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临床试验/NCT00633906
NCT00633906已完成不适用

Reducing HIV Risk in Female Teens: A Tailored Approach

Emory University6 个研究点 分布在 1 个国家目标入组 715 人开始时间: 2002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
715
试验地点
6
主要终点
Proportion of condom protected vaginal sex acts over the last 60 days

研究概览

简要总结

The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.

详细描述

African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:

  1. To evaluate the efficacy of the HORIZONS HIV intervention plus standard of care counseling versus the standard of care counseling alone in reducing self-reported HIV sexual risk behaviors and incident STDs over a 12 month follow-up period.
  2. To evaluate the cost-effectiveness of the HORIZONS HIV intervention plus standard of care counseling to the standard of care counseling alone with respect to reducing risky sexual behavior and averting incident STDs.

715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • African American
  • Ages 15-21
  • Receiving care at participating clinic
  • Vaginal sex in the past 60 days
  • Ability to give written informed consent

排除标准

  • In a detention center

结局指标

主要结局

Proportion of condom protected vaginal sex acts over the last 60 days

时间窗: 6 and 12 months post-randomization

次要结局

  • Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing(6 and 12 months post-randomization)

研究者

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

Ralph J. DiClemente

Principal

Emory University

研究点 (6)

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