Cargando…
Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial t...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022208/ https://www.ncbi.nlm.nih.gov/pubmed/36962706 http://dx.doi.org/10.1371/journal.pgph.0000464 |
_version_ | 1784908679693205504 |
---|---|
author | Lengeler, Christian Burri, Christian Awor, Phyllis Athieno, Prosciova Kimera, Joseph Tumukunde, Gloria Angiro, Irene Tshefu, Antoinette Okitawutshu, Jean Kalenga, Jean-Claude Omoluabi, Elizabeth Akano, Babatunde Ayodeji, Kazeem Okon, Charles Yusuf, Ocheche Brunner, Nina C. Delvento, Giulia Lee, Tristan Lambiris, Mark Visser, Theodoor Napier, Harriet G. Cohen, Justin M. Buj, Valentina Signorell, Aita Hetzel, Manuel W. |
author_facet | Lengeler, Christian Burri, Christian Awor, Phyllis Athieno, Prosciova Kimera, Joseph Tumukunde, Gloria Angiro, Irene Tshefu, Antoinette Okitawutshu, Jean Kalenga, Jean-Claude Omoluabi, Elizabeth Akano, Babatunde Ayodeji, Kazeem Okon, Charles Yusuf, Ocheche Brunner, Nina C. Delvento, Giulia Lee, Tristan Lambiris, Mark Visser, Theodoor Napier, Harriet G. Cohen, Justin M. Buj, Valentina Signorell, Aita Hetzel, Manuel W. |
author_sort | Lengeler, Christian |
collection | PubMed |
description | The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention. |
format | Online Article Text |
id | pubmed-10022208 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-100222082023-03-17 Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda Lengeler, Christian Burri, Christian Awor, Phyllis Athieno, Prosciova Kimera, Joseph Tumukunde, Gloria Angiro, Irene Tshefu, Antoinette Okitawutshu, Jean Kalenga, Jean-Claude Omoluabi, Elizabeth Akano, Babatunde Ayodeji, Kazeem Okon, Charles Yusuf, Ocheche Brunner, Nina C. Delvento, Giulia Lee, Tristan Lambiris, Mark Visser, Theodoor Napier, Harriet G. Cohen, Justin M. Buj, Valentina Signorell, Aita Hetzel, Manuel W. PLOS Glob Public Health Research Article The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention. Public Library of Science 2022-09-06 /pmc/articles/PMC10022208/ /pubmed/36962706 http://dx.doi.org/10.1371/journal.pgph.0000464 Text en © 2022 Lengeler et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Lengeler, Christian Burri, Christian Awor, Phyllis Athieno, Prosciova Kimera, Joseph Tumukunde, Gloria Angiro, Irene Tshefu, Antoinette Okitawutshu, Jean Kalenga, Jean-Claude Omoluabi, Elizabeth Akano, Babatunde Ayodeji, Kazeem Okon, Charles Yusuf, Ocheche Brunner, Nina C. Delvento, Giulia Lee, Tristan Lambiris, Mark Visser, Theodoor Napier, Harriet G. Cohen, Justin M. Buj, Valentina Signorell, Aita Hetzel, Manuel W. Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title | Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title_full | Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title_fullStr | Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title_full_unstemmed | Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title_short | Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda |
title_sort | community access to rectal artesunate for malaria (caramal): a large-scale observational implementation study in the democratic republic of the congo, nigeria and uganda |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022208/ https://www.ncbi.nlm.nih.gov/pubmed/36962706 http://dx.doi.org/10.1371/journal.pgph.0000464 |
work_keys_str_mv | AT lengelerchristian communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT burrichristian communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT aworphyllis communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT athienoprosciova communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT kimerajoseph communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT tumukundegloria communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT angiroirene communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT tshefuantoinette communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT okitawutshujean communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT kalengajeanclaude communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT omoluabielizabeth communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT akanobabatunde communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT ayodejikazeem communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT okoncharles communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT yusufocheche communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT brunnerninac communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT delventogiulia communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT leetristan communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT lambirismark communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT vissertheodoor communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT napierharrietg communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT cohenjustinm communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT bujvalentina communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT signorellaita communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT hetzelmanuelw communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda AT communityaccesstorectalartesunateformalariacaramalalargescaleobservationalimplementationstudyinthedemocraticrepublicofthecongonigeriaanduganda |