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3. The impact of risk factors on aspirin's efficacy for the prevention of preterm birth

Author

Nuss, Emily E., Hoffman, Matthew K., Goudar, Shivaprasad S., Kavi, Avinash, Metgud, Mrityunjay, Somannavar, Manjunath, Okitawutshu, Jean, Lokangaka, Adrien, Tshefu, Antoinette, Bauserman, Melissa, Tembo, Abigail Mwapule, Chomba, Elwyn, Carlo, Waldemar A., Figueroa, Lester, Krebs, Nancy F., Jessani, Saleem, Saleem, Sarah, Goldenberg, Robert L., Kurhe, Kunal, Das, Prabir, Hibberd, Patricia L., Achieng, Emmah, Nyongesa, Paul, Esamai, Fabian, Liechty, Edward A., Bucher, Sherri, Goco, Norman, Hemingway-Foday, Jennifer, Moore, Janet, McClure, Elizabeth M., Silver, Robert M., and Derman, Richard J.

Published
2023
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4. Cost-effectiveness of low-dose aspirin for the prevention of preterm birth: a prospective study of the Global Network for Women's and Children's Health Research

Author

Patterson, Jackie K, Neuwahl, Simon, Goco, Norman, Moore, Janet, Goudar, Shivaprasad S, Derman, Richard J, Hoffman, Matthew, Metgud, Mrityunjay, Somannavar, Manjunath, Kavi, Avinash, Okitawutshu, Jean, Lokangaka, Adrien, Tshefu, Antoinette, Bose, Carl L, Mwapule, Abigail, Mwenechanya, Musaku, Chomba, Elwyn, Carlo, Waldemar A, Chicuy, Javier, Figueroa, Lester, Krebs, Nancy F, Jessani, Saleem, Saleem, Sarah, Goldenberg, Robert L, Kurhe, Kunal, Das, Prabir, Patel, Archana, Hibberd, Patricia L, Achieng, Emmah, Nyongesa, Paul, Esamai, Fabian, Bucher, Sherri, Liechty, Edward A, Bresnahan, Brian W, Koso-Thomas, Marion, and McClure, Elizabeth M

Published
2023
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5. Health system readiness and the implementation of rectal artesunate for severe malaria in sub-Saharan Africa: an analysis of real-world costs and constraints

Author

Lambiris, Mark J, Venga, Guy Ndongala, Ssempala, Richard, Balogun, Victor, Galactionova, Katya, Musiitwa, Michael, Kagwire, Fred, Olosunde, Oluseyi, Emedo, Emmanel, Luketa, Sylvie, Sangare, Moulaye, Buj, Valentina, Delvento, Giulia, Tshefu, Antoinette, Okitawutshu, Jean, Omoluabi, Elizabeth, Awor, Phyllis, Signorell, Aita, Hetzel, Manuel W, Lee, Tristan T, Brunner, Nina C, Cereghetti, Nadja, Visser, Theodoor, Napier, Harriet G, Burri, Christian, and Lengeler, Christian

Published
2023
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6. Acceptability of pre-referral rectal artesunate for severe malaria in children under 5 years by health workers and caregivers in the Democratic Republic of the Congo, Nigeria and Uganda

Author

Awor, Phyllis, Kimera, Joseph, Athieno, Proscovia, Tumukunde, Gloria, Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Signorell, Aita, Brunner, Nina, Kalenga, Jean-Claude, Akano, Babatunde, Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Delvento, Giulia, Lee, Tristan, Burri, Christian, Lengeler, Christian, and Hetzel, Manuel W.

Published
2022
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8. Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children under 5 years of age: a multi-country observational study

Author

Hetzel, Manuel W., Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Awor, Phyllis, Signorell, Aita, Brunner, Nina C., Kalenga, Jean-Claude, Akano, Babatunde K., Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Athieno, Proscovia, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Delvento, Giulia, Lee, Tristan T., Lambiris, Mark J., Kwiatkowski, Marek, Cereghetti, Nadja, Visser, Theodoor, Napier, Harriet G., Cohen, Justin M., Buj, Valentina, Burri, Christian, and Lengeler, Christian

Published
2022
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9. Correction: Health worker compliance with severe malaria treatment guidelines in the context of implementing pre-referral rectal artesunate in the Democratic Republic of the Congo, Nigeria, and Uganda: An operational study

