Linking Infectious and Narcology Care in Russia (LINC)
Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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St. Petersburg, 러시아 연방
- City Addiction Hospital
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St. Petersburg, 러시아 연방
- Pavlov State Medical University
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St. Petersburg, 러시아 연방
- Botkin Infectious Disease Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- currently on ART
- not fluent in Russian
- cognitive impairment precluding informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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).
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실험적: LINC Case Management (Intervention)
LINC Case Management (study Intervention) - see Intervention description
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The 1st case management (CM) session will be at the Narcology Hospital and will follow a modified strengths-based case management curriculum.
As part of this first session, the CM will show a 10 minute video clip produced by a Russian NGO of HIV-infected patients talking about accessing HIV care.
The CM will also tell the patient what his/her CD4 cell count is and discuss what it means with the patient.
The case manager will help the client identify the outpatient HIV clinic on a map and will discuss basic drug harm reduction ideas with the client.
The remaining 4 CM sessions will happen over the following 6 months.
Sessions may happen at the HIV clinic, NGOs, or in the community.
The HIV CM helps the client understand the importance of HIV care, identify barriers to care acquisition and recognize one's own strengths, abilities and assets to reduce self-identified barriers to care.
The HIV CM's primary aim is to have the client attend an appointment at the HIV outpatient clinic.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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1) initiation of HIV care
기간: 6 months
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Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment
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6 months
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2) retention in HIV care
기간: 12 months
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Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months
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12 months
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3) appropriate HIV care
기간: 12 months
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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.)
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12 months
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4) improved HIV health outcomes
기간: 12 months
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CD4 cell count at 12 months (compared to CD4 cell count at baseline)
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12 months
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5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia
기간: 4 years
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Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia.
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4 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jeffrey Samet, MD, MA, MPH, Boston Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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