Protect and Connect: Couple HIV Prevention for Drug Involved Male Offenders, An Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change in biologically confirmed sexually transmitted infections
研究概览
简要总结
This study is a randomized controlled trial (RCT) that will rigorously evaluate the implementation, effectiveness and cost-effectiveness of a couple-based integrated human immunodeficiency virus (HIV) and drug abuse prevention intervention (Connect II) with drug-involved male offenders charged with misdemeanors and their primary female sexual partners, implemented by frontline providers in Criminal Court, Community Court or probation (CCP) sites in NYC, compared to CCP standard treatment of care services (TAU). The primary outcomes are to reduce sexually transmitted infections (STIs) and increase condom use.
详细描述
HIV/acquired immune deficiency syndrome (AIDS) and criminal justice involvement are critical intersecting public health issues for drug-involved men. Low income, Black and Hispanic men especially bear the burden of the HIV epidemic and are over-represented in the U.S. criminal justice system. Recent Centers for Disease Control and Prevention (CDC) surveillance data suggest that the health disparity in HIV rates is actually increasing for Black men: current estimates suggest 1 in 16 Black men in the U.S. will be infected with HIV in their life time. These HIV/STI transmission risks are fueled by high rates of poverty, incarceration, unemployment, and lack of access to health care and prevention services. The proposed study thus targets an underserved population at the epicenter of the epidemic in the U.S.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Both partners are aged 18 or older
- •Identify each other as their primary sexual partner of opposite sex
- •Relationship has existed at least 3 months
- •At least one partner reports having unprotected vaginal or anal intercourse with the other partner in the past 90 days
- •At least one partner reports exposure to an outside HIV risk in the past year
- •Male partner reports and is verified by court records of being charged with a misdemeanor
- •Male partner is currently under court supervision or probation
排除标准
- •Either partner shows evidence of significant psychiatric or could impairment as confirmed by the MacArthur Competence Assessment Tool during the screening eligibility interview.
- •Either partner reports severe physical or sexual violence perpetrated by the other partner in the past year as measured on the Revised Conflict Tactics Scale
- •Either partner is unable to commit to participate in the study through to completion
- •Either partner reports that the couple is planning a pregnancy within the next 12 months
- •Either partner is not fluent in English as determined during Informed Consent
研究组 & 干预措施
TAU
TAU control condition delivered to the male participant
干预措施: TAU (Behavioral)
PACT + TAU
4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
干预措施: TAU (Behavioral)
PACT + TAU
4-session PACT delivered to both partners together + standard treatment of care services (TAU) delivered to the male participant
干预措施: PACT (Behavioral)
结局指标
主要结局
Change in biologically confirmed sexually transmitted infections
时间窗: Baseline and up to 12 months post intervention
Change in proportion of unprotected sexual acts
时间窗: Baseline and up to 12 months post intervention
次要结局
- Change in utilization of drug treatment(Baseline and up to 12 months post intervention)
- Change in recidivism(Up to 12 months post intervention)
- Change in drug use(Baseline and up to 12 months post intervention)
研究者
Nabila El-Bassel, PhD
Professor of Social Work
Columbia University