Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda
Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to P...
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Gespeichert in:
| Autor*in: |
Kadota, Jillian L. [verfasserIn] Musinguzi, Allan [verfasserIn] Nabunje, Juliet [verfasserIn] Welishe, Fred [verfasserIn] Ssemata, Jackie L. [verfasserIn] Bishop, Opira [verfasserIn] Berger, Christopher A. [verfasserIn] Patel, Devika [verfasserIn] Sammann, Amanda [verfasserIn] Katahoire, Anne [verfasserIn] Nahid, Payam [verfasserIn] Belknap, Robert [verfasserIn] Phillips, Patrick P. J. [verfasserIn] Namusobya, Jennifer [verfasserIn] Kamya, Moses [verfasserIn] Handley, Margaret A. [verfasserIn] Kiwanuka, Noah [verfasserIn] Katamba, Achilles [verfasserIn] Dowdy, David [verfasserIn] Semitala, Fred C. [verfasserIn] Cattamanchi, Adithya [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2020 |
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| Schlagwörter: |
Effectiveness-implementation hybrid |
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| Übergeordnetes Werk: |
Enthalten in: Implementation science - London : BioMed Central, 2006, 15(2020), 1 vom: 12. Aug. |
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| Übergeordnetes Werk: |
volume:15 ; year:2020 ; number:1 ; day:12 ; month:08 |
| Links: |
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| DOI / URN: |
10.1186/s13012-020-01025-8 |
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| Katalog-ID: |
SPR040634116 |
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| 245 | 1 | 0 | |a Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda |
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| 520 | |a Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. | ||
| 650 | 4 | |a Effectiveness-implementation hybrid |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Rifapentine |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Isoniazid |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Tuberculosis preventive therapy |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a HIV/AIDS |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Person-centered care |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Patient choice |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Preference trials |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Musinguzi, Allan |e verfasserin |4 aut | |
| 700 | 1 | |a Nabunje, Juliet |e verfasserin |4 aut | |
| 700 | 1 | |a Welishe, Fred |e verfasserin |4 aut | |
| 700 | 1 | |a Ssemata, Jackie L. |e verfasserin |4 aut | |
| 700 | 1 | |a Bishop, Opira |e verfasserin |4 aut | |
| 700 | 1 | |a Berger, Christopher A. |e verfasserin |4 aut | |
| 700 | 1 | |a Patel, Devika |e verfasserin |4 aut | |
| 700 | 1 | |a Sammann, Amanda |e verfasserin |4 aut | |
| 700 | 1 | |a Katahoire, Anne |e verfasserin |4 aut | |
| 700 | 1 | |a Nahid, Payam |e verfasserin |4 aut | |
| 700 | 1 | |a Belknap, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Phillips, Patrick P. J. |e verfasserin |4 aut | |
| 700 | 1 | |a Namusobya, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Kamya, Moses |e verfasserin |4 aut | |
| 700 | 1 | |a Handley, Margaret A. |e verfasserin |4 aut | |
| 700 | 1 | |a Kiwanuka, Noah |e verfasserin |4 aut | |
| 700 | 1 | |a Katamba, Achilles |e verfasserin |4 aut | |
| 700 | 1 | |a Dowdy, David |e verfasserin |4 aut | |
| 700 | 1 | |a Semitala, Fred C. |e verfasserin |4 aut | |
| 700 | 1 | |a Cattamanchi, Adithya |e verfasserin |4 aut | |
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10.1186/s13012-020-01025-8 doi (DE-627)SPR040634116 (SPR)s13012-020-01025-8-e DE-627 ger DE-627 rakwb eng 610 ASE Kadota, Jillian L. verfasserin aut Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. Effectiveness-implementation hybrid (dpeaa)DE-He213 Rifapentine (dpeaa)DE-He213 Isoniazid (dpeaa)DE-He213 Tuberculosis preventive therapy (dpeaa)DE-He213 HIV/AIDS (dpeaa)DE-He213 Person-centered care (dpeaa)DE-He213 Patient choice (dpeaa)DE-He213 Preference trials (dpeaa)DE-He213 Musinguzi, Allan verfasserin aut Nabunje, Juliet verfasserin aut Welishe, Fred verfasserin aut Ssemata, Jackie L. verfasserin aut Bishop, Opira verfasserin aut Berger, Christopher A. verfasserin aut Patel, Devika verfasserin aut Sammann, Amanda verfasserin aut Katahoire, Anne verfasserin aut Nahid, Payam verfasserin aut Belknap, Robert verfasserin aut Phillips, Patrick P. J. verfasserin aut Namusobya, Jennifer verfasserin aut Kamya, Moses verfasserin aut Handley, Margaret A. verfasserin aut Kiwanuka, Noah verfasserin aut Katamba, Achilles verfasserin aut Dowdy, David verfasserin aut Semitala, Fred C. verfasserin aut Cattamanchi, Adithya verfasserin aut Enthalten in Implementation science London : BioMed Central, 2006 15(2020), 1 vom: 12. Aug. (DE-627)509006191 (DE-600)2225822-X 1748-5908 nnns volume:15 year:2020 number:1 day:12 month:08 https://dx.doi.org/10.1186/s13012-020-01025-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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 15 2020 1 12 08 |
