A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.

<h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Babafemi O Taiwo [verfasserIn] Lisa M Kuhns [verfasserIn] Olayinka Omigbodun [verfasserIn] Olutosin Awolude [verfasserIn] Kehinde M Kuti [verfasserIn] Adedotun Adetunji [verfasserIn] Baiba Berzins [verfasserIn] Patrick Janulis [verfasserIn] Sulaimon Akanmu [verfasserIn] Oche Agbaji [verfasserIn] Agatha N David [verfasserIn] Akinsegun Akinbami [verfasserIn] Abiodun Folashade Adekambi [verfasserIn] Amy K Johnson [verfasserIn] Ogochukwu Okonkwor [verfasserIn] Bibilola D Oladeji [verfasserIn] Marbella Cervantes [verfasserIn] Olubusuyi M Adewumi [verfasserIn] Bill Kapogiannis [verfasserIn] Robert Garofalo [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Übergeordnetes Werk:	In: PLoS ONE - Public Library of Science (PLoS), 2007, 18(2023), 7, p e0274031
Übergeordnetes Werk:	volume:18 ; year:2023 ; number:7, p e0274031

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1371/journal.pone.0274031

Katalog-ID:	DOAJ095828400

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allfields	10.1371/journal.pone.0274031 doi (DE-627)DOAJ095828400 (DE-599)DOAJ5df386a5e1324e2195e198207f050fb9 DE-627 ger DE-627 rakwb eng Babafemi O Taiwo verfasserin aut A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Medicine R Science Q Lisa M Kuhns verfasserin aut Olayinka Omigbodun verfasserin aut Olutosin Awolude verfasserin aut Kehinde M Kuti verfasserin aut Adedotun Adetunji verfasserin aut Baiba Berzins verfasserin aut Patrick Janulis verfasserin aut Sulaimon Akanmu verfasserin aut Oche Agbaji verfasserin aut Agatha N David verfasserin aut Akinsegun Akinbami verfasserin aut Abiodun Folashade Adekambi verfasserin aut Amy K Johnson verfasserin aut Ogochukwu Okonkwor verfasserin aut Bibilola D Oladeji verfasserin aut Marbella Cervantes verfasserin aut Olubusuyi M Adewumi verfasserin aut Bill Kapogiannis verfasserin aut Robert Garofalo verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 18(2023), 7, p e0274031 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:18 year:2023 number:7, p e0274031 https://doi.org/10.1371/journal.pone.0274031 kostenfrei https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 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_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 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_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 7, p e0274031
spelling	10.1371/journal.pone.0274031 doi (DE-627)DOAJ095828400 (DE-599)DOAJ5df386a5e1324e2195e198207f050fb9 DE-627 ger DE-627 rakwb eng Babafemi O Taiwo verfasserin aut A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Medicine R Science Q Lisa M Kuhns verfasserin aut Olayinka Omigbodun verfasserin aut Olutosin Awolude verfasserin aut Kehinde M Kuti verfasserin aut Adedotun Adetunji verfasserin aut Baiba Berzins verfasserin aut Patrick Janulis verfasserin aut Sulaimon Akanmu verfasserin aut Oche Agbaji verfasserin aut Agatha N David verfasserin aut Akinsegun Akinbami verfasserin aut Abiodun Folashade Adekambi verfasserin aut Amy K Johnson verfasserin aut Ogochukwu Okonkwor verfasserin aut Bibilola D Oladeji verfasserin aut Marbella Cervantes verfasserin aut Olubusuyi M Adewumi verfasserin aut Bill Kapogiannis verfasserin aut Robert Garofalo verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 18(2023), 7, p e0274031 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:18 year:2023 number:7, p e0274031 https://doi.org/10.1371/journal.pone.0274031 kostenfrei https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 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_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 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_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 7, p e0274031
allfields_unstemmed	10.1371/journal.pone.0274031 doi (DE-627)DOAJ095828400 (DE-599)DOAJ5df386a5e1324e2195e198207f050fb9 DE-627 ger DE-627 rakwb eng Babafemi O Taiwo verfasserin aut A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Medicine R Science Q Lisa M Kuhns verfasserin aut Olayinka Omigbodun verfasserin aut Olutosin Awolude verfasserin aut Kehinde M Kuti verfasserin aut Adedotun Adetunji verfasserin aut Baiba Berzins verfasserin aut Patrick Janulis verfasserin aut Sulaimon Akanmu verfasserin aut Oche Agbaji verfasserin aut Agatha N David verfasserin aut Akinsegun Akinbami verfasserin aut Abiodun Folashade Adekambi verfasserin aut Amy K Johnson verfasserin aut Ogochukwu Okonkwor verfasserin aut Bibilola D Oladeji verfasserin aut Marbella Cervantes verfasserin aut Olubusuyi M Adewumi verfasserin aut Bill Kapogiannis verfasserin aut Robert Garofalo verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 18(2023), 7, p e0274031 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:18 year:2023 number:7, p e0274031 https://doi.org/10.1371/journal.pone.0274031 kostenfrei https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 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_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 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_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 7, p e0274031
allfieldsGer	10.1371/journal.pone.0274031 doi (DE-627)DOAJ095828400 (DE-599)DOAJ5df386a5e1324e2195e198207f050fb9 DE-627 ger DE-627 rakwb eng Babafemi O Taiwo verfasserin aut A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Medicine R Science Q Lisa M Kuhns verfasserin aut Olayinka Omigbodun verfasserin aut Olutosin Awolude verfasserin aut Kehinde M Kuti verfasserin aut Adedotun Adetunji verfasserin aut Baiba Berzins verfasserin aut Patrick Janulis verfasserin aut Sulaimon Akanmu verfasserin aut Oche Agbaji verfasserin aut Agatha N David verfasserin aut Akinsegun Akinbami verfasserin aut Abiodun Folashade Adekambi verfasserin aut Amy K Johnson verfasserin aut Ogochukwu Okonkwor verfasserin aut Bibilola D Oladeji verfasserin aut Marbella Cervantes verfasserin aut Olubusuyi M Adewumi verfasserin aut Bill Kapogiannis verfasserin aut Robert Garofalo verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 18(2023), 7, p e0274031 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:18 year:2023 number:7, p e0274031 https://doi.org/10.1371/journal.pone.0274031 kostenfrei https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 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_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 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_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 7, p e0274031
