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HIV Prevention Program for African American Teen Males

2017年7月11日 更新者:Richard Crosby

A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males

The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.

研究概览

详细说明

Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a "health crisis" for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males).

The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.

研究类型

介入性

注册 (预期的)

840

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

    • Louisiana
      • New Orleans、Louisiana、美国、70118
        • Adolescent Medicine Program, LSU School of Medicine

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

15年 至 23年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • at least 15, but not more than 23 years of age
  • attending the clinic for the expressed purpose of being tested for sexually transmitted infections
  • engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months
  • willingness to return for the two planned follow-up assessments

Exclusion Criteria:

  • self-report of being HIV positive

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:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Male Sexual Health Program
An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size "fits all" condoms) and a brief (nurse-delivered) counseling message to practice safer sex.
实验性的:Focus on the Future Program
A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Incidence rate of laboratory-confirmed STIs
大体时间:2- and 6-month follow-up, as well as 12-month follow-up medical records review
2- and 6-month follow-up, as well as 12-month follow-up medical records review
Self-report of unprotected penetrative sex (past 30 days)
大体时间:2- and 6-month follow-up
2- and 6-month follow-up
Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days)
大体时间:2 and 6-month follow-up
2 and 6-month follow-up
Self-report of negative experiences with the correct use of condoms (past 30 days)
大体时间:2- and 6-month follow-up
2- and 6-month follow-up

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。

调查人员

  • 首席研究员:Ryan Pasternak, MD, MPH、Louisiana State University Health Sciences Center in New Orleans

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2009年2月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2013年9月1日

研究注册日期

首次提交

2009年2月23日

首先提交符合 QC 标准的

2009年2月23日

首次发布 (估计)

2009年2月24日

研究记录更新

最后更新发布 (实际的)

2017年7月14日

上次提交的符合 QC 标准的更新

2017年7月11日

最后验证

2017年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 080666
  • NIH Grant # 1R01MH083621

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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