Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 3
- 主要终点
- 2) retention in HIV care
研究概览
简要总结
The purpose of this study is to implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.
详细描述
The objective of this study "Linking Infectious and Narcology Care (LINC)" is to improve upon the treat and retain dimensions of the "seek, test, treat, and retain" paradigm in Eastern Europe. We will implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes.
LINC is a clinical model designed to coordinate narcology and HIV systems of care using elements shown to facilitate engagement in medical care: HIV case management and point-of-care CD4 testing. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.
Implementation research recognizes that effective interventions may not translate successfully across different contexts and systems. Hence, we will assess the organizational and operational issues that drive engagement in HIV care in Russia.
The project will be undertaken by an international research team experienced in addressing HIV, substance use, and clinical interventions in Russia. This proposal's Specific Aims are to assess the effectiveness of the LINC intervention compared to standard of care on 4 distinct outcomes: 1) initiation of HIV care (> 1 visit to HIV medical care) within 6 months of enrollment; 2) retention in HIV care (> 1 visit to medical care in 2 consecutive 6 month periods) within 12 months; 3) appropriate HIV care (prescribed ART if CD4 cell count is <350 or having a second CD4 count if CD4 ≥350 within 12 months; and 4) improved HIV health outcomes (CD4 cell count at 12 months). The final Specific Aim is to establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia. If LINC can embed effectively within Eastern European medical systems, then it has the potential to be widely implemented in this region of the world and have a major impact on the HIV epidemic among IDUs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 70 years
- •HIV-infected
- •hospitalized at a narcology hospital
- •history of injection drug use
- •available for CD4 testing
- •has 2 contacts to assist with follow-up
- •lives within 100 km of St. Petersburg, Russia
- •has telephone
- •willing to receive care at Botkin Infectious Disease Hospital
排除标准
- •currently on ART
- •not fluent in Russian
- •cognitive impairment precluding informed consent
研究组 & 干预措施
Standard of Care
Control participants will receive the narcology hospital's standard of care. With regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care - the outpatient clinic that is involved in the intervention. Control patients will be referred to outpatient narcology care as part of standard of care. If control participants are newly diagnosed with HIV infection at the addiction hospital, they will receive HIV post test counseling consistent with CDC recommendations (this represents an enhancement of the current standard of care in Russia).
LINC Case Management (Intervention)
LINC Case Management (study Intervention) - see Intervention description
干预措施: LINC Case Management (Behavioral)
结局指标
主要结局
2) retention in HIV care
时间窗: 12 months
Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months
1) initiation of HIV care
时间窗: 6 months
Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment
3) appropriate HIV care
时间窗: 12 months
prescribed ART if CD4 cell count is less than 350 or having a second CD4 count if CD4 is greater than or equal to 350 within 12 months (Note: As guidelines change over time, this outcome may be updated accordingly.)
4) improved HIV health outcomes
时间窗: 12 months
CD4 cell count at 12 months (compared to CD4 cell count at baseline)
5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia
时间窗: 4 years
Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia.
次要结局
未报告次要终点
研究者
Jeffrey Samet
Chief, Section of General Internal Medicine
Boston Medical Center