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临床试验/NCT00619320
NCT00619320已完成2 期

Reducing HIV: Safer Sex Skill Building in Pregnant Drug Abusing Women

Virginia Commonwealth University4 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2008年12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
380
试验地点
4
主要终点
Number of penetrative unprotected sexual intercourse occasions

研究概览

简要总结

This study will examine safer sex skills building (SSB), a targeted behavioral HIV prevention and risk reduction group intervention in two samples of pregnant drug abusing women.

详细描述

"Safer Sex Skills Building" in Pregnant Women: Dace Svikis, (Psychology, Ob-Gyn, Psychiatry) PI, Diane Langhorst (Social Work) and Nichole Karjane, (OB-Gyn) Co-Investigators). This study will focus on increasing Safer Sex Skills development among pregnant women at high risk for HIV infection. The "Safer Sex Skill Building" (SSB) program developed by El Bassel and Schilling (1991, 1992), has demonstrated efficacy in national studies in reducing sexual risk for HIV and other STD transmission. This manual-driven, gender-specific intervention has proven effective in reducing sexual risk behaviors in both methadone maintenance and outpatient drug-free patients. To date, however, the intervention has not been tested with pregnant drug abusing women who may actually be at increased risk if they stop using condoms or continue drug use during pregnancy. This study will examine SSB, a targeted behavioral HIV prevention and risk reduction intervention in two samples of pregnant drug abusing women. Using a 2x2 design, a randomized clinical trial will compare the five-session SSB group intervention to a one-session standard group HIV Education intervention (SE). Study findings will provide benchmark data on the efficacy of SSB for HIV and STD prevention in a diverse sample of pregnant drug abusing women.

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
Female
接受健康志愿者

入选标准

  • 18 years of age and older, pregnant
  • At prenatal care (PCC) site: screen positive for on T-ACE and TWEAK and/or drug CAGE, report drinking 3 or more drinks on at least one occasion and/or using an illicit drug at least once in the 30 days prior to pregnancy awareness, and report at least one incident of unprotected penetrative (vaginal or anal) intercourse with a male partner within the six months prior to baseline assessment.
  • At community treatment (RBHA) site, inclusion criteria are the same except post-partum women (i.e., those who gave birth to a child 2 years of age or less) will also be eligible for study enrollment.

排除标准

  • Both sites:
  • Unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers

结局指标

主要结局

Number of penetrative unprotected sexual intercourse occasions

时间窗: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

The proportion of sex episodes involving alcohol or other drugs

时间窗: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

The proportion of penetrative unprotected sex occasions (of all sex occasions)

时间窗: baseline, 1 month, 3 months, and 6 months post-randomization follow-up assessment

次要结局

  • Perceived self-efficacy to carry out safer sex and the carrying of condoms(baseline, 1 month, 3 months, and 6 months post-randomization follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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