A Phase 4 interventional study of Rapid ART initiation and Pharmacotherapy for opioid use disorder in HIV Infection and Drug Use, sponsored by Boston Medical Center. Completed at 2 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Boston Medical Center · Phase 4, Interventional, and Health services research
Among 19 studies in HIV Infections by Boston Medical Center — none open to participants now, 1 under way, none of them phase 3. HIV Infections · Boston Medical Center.
Among the 19 studies in HIV Infections by Boston Medical Center, this one is the 6th largest by enrollment of the 14 interventional ones, is one of 2 that started in 2018, is the only one in phase 4, and was the 13th registered.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 225 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →None of the 19 studies in HIV Infections by Boston Medical Center is open now.
Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →19 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2018.
Median enrollment 105 across the 14 interventional studies, 170 across the 5 observational. Of the 18 that completed or were terminated, 7 (39%) have results posted.
Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
1 of the studies in HIV Infections by Boston Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06679751Boston Medical CenterInfectious Disease (ID) Testing OUtreach in Carceral Hubs | 2026-12 |
Among the 19 studies in HIV Infections by Boston Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the world, with highest transmission risks among people who inject drugs (PWID) and their sexual partners. While routine HIV testing within addiction treatment systems in Russia (i.e., narcology hospitals) is the norm, links between the narcology and HIV care systems are limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this population less than 10% are on antiretroviral therapy (ART). For Russia to make progress toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is required. The objective of this study, "Linking Infectious and Narcology Care - Part II (LINC-II)," is to implement and evaluate, via a two-armed randomized controlled trial among 240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management.
The central hypothesis is that LINC-II will lead to marked progress toward the achievement of the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current standard of care, and that LINC-II will facilitate health system coordination of narcology and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed methods data from health care providers, administrators, and patients; and 3) evaluate the cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II approach both within Russia and other countries with HIV epidemics driven by injection drug use.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.
Other: Rapid ART initiation · Drug: Pharmacotherapy for opioid use disorder · Behavioral: Strengths-based HIV case management
Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.
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.
Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).
Also known as: Naltrexone
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.
Undetectable HIV Viral Load at 12 Months
Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter)
Time frame: 12 months post randomization
Initiation of Antiretroviral Therapy (ART)
Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
Time frame: Within 28 days of randomization
Change in Mean CD4 Count From Baseline to 12 Months
The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results
Time frame: Change from baseline to 12 months
Retention in HIV Care
Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.
Time frame: 12 months
Undetectable HIV Viral Load at 6 Months
Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (\<40 copies per milliliter).
Time frame: 6 months
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 111 | 114 |
| Not completed | 0 | 0 |
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 79 | 85 |
| Not completed | 32 | 29 |
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 82 | 83 |
| Not completed | 29 | 31 |
Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter)
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Undetectable HIV Viral Load at 12 Months | 46.9 | 22.7 |
Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Initiation of Antiretroviral Therapy (ART) | 73.9 | 11.4 |
The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results
| cells per cubic millimeter | LINC-II | Standard of Care |
|---|---|---|
| Change in Mean CD4 Count From Baseline to 12 Months | 56 ± 171 | -8 ± 193 |
Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Retention in HIV Care | 51.4 | 35.1 |
Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (\<40 copies per milliliter).
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Undetectable HIV Viral Load at 6 Months | 35.4 | 12.9 |
Collected over Adverse event data were collected over the course of the 12-month study period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LINC-II | 4/111 (3.6%) | 9/111 (8.1%) | 13/111 (11.7%) |
| Standard of Care | 10/114 (8.8%) | 13/114 (11.4%) | 3/114 (2.6%) |
| Event | LINC-II | Standard of Care |
|---|---|---|
| PneumoniaInfections and infestations | 4/111 | 1/114 |
| Death due to overdoseSocial circumstances | 3/111 | 2/114 |
| Death due to heart failureCardiac disorders | 1/111 | 3/114 |
| Death due to COVIDInfections and infestations | 0/111 | 2/114 |
| TuberculosisRespiratory, thoracic and mediastinal disorders | 1/111 | 1/114 |
| Acute bronchitisRespiratory, thoracic and mediastinal disorders | 0/111 | 1/114 |
| Death due to suicideSocial circumstances | 0/111 | 1/114 |
| Death due to sepsisInfections and infestations | 0/111 | 1/114 |
| Death due to acute alcohol intoxicationSocial circumstances | 0/111 | 1/114 |
| Event | LINC-II | Standard of Care |
|---|---|---|
| PneumoniaInfections and infestations | 4/111 | 1/114 |
| Elevated ASTInvestigations | 4/111 | 0/114 |
| Back painMusculoskeletal and connective tissue disorders | 1/111 | 0/114 |
| Muscle painMusculoskeletal and connective tissue disorders | 1/111 | 0/114 |
| InsomniaPsychiatric disorders | 1/111 | 0/114 |
| General weaknessGeneral disorders | 1/111 | 0/114 |
| HyperbilirubinemiaHepatobiliary disorders | 1/111 | 0/114 |
| Elevated ALTInvestigations | 1/111 | 0/114 |
| Wound infectionSurgical and medical procedures | 1/111 | 0/114 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/111 | 0/114 |
| Age, Continuous(years) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Mean | 37 ± 5 | 37 ± 5 | 37 ± 5 |
| Sex: Female, Male(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Female | 47 | 42 | 89 |
| Male | 64 | 72 | 136 |
| Ethnicity (NIH/OMB)(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 111 | 114 | 225 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 110 | 113 | 223 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Russia | 111 | 114 | 225 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Naltrexone