跳至主要内容
临床试验/NCT00640653
NCT00640653已完成不适用

HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 662 人开始时间: 2001年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
662
试验地点
2
主要终点
Self-report of Ever Having Sexual Intercourse

研究概览

简要总结

This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually transmitted disease risk-reduction interventions in reducing sexual risk behavior among young African-American adolescents.

详细描述

Adolescents risk the negative consequences of early sexual involvement, including not only HIV, but other sexually transmitted diseases (STDs) and unintended pregnancies. Compared with older adults, young people, especially African-American young people, are at higher risk of acquiring an STD. Specifically, people 15 to 24 years of age acquire nearly 50% of all new STDs in the United States, but this age group represents only 25% of the sexually active population. Adolescents are especially vulnerable to STD infections because of a lack of education about proper condom use and consequences of sexual risk behaviors. Previous research has suggested that behavioral interventions can reduce adolescents' sexual behaviors tied to risk of acquiring STDs. Nevertheless, there is continuous debate over the appropriateness and effectiveness of different types of adolescent sexual-risk-reduction interventions, including abstinence education or comprehensive sexual education. Few studies have tested the long-term effectiveness of abstinence education, which emphasizes delaying sexual initiation for sexually inexperienced adolescents. This study will compare the effectiveness of an abstinence-only HIV/STD risk-reduction intervention with other types of interventions in reducing sexual risk behavior among young African-American adolescents.

Participation in this study will last 24 months. Participants at participating schools will be randomly assigned to one of five treatment groups:

  • Abstinence-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. This is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention is not designed to affect condom use.
  • Safer-sex-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.
  • Long comprehensive group participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention will consist of 4 hours each of the safer-sex-specific content, the abstinence-specific content, and the general content that is common to both of the single-component interventions.
  • Short comprehensive group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.
  • Health promotion control participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers.

Sessions for all groups will be led by trained adult facilitators and will include group discussions, videos, games, brainstorming, experiential exercises, and skill-building activities designed to be educational, interactive, and entertaining. All participants will complete self-reports concerning sexual behaviors, condom use, and knowledge about STDs at baseline and Months 3, 6, 12, 18, and 24 of follow-up.

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

性别
All
接受健康志愿者

入选标准

  • Grade 6 or 7 student at a participating school
  • Written parent or guardian consent to participate
  • Self-identifies as African American or black

排除标准

  • Those not meeting inclusion criteria were excluded.

研究组 & 干预措施

Abstinence-only

Experimental

Participants will receive the abstinence-only HIV/STD risk-reduction intervention.

干预措施: Abstinence-only HIV/STD risk-reduction intervention (Behavioral)

Safer-sex only

Experimental

Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.

干预措施: Safer-sex-only HIV/STD risk-reduction intervention (Behavioral)

Comprehensive-long

Experimental

Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.

干预措施: Long comprehensive HIV/STD risk-reduction intervention (Behavioral)

Comprehensive-short

Experimental

Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.

干预措施: Short comprehensive HIV/STD risk-reduction intervention (Behavioral)

Health-promotion control

Active Comparator

Participants will receive the health promotion control intervention.

干预措施: Health promotion control intervention (Behavioral)

结局指标

主要结局

Self-report of Ever Having Sexual Intercourse

时间窗: 24 months post-intervention

Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

次要结局

  • Self-reported Sexual Intercourse in the Past 3 Months(Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention)
  • Self-report of Having Multiple Sexual Partners in the Past 3 Months(Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention)
  • Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months(Measured at baseline and3, 6, 12, 18, and 24 months post-intervention)
  • Self-reported Consistent Condom Use in the Past 3 Months(Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention)

研究者

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

John Jemmott

Kenneth B. Clark Professor of Communication and Psychiatry

University of Pennsylvania

研究点 (2)

Loading locations...

相似试验

Efficacy of an Abstinence-Only HIV Risk-Reduction... | 临床试验