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临床试验/NCT00080093
NCT00080093Unknown不适用

Increasing Condom Use With a Stage-Matched Intervention

National Institute of Allergy and Infectious Diseases (NIAID)0 个研究点目标入组 534 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
534
主要终点
Frequency of condom use

研究概览

简要总结

This study will evaluate a new program designed to increase condom use in both women and men.

详细描述

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

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 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Frequency of condom use

时间窗: At 30 days and 2 months before each assessment

Number of occurances of unprotected sex

时间窗: At 30 days before each assessment

Stage of change for condom use with main and nonmain partners, and men and women

时间窗: Throughout study

次要结局

  • Number and ratios of protected sex occasions with main and nonmain partners, and men and women(Throughout study)
  • Frequency of condom use with main and nonmain partners, and men and women(Throughout Study)
  • Stage of change for condom use with main and nonmain partners, and men and women(Throughout Study)

研究者

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