Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men
2020年3月10日 更新者:ViiV Healthcare
A Cohort Study to Determine the Incidence of HIV-1 Infection in HIV-1 Uninfected High Risk Participants Who Are Male Sex at Birth and Have Sex With Men
Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates.
The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence.
This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection.
Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort.
This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment.
It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
578
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100015
- GSK Investigational Site
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Beijing、中国、100069
- GSK Investigational Site
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Changsha、中国、410005
- GSK Investigational Site
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Shanghai、中国、201508
- GSK Investigational Site
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Shenzhen、中国、518020
- GSK Investigational Site
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Guangdong
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Guangzhou、Guangdong、中国、510060
- GSK Investigational Site
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Liaoning
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Shenyang、Liaoning、中国、110001
- GSK Investigational Site
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Sichuan
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Chengdu、Sichuan、中国、610066
- GSK Investigational Site
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This prospective cohort study will involve population of HIV-1 uninfected Chinese MSM and TGW who are at high-risk of HIV infection.
描述
Inclusion Criteria:
- Subjects are Chinese MSM and/or TGW and must be 18 years or older at the time of screening.
Subjects of male sex at birth and who have sex with men, who in the 6 months prior to screening report one or more of the following risk criteria:
- Unprotected (condomless) receptive anal intercourse with one or more partners.
- More than five partners in the 6 months prior to enrolment (regardless of condom use and HIV serostatus, as reported by the enrolee).
- Reported STI with syphilis, gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.
Subjects in a monogamous relationship with an HIV-1 seronegative partner or a virologically-suppressed HIV-1 + partner for >1 year are not eligible for participation.
- Males, agree to appropriate use of contraceptive measures during heterosexual intercourse.
- Subjects who have non reactive fourth generation HIV test and undetectable HIV-1 RNA at screening.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Subjects with known moderate to severe hepatic impairment as per liver function test criteria outlined below.
- Subject who, in the investigator's judgment, poses a significant suicide risk.
- The Subject has a tattoo or other dermatological condition overlying the gluteus region.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease.
- Use of PrEP or post exposure prophylaxis (PEP) within the last 30 days prior to screening.
- Current use or anticipated need for use high dose aspirin or other anticoagulants including antiplatelet medications that would interfere with the ability to receive intramuscular (IM) injections.
- Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the screening.
- Anti-tuberculosis therapy.
- Alcohol use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- Active injection drug use that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- Any medical condition, including psychiatric conditions, that in the judgment of the investigator would interfere with the subject's ability to complete study procedures.
- A reactive HIV test at screening.
- A positive Hepatitis B surface antigen.
- A positive Hepatitis C antibody with an HCV viral ribose nucleic acid (RNA) above the lower limit of detection.
Any of the following laboratory values at screening:
- Hemoglobin (Hgb) <11 gram per deciliter (g/dL).
- Absolute neutrophil count <750 cells per cubic millimeter (cells/mm^3).
- Platelet count <100,000 cells/mm^3.
- Presence of a coagulopathy defined by an international normalized ratio (INR)>1.5 or a partial thromboplastin time (PTT)>45 seconds.
- Creatinine clearance <60 milliliter per minute (mL/min) using the Cockroft-Gault equation.
- Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN).
- Direct Bilirubin >2.0 milligram per deciliter (mg/dL).
- Co-enrolment in any other HIV interventional studies.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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HIV-1 uninfected high risk subjects
The study will involve HIV-1 uninfected high risk MSM and TGW subjects.
They will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
Visits will include Baseline screening for HIV followed by screenings at Day 1, Weeks 5, 9, and 8 week intervals thereafter until study conclusion.
Screening for other STIs will occur at Baseline, Week 9, and every 16 weeks thereafter.
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Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded.
Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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HIV-1 seroincidence rate in a cohort of high-risk MSM and TGW
大体时间:Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
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Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits.
Confirmatory HIV serology test will be performed at seroconversion visit.
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Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
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HIV-1 seroincidence rate in a cohort of high-risk TGW
大体时间:Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
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Incidence of HIV-1 infection in subject's post-study entry will be assessed by determining number of subjects who become infected with HIV-1 post-screening and after study entry including Day 1 and subsequent observation visits.
Confirmatory HIV serology test will be performed at seroconversion visit.
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Baseline, Day 1, Weeks 5, 9, and every 8 week intervals thereafter until study completion, an average of 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of subjects diagnosed with gonorrhea, chlamydia, and syphilis post screening
大体时间:Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
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Infections like gonorrhea, chlamydia, and syphilis will be assessed by toluidine red unheated serum test (TRUST) for syphilis and STI testing.
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Day 1, Week 9, and every 16 weeks interval thereafter until study completion, an average of 12 months
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Number of subjects with demographic factors
大体时间:Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
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Demographic factors associated with HIV seroconversion and STI acquisition will be assessed by computer-assisted self-interview (CASI).
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Day 1, Week 9, and every 8 weeks interval thereafter until study completion, an average of 12 months
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Number of subjects enrolled and retained in to the study
大体时间:Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
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Measures will be utilized to effectively engage and retain the subjects in the study.
Retention strategies to be studied may include community engagement, interpersonal relationship building and reduction of external barriers.
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Day 1, Weeks 5, 9, and every 8 or 16 weeks interval thereafter until study completion, an average of 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月31日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2017年9月21日
首先提交符合 QC 标准的
2017年10月9日
首次发布 (实际的)
2017年10月16日
研究记录更新
最后更新发布 (实际的)
2020年3月12日
上次提交的符合 QC 标准的更新
2020年3月10日
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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