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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTC/TDF as PrEP | Experimental | Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention |
|
| Placebo Pill Control | Placebo Comparator | Blinded administration of placebo pill; HIV behavioral intervention |
|
| No Pill Control | Active Comparator | Subjects receive HIV behavioral intervention but no pill. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP | Drug | Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Actual Number of Study Visits Completed by 24 Weeks | This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. | 24 weeks |
| Acceptability of Size of Pill | Week 24 | |
| Acceptability of the Taste of the Pill | Week 24 | |
| Acceptability of the Color of the Pill | Week 24 | |
| Acceptability of Taking the Pill Everyday | Week 24 | |
| Acceptability of Taking Part in the Study | Week 24 | |
| Acceptability of Participating in Group Sessions | Week 24 | |
| Acceptability of Being Randomly Assigned to a Group | Week 24 | |
| Acceptability of Having an HIV Test at Every Visit | Week 24 | |
| Acceptability of Risk Reduction Counseling at Every Visit | Week 24 | |
| Acceptability of Questions About Sexual Behavior at Every Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sybil Hosek, PhD | Adolescent Trials Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital | Chicago | Illinois | 60612 | United States | ||
| Childrens Memorial Hospital |
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| Label | URL |
|---|---|
| Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Website | View source |
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Young males were approached for screening in the community. If eligible, a clinic-based screening was done to confirm eligibility. If confirmed, participants attended a behavioral intervention. Then a week 0 was scheduled for randomization. 68 participants were enrolled; 10 discontinued prior to randomization, for a total of 58 participants.
This research was conducted at two clinical sites in Chicago. Accrual was open between August 2009 and May 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | FTC/TDF as PrEP | Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| FG001 | Placebo Pill Control | Blinded administration of placebo pill; HIV behavioral intervention Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| FG002 | No Pill Control | Subjects receive HIV behavioral intervention but no pill. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | FTC/TDF as PrEP | Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Actual Number of Study Visits Completed by 24 Weeks | This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. | Posted | Least Squares Mean | Standard Error | Visits | 24 weeks |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FTC/TDC | Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Bilirubin Increased | Investigations | Systematic Assessment | Grade 3 |
After release of Pre-exposure Prophylaxis Initiative efficacy results, the Data and Safety Monitoring Board recommended that subjects be unblinded, enrollment stopped, all be offered option of PrEP, subjects on PrEP arm continued as scheduled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bob Harris | Westat | 301-251-1500 | bobharris@westat.com |
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| ID | Term |
|---|---|
| C075889 | Racivir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Placebo | Drug | Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. |
|
| Many Men, Many Voices (3MV) | Behavioral | Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
|
| Week 24 |
| Acceptability of Being Contacted by the Research Team in Between Visits | Week 24 |
| Acceptability of Physical Examination by a Doctor | Week 24 |
| Acceptability of Health Clinic for Study Visits | Week 24 |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 4 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | 4 weeks |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 8 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 8 |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 12 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 12 |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 16 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 16 |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 20 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 20 |
| Number of Missed Doses Based on Self-Report Calendar Data-Week 24 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 24 |
| Number of Missed Doses Over Time Based on Self-Report Calendar Data | The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. | 24 weeks |
| Number of Missed Doses Based on Medication Refill Dates-Week 4 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 4 |
| Number of Missed Doses Based on Medication Refill Dates-Week 8 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 8 |
| Number of Missed Doses Based on Medication Refill Dates-Week 12 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 12 |
| Number of Missed Doses Based on Medication Refill Dates-Week 16 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 16 |
| Number of Missed Doses Based on Medication Refill Dates-Week 20 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Week 20 |
| Number of Missed Doses Based on Medication Refill Dates-Overall | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | 20 Weeks |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Baseline |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 4 |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 8 |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 12 |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 16 |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 20 |
| Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Week 24 |
| Frequency of Missing Study Pills Because Participant Was Away From Home | 24 Weeks |
| Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | 24 Weeks |
| Frequency of Missing Study Pills Because Participant Simply Forgot | 24 Weeks |
| Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | 24 weeks |
| Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | 24 weeks |
| Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | 24 weeks |
| Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | 24 weeks |
| Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | 24 weeks |
| Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | 24 weeks |
| Frequency of Missing Study Pills Because Participant Felt Sick or Ill | 24 weeks |
| Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | 24 weeks |
| Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | 24 weeks |
| Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | 24 weeks |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Week 4 |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Week 8 |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Week 12 |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Week 16 |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Week 20 |
| Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Week 24 |
| Perceived Risk of Becoming HIV Positive at Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 4 |
| Perceived Risk of Becoming HIV Positive at Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 8 |
| Perceived Risk of Becoming HIV Positive at Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 12 |
| Perceived Risk of Becoming HIV Positive at Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 16 |
| Perceived Risk of Becoming HIV Positive at Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 20 |
| Perceived Risk of Becoming HIV Positive at Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Week 24 |
| Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Week 4 |
| Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Week 8 |
| Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Week 12 |
| Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Week 16 |
| Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Week 20 |
| Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study." | Week 24 |
| Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 4 |
| Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 8 |
| Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 12 |
| Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 16 |
| Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 20 |
| Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Week 24 |
| Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 4 |
| Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 8 |
| Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 12 |
| Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 16 |
| Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 20 |
| Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Week 24 |
| Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 4 |
| Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 8 |
| Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 12 |
| Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 16 |
| Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 20 |
| Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Week 24 |
| Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Week 4 |
| Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Week 8 |
| Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been on this study." | Week 12 |
| Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Week 16 |
| Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Week 20 |
| Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Week 24 |
| Baseline |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 4 |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 8 |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 12 |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 16 |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 20 |
| Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Week 24 |
| Chicago |
| Illinois |
| 60614 |
| United States |
| Enrolled in Extension Study |
|
| BG001 | Placebo Pill Control | Blinded administration of placebo pill; HIV behavioral intervention Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| BG002 | No Pill Control | Subjects receive HIV behavioral intervention but no pill. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Not all participants answered every question. | Number | participants |
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| Current Employment | Number | participants |
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| Housing Experience (Responded YES) | Not all participants answered every question | Number | participants |
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| Unprotected Anal Sex with Man in Past 30 Days | Number | participants |
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| Unprotected Anal or Vaginal Sex with Woman | Number | participants |
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Blinded administration of placebo pill; HIV behavioral intervention Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
| OG002 | No Pill Control | Subjects receive HIV behavioral intervention but no pill. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Posted | Number | participants | Baseline |
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| Primary | Acceptability of Size of Pill | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | Participants | Week 24 |
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| Primary | Acceptability of the Taste of the Pill | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of the Color of the Pill | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Taking the Pill Everyday | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Taking Part in the Study | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Participating in Group Sessions | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Being Randomly Assigned to a Group | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Having an HIV Test at Every Visit | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Risk Reduction Counseling at Every Visit | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Questions About Sexual Behavior at Every Visit | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Being Contacted by the Research Team in Between Visits | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Physical Examination by a Doctor | Not all participants answered every question and therefore the number of responses in the outcome measure data table does not match the number of participants analyzed. | Posted | Number | participants | Week 24 |
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| Primary | Acceptability of Health Clinic for Study Visits | Not all participants answered every question. | Posted | Number | participants | Week 24 |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 4 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | 4 weeks |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 8 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | Week 8 |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 12 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | Week 12 |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 16 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | Week 16 |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 20 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | Week 20 |
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| Primary | Number of Missed Doses Based on Self-Report Calendar Data-Week 24 | Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed Doses | Week 24 |
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| Primary | Number of Missed Doses Over Time Based on Self-Report Calendar Data | The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. | Posted | Least Squares Mean | Standard Error | Doses | 24 weeks |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Week 4 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | Week 4 |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Week 8 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | Week 8 |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Week 12 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | Week 12 |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Week 16 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | Week 16 |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Week 20 | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | Week 20 |
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| Primary | Number of Missed Doses Based on Medication Refill Dates-Overall | Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. | Posted | Median | Full Range | Missed doses | 20 Weeks |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at baseline. All subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at baseline. | Posted | Number | percentage of participants | Baseline |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | Only two subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 4. 19 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 4. | Posted | Number | percentage of participants | Week 4 |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | 18 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 8. 17 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 17 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 8. | Posted | Number | percentage of participants | Week 8 |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 12. 15 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 1 subject in the No Pill arm had tenofovir plasma concentration testing at Week 12. | Posted | Number | percentage of participants | Week 12 |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | 13 subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 16. 13 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and 14 subjects in the No Pill arm had tenofovir plasma concentration testing at Week 16. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | One subject in the Placebo Pill Control arm was randomly selected for tenofovir plasma concentration testing at Week 20. 12 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 20. | Posted | Number | percentage of participants | Week 20 |
