$ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID
Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address t...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Martel-Laferrière, Valérie [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Anmerkung: |
© The Author(s) 2022. corrected publication 2022 |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 23(2022), 1 vom: 23. Apr. |
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| Übergeordnetes Werk: |
volume:23 ; year:2022 ; number:1 ; day:23 ; month:04 |
| Links: |
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| DOI / URN: |
10.1186/s13063-022-06085-3 |
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| Katalog-ID: |
SPR050661841 |
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| 520 | |a Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. | ||
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| 700 | 1 | |a Feaster, Daniel J. |4 aut | |
| 700 | 1 | |a Metsch, Lisa R. |4 aut | |
| 700 | 1 | |a Schackman, Bruce R. |4 aut | |
| 700 | 1 | |a Loignon, Christine |4 aut | |
| 700 | 1 | |a Nosyk, Bohdan |4 aut | |
| 700 | 1 | |a Tookes, Hansel |4 aut | |
| 700 | 1 | |a Behrends, Czarina N. |4 aut | |
| 700 | 1 | |a Arruda, Nelson |4 aut | |
| 700 | 1 | |a Adigun, Oluleye |4 aut | |
| 700 | 1 | |a Goyer, Marie-Eve |4 aut | |
| 700 | 1 | |a Kolber, Michael A. |4 aut | |
| 700 | 1 | |a Mary, Jean-Francois |4 aut | |
| 700 | 1 | |a Rodriguez, Allan E. |4 aut | |
| 700 | 1 | |a Yanez, Iveth G. |4 aut | |
| 700 | 1 | |a Pan, Yue |4 aut | |
| 700 | 1 | |a Khemiri, Rania |4 aut | |
| 700 | 1 | |a Gooden, Lauren |4 aut | |
| 700 | 1 | |a Sako, Aïssata |4 aut | |
| 700 | 1 | |a Bruneau, Julie |4 aut | |
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10.1186/s13063-022-06085-3 doi (DE-627)SPR050661841 (SPR)s13063-022-06085-3-e DE-627 ger DE-627 rakwb eng Martel-Laferrière, Valérie verfasserin (orcid)0000-0001-7973-8582 aut $ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022. corrected publication 2022 Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 Feaster, Daniel J. aut Metsch, Lisa R. aut Schackman, Bruce R. aut Loignon, Christine aut Nosyk, Bohdan aut Tookes, Hansel aut Behrends, Czarina N. aut Arruda, Nelson aut Adigun, Oluleye aut Goyer, Marie-Eve aut Kolber, Michael A. aut Mary, Jean-Francois aut Rodriguez, Allan E. aut Yanez, Iveth G. aut Pan, Yue aut Khemiri, Rania aut Gooden, Lauren aut Sako, Aïssata aut Bruneau, Julie aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 23. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:23 month:04 https://dx.doi.org/10.1186/s13063-022-06085-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 23 04 |
| spelling |
10.1186/s13063-022-06085-3 doi (DE-627)SPR050661841 (SPR)s13063-022-06085-3-e DE-627 ger DE-627 rakwb eng Martel-Laferrière, Valérie verfasserin (orcid)0000-0001-7973-8582 aut $ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022. corrected publication 2022 Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 Feaster, Daniel J. aut Metsch, Lisa R. aut Schackman, Bruce R. aut Loignon, Christine aut Nosyk, Bohdan aut Tookes, Hansel aut Behrends, Czarina N. aut Arruda, Nelson aut Adigun, Oluleye aut Goyer, Marie-Eve aut Kolber, Michael A. aut Mary, Jean-Francois aut Rodriguez, Allan E. aut Yanez, Iveth G. aut Pan, Yue aut Khemiri, Rania aut Gooden, Lauren aut Sako, Aïssata aut Bruneau, Julie aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 23. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:23 month:04 https://dx.doi.org/10.1186/s13063-022-06085-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 23 04 |