Author

Signorell, Aita, Awor, Phyllis, Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Hetzel, Manuel W., Athieno, Proscovia, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Kalenga, Jean-Claude, Akano, Babatunde K., Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Delvento, Giulia, Lee, Tristan T., Brunner, Nina C., Lambiris, Mark J., Okuma, James, Cereghetti, Nadja, Buj, Valentina, Visser, Theodoor, Napier, Harriet G., Lengeler, Christian, and Burri, Christian

Subjects
Biological sciences
Abstract

Author(s): Aita Signorell, Phyllis Awor, Jean Okitawutshu, Antoinette Tshefu, Elizabeth Omoluabi, Manuel W. Hetzel, Proscovia Athieno, Joseph Kimera, Gloria Tumukunde, Irene Angiro, Jean-Claude Kalenga, Babatunde K. Akano, Kazeem Ayodeji, Charles [...]

Published
2023
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10. Health worker compliance with severe malaria treatment guidelines in the context of implementing pre-referral rectal artesunate in the Democratic Republic of the Congo, Nigeria, and Uganda: An operational study

Author

Signorell, Aita, Awor, Phyllis, Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Hetzel, Manuel W., Athieno, Proscovia, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Kalenga, Jean-Claude, Akano, Babatunde K., Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Delvento, Giulia, Lee, Tristan T., Brunner, Nina C., Lambiris, Mark J., Okuma, James, Cereghetti, Nadja, Buj, Valentina, Visser, Theodoor, Napier, Harriet G., Lengeler, Christian, and Burri, Christian

Subjects
Practice guidelines (Medicine) -- Evaluation, Rectum, Medication by -- Usage, Malaria -- Drug therapy, Communicable diseases in children -- Drug therapy, Medical care -- Quality management, Medical personnel -- Behavior -- Evaluation, Biological sciences
Abstract

Background For a full treatment course of severe malaria, community-administered pre-referral rectal artesunate (RAS) should be completed by post-referral treatment consisting of an injectable antimalarial and oral artemisinin-based combination therapy (ACT). This study aimed to assess compliance with this treatment recommendation in children under 5 years. Methods and findings This observational study accompanied the implementation of RAS in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda between 2018 and 2020. Antimalarial treatment was assessed during admission in included referral health facilities (RHFs) in children under 5 with a diagnosis of severe malaria. Children were either referred from a community-based provider or directly attending the RHF. RHF data of 7,983 children was analysed for appropriateness of antimalarials; a subsample of 3,449 children was assessed additionally for dosage and method of ACT provision (treatment compliance). A parenteral antimalarial and an ACT were administered to 2.7% (28/1,051) of admitted children in Nigeria, 44.5% (1,211/2,724) in Uganda, and 50.3% (2,117/4,208) in DRC. Children receiving RAS from a community-based provider were more likely to be administered post-referral medication according to the guidelines in DRC (adjusted odds ratio (aOR) = 2.13, 95% CI 1.55 to 2.92, P < 0.001), but less likely in Uganda (aOR = 0.37, 95% CI 0.14 to 0.96, P = 0.04) adjusting for patient, provider, caregiver, and other contextual factors. While in DRC, inpatient ACT administration was common, ACTs were often prescribed at discharge in Nigeria (54.4%, 229/421) and Uganda (53.0%, 715/1,349). Study limitations include the unfeasibility to independently confirm the diagnosis of severe malaria due to the observational nature of the study. Conclusions Directly observed treatment was often incomplete, bearing a high risk for partial parasite clearance and disease recrudescence. Parenteral artesunate not followed up with oral ACT constitutes an artemisinin monotherapy and may favour the selection of resistant parasites. In connection with the finding that pre-referral RAS had no beneficial effect on child survival in the 3 study countries, concerns about an effective continuum of care for children with severe malaria seem justified. Stricter compliance with the WHO severe malaria treatment guidelines is critical to effectively manage this disease and further reduce child mortality. Trial registration ClinicalTrials.gov (NCT03568344)., Author(s): Aita Signorell 1,2,*, Phyllis Awor 3, Jean Okitawutshu 1,2,4, Antoinette Tshefu 4, Elizabeth Omoluabi 5, Manuel W. Hetzel 1,2, Proscovia Athieno 3, Joseph Kimera 3, Gloria Tumukunde 3, Irene [...]

