Skip to main content
Top
Published in: Malaria Journal 1/2010

Open Access 01-12-2010 | Case study

Engaging diverse communities participating in clinical trials: case examples from across Africa

Authors: Aceme Nyika, Roma Chilengi, Deus Ishengoma, Sally Mtenga, Mahamadou A Thera, Mahamadou S Sissoko, John Lusingu, Alfred B Tiono, Ogobara Doumbo, Sodiomon B Sirima, Martha Lemnge, Wen L Kilama

Published in: Malaria Journal | Issue 1/2010

Login to get access

Abstract

Background

In the advent of increasing international collaborative research involving participants drawn from populations with diverse cultural backgrounds, community engagement becomes very critical for the smooth conduction of the research. The African Malaria Network Trust (AMANET) is a pan-African non-governmental organization that sponsors and technically supports malaria vaccine trials in various African countries.

Case description

AMANET sponsored phase Ib or IIb clinical trials of several malaria vaccine candidates in various Africa countries. In Burkina Faso, Mali and Tanzania trials of the merozoite surface protein 3 -- in its Long Synthetic Peptide configuration (MSP3 LSP) -- were conducted. In Mali, the apical membrane antigen 1 (AMA1) was tested, while a hybrid of glutamate rich protein (GLURP) and MSP3 (GMZ2) was tested in Gabon. AMANET recognizes the importance of engaging with the communities from which trial participants are drawn, hence community engagement was given priority in all project activities conducted in the various countries.

Discussion and evaluation

Existing local social systems were used to engage the communities from which clinical trial participants were drawn. This article focuses on community engagement activities employed at various AMANET-supported clinical trial sites in different countries, highlighting subtle differences in the approaches used. The paper also gives some general pros and cons of community engagement.

