 | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior | 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 | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam | 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 | Participants enrolled at Week 12 who provided a response to this question. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Primary | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure | 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). | Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations. | Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | pmol/punch | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Primary | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) | 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. | Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group. | Posted | | Mean | Standard Deviation | fmol/punch | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48 | | | | ID | Title | Description |
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| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
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| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
|
| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
|
| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
|
| Secondary | 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." | 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" | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | 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." | 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." | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
|
| Secondary | 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." | 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." | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | 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." | 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." | Participants providing a response to this question on the Session Evaluation Form | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 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 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | 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. |
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| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) | 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. | | Posted | | Mean | Standard Deviation | years | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | 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. | | | Posted | | | | | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
| | | |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) | 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) | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) | 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) | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) | 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) | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) | 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. | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) | 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) | | Posted | | Mean | Standard Deviation | copies/ml | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) | 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?" | Participants providing ACASI data for these questions | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | On Prep | | | OG001 | Off Prep | Prematurely discontinued from the study agent |
| |
| Secondary | Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders | Total number of subjects who signed up for text message reminders | This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
| |
| Secondary | Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders | Number of subjects who discontinued receiving text message reminders while they were still on the study agent | Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | All Study Participants | Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study. |
| |
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group | |
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| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
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| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group | |
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| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
|
| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group | |
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| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
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| Secondary | 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) | 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?" | | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group | PCC Behavioral Intervention 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 |
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| Secondary | 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) | 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?" | Participants enrolled at Week 48 providing a response to this question. | Posted | | Count of Participants | | Participants | | 48 weeks | | | | ID | Title | Description |
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| OG000 | 3MV Behavioral Intervention Group | 3MV Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP 3MV: Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia. Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. | | OG001 | PCC Behavioral Intervention Group |
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