Published
2023
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11. Corrigendum to The impact of risk factors on aspirin's efficacy for the prevention of preterm birth. American Journal of Obstetrics & Gynecology MFM. Volume 5, Issue 10, October 2023, 101095

Author

Nuss, Emily E., Hoffman, Matthew K., Goudar, Shivaprasad S., Kavi, Avinash, Metgud, Mrityunjay, Somannavar, Manjunath, Okitawutshu, Jean, Lokangaka, Adrien, Tshefu, Antoinette, Bauserman, Melissa, Tembo, Abigail Mwapule, Chomba, Elwyn, Carlo, Waldemar A., Figueroa, Lester, Krebs, Nancy F., Jessani, Saleem, Saleem, Sarah, Goldenberg, Robert L., Kurhe, Kunal, Das, Prabir, Hibberd, Patricia L., Achieng, Emmah, Nyongesa, Paul, Esamai, Fabian, Liechty, Edward A., Bucher, Sherri, Goco, Norman, Hemingway-Foday, Jennifer, Moore, Janet, McClure, Elizabeth M., Silver, Robert M., Derman, Richard J., and Patel, Archana

Published
2024
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12. Low-Dose Aspirin for the Prevention of Preterm Delivery in Nulliparous Women With a Singleton Pregnancy (ASPIRIN): A Randomized, Double-blind, Placebo-Controlled Trial

Author

Hoffman, Matthew K., Goudar, Shivaprasad S., Kodkany, Bhalachandra S., Metgud, Mrityunjay, Somannavar, Manjunath, Okitawutshu, Jean, Lokangaka, Adrien, Tshefu, Antoinette, Bose, Carl L., Mwapule, Abigail, Mwenechanya, Musaku, Chomba, Elwyn, Carlo, Waldemar A., Chicuy, Javier, Figueroa, Lester, Garces, Ana, Krebs, Nancy F., Jessani, Saleem, Zehra, Farnaz, Saleem, Sarah, Goldenberg, Robert L., Kurhe, Kunal, Das, Prabir, Patel, Archana, Hibberd, Patricia L., Achieng, Emmah, Nyongesa, Paul, Esamai, Fabian, Liechty, Edward A., Goco, Norman, Hemingway-Foday, Jennifer, Moore, Janet, Nolen, Tracy L., McClure, Elizabeth M., Koso-Thomas, Marion, Miodovnik, Menachem, Silver, R., and Derman, Richard J.

Published
2020
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13. Real world costs and barriers to the successful implementation of rectal artesunate as pre-referral treatment for severe malaria in Sub-Saharan Africa

Author

Lambiris, Mark, primary, Ndongala, Guy, additional, Ssempala, Richard, additional, Balogun, Victor, additional, Musiitwa, Michael, additional, Kagwire, Fred, additional, Olosunde, Oluseyi, additional, Emedo, Emmanel, additional, Luketa, Sylvie, additional, Sangare, Moulaye, additional, Buj, Valentina, additional, Delvento, Giulia, additional, Galactionova, Katya, additional, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Omoluabi, Elizabeth, additional, Awor, Phyllis, additional, Signorell, Aita, additional, Hetzel, Manuel W., additional, Lee, Tristan T., additional, Brunner, Nina C., additional, Cereghetti, Nadja, additional, Visser, Theodoor, additional, Napier, Harriet G., additional, Burri, Christian, additional, and Lengeler, Christian, additional

Published
2022
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14. Prereferral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Author

Brunner, Nina C, primary, Omoluabi, Elizabeth, additional, Awor, Phyllis, additional, Okitawutshu, Jean, additional, Tshefu Kitoto, Antoinette, additional, Signorell, Aita, additional, Akano, Babatunde, additional, Ayodeji, Kazeem, additional, Okon, Charles, additional, Yusuf, Ocheche, additional, Athieno, Proscovia, additional, Kimera, Joseph, additional, Tumukunde, Gloria, additional, Angiro, Irene, additional, Kalenga, Jean-Claude, additional, Delvento, Giulia, additional, Lee, Tristan T, additional, Lambiris, Mark J, additional, Ross, Amanda, additional, Cereghetti, Nadja, additional, Visser, Theodoor, additional, Napier, Harriet G, additional, Buj, Valentina, additional, Burri, Christian, additional, Lengeler, Christian, additional, and Hetzel, Manuel W, additional

