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A Self-Guided Intervention to Promote Condom Use Among African American Males

2018年9月16日 更新者:Stephanie Sanders、Indiana University

The Centers for Disease Control and Prevention has declared that AIDS is a "state of emergency" in the US for African Americans - young African American men are especially vulnerable in this epidemic. Thus, the development of effective interventions tailored to this population is a national priority. The investigators previous preliminary studies suggest that a brief, clinic-initiated, home-based, self-guided condom use program may effectively promote the acceptance of condom use and increase the quality and consistency of condom-protected sexual behaviors. This pilot study will (1) develop and test the feasibility of this program (Homework Intervention Strategy, HIS) for young African American men attending an urban STD clinic and (2) identify variables that may mediate the efficacy of the program. The HIS has the potential to be readily translated into widespread practice, while requiring only minimal resources. Unlike previously tested interventions, the HIS can be applied to all men who use condoms, regardless of the sex of their partners or their HIV/STI status. To develop the HIS to meet the needs of these high-risk men, the proposed study will include a formative phase during which the basic intervention "instructions" which will be delivered by DVD will be refined and tailored for this population.

One hundred young African American men recruited from an urban STD clinic will be randomized to each of two groups (HIS vs. "standard of care") in a randomized 2-arm trial with 5 assessment periods over the course of 6 months. Assessments will compare the groups on frequency of unprotected sex, quality of the condom use experience, experience of condom use errors and problems, attitudes regarding condom use, condom use acceptability, and condom use self-efficacy and confidence.

研究概览

研究类型

介入性

注册 (实际的)

193

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

    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Bell Flower Clinic

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 24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:

  • African American men
  • 15 to 24 years of age
  • able to read, write and comprehend English
  • have engaged penile-vaginal intercourse (PVI) or insertive penile-anal intercourse (PAI) with a partner at least once in the past 30 days
  • willing to use a condom
  • does not intend to get a partner pregnant in the next 6 months
  • consent to participate in the study
  • client of the Bell Flower Clinic in Indianapolis, IN in the past 12 months
  • has maintained a cell-phone number for the past three months and is willing to use it for data collection and incur fees for voice communication or text messaging it they do not have unlimited plans

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
无干预:控制
实验性的:Homework Intervention Strategy
Participants assigned to intervention will receive a condom "ditty bag" containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change from baseline in number of unprotected sex events at 2 months
大体时间:30 days
30 days
Change from baseline in number of unprotected sex events at 4 months
大体时间:30 days
30 days
Change from baseline in number of unprotected sex events at 7 months
大体时间:30 days
30 days

次要结果测量

结果测量
大体时间
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 2 months.
大体时间:30 days
30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 4 months.
大体时间:30 days
30 days
Change from baseline in condom use errors/problems score as measured by the Condom Use Errors/Problems Survey (CUES) at 7 months.
大体时间:30 days
30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 2 months.
大体时间:30 days
30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale (CCUSES) at 4 months.
大体时间:30 days
30 days
Change from baseline in self-efficacy for correct condom use score as measured by the Correct Condom Use Self-Efficacy Scale(CCUSES) at 7 months.
大体时间:30 days
30 days

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:Stephanie A Sanders, Ph.D.、Indiana University
  • 首席研究员:William L Yarber, Ph.D.、Indiana University

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

2012年1月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2011年7月20日

首先提交符合 QC 标准的

2012年2月21日

首次发布 (估计)

2012年2月22日

研究记录更新

最后更新发布 (实际的)

2018年9月18日

上次提交的符合 QC 标准的更新

2018年9月16日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 5R21MH090892-02 (美国 NIH 拨款/合同)

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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