Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 10
- 主要终点
- The proportion of referred intervention patients who enroll in HIV care
研究概览
简要总结
This study proposes to assess whether a modified Antiretroviral Treatment Access Study intervention, proved to be effective in the U.S. and based on the nurse case management approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in specialized health care clinics in three regions in Ukraine, using the existing local infrastructure. The proposed study addresses a significant public health issue of non-/late enrollment of HIV-positive persons in HIV care and treatment.
详细描述
Individual, parallel, two-arm, 1:1 RCT. The study participants were recruited between October 2015 and December 2016 at 9 clinics located in Dnipropetrovsk region (Dnipropetrovsk Regional Narcological Dispensary; Dnipropetrovsk Regional Dermatovenereologic Dispensary; Kryvyi Rih Infectious Disease Clinic No. 1), Mykolaiv region (Mykolaiv Regional Narcological Dispensary; Mykolaiv Regional Dermatovenereologic Dispensary; Mykolaiv Regional Infectious Disease Clinic), and Odesa region (Odesa Regional Dermatovenereologic Dispensary; Odesa Infectious Disease Clinic; Odesa Regional Center of Mental Health). These three types of clinical sites (treating addiction, sexually transmitted infections [STIs], and infectious diseases [IDs]) were located in the regions with the highest HIV prevalence in Ukraine, but were not co-located with HIV care facilities. Participants assigned to the standard of care (SOC) arm and the MARTAS arm received referrals to the local AIDS Centers (Dnipropetrovsk Regional AIDS Center, Kryvyi Rih AIDS Center, Mykolaiv Regional Center for Palliative Care and Integrated Services (former Mykolaiv AIDS Center), and Odesa Regional AIDS Center) or their departments ("Trust" offices) located in each study region. Investigators affiliated with The Ukrainian Institute on Public Health Policy (UIPHP) were responsible for all aspects of study design, management, and analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18+ years;
- •Tested HIV-positive
- •Fluent in Russian or Ukrainian;
- •Able to read/understand and sign an informed consent
排除标准
- •Enrolled in HIV care;
- •Plan to move out of the study region before the end of their follow-up period
- •Cognitive impairment
- •Have pending legal issues, independent of their lifetime history of incarceration
- •Subject is a part of another intervention or/and research study with similar linkage-to-care objectives
结局指标
主要结局
The proportion of referred intervention patients who enroll in HIV care
时间窗: 3 months
Linkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record.
次要结局
未报告次要终点
研究者
Oleksandr Neduzhko
Researcher
Ukrainian Institute on Public Health Policy