Published
2022
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15. Additional file 1 of Key factors predicting suspected severe malaria case management and health outcomes: an operational study in the Democratic Republic of the Congo

Author

Okitawutshu, Jean, Signorell, Aita, Kalenga, Jean-Claude, Mukomena, Eric, Delvento, Giulia, Burri, Christian, Mwaluke, Fatou, Buj, Valentina, Sangare, Moulaye, Luketa, Sylvie, Brunner, Nina, Lee, Tristan, Hetzel, Manuel, Lengeler, Christian, and Tshefu, Antoinette

Abstract

Additional file 1: Figure S1. Map displaying the three CARAMAL study health zones in the Democratic Republicof the Congo.

Published
2022
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16. Additional file 2 of Key factors predicting suspected severe malaria case management and health outcomes: an operational study in the Democratic Republic of the Congo

Author

Okitawutshu, Jean, Signorell, Aita, Kalenga, Jean-Claude, Mukomena, Eric, Delvento, Giulia, Burri, Christian, Mwaluke, Fatou, Buj, Valentina, Sangare, Moulaye, Luketa, Sylvie, Brunner, Nina, Lee, Tristan, Hetzel, Manuel, Lengeler, Christian, and Tshefu, Antoinette

Abstract

Additional file 2: Figure S2. iCCM general danger signs and DRC-specific iCCM danger signs.

Published
2022
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17. Additional file 1 of Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children under 5 years of age: a multi-country observational study

Author

Hetzel, Manuel W., Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Awor, Phyllis, Signorell, Aita, Brunner, Nina C., Kalenga, Jean-Claude, Akano, Babatunde K., Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Athieno, Proscovia, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Delvento, Giulia, Lee, Tristan T., Lambiris, Mark J., Kwiatkowski, Marek, Cereghetti, Nadja, Visser, Theodoor, Napier, Harriet G., Cohen, Justin M., Buj, Valentina, Burri, Christian, and Lengeler, Christian

Abstract

Additional file 1: Table S1. Study settings. Table S2. Adjusted regression estimates, overall and restricted to pre-COVID-19 period (before April 2020).

Published
2022
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18. Additional file 2 of Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children under 5 years of age: a multi-country observational study

Author

Hetzel, Manuel W., Okitawutshu, Jean, Tshefu, Antoinette, Omoluabi, Elizabeth, Awor, Phyllis, Signorell, Aita, Brunner, Nina C., Kalenga, Jean-Claude, Akano, Babatunde K., Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Athieno, Proscovia, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Delvento, Giulia, Lee, Tristan T., Lambiris, Mark J., Kwiatkowski, Marek, Cereghetti, Nadja, Visser, Theodoor, Napier, Harriet G., Cohen, Justin M., Buj, Valentina, Burri, Christian, and Lengeler, Christian

Abstract

Additional file 2: Figure S1. Inclusion flow-charts. Figure S2. Complementary day 28 health outcome indicators, by country. Figure S3. Results of HRP2/pLDH Combo tests at day 28 follow-up, by detected antigen (HRP2 and/or pLDH), in a sub-sample of study patients. Figure S4. Mean haemoglobin (Hb) concentration and percent of children with anaemia (Hb

Published
2022
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19. Additional file 4 of Key factors predicting suspected severe malaria case management and health outcomes: an operational study in the Democratic Republic of the Congo

Author

Okitawutshu, Jean, Signorell, Aita, Kalenga, Jean-Claude, Mukomena, Eric, Delvento, Giulia, Burri, Christian, Mwaluke, Fatou, Buj, Valentina, Sangare, Moulaye, Luketa, Sylvie, Brunner, Nina, Lee, Tristan, Hetzel, Manuel, Lengeler, Christian, and Tshefu, Antoinette

Abstract

Additional file 4: Table S1. Number of deaths among community enrolment during post-RAS per iCCM general danger signs and DRC-specific iCCM danger signs. N = 2281.

