CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 225 enrolled
Drug / intervention
Pharmacotherapy for opioid use disorder +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03290391
NCT03290391Phase 4Completed
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Linking Infectious and Narcology Care-Part II

Boston Medical Center·interventional·Posted Sep 21, 2017·Updated Apr 18, 2023

In Brief

A Phase 4 clinical trial evaluating Rapid ART initiation, Pharmacotherapy for opioid use disorder, and 1 other intervention for HIV Infection and Drug Use. Completed, enrolled 225 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, Drug Use
CountriesRussia
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedSep 21, 2017
Enrollment StartSep 19, 2018
Primary CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.8 years ago

Interventions

Rapid ART initiationother

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.

Pharmacotherapy for opioid use disorderdrug

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

Strengths-based HIV case managementbehavioral

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.