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Comprehensive HIV Prevention Package for MSM in Port Elizabeth

2017年7月4日 更新者：Patrick S Sullivan、Emory University
The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in Africa. Experience implementing the prevention interventions and preliminary data collected regarding the acceptability of the HIV prevention package will be used to develop a proposal to design a larger efficacy trial to test the combination HIV prevention package for MSM.

研究类型

介入性

注册 (实际的)

101

阶段

  • 不适用

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

  • 南非
      • Port Elizabeth、南非
        • Human Sciences Research Council

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

男性

描述

Inclusion Criteria:

  • Male sex at birth
  • Anal sex with another man in the past 12 months
  • 18 years of age or older
  • Resident of the study city, Port Elizabeth
  • Able to complete study instruments, with or without assistance, in English, Xhosa or Afrikaans
  • Willing to provide contact information
  • Has a phone

Exclusion Criteria:

  • Not male sex at birth
  • No self-reported anal sex with a man in the past 12 months
  • Less than 18 years of age
  • Not a resident of the study city
  • Plans to move from the study city within the year after enrollment
  • Not able to complete study instructions, with or without assistance, in English, Xhosa or Afrikaans
  • Not willing to provide contact information
  • Does not have a phone

Additional Inclusion and Exclusion Criteria for participants on PrEP:

PrEP Inclusion Criteria:

  • Identified as high-risk for HIV by the provider by meeting one or more of the criteria below:
  • Have multiple partners
  • Engage in transactional sex, including sex workers
  • Use or abuse drugs
  • Drink alcohol heavily
  • Had more than 1 episode of a STI in the last year
  • Is the HIV-negative partner in a discordant relationship, especially if the HIV-positive partner is not on antiretroviral therapy (ART)
  • Is in a non-monogamous concordant relationship with a HIV-negative partner
  • Is unable or unwilling to achieve consistent use of male condoms
  • No contra-indications to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
  • Calculated creatinine clearance of at least 60 mL/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x upper limit of normal (ULN)
  • Hepatitis B surface antigen (HBsAg) negative
  • Motivated to follow PrEP prescribing guidelines
  • Willing to adhere to daily oral dosing
  • Willing to attend PrEP maintenance visits every 3 months

PrEP Exclusion Criteria:

  • HIV positive
  • Signs or symptoms suggestive of acute HIV infection
  • Have baseline creatinine clearance <60 ml/min
  • Are unwilling to follow PrEP prescribing guidelines
  • Are unwilling to attend PrEP maintenance visits every 3 months
  • Are known to have hypertensives or diabetes
  • Are hepatitis B susceptible (test HBsAg and HBsAb negative) and refuse to take a hepatitis B vaccine series
  • Any contraindication to taking FTC/TDF
  • Proteinuria 2+ or greater at screening
  • Glucosuria 2+ or greater at screening
  • Use of antiretroviral (ARV) therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry

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

  • 主要用途：预防
  • 分配：非随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：HIV+ subjects
Men who test positive for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, risk-reduction counseling, couples HIV counseling and testing, and linkage to care
行为的：安全套的选择
男性将在他们的基线访问时收到包括各种样式、尺寸、特征和颜色的安全套包装，并且可以在访问后的任何时间通过在门诊时间到研究诊所免费获得更多安全套，或者在预定的学习访问期间。
行为的：安全套兼容的润滑剂选择
男性将在基线研究访视时获得安全套兼容的润滑剂，其中包括不同类型的润滑剂（例如硅基润滑剂）和不同的包装（独立小袋或扁平、谨慎的包装），并且参与者将能够获得增强的安全套兼容在访问后的任何时间通过在门诊时间或预定的研究访问期间到研究诊所使用润滑剂。
行为的：夫妻 HIV 咨询和检测 (CVCT)
参与者将被邀请在他们完成基线研究访问后的任何时间安排与诊所顾问的夫妇自愿 HIV 咨询和检测 (CVCT) 预约。
其他：Linkage to care
Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.
行为的：Risk-reduction counseling
Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
实验性的：HIV- subjects

