Pre-Exposure Prophylaxis in YMSM

Phase 2

Completed

• Conditions: HIV
• Interventions: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Drug: Placebo; Behavioral: Many Men, Many Voices (3MV)

• Registration Number: NCT01033942
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2014-10-28
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-08
• Results First Posted: 2017-03-29
• Last Update Submitted: 2017-04-14
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

Inclusion Criteria

• Willing and able to independently provide written informed consent;
• Of male gender at birth;
• Between the ages of 18 years and 0 days through 22 years and 364 days at the time of signed informed consent;
• Self-reporting at least one episode of unprotected anal intercourse with a male within the last 12 months at the time of Personal Digital Assistant (PDA) Screening Interview;
• Tests HIV negative at time of screening (using any FDA-approved HIV diagnostic test);
• Willing to provide locator information to study staff;
• Willing to be assigned to any of the three biomedical intervention conditions;
• Does not report intention to relocate out of the study area during the course of the study; and
• Does not have job/other obligations that would require long absences from the area (> 4 weeks at a time).

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Exclusion Criteria

• Transgender (behavioral intervention not targeted toward this population);
• Presence of serious psychiatric symptoms (e.g., active hallucinations);
• Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior);
• Intoxicated or under the influence of alcohol or other drugs at the time of consent;
• Acute or chronic hepatitis B infection (exclude if hepatitis B surface antigen positive);
• Renal dysfunction (Creatinine Clearance < 75 ml/min); Use Cockcroft-Gault equation: Glomerular Filtration Rate (GFR) = (140-Age in years) x (Weight in kg) / (72 x serum creatinine) for males
• Any history of bone fractures not explained by trauma;
• Confirmed proteinuria (repeated positive [> 2+] urine dipstick), unless explained by orthostatic proteinuria;
• Confirmed glucosuria (repeated positive [> 1+] urine dipstick) in the presence of normal blood glucose (<120 mg/dL);
• Any Grade 3 toxicity on screening tests/assessments;
• Concurrent participation in an HIV vaccine study or other investigational drug study; or
• Known allergy/sensitivity to the study drug or its components.
• Use of disallowed medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FTC/TDF as PrEP	coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP	Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
FTC/TDF as PrEP	Many Men, Many Voices (3MV)	Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Placebo Pill Control	Placebo	Blinded administration of placebo pill; HIV behavioral intervention
Placebo Pill Control	Many Men, Many Voices (3MV)	Blinded administration of placebo pill; HIV behavioral intervention
No Pill Control	Many Men, Many Voices (3MV)	Subjects receive HIV behavioral intervention but no pill.

Primary Outcome Measures

Name	Time	Method
Actual Number of Study Visits Completed by 24 Weeks	24 weeks	This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.
Acceptability of Size of Pill	Week 24
Acceptability of the Taste of the Pill	Week 24
Acceptability of Taking Part in the Study	Week 24
Acceptability of Having an HIV Test at Every Visit	Week 24
Number of Missed Doses Based on Self-Report Calendar Data-Week 4	4 weeks	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.
Number of Missed Doses Based on Self-Report Calendar Data-Week 8	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.
Number of Missed Doses Based on Self-Report Calendar Data-Week 12	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.
Number of Missed Doses Based on Self-Report Calendar Data-Week 16	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.
Number of Missed Doses Based on Self-Report Calendar Data-Week 20	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.
Acceptability of Participating in Group Sessions	Week 24
Acceptability of Being Randomly Assigned to a Group	Week 24
Number of Missed Doses Based on Self-Report Calendar Data-Week 24	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.
Number of Missed Doses Over Time Based on Self-Report Calendar Data	24 weeks	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.
Number of Missed Doses Based on Medication Refill Dates-Week 4	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.
Acceptability of the Color of the Pill	Week 24
Frequency of Missing Study Pills Because Participant Was Away From Home	24 Weeks
Acceptability of Taking the Pill Everyday	Week 24
Acceptability of Risk Reduction Counseling at Every Visit	Week 24
Acceptability of Questions About Sexual Behavior at Every Visit	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
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
Number of Missed Doses Based on Medication Refill Dates-Week 8	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.
Number of Missed Doses Based on Medication Refill Dates-Week 12	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.
Number of Missed Doses Based on Medication Refill Dates-Week 16	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.
Number of Missed Doses Based on Medication Refill Dates-Week 20	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.
Number of Missed Doses Based on Medication Refill Dates-Overall	20 Weeks	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20	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.
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24	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.
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 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	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".
Perceived Risk of Becoming HIV Positive at Week 12	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".
Perceived Risk of Becoming HIV Positive at Week 16	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".
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16	Week 16
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 20	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".
Perceived Risk of Becoming HIV Positive at Week 8	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".
Perceived Risk of Becoming HIV Positive at Week 20	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".
Perceived Risk of Becoming HIV Positive at Week 24	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".
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 4	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".
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 8	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".
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 12	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".
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 16	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".
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study	Week 24	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."
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 20	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."
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 24	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."
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 4	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."
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 8	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."
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 12	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."
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 16	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."
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 20	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."
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study	Week 24	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."
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 4	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."
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 8	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."
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 12	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."
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 16	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."
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 20	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."
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex	Week 24	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."
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 4	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."
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 8	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."
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 12	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."
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 16	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."
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 20	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."
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP	Week 24	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."
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 4	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."
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 8	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."
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 12	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."
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study	Week 16	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."

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24	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?
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline	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?

Trial Locations

Locations (2)

Childrens Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital; 🇺🇸 Chicago, Illinois, United States