Published
2022
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20. Acceptability of Rectal Artesunate as pre-referral treatment for severe malaria in children under 5 years by health workers and caregivers in the Democratic Republic of the Congo, Nigeria and Uganda

Author

Awor, Phyllis, primary, Kimera, Joseph, additional, Athieno, Proscovia, additional, Tumukunde, Gloria, additional, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Omoluabi, Elizabeth, additional, Signorell, Aita, additional, Brunner, Nina, additional, Kalenga, Jean-Claude, additional, Akano, Babatunde, additional, Ayodeji, Kazeem, additional, Okon, Charles, additional, Yusuf, Ocheche, additional, Delvento, Giulia, additional, Lee, Tristan, additional, Burri, Christian, additional, Lengeler, Christian, additional, and Hetzel, Manuel W., additional

Published
2021
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21. Danger signs and management of suspected severe malaria cases at community level and in referral health facilities: an operational study in the Democratic Republic of the Congo

Author

Okitawutshu, Jean, primary, Signorell, Aita, additional, Kalenga, Jean-Claude, additional, Mukomena, Eric, additional, Delvento, Giulia, additional, Burri, Christian, additional, Mwaluke, Fatou, additional, Buj, Valentina, additional, Sangare, Moulaye, additional, Luketa, Sylvie, additional, Brunner, Nina C., additional, Lee, Tristan T., additional, Hetzel, Manuel W., additional, Lengeler, Christian, additional, and Tshefu, Antoinette, additional

Published
2021
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22. Health worker compliance with severe malaria treatment guidelines in the context of implementing pre-referral rectal artesunate: an operational study in three high burden countries

Author

Signorell, Aita, primary, Awor, Phyllis, additional, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Omoluabi, Elizabeth, additional, Hetzel, Manuel W., additional, Athieno, Prosciova, additional, Kimera, Joseph, additional, Tumukunde, Gloria, additional, Angiro, Irene, additional, Kalenga, Jean-Claude, additional, Akano, Babatunde, additional, Ayodeji, Kazeem, additional, Okon, Charles, additional, Yusuf, Ocheche, additional, Delvento, Giulia, additional, Lee, Tristan T., additional, Brunner, Nina C., additional, Lambiris, Mark, additional, Okuma, James, additional, Cereghetti, Nadja, additional, Buj, Valentina, additional, Visser, Theodoor, additional, Napier, Harriet G, additional, Lengeler, Christian, additional, and Burri, Christian, additional

Published
2021
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23. Pre-referral rectal artesunate and referral completion among children with suspected severe malaria in the Democratic Republic of the Congo, Nigeria and Uganda

Author

Brunner, Nina C, primary, Omoluabi, Elizabeth, additional, Awor, Phyllis, additional, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Signorell, Aita, additional, Akano, Babatunde, additional, Ayodeji, Kazeem, additional, Okon, Charles, additional, Yusuf, Ocheche, additional, Athieno, Proscovia, additional, Kimera, Joseph, additional, Tumukunde, Gloria, additional, Angiro, Irene, additional, Kalenga, Jean-Claude, additional, Delvento, Giulia, additional, Lee, Tristan, additional, Lambiris, Mark, additional, Ross, Amanda, additional, Cereghetti, Nadja, additional, Visser, Theodoor, additional, Napier, Harriet G, additional, Buj, Valentina, additional, Burri, Christian, additional, Lengeler, Christian, additional, and Hetzel, Manuel W, additional

Published
2021
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24. Effectiveness of rectal artesunate as pre-referral treatment for severe malaria in children <5 years of age

Author

Hetzel, Manuel W., primary, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Omoluabi, Elizabeth, additional, Awor, Phyllis, additional, Signorell, Aita, additional, Brunner, Nina C., additional, Kalenga, Jean-Claude, additional, Akano, Babatunde, additional, Ayodeji, Kazeem, additional, Okon, Charles, additional, Yusuf, Ocheche, additional, Athieno, Proscovia, additional, Kimera, Joseph, additional, Tumukunde, Gloria, additional, Angiro, Irene, additional, Delvento, Giulia, additional, Lee, Tristan, additional, Lambiris, Mark, additional, Kwiatkowski, Marek, additional, Cereghetti, Nadja, additional, Visser, Theodoor, additional, Napier, Harriet G., additional, Cohen, Justin M., additional, Buj, Valentina, additional, Burri, Christian, additional, and Lengeler, Christian, additional

Published
2021
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25. Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries