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10.1186/s13012-020-01025-8 doi (DE-627)SPR040634116 (SPR)s13012-020-01025-8-e DE-627 ger DE-627 rakwb eng 610 ASE Kadota, Jillian L. verfasserin aut Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. Effectiveness-implementation hybrid (dpeaa)DE-He213 Rifapentine (dpeaa)DE-He213 Isoniazid (dpeaa)DE-He213 Tuberculosis preventive therapy (dpeaa)DE-He213 HIV/AIDS (dpeaa)DE-He213 Person-centered care (dpeaa)DE-He213 Patient choice (dpeaa)DE-He213 Preference trials (dpeaa)DE-He213 Musinguzi, Allan verfasserin aut Nabunje, Juliet verfasserin aut Welishe, Fred verfasserin aut Ssemata, Jackie L. verfasserin aut Bishop, Opira verfasserin aut Berger, Christopher A. verfasserin aut Patel, Devika verfasserin aut Sammann, Amanda verfasserin aut Katahoire, Anne verfasserin aut Nahid, Payam verfasserin aut Belknap, Robert verfasserin aut Phillips, Patrick P. J. verfasserin aut Namusobya, Jennifer verfasserin aut Kamya, Moses verfasserin aut Handley, Margaret A. verfasserin aut Kiwanuka, Noah verfasserin aut Katamba, Achilles verfasserin aut Dowdy, David verfasserin aut Semitala, Fred C. verfasserin aut Cattamanchi, Adithya verfasserin aut Enthalten in Implementation science London : BioMed Central, 2006 15(2020), 1 vom: 12. Aug. (DE-627)509006191 (DE-600)2225822-X 1748-5908 nnns volume:15 year:2020 number:1 day:12 month:08 https://dx.doi.org/10.1186/s13012-020-01025-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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 15 2020 1 12 08 |
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10.1186/s13012-020-01025-8 doi (DE-627)SPR040634116 (SPR)s13012-020-01025-8-e DE-627 ger DE-627 rakwb eng 610 ASE Kadota, Jillian L. verfasserin aut Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. Effectiveness-implementation hybrid (dpeaa)DE-He213 Rifapentine (dpeaa)DE-He213 Isoniazid (dpeaa)DE-He213 Tuberculosis preventive therapy (dpeaa)DE-He213 HIV/AIDS (dpeaa)DE-He213 Person-centered care (dpeaa)DE-He213 Patient choice (dpeaa)DE-He213 Preference trials (dpeaa)DE-He213 Musinguzi, Allan verfasserin aut Nabunje, Juliet verfasserin aut Welishe, Fred verfasserin aut Ssemata, Jackie L. verfasserin aut Bishop, Opira verfasserin aut Berger, Christopher A. verfasserin aut Patel, Devika verfasserin aut Sammann, Amanda verfasserin aut Katahoire, Anne verfasserin aut Nahid, Payam verfasserin aut Belknap, Robert verfasserin aut Phillips, Patrick P. J. verfasserin aut Namusobya, Jennifer verfasserin aut Kamya, Moses verfasserin aut Handley, Margaret A. verfasserin aut Kiwanuka, Noah verfasserin aut Katamba, Achilles verfasserin aut Dowdy, David verfasserin aut Semitala, Fred C. verfasserin aut Cattamanchi, Adithya verfasserin aut Enthalten in Implementation science London : BioMed Central, 2006 15(2020), 1 vom: 12. Aug. (DE-627)509006191 (DE-600)2225822-X 1748-5908 nnns volume:15 year:2020 number:1 day:12 month:08 https://dx.doi.org/10.1186/s13012-020-01025-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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 15 2020 1 12 08 |
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10.1186/s13012-020-01025-8 doi (DE-627)SPR040634116 (SPR)s13012-020-01025-8-e DE-627 ger DE-627 rakwb eng 610 ASE Kadota, Jillian L. verfasserin aut Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. Effectiveness-implementation hybrid (dpeaa)DE-He213 Rifapentine (dpeaa)DE-He213 Isoniazid (dpeaa)DE-He213 Tuberculosis preventive therapy (dpeaa)DE-He213 HIV/AIDS (dpeaa)DE-He213 Person-centered care (dpeaa)DE-He213 Patient choice (dpeaa)DE-He213 Preference trials (dpeaa)DE-He213 Musinguzi, Allan verfasserin aut Nabunje, Juliet verfasserin aut Welishe, Fred verfasserin aut Ssemata, Jackie L. verfasserin aut Bishop, Opira verfasserin aut Berger, Christopher A. verfasserin aut Patel, Devika