A Self-Guided Intervention to Promote Condom Use Among African American Males
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Bell Flower Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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无干预:控制
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实验性的:Homework Intervention Strategy
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from baseline in number of unprotected sex events at 2 months
大体时间:30 days
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30 days
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Change from baseline in number of unprotected sex events at 4 months
大体时间:30 days
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30 days
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Change from baseline in number of unprotected sex events at 7 months
大体时间:30 days
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30 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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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
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30 days
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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
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30 days
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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
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30 days
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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
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30 days
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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
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30 days
|
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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
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30 days
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合作者和调查者
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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)
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