Author

Short, Vanessa L., primary, Hoffman, Matthew, additional, Metgud, Mrityunjay, additional, Kavi, Avinash, additional, Goudar, Shivaprasad S., additional, Okitawutshu, Jean, additional, Tshefu, Antoinette, additional, Bose, Carl L., additional, Mwenechanya, Musaku, additional, Chomba, Elwyn, additional, Carlo, Waldemar A., additional, Figueroa, Lester, additional, Garces, Ana, additional, Krebs, Nancy F., additional, Jessani, Saleem, additional, Saleem, Sarah, additional, Goldenberg, Robert L., additional, Das, Prabir Kumar, additional, Patel, Archana, additional, Hibberd, Patricia L., additional, Achieng, Emmah, additional, Nyongesa, Paul, additional, Esamai, Fabian, additional, Bucher, Sherri, additional, Nowak, Kayla J., additional, Goco, Norman, additional, Nolen, Tracy L., additional, McClure, Elizabeth M., additional, Koso-Thomas, Marion, additional, Miodovnik, Menachem, additional, and Derman, Richard J., additional

Published
2021
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26. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial

Author

Hoffman, Matthew K, primary, Goudar, Shivaprasad S, additional, Kodkany, Bhalachandra S, additional, Metgud, Mrityunjay, additional, Somannavar, Manjunath, additional, Okitawutshu, Jean, additional, Lokangaka, Adrien, additional, Tshefu, Antoinette, additional, Bose, Carl L, additional, Mwapule, Abigail, additional, Mwenechanya, Musaku, additional, Chomba, Elwyn, additional, Carlo, Waldemar A, additional, Chicuy, Javier, additional, Figueroa, Lester, additional, Garces, Ana, additional, Krebs, Nancy F, additional, Jessani, Saleem, additional, Zehra, Farnaz, additional, Saleem, Sarah, additional, Goldenberg, Robert L, additional, Kurhe, Kunal, additional, Das, Prabir, additional, Patel, Archana, additional, Hibberd, Patricia L, additional, Achieng, Emmah, additional, Nyongesa, Paul, additional, Esamai, Fabian, additional, Liechty, Edward A, additional, Goco, Norman, additional, Hemingway-Foday, Jennifer, additional, Moore, Janet, additional, Nolen, Tracy L, additional, McClure, Elizabeth M, additional, Koso-Thomas, Marion, additional, Miodovnik, Menachem, additional, Silver, R, additional, Derman, Richard J, additional, Bauserman, Melissa, additional, Bose, Carl, additional, Bucher, Sherri, additional, Carlo, Waldemar, additional, Charantimath, Umesh S, additional, Derman, Richard, additional, Ganachari, MS, additional, Goco, Noman, additional, Goldenberg, Robert, additional, Goudar, Shivaprasad, additional, Hibberd, Patricia, additional, Hoffman, Matthew, additional, Honnungar, Narayan V, additional, Kavi, Avinash, additional, Kodkany, Bhalachandra, additional, Krebs, Nancy, additional, Kumar Shashikanth, Yogesh, additional, Liechty, Edward, additional, MacGuire, Emily, additional, Mallapur, Ashalata A, additional, McClure, Elizabeth, additional, Naqvi, Farnaz, additional, Naqvi, Seemab, additional, Nathan, Robert, additional, Nolen, Tracy, additional, Parepalli, Suchita, additional, Ramadurg, Umesh Y, additional, Silver, Robert, additional, Soomro, Zahid, additional, Vernekar, Sunil S, additional, and Wallace, Dennis, additional

Published
2020
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27. Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda.

Author

Lengeler C, Burri C, Awor P, Athieno P, Kimera J, Tumukunde G, Angiro I, Tshefu A, Okitawutshu J, Kalenga JC, Omoluabi E, Akano B, Ayodeji K, Okon C, Yusuf O, Brunner NC, Delvento G, Lee T, Lambiris M, Visser T, Napier HG, Cohen JM, Buj V, Signorell A, and Hetzel MW

Abstract

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., Competing Interests: Authors EO, BA, KA, CO, and OY are employees of Akena Associates. There are no patents, products in development or marketed products to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials. None of the authors have any competing interests in the topic presented in this manuscript., (Copyright: © 2022 Lengeler et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2022
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