Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II) : an open-label, randomised controlled trial
Copyright © 2023 Elsevier Ltd. All rights reserved..
BACKGROUND: Antiretroviral therapy (ART) coverage in Russia is low for people with HIV who inject drugs. HIV and addiction treatment in Russia are not well integrated. We aimed to evaluate an intervention to link people with HIV in addiction treatment to HIV care to achieve HIV viral load suppression.
METHODS: LINC-II was a two-arm, open-label, randomised controlled trial at the City Addiction Hospital, Saint Petersburg, Russia. Eligible participants were aged 18 years or older, had a positive HIV status, were not currently on ART, were admitted to a narcology hospital, and had a current diagnosis of opioid use disorder. Participants were randomly assigned (1:1) to a multicomponent intervention (ie, rapid access to ART, naltrexone for opioid use disorder, and strengths-based case management) or standard of care. Blocked randomisation was stratified by history of ART use. The primary outcome was undetectable HIV viral load at 12 months, defined as less than 40 copies per mL. The trial was conducted and analysed according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, NCT03290391.
FINDINGS: Between Sept 19, 2018, and Dec 25, 2020, 953 individuals were screened for eligibility, 225 of whom were randomly assigned to the intervention (n=111) or standard of care (n=114). 136 (60%) participants were male and 89 (40%) were female. Participants in the intervention group had higher odds of HIV viral load suppression at 12 months compared with participants in the standard-of-care group (52 [47%] vs 26 [23%]; adjusted odds ratio 3·0 [95% CI 1·4-6·4]; p=0·0039). 21 adverse events (18 in the intervention group and three in the standard-of-care group)and 14 deaths (four in the intervention group and ten in the standard-of-care group) were reported in the study.
INTERPRETATION: Given the effectiveness of the LINC-II intervention, scaling up this model could be one strategy to advance the UNAIDS goal of ending the HIV epidemic.
FUNDING: National Institute on Drug Abuse and Providence/Boston Center for AIDS Research.
| Errataetall: |
CommentIn: Lancet HIV. 2023 Sep;10(9):e559-e560. - PMID 37659840 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
The lancet. HIV - 10(2023), 9 vom: 09. Sept., Seite e578-e587 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Samet, Jeffrey H [VerfasserIn] |
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| Links: |
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| Themen: |
5S6W795CQM |
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| Anmerkungen: |
Date Completed 04.09.2023 Date Revised 19.11.2023 published: Print ClinicalTrials.gov: NCT03290391 CommentIn: Lancet HIV. 2023 Sep;10(9):e559-e560. - PMID 37659840 Citation Status MEDLINE |
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| doi: |
10.1016/S2352-3018(23)00143-1 |
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| 245 | 1 | 0 | |a Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II) |b an open-label, randomised controlled trial |
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| 500 | |a Date Revised 19.11.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT03290391 | ||
| 500 | |a CommentIn: Lancet HIV. 2023 Sep;10(9):e559-e560. - PMID 37659840 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier Ltd. All rights reserved. | ||
| 520 | |a BACKGROUND: Antiretroviral therapy (ART) coverage in Russia is low for people with HIV who inject drugs. HIV and addiction treatment in Russia are not well integrated. We aimed to evaluate an intervention to link people with HIV in addiction treatment to HIV care to achieve HIV viral load suppression | ||
| 520 | |a METHODS: LINC-II was a two-arm, open-label, randomised controlled trial at the City Addiction Hospital, Saint Petersburg, Russia. Eligible participants were aged 18 years or older, had a positive HIV status, were not currently on ART, were admitted to a narcology hospital, and had a current diagnosis of opioid use disorder. Participants were randomly assigned (1:1) to a multicomponent intervention (ie, rapid access to ART, naltrexone for opioid use disorder, and strengths-based case management) or standard of care. Blocked randomisation was stratified by history of ART use. The primary outcome was undetectable HIV viral load at 12 months, defined as less than 40 copies per mL. The trial was conducted and analysed according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, NCT03290391 | ||
| 520 | |a FINDINGS: Between Sept 19, 2018, and Dec 25, 2020, 953 individuals were screened for eligibility, 225 of whom were randomly assigned to the intervention (n=111) or standard of care (n=114). 136 (60%) participants were male and 89 (40%) were female. Participants in the intervention group had higher odds of HIV viral load suppression at 12 months compared with participants in the standard-of-care group (52 [47%] vs 26 [23%]; adjusted odds ratio 3·0 [95% CI 1·4-6·4]; p=0·0039). 21 adverse events (18 in the intervention group and three in the standard-of-care group)and 14 deaths (four in the intervention group and ten in the standard-of-care group) were reported in the study | ||
| 520 | |a INTERPRETATION: Given the effectiveness of the LINC-II intervention, scaling up this model could be one strategy to advance the UNAIDS goal of ending the HIV epidemic | ||
| 520 | |a FUNDING: National Institute on Drug Abuse and Providence/Boston Center for AIDS Research | ||
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