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10.1186/s13063-022-06085-3 doi (DE-627)SPR050661841 (SPR)s13063-022-06085-3-e DE-627 ger DE-627 rakwb eng Martel-Laferrière, Valérie verfasserin (orcid)0000-0001-7973-8582 aut $ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022. corrected publication 2022 Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 Feaster, Daniel J. aut Metsch, Lisa R. aut Schackman, Bruce R. aut Loignon, Christine aut Nosyk, Bohdan aut Tookes, Hansel aut Behrends, Czarina N. aut Arruda, Nelson aut Adigun, Oluleye aut Goyer, Marie-Eve aut Kolber, Michael A. aut Mary, Jean-Francois aut Rodriguez, Allan E. aut Yanez, Iveth G. aut Pan, Yue aut Khemiri, Rania aut Gooden, Lauren aut Sako, Aïssata aut Bruneau, Julie aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 23. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:23 month:04 https://dx.doi.org/10.1186/s13063-022-06085-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 23 04 |
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10.1186/s13063-022-06085-3 doi (DE-627)SPR050661841 (SPR)s13063-022-06085-3-e DE-627 ger DE-627 rakwb eng Martel-Laferrière, Valérie verfasserin (orcid)0000-0001-7973-8582 aut $ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022. corrected publication 2022 Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 Feaster, Daniel J. aut Metsch, Lisa R. aut Schackman, Bruce R. aut Loignon, Christine aut Nosyk, Bohdan aut Tookes, Hansel aut Behrends, Czarina N. aut Arruda, Nelson aut Adigun, Oluleye aut Goyer, Marie-Eve aut Kolber, Michael A. aut Mary, Jean-Francois aut Rodriguez, Allan E. aut Yanez, Iveth G. aut Pan, Yue aut Khemiri, Rania aut Gooden, Lauren aut Sako, Aïssata aut Bruneau, Julie aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 23. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:23 month:04 https://dx.doi.org/10.1186/s13063-022-06085-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 23 04 |
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10.1186/s13063-022-06085-3 doi (DE-627)SPR050661841 (SPR)s13063-022-06085-3-e DE-627 ger DE-627 rakwb eng Martel-Laferrière, Valérie verfasserin (orcid)0000-0001-7973-8582 aut $ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022. corrected publication 2022 Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 Feaster, Daniel J. aut Metsch, Lisa R. aut Schackman, Bruce R. aut Loignon, Christine aut Nosyk, Bohdan aut Tookes, Hansel aut Behrends, Czarina N. aut Arruda, Nelson aut Adigun, Oluleye aut Goyer, Marie-Eve aut Kolber, Michael A. aut Mary, Jean-Francois aut Rodriguez, Allan E. aut Yanez, Iveth G. aut Pan, Yue aut Khemiri, Rania aut Gooden, Lauren aut Sako, Aïssata aut Bruneau, Julie aut Enthalten in Trials London : BioMed Central, 2000 23(2022), 1 vom: 23. Apr. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:23 year:2022 number:1 day:23 month:04 https://dx.doi.org/10.1186/s13063-022-06085-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 23 2022 1 23 04 |
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Martel-Laferrière, Valérie @@aut@@ Feaster, Daniel J. @@aut@@ Metsch, Lisa R. @@aut@@ Schackman, Bruce R. @@aut@@ Loignon, Christine @@aut@@ Nosyk, Bohdan @@aut@@ Tookes, Hansel @@aut@@ Behrends, Czarina N. @@aut@@ Arruda, Nelson @@aut@@ Adigun, Oluleye @@aut@@ Goyer, Marie-Eve @@aut@@ Kolber, Michael A. @@aut@@ Mary, Jean-Francois @@aut@@ Rodriguez, Allan E. @@aut@@ Yanez, Iveth G. @@aut@@ Pan, Yue @@aut@@ Khemiri, Rania @@aut@@ Gooden, Lauren @@aut@@ Sako, Aïssata @@aut@@ Bruneau, Julie @@aut@@ |
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$ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID Pre-exposure prophylaxis (PrEP) (dpeaa)DE-He213 Hepatitis C treatment (dpeaa)DE-He213 People who inject drugs (dpeaa)DE-He213 Patient navigator (dpeaa)DE-He213 Adherence counselor (dpeaa)DE-He213 |
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Martel-Laferrière, Valérie Feaster, Daniel J. Metsch, Lisa R. Schackman, Bruce R. Loignon, Christine Nosyk, Bohdan Tookes, Hansel Behrends, Czarina N. Arruda, Nelson Adigun, Oluleye Goyer, Marie-Eve Kolber, Michael A. Mary, Jean-Francois Rodriguez, Allan E. Yanez, Iveth G. Pan, Yue Khemiri, Rania Gooden, Lauren Sako, Aïssata Bruneau, Julie |
