Trial Outcomes & Findings for Linking Infectious and Narcology Care-Part II (NCT NCT03290391)

NCT ID: NCT03290391

Last Updated: 2023-04-18

Results Overview

Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 225 participants
• Primary outcome timeframe: 12 months post randomization
• Results posted on: 2023-04-18

Participant Flow

953 potential participants were assessed for eligibility via medical record pre-screen. 642 were ineligible and 75 did not proceed with in-person screener due to being previously enrolled or discharged early. 236 potential eligible participants completed the in-person screener; 7 did not meet the inclusion criteria and 4 declined to participate. 225 completed the baseline interview and were randomized.

Participant milestones

Measure	LINC-II 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care 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.
Allocation STARTED	111	114
Allocation COMPLETED	111	114
Allocation NOT COMPLETED	0	0
Completed 6 Month Assessment STARTED	111	114
Completed 6 Month Assessment COMPLETED	79	85
Completed 6 Month Assessment NOT COMPLETED	32	29
Completed 12 Month Assessment STARTED	111	114
Completed 12 Month Assessment COMPLETED	82	83
Completed 12 Month Assessment NOT COMPLETED	29	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Linking Infectious and Narcology Care-Part II

Baseline characteristics by cohort

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.	Total n=225 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 5 • n=5 Participants	37 years STANDARD_DEVIATION 5 • n=7 Participants	37 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	42 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	72 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants n=5 Participants	114 Participants n=7 Participants	225 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	113 Participants n=7 Participants	223 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Russia	111 Participants n=5 Participants	114 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post randomization

Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).

Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter)

Outcome measures

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.
Undetectable HIV Viral Load at 12 Months	46.9 percentage of participants	22.7 percentage of participants

SECONDARY outcome

Timeframe: Within 28 days of randomization

Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).

Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.

Outcome measures

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.
Initiation of Antiretroviral Therapy (ART)	73.9 percentage of participants	11.4 percentage of participants

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).

The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results

Outcome measures

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.
Change in Mean CD4 Count From Baseline to 12 Months	56 cells per cubic millimeter Standard Deviation 171	-8 cells per cubic millimeter Standard Deviation 193

SECONDARY outcome

Timeframe: 12 months

Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).

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.

Outcome measures

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.
Retention in HIV Care	51.4 percentage of participants	35.1 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).

Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter).

Outcome measures

Measure	LINC-II n=111 Participants 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 Participants 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.
Undetectable HIV Viral Load at 6 Months	35.4 percentage of participants	12.9 percentage of participants

Adverse Events

LINC-II

Serious events: 9 serious events

Other events: 13 other events

Deaths: 4 deaths

Standard of Care

Serious events: 13 serious events

Other events: 3 other events

Deaths: 10 deaths

Serious adverse events

Measure	LINC-II n=111 participants at risk 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Acute bronchitis	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Respiratory, thoracic and mediastinal disorders Tuberculosis	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Pneumonia	3.6% 4/111 • Number of events 4 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Social circumstances Death due to overdose	2.7% 3/111 • Number of events 3 • Adverse event data were collected over the course of the 12-month study period.	1.8% 2/114 • Number of events 2 • Adverse event data were collected over the course of the 12-month study period.
Cardiac disorders Death due to heart failure	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	2.6% 3/114 • Number of events 3 • Adverse event data were collected over the course of the 12-month study period.
Social circumstances Death due to suicide	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Death due to sepsis	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Death due to COVID	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	1.8% 2/114 • Number of events 2 • Adverse event data were collected over the course of the 12-month study period.
Social circumstances Death due to acute alcohol intoxication	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.

Other adverse events

Measure	LINC-II n=111 participants at risk 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. 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. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). 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.	Standard of Care n=114 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations Pneumonia	3.6% 4/111 • Number of events 4 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Musculoskeletal and connective tissue disorders Back pain	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Musculoskeletal and connective tissue disorders Muscle pain	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Psychiatric disorders Insomnia	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
General disorders General weakness	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Hepatobiliary disorders Hyperbilirubinemia	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Investigations Elevated AST	3.6% 4/111 • Number of events 4 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Investigations Elevated ALT	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Surgical and medical procedures Wound infection	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Skin and subcutaneous tissue disorders Skin irritation	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.
Respiratory, thoracic and mediastinal disorders Pulmonary tuberculosis	0.00% 0/111 • Adverse event data were collected over the course of the 12-month study period.	0.88% 1/114 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.
Infections and infestations COVID	0.90% 1/111 • Number of events 1 • Adverse event data were collected over the course of the 12-month study period.	0.00% 0/114 • Adverse event data were collected over the course of the 12-month study period.

Additional Information

Jeffrey Samet, MD MA MPH

Boston Medical Center and BU Chobanian & Avedisian School of Medicine

Phone: (617) 414-7288

Email: jsamet@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place