NCT01808352已完成4 期
Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence Among Black Men Who Have Sex With Men (BMSM) in Three U.S. Cities
HIV Prevention Trials Network3 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2013年8月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 3
- 主要终点
- Initiation of PrEP
研究概览
简要总结
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
详细描述
An open label demonstration study with PrEP and Client Centered Care Coordination (C4) to assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM) in three US Cities. A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. The study will recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will include those aged 18 and over with an effort to recruit an equal number of BMSM under age 25 and over age 25 with a total of 225 participants (75 per site).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMSM who meet all of the following criteria are eligible for inclusion in this study:
- •18 years of age or older
- •No prior HIV diagnosis (self-report)
- •Male at birth
- •High risk for acquiring HIV infection including any one of the following in the previous 6 months:
- •Unprotected sex during receptive or insertive anal intercourse with a male partner
- •Any protected or unprotected:
- •i. Receptive or insertive anal intercourse with more than three male sex partners ii. Exchange of money, gifts, shelter or drugs for receptive or insertive anal sex with a male partner iii. Receptive or insertive anal sex while under the influence of drugs or alcohol (i.e., high or drunk within two hours of the sex act) according to self-report"
- •STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report
- •Willing to provide locator information in accordance with the Study Specific Procedures (SSP) Manual
- •Urine dipstick negative or trace for protein and glucose
- •Hemoglobin > 11 g/dL, absolute neutrophil count > 750 cells/mm3, and platelet count ≥ 100,000/mm3
- •Serum creatinine < upper limit of normal (ULN) and calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula where:
- •o eCcr in mL/min = [(140 - age in years) x (actual body weight in kg)] / (72 x serum creatinine in mg/dL) Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) < 3 times the upper limit of normal (ULN)
- •Total bilirubin < 2.5 ULN
- •Hepatitis B surface antigen (HBsAg) negative
排除标准
- •BMSM who meet any of the following criteria will be excluded from this study:
- •Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
- •Transgender
- •Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb testing)
- •Planning to move out of the area or to travel for more than 3 months during the study follow-up period
- •Unwilling to adhere to study procedures
- •Current participation in any research study via self-report (however, strictly non-HIV centered observational studies are not exclusionary)
- •Previous participation in an HIV vaccine study is exclusionary unless documented evidence of enrollment into a placebo arm
- •Use of ARV drugs (PrEP or PEP) in the last 60 days
- •Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report, or obtained from medical history or records)
- •Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid) - (provided by self-report, or obtained from medical history or medical records)
- •Any condition, that in the opinion of study staff, would make participation in the study unsafe, or interfere with achieving the study objective
结局指标
主要结局
Initiation of PrEP
时间窗: 30 months
Documented in either study CRFs or ACASI
Adherence to PrEP
时间窗: 30 months
Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration
次要结局
- Adverse events(30 months)
- STIs(30 months)
- Incident HIV-seroconversions/characteristics(30 months)
- Changes in sexual risk-taking behavior(30 months)
- Initiate or decline PrEP(30 months)
- Participant perception of care and referral plan(30 months)
研究者
研究点 (3)
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