Conclusions

Community engagement enables two-way sharing of accurate information and ideas between researchers and researched communities, which helps to create an environment conducive to smooth research activities with enhanced sense of research ownership by the communities.
Appendix
Available only for authorised users
Literature
1.
go back to reference Doumbo O: It takes a village: medical research and ethics in Mali. Science. 2005, 307: 679-681. 10.1126/science.1109773.CrossRefPubMed Doumbo O: It takes a village: medical research and ethics in Mali. Science. 2005, 307: 679-681. 10.1126/science.1109773.CrossRefPubMed
2.
go back to reference Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA: Community permission for medical research in developing countries. Clin Infect Dis. 2005, 41: 255-259. 10.1086/430707.CrossRefPubMed Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA: Community permission for medical research in developing countries. Clin Infect Dis. 2005, 41: 255-259. 10.1086/430707.CrossRefPubMed
3.
go back to reference Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, Kwiatkowski DP, Doumbo OK: Valid consent for genomic epidemiology in developing countries. PLoS Med. 2007, 4: e95-10.1371/journal.pmed.0040095.PubMedCentralCrossRefPubMed Chokshi DA, Thera MA, Parker M, Diakite M, Makani J, Kwiatkowski DP, Doumbo OK: Valid consent for genomic epidemiology in developing countries. PLoS Med. 2007, 4: e95-10.1371/journal.pmed.0040095.PubMedCentralCrossRefPubMed
4.
go back to reference Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS, Singer PA, Frohlich J, Lavery JV: Grand challenges in global health: community engagement in research in developing countries. Plos Med. 2007, 4: e273-10.1371/journal.pmed.0040273.PubMedCentralCrossRefPubMed Tindana PO, Singh JA, Tracy CS, Upshur REG, Daar AS, Singer PA, Frohlich J, Lavery JV: Grand challenges in global health: community engagement in research in developing countries. Plos Med. 2007, 4: e273-10.1371/journal.pmed.0040273.PubMedCentralCrossRefPubMed
5.
go back to reference Geissler PW, Pool R: Popular concerns about medical research projects in sub-Saharan Africa: a critical voice in debates about medical ethics. Trop Med Int Health. 2006, 11: 975-982. 10.1111/j.1365-3156.2006.01682.x.CrossRefPubMed Geissler PW, Pool R: Popular concerns about medical research projects in sub-Saharan Africa: a critical voice in debates about medical ethics. Trop Med Int Health. 2006, 11: 975-982. 10.1111/j.1365-3156.2006.01682.x.CrossRefPubMed
6.
go back to reference Mills EJ, Singh S, Singh JA, Orbinski JJ, Warren M, Upshur RE: Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early. BMJ. 2005, 331: 1403-1406. 10.1136/bmj.331.7529.1403.PubMedCentralCrossRefPubMed Mills EJ, Singh S, Singh JA, Orbinski JJ, Warren M, Upshur RE: Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early. BMJ. 2005, 331: 1403-1406. 10.1136/bmj.331.7529.1403.PubMedCentralCrossRefPubMed
7.
go back to reference Rothenberg KH: Breast cancer, the genetic "quick fix", and the Jewish community. Ethical, legal and social challenges. Health Matrix. 1997, 7: 97-124.PubMed Rothenberg KH: Breast cancer, the genetic "quick fix", and the Jewish community. Ethical, legal and social challenges. Health Matrix. 1997, 7: 97-124.PubMed
8.
go back to reference Woodage T, King SM, Wacholder S, Hartge P, Struewing JP, McAdams M, Laken SJ, Tucker MA, Brody LC: The APCI1307K allel and cancer in a community-based study of Ashkenazi Jews. Nat Genet. 1998, 20: 62-65. 10.1038/1722.CrossRefPubMed Woodage T, King SM, Wacholder S, Hartge P, Struewing JP, McAdams M, Laken SJ, Tucker MA, Brody LC: The APCI1307K allel and cancer in a community-based study of Ashkenazi Jews. Nat Genet. 1998, 20: 62-65. 10.1038/1722.CrossRefPubMed
9.
go back to reference Rothenberg K, Rutkin AB: Toward a framework of mutualism: the Jewish community in genetics research. Commun Genet. 1998, 1: 148-153. 10.1159/000016154.CrossRef Rothenberg K, Rutkin AB: Toward a framework of mutualism: the Jewish community in genetics research. Commun Genet. 1998, 1: 148-153. 10.1159/000016154.CrossRef
10.
go back to reference International HapMap Consortium: The International HapMap Project. Nature. 2003, 426: 789-796. 10.1038/nature02168.CrossRef International HapMap Consortium: The International HapMap Project. Nature. 2003, 426: 789-796. 10.1038/nature02168.CrossRef
15.
go back to reference Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical?. JAMA. 2000, 283: 2701-2711. 10.1001/jama.283.20.2701.CrossRefPubMed Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical?. JAMA. 2000, 283: 2701-2711. 10.1001/jama.283.20.2701.CrossRefPubMed
17.
go back to reference Sirima SB, N'ebi'e I, Ou'edraogo A, Tiono AB, Konat'e Gansan'e A, Derm'e AI, Diarra A, Ou'edraogo A, Soulama I, Cuzzin-Ouattara N, Cousens S, Leroy O: Safety and immunogenicity of the Plasmodium falciparum merozoite surface protein-3 long synthetic peptide (MSP3-LSP) malaria vaccine in healthy, semi-immune adult males in Burkina Faso, West Africa. Vaccine. 2007, 25: 2723-2732. 10.1016/j.vaccine.2006.05.090.CrossRefPubMed Sirima SB, N'ebi'e I, Ou'edraogo A, Tiono AB, Konat'e Gansan'e A, Derm'e AI, Diarra A, Ou'edraogo A, Soulama I, Cuzzin-Ouattara N, Cousens S, Leroy O: Safety and immunogenicity of the Plasmodium falciparum merozoite surface protein-3 long synthetic peptide (MSP3-LSP) malaria vaccine in healthy, semi-immune adult males in Burkina Faso, West Africa. Vaccine. 2007, 25: 2723-2732. 10.1016/j.vaccine.2006.05.090.CrossRefPubMed