Men who test negative for HIV will receive a comprehensive package of HIV prevention services, including condom choices, condom-compatible lubricant choices, enhanced HIV testing options, risk-reduction counseling, couples HIV counseling and testing, linkage to care, and screening for and offering of pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

If men test positive for HIV during the study, they will be transitioned into the HIV+ subjects arm.
行为的：安全套的选择
男性将在他们的基线访问时收到包括各种样式、尺寸、特征和颜色的安全套包装，并且可以在访问后的任何时间通过在门诊时间到研究诊所免费获得更多安全套，或者在预定的学习访问期间。
行为的：安全套兼容的润滑剂选择
男性将在基线研究访视时获得安全套兼容的润滑剂，其中包括不同类型的润滑剂（例如硅基润滑剂）和不同的包装（独立小袋或扁平、谨慎的包装），并且参与者将能够获得增强的安全套兼容在访问后的任何时间通过在门诊时间或预定的研究访问期间到研究诊所使用润滑剂。
行为的：夫妻 HIV 咨询和检测 (CVCT)
参与者将被邀请在他们完成基线研究访问后的任何时间安排与诊所顾问的夫妇自愿 HIV 咨询和检测 (CVCT) 预约。
其他：Linkage to care
Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.
行为的：Risk-reduction counseling
Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
药品：Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF).

For men who meet eligibility criteria, Pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit.

其他名称：
  • 特鲁瓦达
其他：HIV Testing
Rapid HIV testing at multiple time points
程序：Post-exposure prophylaxis (PEP)
Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days.

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
Retention in the cohort
大体时间：12 months
Will assess the ability of the study to retain participants for full study period. This will be measured by the proportion of enrolled participants who attend all subsequent study visits through the 12-month visit.
12 months
Use of PrEP
大体时间：6 months
Will assess uptake of PrEP by study participants. This will be measured as the proportion of enrolled participants eligible for PrEP at the 3 and 6-month study visits who choose to initiate PrEP at those visits.
6 months
Incident HIV infection
大体时间：12 months
This will be measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.
12 months

次要结果测量

结果测量
措施说明
大体时间
Condom use
大体时间：3 months
Measured as the proportion of anal intercourse that is protected by condoms in the prior 3 months as self-reported reported in the questionnaire at each study visit.
3 months
Lubricant use
大体时间：3 months
Measured as the proportion of condom-protected anal intercourse in the prior for 3 months for which condom-compatible lubricant is used as self-reported in the questionnaire at each study visit.
3 months
VCT and CVCT uptake
大体时间：12 months
Measured as the number of times participants report HIV testing in the study period as part of the study visits and outside study visits compared to the number of time participants reported HIV testing in the year prior at baseline.
12 months
Serodiscordant unprotected anal intercourse (UAI)
大体时间：3 months
Measured as self-reported UAI in the last 3 months with a partner of positive or unknown HIV status as self-reported in the questionnaire at each study visit, pre- and post-intervention.
3 months
Acceptability of PEP
大体时间：12 months
Measured as the proportion of men who report an eligible exposure who accept and initiate PEP.
12 months
MSM-specific provider training
大体时间：12 months
Measured as the proportion of providers who are offered training who accept the training.
12 months

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。

赞助

Emory University

调查人员

  • 首席研究员：Stefan Baral, MD, MPH, CCFP、Johns Hopkins Bloomberg School of Public Health
  • 首席研究员：Nancy Phaswanamafuya, PhD、Human Sciences Research Council

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)

2015年5月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2017年3月1日

研究注册日期

首次提交

2015年5月18日

首先提交符合 QC 标准的

2015年5月18日

首次发布 (估计)

2015年5月20日

研究记录更新

最后更新发布 (实际的)

2017年7月6日

上次提交的符合 QC 标准的更新

2017年7月4日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00079727

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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