临床试验/NCT01033942

NCT01033942已完成2 期

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

University of North Carolina, Chapel Hill2 个研究点分布在 1 个国家目标入组 68 人开始时间: 2009年8月最近更新: 2017年4月17日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University of North Carolina, Chapel Hill
入组人数: 68
试验地点: 2
主要终点: Actual Number of Study Visits Completed by 24 Weeks

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 22 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•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).

排除标准

•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

研究组 & 干预措施

FTC/TDF as PrEP

Experimental

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

干预措施: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP (Drug)

FTC/TDF as PrEP

Experimental

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

干预措施: Many Men, Many Voices (3MV) (Behavioral)

Placebo Pill Control

Placebo Comparator

Blinded administration of placebo pill; HIV behavioral intervention

干预措施: Placebo (Drug)

Placebo Pill Control

Placebo Comparator

Blinded administration of placebo pill; HIV behavioral intervention

干预措施: Many Men, Many Voices (3MV) (Behavioral)

No Pill Control

Active Comparator

Subjects receive HIV behavioral intervention but no pill.

干预措施: Many Men, Many Voices (3MV) (Behavioral)

结局指标

主要结局

Actual Number of Study Visits Completed by 24 Weeks

时间窗: 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

时间窗: Week 24

Acceptability of the Taste of the Pill

时间窗: Week 24

Acceptability of Taking Part in the Study

时间窗: Week 24

Acceptability of Having an HIV Test at Every Visit

时间窗: Week 24

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

时间窗: 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

时间窗: Week 8

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

时间窗: Week 12

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

时间窗: Week 16

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

时间窗: Week 20

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

时间窗: Week 24

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

时间窗: 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

时间窗: 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

时间窗: Week 24

Acceptability of Participating in Group Sessions

时间窗: Week 24

Acceptability of Being Randomly Assigned to a Group

时间窗: Week 24

Acceptability of Taking the Pill Everyday

时间窗: Week 24

Acceptability of Risk Reduction Counseling at Every Visit

时间窗: Week 24

Acceptability of Questions About Sexual Behavior at Every Visit

时间窗: Week 24

Acceptability of Being Contacted by the Research Team in Between Visits

时间窗: Week 24

Acceptability of Physical Examination by a Doctor

时间窗: Week 24

Acceptability of Health Clinic for Study Visits

时间窗: Week 24

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

时间窗: Week 8

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

时间窗: Week 12

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

时间窗: Week 16

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

时间窗: Week 20

Number of Missed Doses Based on Medication Refill Dates-Overall

时间窗: 20 Weeks

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

时间窗: Baseline