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| Primary | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 | Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. | No subjects in the Placebo Pill Control arm were randomly selected for tenofovir plasma concentration testing at Week 24. 10 subjects in the FTC/TDF as PrEP arm had tenofovir plasma concentration testing and no subjects in the No Pill arm had tenofovir plasma concentration testing at Week 24. | Posted | Number | percentage of participants | Week 24 |
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| Primary | Frequency of Missing Study Pills Because Participant Was Away From Home | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 Weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 Weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Simply Forgot | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 Weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Felt Sick or Ill | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex | Participants in the No Pill Control arm were not included in the analysis. Analysis measure type is the percentage of participants in each frequency category for missed dose reason. | Posted | Number | % of participants in each category | 24 weeks |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 | Not all participants answered every question | Posted | Number | participants | Week 4 |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 | Not all participants answered every question | Posted | Number | participants | Week 8 |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 | Not all participants answered every question | Posted | Number | participants | Week 12 |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 | Not all participants answered every question | Posted | Number | participants | Week 16 |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 | Not all participants answered every question | Posted | Number | participants | Week 20 |
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| Primary | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 | Not all participants answered every question | Posted | Number | participants | Week 24 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 4 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 8 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 12 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 16 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of partcipants | Week 16 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 20 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived Risk of Becoming HIV Positive at Week 24 | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "Because I am in this PrEP study, I am less concerned about becoming HIV positive". | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Primary | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Not all participants answered every question | Posted | Number | percentage of participants | Week 16 |
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| Primary | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study". | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am more willing to take a chance of getting infected now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Primary | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 16 |
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| Primary | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Primary | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 16 |
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| Primary | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "The availability of PrEP makes me less worried about having unprotected sex." | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Primary | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 16 |
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| Primary | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I am less concerned about having unprotected anal sex now that I am in this PrEP study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Primary | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 4 |
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| Primary | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 8 |
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| Primary | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been on this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 12 |
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| Primary | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 16 |
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| Primary | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 20 |
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| Primary | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study | Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: "I have already risked getting infected with HIV through unsafe sex while I've been in this study." | Not all participants answered every question | Posted | Number | percentage of participants | Week 24 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question | Posted | Number | participants | Week 4 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question | Posted | Number | participants | Week 8 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question. | Posted | Number | participants | Week 12 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question. | Posted | Number | participants | Week 16 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question | Posted | Number | participants | Week 20 |
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| Secondary | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 | A high-risk sex act was defined as an answer of greater than 0 to any of the following questions: With your male HIV positive male partners during the past month: How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? | Not all participants answered every question | Posted | Number | participants | Week 24 |
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| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Placebo | Blinded administration of placebo pill; HIV behavioral intervention Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. | 0 | 19 | 1 | 19 |
| EG002 | No Pill Control | Subjects receive HIV behavioral intervention but no pill. Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. | 0 | 19 | 0 | 19 |
| Protein Urine Present | Investigations | Systematic Assessment | Grade 2 |
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| Creatinine Renal Clearance Decreased | Investigations | Systematic Assessment | Grade 3 |
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| Migraine | Nervous system disorders | Systematic Assessment | Grade 3 |
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| Suicidal Ideation | Psychiatric disorders | Systematic Assessment | Grade 4 |
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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.
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Agree |
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| Neutral |
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| Agree |
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| Strongly Agree |
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