18.
go back to reference Sirima SB, Tiono AB, Ouédraogo A, Diarra A, Ouédraogo AL, Yaro JB, Ouédraogo E, Gansané A, Bougouma E, Konaté AT, Kaboré Y, Traoré A, Chilengi R, Soulama I, Luty AJF, Cousens S, Nébié I: Safety and immunogenicity of the malaria vaccine candidate MSP3 Long Synthetic Peptide in 12-24 months-old Burkinabe children. Plos One. 2009, 4: e7549-10.1371/journal.pone.0007549.PubMedCentralCrossRefPubMed Sirima SB, Tiono AB, Ouédraogo A, Diarra A, Ouédraogo AL, Yaro JB, Ouédraogo E, Gansané A, Bougouma E, Konaté AT, Kaboré Y, Traoré A, Chilengi R, Soulama I, Luty AJF, Cousens S, Nébié I: Safety and immunogenicity of the malaria vaccine candidate MSP3 Long Synthetic Peptide in 12-24 months-old Burkinabe children. Plos One. 2009, 4: e7549-10.1371/journal.pone.0007549.PubMedCentralCrossRefPubMed
20.
go back to reference Kilama WL, Chilengi R, Wanga CL: Towards an African-Driven Malaria Vaccine Development Program: History and Activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg. 2007, 77: 282-288.PubMed Kilama WL, Chilengi R, Wanga CL: Towards an African-Driven Malaria Vaccine Development Program: History and Activities of the African Malaria Network Trust (AMANET). Am J Trop Med Hyg. 2007, 77: 282-288.PubMed
25.
go back to reference Mmbando BP, Segeja MD, Msangeni HA, Sembuche SH, Ishengoma DS, Seth MD, Francis F, Rutta AS, Kamugisha ML, Lemnge MM: Epidemiology of malaria in an area prepared for clinical trials in Korogwe, north-eastern Tanzania. Malar J. 2009, 8: 165-10.1186/1475-2875-8-165.PubMedCentralCrossRefPubMed Mmbando BP, Segeja MD, Msangeni HA, Sembuche SH, Ishengoma DS, Seth MD, Francis F, Rutta AS, Kamugisha ML, Lemnge MM: Epidemiology of malaria in an area prepared for clinical trials in Korogwe, north-eastern Tanzania. Malar J. 2009, 8: 165-10.1186/1475-2875-8-165.PubMedCentralCrossRefPubMed
26.
go back to reference Lusingu JPA, Gesase S, Msham S, Francis F, Lemnge MM, Seth M, Sembuche S, Rutta A, Minja D, Segeja MD, Bosomprah S, Cousens S, Noor R, Chilengi R, Druilhe P: Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12-24 months. Malar J. 2009, 8: 163-10.1186/1475-2875-8-163.PubMedCentralCrossRefPubMed Lusingu JPA, Gesase S, Msham S, Francis F, Lemnge MM, Seth M, Sembuche S, Rutta A, Minja D, Segeja MD, Bosomprah S, Cousens S, Noor R, Chilengi R, Druilhe P: Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12-24 months. Malar J. 2009, 8: 163-10.1186/1475-2875-8-163.PubMedCentralCrossRefPubMed
27.
go back to reference Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Mshamu S, Lang T, Gould J, Dubois M, Demoitié M, Stallaert J, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, Seidlein L: Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. NEJM. 2008, 359: 2521-2532. 10.1056/NEJMoa0807381.PubMedCentralCrossRefPubMed Bejon P, Lusingu J, Olotu A, Leach A, Lievens M, Vekemans J, Mshamu S, Lang T, Gould J, Dubois M, Demoitié M, Stallaert J, Vansadia P, Carter T, Njuguna P, Awuondo KO, Malabeja A, Abdul O, Gesase S, Mturi N, Drakeley CJ, Savarese B, Villafana T, Ballou WR, Cohen J, Riley EM, Lemnge MM, Marsh K, Seidlein L: Efficacy of RTS,S/AS01E vaccine against malaria in children 5 to 17 months of age. NEJM. 2008, 359: 2521-2532. 10.1056/NEJMoa0807381.PubMedCentralCrossRefPubMed
32.
go back to reference Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, Membi C, Omari S, Urassa A, Mshinda H, Jumanne A, Salim N, Shomari M, Aebi T, Schellenberg DM, Carter T, Villafana T, Demoitié M, Dubois M, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M: Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants. NEJM. 2008, 359: 2533-2544. 10.1056/NEJMoa0807773.CrossRefPubMed Abdulla S, Oberholzer R, Juma O, Kubhoja S, Machera F, Membi C, Omari S, Urassa A, Mshinda H, Jumanne A, Salim N, Shomari M, Aebi T, Schellenberg DM, Carter T, Villafana T, Demoitié M, Dubois M, Leach A, Lievens M, Vekemans J, Cohen J, Ballou WR, Tanner M: Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants. NEJM. 2008, 359: 2533-2544. 10.1056/NEJMoa0807773.CrossRefPubMed
33.
go back to reference DeCosta A, D'Souza N, Krisnan S, Chabra MS, Shihaam I, Goswami K: Community based trials and informed consent in rural North India. JME. 2004, 30: 318-323. DeCosta A, D'Souza N, Krisnan S, Chabra MS, Shihaam I, Goswami K: Community based trials and informed consent in rural North India. JME. 2004, 30: 318-323.
34.
go back to reference Nyika A, Wassenaar DR, Mamotte N: The effect of relationships on decision-making process of women in Harare, Zimbabwe. Ethics & Behavior. 2009, 19: 184-200.CrossRef Nyika A, Wassenaar DR, Mamotte N: The effect of relationships on decision-making process of women in Harare, Zimbabwe. Ethics & Behavior. 2009, 19: 184-200.CrossRef
Metadata
Title
Engaging diverse communities participating in clinical trials: case examples from across Africa
Authors
Aceme Nyika
Roma Chilengi
Deus Ishengoma
Sally Mtenga
Mahamadou A Thera
Mahamadou S Sissoko
John Lusingu
Alfred B Tiono
Ogobara Doumbo
Sodiomon B Sirima
Martha Lemnge
Wen L Kilama
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Malaria Journal / Issue 1/2010
Electronic ISSN: 1475-2875
DOI
https://doi.org/10.1186/1475-2875-9-86

Other articles of this Issue 1/2010

Malaria Journal 1/2010 Go to the issue