跳至主要内容
临床试验/NCT02118948
NCT02118948已完成不适用

Development of a Novel HIV Risk Reduction Intervention for Abused Women

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
change in number of sexual partners in the past 3 months

研究概览

简要总结

The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • history of abuse
  • current sexual risk behavior

排除标准

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

结局指标

主要结局

change in number of sexual partners in the past 3 months

时间窗: 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

change in number of episodes of unprotected sex in the past 3 months

时间窗: 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

次要结局

  • change in scores on Abuse-Related Beliefs Questionnaire(baseline and 3 months)
  • change in performance on condom application exercise(baseline and 3 months)
  • change in scores on Dyadic Trust Scale(baseline and 3 months)
  • change in scores on Condom Attitudes measure(baseline and 3 months)
  • change in scores on the HIV Knowledge Questionnaire(baseline and 3 months)
  • change in scores on Traumatic Sexualization Survey(baseline and 3 months)
  • change in scores on Sexual Relationship Power Scale(baseline and 3 months)
  • change in scoress on the PTSD Checklist-Civilian Version(baseline and after each intervention session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa E. Senn

Senior Research Scientist and Associate Professor (Research)

The Miriam Hospital

研究点 (2)

Loading locations...

相似试验

Development of a Novel HIV Risk Reduction... | 临床试验