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临床试验/NCT00787696
NCT00787696已完成1 期

HIV Risk Reduction Among Young Incarcerated Females

Mississippi State University2 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2003年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
333
试验地点
2
主要终点
infection with chlamydia or gonorrhea

研究概览

简要总结

This project assesses the efficacy of an HIV prevention program with adolescent females incarcerated in the Mississippi training school for girls. Participants in both the health education control group and the HIV prevention group will increase health knowledge as a result of their participation in the health classes while incarcerated. However, participants in the HIV prevention group will increase their condom application, assertiveness, and communication skills relative to girls in the health education only group. In addition, after release from the training school, participants in the HIV prevention group will report lower sexual risk behaviors and will have lower rates of infection with chlamydia and gonorrhea during the 12-month follow-up period than participants in the health education only group.

详细描述

This study is a longitudinal analysis of STD/HIV exposure among adolescent female offenders in Mississippi, a population that is disproportionately African American, and at higher risk than adolescents in general due to their propensity to engage in a variety of risk-taking behaviors, earlier onset of sexual behaviors, and the greater prevalence of mental disorders, substance abuse disorders, maltreatment, and family dysfunction. Based on social cognitive theory and Fisher and Fisher's (1992) IMB (Information, Motivation, and Behavioral skills) model, we will evaluate a drug abuse related HIV risk reduction intervention and compare outcomes against a STD/HIV information and health education control condition.

Approximately 400 females committed to the state reformatory/training school for girls will be recruited for participation. The research design will consist of alternating cohort/waves of about 50 subjects each. One treatment condition will be administered at a time with a washout period between cohort/waves. Over a three year period, one half of subjects will get 18 hours of STD/HIV prevention and one half will get 18 hours of Health Education. All subjects will receive one individual counseling session designed to enhance motivation for behavioral change just prior to release from training school. Before and after the intervention, subjects' social competency skills, condom application skills, and health knowledge will be measured. Before intervention and at 6-month and 12-month follow-up, self-report measures of alcohol and drug use, condom use, sexual risk behaviors, and measures of victimization, partner risk, condom attitudes, self-efficacy, and communication related to condom use and risk reduction will be collected. Urine tests for the detection of 2 STDs (chlamydia and gonorrhea) will also be performed at admission to Columbia Training School and at 6-month and 12-month 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
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Female, ages 13 to 17 years, committed to Columbia Training School, who provide written informed assent.

排除标准

  • Acute or chronic physically illness that would preclude participation as determined by facility physician; placement in maximum security unit; study participation during a prior commitment

结局指标

主要结局

infection with chlamydia or gonorrhea

时间窗: one year

number of partners and frequency of sexual risk behaviors

时间窗: at 6 & 12 months

Sexual behaviors included condom use in the 3 months prior to each assessment. Unprotected sex occasions (USOs) was calculated by subtracting the number of condom-protected vaginal and anal intercourse occasions from the total number of vaginal and anal intercourse occasions. Sex under the influence is the number of times participant reported sexual intercourse after drinking alcohol or using another drug. Safer sex was categorized as sexually abstinent or consistent condom use.

次要结局

  • Communication skills(pre and post-intervention)
  • Perceived barriers to condom use(at baseline, 6 and 12 month follow-up)
  • condom application skill(pre and post-intervention)
  • reproductive health knowledge(pre and post-intervention)

研究者

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

Angela A. Robertson, PhD

Research Professor

Mississippi State University

研究点 (2)

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