HIV Prevention Maintenance for African American Teens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 701
- 试验地点
- 6
- 主要终点
- Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
研究概览
简要总结
AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young African American females through a culturally and gender appropriate intervention (group sessions) coupled with an individualized HIV Telephone Maintenance Intervention.
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 educational programs can significantly reduce sexual risk behaviors among this vulnerable population over the short term. It is unclear as to whether these programs have long-term effects. Thus, the aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote long-term maintenance of HIV preventive sexual behaviors over a long follow-up period.
700 African-American female adolescents' between the ages of 14-20 will be enrolled in this trial. Adolescents will be recruited from youth currently seeking services at several family planning clinics in Atlanta, Georgia. Adolescents who are eligible and willing to participate in the project will complete an initial ACASI survey. The survey is designed to assess adolescents' sexual risk and preventive behaviors. Biological specimens are collected and tested for common STI's. Free DOT (Directly Observed Therapy) is provided through the clinics. Urine pregnancy screens will also be conducted. After they complete the assessment, adolescents will receive a sexual health education program that was developed by the Principal Investigator. This program (HORIZONS) has been shown to be effective in reducing sexual risk behaviors over the short-term. Trained African American female health educators will deliver the sexual health education program. Adolescents will then be assigned, by chance alone, to one of two groups: one group will get periodic telephone contacts designed to reinforce sexual health promotion and the other group will get periodic telephone contacts that promote healthy dietary practices. Thus, while all adolescents receive the same sexual health education program, half will get telephone calls emphasizing sexual health and half will get an equal number of telephone calls emphasizing nutritional health.
The primary aims of the proposed project are:
Primary Aim 1. To determine whether adding a telephone educational component to a sexual health education program will reduce incident STD infection over a 36-month follow-up.
Primary Aim 2. To determine if adding a telephone educational component to a sexual health education program can maintain HIV-preventive behaviors.
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
- 14 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female; African American; age 14-20; receiving care at participating clinic;report having unprotected vaginal sex in last 6 months; ability to give written informed consent
排除标准
- •pregnant or trying to get pregnant; married; any condition that would preclude attending group-based intervention sessions.
结局指标
主要结局
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
时间窗: 36 months post-randomization.
次要结局
- Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up.(36 months post-randomization)
研究者
Ralph J. DiClemente
Professor
Emory University