跳至主要内容
临床试验/NCT00164619
NCT00164619已完成2 期

Testing the Effectiveness of the VOICES/VOCES Intervention Package as Implemented by STD and HIV Prevention Agencies That Target Hispanics and African Americans in the U.S. and Puerto Rico

Centers for Disease Control and Prevention3 个研究点 分布在 2 个国家目标入组 3,660 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
3,660
试验地点
3
主要终点
Repeat STD infection

研究概览

简要总结

The purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies.

VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult men and women at high risk for STD/HIV. It encourages condom use and improves condom negotiation skills. A health educator delivers the intervention to groups of 4 to 8 clinic patients in a private room. Groups are made up of people of the same sex and same race or ethnicity. Information on STD/HIV risk behaviors and condom use is delivered by culturally-specific videos, group discussion, and a poster presenting features of various condom brands. Participants role-play condom negotiation modeled in the videos. At the end of the session they are given sample condoms of their choice.

In this project, health educators from the health departments of New York City and San Juan, Puerto Rico conducted the VOICES/VOCES intervention with a sample of patients from one STD clinic in each of their cities. Researchers helped the health departments test whether the intervention is effective when local health educators deliver it.

详细描述

This project was an RCT with 1699 patients assigned to receive the VOICES/VOCES intervention and 1707 to receive standard of care at each of the two STD clinics (total N=3406). Participant outcomes and their measures are:

  1. Change in knowledge and attitudes about condoms as determined by participant profile and survey data
  2. Condom acquisition as determined by project coupon redemption data
  3. STD incidence as determined by medical chart review and/or surveillance data

In addition, cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the intervention's cost-effectiveness. Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention.

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
All
接受健康志愿者

入选标准

  • STD infection at time of recruitment
  • Accept treatment for STD infection at time of recruitment

排除标准

  • Age under 18 years

结局指标

主要结局

Repeat STD infection

时间窗: Average of 15-months post-intervention

次要结局

  • Change in knowledge and attitudes(Immediately post-intervention)
  • Condom coupon redemption(3-months post-intervention)

研究者

研究点 (3)

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