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Linking Infectious and Narcology Care-Part II

NCT03290391 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2023-04-18

Study results available
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Summary

This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load suppression), impact on care systems and cost-effectiveness of the intervention.

Conditions

  • HIV Infection
  • Drug Use

Interventions

OTHER

Rapid ART initiation

The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.

DRUG

Pharmacotherapy for opioid use disorder

Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).

BEHAVIORAL

Strengths-based HIV case management

Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Samet, MD MA MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2022-04-06
Completion
2022-04-06
FDA Drug
Yes

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290391 on ClinicalTrials.gov