allfieldsSound	10.1371/journal.pone.0274031 doi (DE-627)DOAJ095828400 (DE-599)DOAJ5df386a5e1324e2195e198207f050fb9 DE-627 ger DE-627 rakwb eng Babafemi O Taiwo verfasserin aut A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/. Medicine R Science Q Lisa M Kuhns verfasserin aut Olayinka Omigbodun verfasserin aut Olutosin Awolude verfasserin aut Kehinde M Kuti verfasserin aut Adedotun Adetunji verfasserin aut Baiba Berzins verfasserin aut Patrick Janulis verfasserin aut Sulaimon Akanmu verfasserin aut Oche Agbaji verfasserin aut Agatha N David verfasserin aut Akinsegun Akinbami verfasserin aut Abiodun Folashade Adekambi verfasserin aut Amy K Johnson verfasserin aut Ogochukwu Okonkwor verfasserin aut Bibilola D Oladeji verfasserin aut Marbella Cervantes verfasserin aut Olubusuyi M Adewumi verfasserin aut Bill Kapogiannis verfasserin aut Robert Garofalo verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 18(2023), 7, p e0274031 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:18 year:2023 number:7, p e0274031 https://doi.org/10.1371/journal.pone.0274031 kostenfrei https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 kostenfrei https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 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_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 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_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 18 2023 7, p e0274031
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source	In PLoS ONE 18(2023), 7, p e0274031 volume:18 year:2023 number:7, p e0274031
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authorswithroles_txt_mv	Babafemi O Taiwo @@aut@@ Lisa M Kuhns @@aut@@ Olayinka Omigbodun @@aut@@ Olutosin Awolude @@aut@@ Kehinde M Kuti @@aut@@ Adedotun Adetunji @@aut@@ Baiba Berzins @@aut@@ Patrick Janulis @@aut@@ Sulaimon Akanmu @@aut@@ Oche Agbaji @@aut@@ Agatha N David @@aut@@ Akinsegun Akinbami @@aut@@ Abiodun Folashade Adekambi @@aut@@ Amy K Johnson @@aut@@ Ogochukwu Okonkwor @@aut@@ Bibilola D Oladeji @@aut@@ Marbella Cervantes @@aut@@ Olubusuyi M Adewumi @@aut@@ Bill Kapogiannis @@aut@@ Robert Garofalo @@aut@@
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Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. 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author	Babafemi O Taiwo
spellingShingle	Babafemi O Taiwo misc Medicine misc R misc Science misc Q A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.
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topic_title	A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol
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title	A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.
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title_full	A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol
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author_browse	Babafemi O Taiwo Lisa M Kuhns Olayinka Omigbodun Olutosin Awolude Kehinde M Kuti Adedotun Adetunji Baiba Berzins Patrick Janulis Sulaimon Akanmu Oche Agbaji Agatha N David Akinsegun Akinbami Abiodun Folashade Adekambi Amy K Johnson Ogochukwu Okonkwor Bibilola D Oladeji Marbella Cervantes Olubusuyi M Adewumi Bill Kapogiannis Robert Garofalo
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title_sort	randomized stepped wedge trial of an intensive combination approach to roll back the hiv epidemic in nigerian adolescents: icare nigeria treatment support protocol
title_auth	A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.
abstract	<h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/.
abstractGer	<h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/.
abstract_unstemmed	<h4<Background</h4<Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<h4<Methods</h4<The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<h4<Discussion</h4<Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<h4<Trial registration</h4<ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/.
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container_issue	7, p e0274031
title_short	A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.
url	https://doi.org/10.1371/journal.pone.0274031 https://doaj.org/article/5df386a5e1324e2195e198207f050fb9 https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0274031&type=printable https://doaj.org/toc/1932-6203
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author2	Lisa M Kuhns Olayinka Omigbodun Olutosin Awolude Kehinde M Kuti Adedotun Adetunji Baiba Berzins Patrick Janulis Sulaimon Akanmu Oche Agbaji Agatha N David Akinsegun Akinbami Abiodun Folashade Adekambi Amy K Johnson Ogochukwu Okonkwor Bibilola D Oladeji Marbella Cervantes Olubusuyi M Adewumi Bill Kapogiannis Robert Garofalo
author2Str	Lisa M Kuhns Olayinka Omigbodun Olutosin Awolude Kehinde M Kuti Adedotun Adetunji Baiba Berzins Patrick Janulis Sulaimon Akanmu Oche Agbaji Agatha N David Akinsegun Akinbami Abiodun Folashade Adekambi Amy K Johnson Ogochukwu Okonkwor Bibilola D Oladeji Marbella Cervantes Olubusuyi M Adewumi Bill Kapogiannis Robert Garofalo
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doi_str	10.1371/journal.pone.0274031
up_date	2024-07-03T16:50:27.875Z
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