Multimedia HIV/STI Prevention for Drug-Involved Female Offenders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- The proportion of condom protected acts of vaginal and anal intercourse
研究概览
简要总结
The proposed study addresses a significant public health threat of Human immunodeficiency virus (HIV) and sexually transmitted infections (STIs) among drug involved women on probation, parole or other community supervision. This randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and HIV/STI prevention intervention (Multimedia Women On the Road To Health (WORTH)) in increasing condom use and decreasing the incidence of sexually transmitted infections (STIs) among 420 drug-involved, female offenders in a large community court setting in New York City, compared to a non-media version of the same intervention (Traditional WORTH) and to a 4-session Wellness Promotion condition.
详细描述
While it is clear that women inmates in jails and prisons bear a high burden of Human immunodeficiency virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), the effective development of prevention interventions for this high-risk group require an understanding of HIV risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system. HIV prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors. This study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •She is 18 or older.
- •She is currently supervised by a criminal justice entity, such as a community court or probation.
- •She reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days
- •She reports any illicit drug use or binge drinking in the past 6 months.
排除标准
- •In addition, potential participants will be ineligible if any of the following criteria are met:
- •Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions.
- •The woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional HIV risk behaviors in the past 90 days:
- •Having sex with more than one partner
- •Having sex with a partner known or suspected to be HIV positive or an injection drug user (IDU)
- •Sharing injection drug use needles or equipment
- •The woman is actively trying to get pregnant/have a baby.
- •Inability to complete informed consent process due to a psychiatric or cognitive impairment.
- •The participant was born male.
结局指标
主要结局
The proportion of condom protected acts of vaginal and anal intercourse
时间窗: Up to 12 months
次要结局
- Cumulative incidence of biologically confirmed STIs (Chlamydia, Gonorrhea and Trichomoniasis)(Up to 12 months)
研究者
Nabila El-Bassel, PhD
Willma and Albert Musher Professor of Social Work
Columbia University