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Completed

NCT Number: NCT01033942

Pre-Exposure Prophylaxis in YMSM

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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Key information

Conditions

HIV

Age range

18 year–22 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Childrens Memorial Hospital, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Actual Number of Study Visits Completed by 24 Weeks

    Time frame: 24 weeks

    This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time.

  2. Acceptability of Size of Pill

    Time frame: Week 24

  3. Acceptability of the Taste of the Pill

    Time frame: Week 24

  4. Acceptability of the Color of the Pill

    Time frame: Week 24

  5. Acceptability of Taking the Pill Everyday

    Time frame: Week 24

  6. Acceptability of Taking Part in the Study

    Time frame: Week 24

  7. Acceptability of Participating in Group Sessions

    Time frame: Week 24

  8. Acceptability of Being Randomly Assigned to a Group

    Time frame: Week 24

  9. Acceptability of Having an HIV Test at Every Visit

    Time frame: Week 24

  10. Acceptability of Risk Reduction Counseling at Every Visit

    Time frame: Week 24

  11. Acceptability of Questions About Sexual Behavior at Every Visit

    Time frame: Week 24

  12. Acceptability of Being Contacted by the Research Team in Between Visits

    Time frame: Week 24

  13. Acceptability of Physical Examination by a Doctor

    Time frame: Week 24

  14. Acceptability of Health Clinic for Study Visits

    Time frame: Week 24

  15. Number of Missed Doses Based on Self-Report Calendar Data-Week 4

    Time frame: 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.

  16. Number of Missed Doses Based on Self-Report Calendar Data-Week 8

    Time frame: 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.

  17. Number of Missed Doses Based on Self-Report Calendar Data-Week 12

    Time frame: 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.

  18. Number of Missed Doses Based on Self-Report Calendar Data-Week 16

    Time frame: 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.

  19. Number of Missed Doses Based on Self-Report Calendar Data-Week 20

    Time frame: 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.

  20. Number of Missed Doses Based on Self-Report Calendar Data-Week 24

    Time frame: 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.

  21. Number of Missed Doses Over Time Based on Self-Report Calendar Data

    Time frame: 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.

  22. Number of Missed Doses Based on Medication Refill Dates-Week 4

    Time frame: 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.

  23. Number of Missed Doses Based on Medication Refill Dates-Week 8

    Time frame: 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.

  24. Number of Missed Doses Based on Medication Refill Dates-Week 12

    Time frame: 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.

  25. Number of Missed Doses Based on Medication Refill Dates-Week 16

    Time frame: 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.

  26. Number of Missed Doses Based on Medication Refill Dates-Week 20

    Time frame: 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.

  27. Number of Missed Doses Based on Medication Refill Dates-Overall

    Time frame: 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.

  28. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline

    Time frame: 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.

  29. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4

    Time frame: 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.

  30. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8

    Time frame: 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.

  31. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12

    Time frame: 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.

  32. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16

    Time frame: 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.

  33. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20

    Time frame: 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.

  34. Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24

    Time frame: 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.

  35. Frequency of Missing Study Pills Because Participant Was Away From Home

    Time frame: 24 Weeks

  36. Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things

    Time frame: 24 Weeks

  37. Frequency of Missing Study Pills Because Participant Simply Forgot

    Time frame: 24 Weeks

  38. Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take

    Time frame: 24 weeks

  39. Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects

    Time frame: 24 weeks

  40. Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications

    Time frame: 24 weeks

  41. Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine

    Time frame: 24 weeks

  42. Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful

    Time frame: 24 weeks

  43. Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time

    Time frame: 24 weeks

  44. Frequency of Missing Study Pills Because Participant Felt Sick or Ill

    Time frame: 24 weeks

  45. Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed

    Time frame: 24 weeks

  46. Frequency of Missing Study Pills Because Participant Ran Out of Study Pills

    Time frame: 24 weeks

  47. Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex

    Time frame: 24 weeks

  48. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4

    Time frame: Week 4

  49. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8

    Time frame: Week 8

  50. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12

    Time frame: Week 12

  51. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16

    Time frame: Week 16

  52. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20

    Time frame: Week 20

  53. Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24

    Time frame: Week 24

  54. Perceived Risk of Becoming HIV Positive at Week 4

    Time frame: 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".

  55. Perceived Risk of Becoming HIV Positive at Week 8

    Time frame: 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".

  56. Perceived Risk of Becoming HIV Positive at Week 12

    Time frame: 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".

  57. Perceived Risk of Becoming HIV Positive at Week 16

    Time frame: 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".

  58. Perceived Risk of Becoming HIV Positive at Week 20

    Time frame: 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".

  59. Perceived Risk of Becoming HIV Positive at Week 24

    Time frame: 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".

  60. Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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".

  61. Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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".

  62. Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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".

  63. Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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".

  64. Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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".

  65. Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study

    Time frame: 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."

  66. Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  67. Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  68. Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  69. Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  70. Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  71. Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex

    Time frame: 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."

  72. Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  73. Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  74. Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  75. Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  76. Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  77. Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP

    Time frame: 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."

  78. Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  79. Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  80. Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  81. Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  82. Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  83. Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study

    Time frame: 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."

  84. Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

  85. Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

  86. Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

  87. Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

  88. Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

  89. Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study

    Time frame: 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."

Secondary outcomes

  1. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline

    Time frame: 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?

  2. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4

    Time frame: 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?

  3. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8

    Time frame: 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?

  4. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12

    Time frame: 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?

  5. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16

    Time frame: 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?

  6. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20

    Time frame: 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?

  7. Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2009
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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