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$ m^{2} $hepprep: study protocol for a multi-site multi-setting randomized controlled trial of integrated hiv prevention and hcv care for pwid |
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$ M^{2} $HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID |
| abstract |
Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. © The Author(s) 2022. corrected publication 2022 |
| abstractGer |
Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. © The Author(s) 2022. corrected publication 2022 |
| abstract_unstemmed |
Background Opioid use is escalating in North America and comes with a multitude of health consequences, including HIV and hepatitis C virus (HCV) outbreaks among persons who inject drugs (PWID). HIV pre-exposure prophylaxis (PrEP) and HCV treatment regimens have transformative potential to address these co-occurring epidemics. Evaluation of innovative multi-modal approaches, integrating harm reduction, opioid agonist therapy (OAT), PrEP, and HCV treatment is required. The aim of this study is to assess the effectiveness of an on-site integrated care model where delivery of PrEP and HCV treatment for PWID takes places at syringe service programs (SSP) and OAT programs compared with referring PWID to clinical services in the community through a patient navigation model and to examine how structural factors interact with HIV prevention adherence and HCV treatment outcomes. Methods The Miami-Montreal Hepatitis C and Pre-Exposure Prophylaxis trial ($ M^{2} $HepPrEP) is an open-label, multi-site, multi-center, randomized, controlled, superiority trial with two parallel treatment arms. A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). Registration date: June 10, 201. © The Author(s) 2022. corrected publication 2022 |
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Feaster, Daniel J. Metsch, Lisa R. Schackman, Bruce R. Loignon, Christine Nosyk, Bohdan Tookes, Hansel Behrends, Czarina N. Arruda, Nelson Adigun, Oluleye Goyer, Marie-Eve Kolber, Michael A. Mary, Jean-Francois Rodriguez, Allan E. Yanez, Iveth G. Pan, Yue Khemiri, Rania Gooden, Lauren Sako, Aïssata Bruneau, Julie |
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A total of 500 persons who injected drugs in the prior 6 months and are eligible for PrEP will be recruited in OAT clinics and SSP in Miami, FL, and Montréal, Québec. Participants will be randomized to either on-site care, with adherence counseling, or referral to off-site clinics assisted by a patient navigator. PrEP will be offered to all participants and HCV treatment to those HCV-infected. Co-primary endpoints will be (1) adherence to pre-exposure prophylaxis medication at 6 months post-randomization and (2) HCV sustained virological response (SVR) 12 weeks post-treatment completion among participants who were randomized within the HCV stratum. Up to 100 participants will be invited to participate in a semi-structured interview regarding perceptions of adherence barriers and facilitators, after their 6-month assessment. A simulation model-based cost-effectiveness analysis will be performed to determine the comparative value of the strategies being evaluated. Discussion The results of this study have the potential to demonstrate the effectiveness and cost-effectiveness of offering PrEP and HCV treatment in healthcare venues frequently attended by PWID. Testing the intervention in two urban centers with high disease burden among PWID, but with different healthcare system dynamics, will increase generalizability of findings. Trial registration Clinicaltrials.gov NCT03981445. Trial registry name: Integrated HIV Prevention and HCV Care for PWID (M2HepPrEP). 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