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

doi:10.1101/2021.12.10.21266567

Cited by 5 publications

(13 citation statements)

References 32 publications

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“…This study has several strengths. First, it covered three different contexts with varying intensities of malaria transmission, access to health care, and differences in the implementation of iCCM/IMCI policies [17]. Secondly, the study was community-based and enrolled a large number of children with severe febrile illness from remote communities.…”

Section: Discussionmentioning

confidence: 99%

“…The overall study population was 2.5 million of which 476,000 (19%) were children under 5 years. Further details are provided elsewhere [17].…”

Section: Methodsmentioning

confidence: 99%

“…The Community Access to Rectal Artesunate for Malaria (CARAMAL) project included an observational study accompanying the implementation of RAS in the Democratic Republic of the Congo (DRC), Nigeria and Uganda and is described in detail in a companion paper [17]. The training provided to CHW and staff of PHCs during the roll-out of RAS emphasised the need to refer severely sick children to an appropriate and recognised RHF capable of managing the child’s severe condition, rather than to the nearest or next-higher level provider.…”

Section: Introductionmentioning

confidence: 99%

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Pre-referral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Brunner

Omoluabi²,

Awor

et al. 2021

Preprint

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Background: Children who receive pre-referral rectal artesunate (RAS) require urgent referral to a health facility where appropriate treatment for severe malaria can be provided. However, the rapid improvement of a child's condition after RAS administration may influence a caregiver's decision to follow this recommendation. Currently, the evidence on the effect of RAS on referral completion is limited. In this study, we investigated the relationship between RAS implementation and administration and referral completion. Methods and Findings: An observational study accompanied the roll-out of RAS in three malaria endemic settings in the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Community health workers and primary health centres enrolled children under five years with suspected severe malaria before and after the roll-out of RAS. All children were followed up 28 days after enrolment to assess their treatment seeking pathways, treatments received, and their health outcome. In total, 8,365 children were enrolled, 77% of whom fulfilled all inclusion criteria and had a known referral completion status. Referral completion was 67% (1,408/2,104) in DRC, 48% (287/600) in Nigeria and 58% (2,170/3,745) in Uganda. In DRC and Uganda, RAS users were less likely to complete referral than RAS non-users in the pre-roll-out phase (adjusted odds ratio [aOR] = 0.48, 95% CI 0.30-0.77 and aOR = 0.72, 95% CI 0.58-0.88, respectively). Among children seeking care from a primary health centre in Nigeria, RAS users were less likely to complete referral compared to RAS non-users in the post-roll-out phase (aOR = 0.18, 95% CI 0.05-0.71). In Uganda, among children who completed referral, RAS users were significantly more likely to complete referral on time than RAS non-users enrolled in the pre-roll-out phase (aOR = 1.81, 95% CI 1.17-2.79). Conclusions: The findings of this study raise legitimate concerns that the roll-out of RAS may lead to lower referral completion in children who were administered pre-referral RAS. To ensure that community-based programmes are effectively implemented, barriers to referral completion need to be addressed at all levels. Alternative effective treatment options should be provided to children unable to complete referral.

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Section: Discussionmentioning

confidence: 99%

“…The overall study population was 2.5 million of which 476,000 (19%) were children under 5 years. Further details are provided elsewhere [17].…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pre-referral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Brunner

Omoluabi²,

Awor

et al. 2021

Preprint

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“…[6][7][8][9][10] Unfortunately, the subsequent deployment of rectal artesunate has gone very slowly, and now it has been halted. 12 THE CARAMAL STUDY This policy reverse is because of a large, 'real world', sequential observational study (CARAMAL), [13][14][15] which evaluated the implementation of RAS in the Democratic Republic of Congo (DRC), Uganda and Nigeria.…”

Section: Bmj Global Healthmentioning

confidence: 99%

“…This policy reverse is because of a large, ‘real world’, sequential observational study (CARAMAL),13–15 which evaluated the implementation of RAS in the Democratic Republic of Congo (DRC), Uganda and Nigeria. The study described shortcomings in patient referral to health facilities after they had received RAS, and incomplete follow-up treatment with oral artemisinin combination treatments.…”

Section: The Caramal Studymentioning

confidence: 99%

Stopping prereferral rectal artesunate — a grave error

et al. 2022

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Prereferral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Brunner

Omoluabi²,

Awor

et al. 2022

BMJ Glob Health

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IntroductionChildren who receive prereferral rectal artesunate (RAS) require urgent referral to a health facility where appropriate treatment for severe malaria can be provided. However, the rapid improvement of a child’s condition after RAS administration may influence a caregiver’s decision to follow this recommendation. Currently, the evidence on the effect of RAS on referral completion is limited.MethodsAn observational study accompanied the roll-out of RAS in three malaria endemic settings in the Democratic Republic of the Congo (DRC), Nigeria and Uganda. Community health workers and primary health centres enrolled children under 5 years with suspected severe malaria before and after the roll-out of RAS. All children were followed up 28 days after enrolment to assess their treatment-seeking pathways.ResultsReferral completion was 67% (1408/2104) in DRC, 48% (287/600) in Nigeria and 58% (2170/3745) in Uganda. In DRC and Uganda, RAS users were less likely to complete referral than RAS non-users in the pre-roll-out phase (adjusted OR (aOR)=0.48, 95% CI 0.30 to 0.77 and aOR=0.72, 95% CI 0.58 to 0.88, respectively). Among children seeking care from a primary health centre in Nigeria, RAS users were less likely to complete referral compared with RAS non-users in the post-roll-out phase (aOR=0.18, 95% CI 0.05 to 0.71). In Uganda, among children who completed referral, RAS users were significantly more likely to complete referral on time than RAS non-users enrolled in the pre-roll-out phase (aOR=1.81, 95% CI 1.17 to 2.79).ConclusionsThe findings of this study raise legitimate concerns that the roll-out of RAS may lead to lower referral completion in children who were administered prereferral RAS. To ensure that community-based programmes are effectively implemented, barriers to referral completion need to be addressed at all levels. Alternative effective treatment options should be provided to children unable to complete referral.Trial registrstion numberNCT03568344; ClinicalTrials.gov.

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Community access to rectal artesunate for malaria (CARAMAL): a large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda

Cited by 5 publications

References 32 publications

Pre-referral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Pre-referral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Stopping prereferral rectal artesunate — a grave error

Prereferral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

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