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Development of a Novel HIV Risk Reduction Intervention for Abused Women

2016年8月26日 更新者:Theresa E. Senn、The Miriam Hospital
The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.

研究概览

详细说明

The purpose of the proposed research is to pilot test an innovative, theoretically-guided sexual risk reduction intervention for women with a history of abuse. T intervention builds on previous findings suggesting that it is important to address the psychological consequences of abuse, as well as the typical antecedents of sexual risk behavior. To inform intervention development, women who reported a history of abuse were recruited to participate in key informant interviews. Based on interview findings and guided by theory and empirical precedent, a novel sexual risk reduction intervention was developed and refined. The intervention will be pilot tested with 80 women recruited from a publicly-funded clinic who report a history of abuse and current sexual risk behavior. These women will complete a computerized survey to assess abuse, adult sexual risk behavior, HIV-related information, safer sex motivation, behavioral skills, interpersonal trust, guilt, and powerlessness. Behavioral skills will also be assessed through role-plays and simulation scenarios. Women will be randomly assigned to the novel intervention or to a structurally equivalent intervention focused only on the psychological antecedents of sexual risk behavior. Three months after intervention completion, women will return to complete computerized interviews and behavioral skills assessments. The long-term goal of this research is to develop a feasible and effective sexual risk reduction intervention for women who have a history of abuse.

研究类型

介入性

注册 (实际的)

86

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

    • New York
      • Rochester、New York、美国、14611
        • University of Rochester

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

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • history of abuse
  • current sexual risk behavior

Exclusion Criteria:

  • less than age 18
  • impaired mentally
  • do not speak English
  • severely depressed or suicidal
  • HIV+

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
实验性的:Abuse-focused intervention
Participants attend 5 weekly, 2-hour intervention sessions focused on the psychological consequences of abuse, current sexual risk behavior, and the link between the two.
有源比较器:Sexual behavior-focused intervention
Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior.

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
change in number of sexual partners in the past 3 months
大体时间:baseline and 3 months
at baseline and at 3 months post intervention, participants will respond to the question, "How many sexual partners have you had in the past 3 months?", assessed by computerized survey
baseline and 3 months
change in number of episodes of unprotected sex in the past 3 months
大体时间:baseline and 3 months
at baseline and at 3 months post intervention, participants will report (a) the number of times they had sex with a primary partner in the past 3 months (b) out of the number of sex episodes with a primary partner in the past 3 months, how many times a condom was used; (c) the number of times they had sex with non-primary partners in the past 3 months; and (d) out of the number of sex episodes with a non-primary partner in the past 3 months, how many times a condom was used; responses to these 4 items will be used to determine the change in the total number of unprotected sex episodes (past 3 months) from baseline to 3 months post-intervention, assessed by computerized survey
baseline and 3 months

次要结果测量

结果测量
措施说明
大体时间
change in scores on the HIV Knowledge Questionnaire
大体时间:baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Condom Attitudes measure
大体时间:baseline and 3 months
condom attitudes measure assessing (a) attitudes towards condom use in primary relationships; (b) attitudes towards condom use in non-primary relationship; (c) pleasure-related condom attitudes; and (d) respect-related condom attitudes, assessed by computerized survey
baseline and 3 months
change in performance on condom application exercise
大体时间:baseline and 3 months
participant is observed and scored while placing a condom on a model
baseline and 3 months
change in scores on Traumatic Sexualization Survey
大体时间:baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Dyadic Trust Scale
大体时间:baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Abuse-Related Beliefs Questionnaire
大体时间:baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scores on Sexual Relationship Power Scale
大体时间:baseline and 3 months
assessed by computerized survey
baseline and 3 months
change in scoress on the PTSD Checklist-Civilian Version
大体时间:baseline and after each intervention session
assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session
baseline and after each intervention session

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

2014年4月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2014年4月14日

首先提交符合 QC 标准的

2014年4月17日

首次发布 (估计)

2014年4月21日

研究记录更新

最后更新发布 (估计)

2016年8月29日

上次提交的符合 QC 标准的更新

2016年8月26日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • R34MH095362 (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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