verfasserin aut Sammann, Amanda verfasserin aut Katahoire, Anne verfasserin aut Nahid, Payam verfasserin aut Belknap, Robert verfasserin aut Phillips, Patrick P. J. verfasserin aut Namusobya, Jennifer verfasserin aut Kamya, Moses verfasserin aut Handley, Margaret A. verfasserin aut Kiwanuka, Noah verfasserin aut Katamba, Achilles verfasserin aut Dowdy, David verfasserin aut Semitala, Fred C. verfasserin aut Cattamanchi, Adithya verfasserin aut Enthalten in Implementation science London : BioMed Central, 2006 15(2020), 1 vom: 12. Aug. (DE-627)509006191 (DE-600)2225822-X 1748-5908 nnns volume:15 year:2020 number:1 day:12 month:08 https://dx.doi.org/10.1186/s13012-020-01025-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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 15 2020 1 12 08 |
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10.1186/s13012-020-01025-8 doi (DE-627)SPR040634116 (SPR)s13012-020-01025-8-e DE-627 ger DE-627 rakwb eng 610 ASE Kadota, Jillian L. verfasserin aut Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. Effectiveness-implementation hybrid (dpeaa)DE-He213 Rifapentine (dpeaa)DE-He213 Isoniazid (dpeaa)DE-He213 Tuberculosis preventive therapy (dpeaa)DE-He213 HIV/AIDS (dpeaa)DE-He213 Person-centered care (dpeaa)DE-He213 Patient choice (dpeaa)DE-He213 Preference trials (dpeaa)DE-He213 Musinguzi, Allan verfasserin aut Nabunje, Juliet verfasserin aut Welishe, Fred verfasserin aut Ssemata, Jackie L. verfasserin aut Bishop, Opira verfasserin aut Berger, Christopher A. verfasserin aut Patel, Devika verfasserin aut Sammann, Amanda verfasserin aut Katahoire, Anne verfasserin aut Nahid, Payam verfasserin aut Belknap, Robert verfasserin aut Phillips, Patrick P. J. verfasserin aut Namusobya, Jennifer verfasserin aut Kamya, Moses verfasserin aut Handley, Margaret A. verfasserin aut Kiwanuka, Noah verfasserin aut Katamba, Achilles verfasserin aut Dowdy, David verfasserin aut Semitala, Fred C. verfasserin aut Cattamanchi, Adithya verfasserin aut Enthalten in Implementation science London : BioMed Central, 2006 15(2020), 1 vom: 12. Aug. (DE-627)509006191 (DE-600)2225822-X 1748-5908 nnns volume:15 year:2020 number:1 day:12 month:08 https://dx.doi.org/10.1186/s13012-020-01025-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA 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 15 2020 1 12 08 |
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Enthalten in Implementation science 15(2020), 1 vom: 12. Aug. volume:15 year:2020 number:1 day:12 month:08 |
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Kadota, Jillian L. @@aut@@ Musinguzi, Allan @@aut@@ Nabunje, Juliet @@aut@@ Welishe, Fred @@aut@@ Ssemata, Jackie L. @@aut@@ Bishop, Opira @@aut@@ Berger, Christopher A. @@aut@@ Patel, Devika @@aut@@ Sammann, Amanda @@aut@@ Katahoire, Anne @@aut@@ Nahid, Payam @@aut@@ Belknap, Robert @@aut@@ Phillips, Patrick P. J. @@aut@@ Namusobya, Jennifer @@aut@@ Kamya, Moses @@aut@@ Handley, Margaret A. @@aut@@ Kiwanuka, Noah @@aut@@ Katamba, Achilles @@aut@@ Dowdy, David @@aut@@ Semitala, Fred C. @@aut@@ Cattamanchi, Adithya @@aut@@ |
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Kadota, Jillian L. Musinguzi, Allan Nabunje, Juliet Welishe, Fred Ssemata, Jackie L. Bishop, Opira Berger, Christopher A. Patel, Devika Sammann, Amanda Katahoire, Anne Nahid, Payam Belknap, Robert Phillips, Patrick P. J. Namusobya, Jennifer Kamya, Moses Handley, Margaret A. Kiwanuka, Noah Katamba, Achilles Dowdy, David Semitala, Fred C. Cattamanchi, Adithya |
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protocol for the 3hp options trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with hiv in uganda |
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Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda |
| abstract |
Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. |
| abstractGer |
Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. |
| abstract_unstemmed |
Background Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. Trial registration ClinicalTrials.gov: NCT03934931; Registered 2 May 2019. |
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The best approach to delivering 3HP to PLHIV remains uncertain. Methods We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks. Discussion 3HP—one of the most promising interventions for TB prevention—will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion. 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