Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt
Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are “controlled” by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research vol...
| Main Authors: | , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-04-01
|
| Series: | Frontiers in Public Health |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2022.793913/full |
| _version_ | 1818009524200538112 |
|---|---|
| author | Noni Mumba Patricia Njuguna Patricia Njuguna Primus Chi Vicki Marsh Vicki Marsh Esther Awuor Mainga Hamaluba Mainga Hamaluba Cynthia Mauncho Salim Mwalukore Johnson Masha Mary Mwangoma Betty Kalama Hassan Alphan Juliana Wambua Philip Bejon Philip Bejon Dorcas Kamuya Dorcas Kamuya Melissa C. Kapulu Melissa C. Kapulu |
| author_facet | Noni Mumba Patricia Njuguna Patricia Njuguna Primus Chi Vicki Marsh Vicki Marsh Esther Awuor Mainga Hamaluba Mainga Hamaluba Cynthia Mauncho Salim Mwalukore Johnson Masha Mary Mwangoma Betty Kalama Hassan Alphan Juliana Wambua Philip Bejon Philip Bejon Dorcas Kamuya Dorcas Kamuya Melissa C. Kapulu Melissa C. Kapulu |
| author_sort | Noni Mumba |
| collection | DOAJ |
| description | Human infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are “controlled” by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases. Traditionally, HIS have been conducted primarily in high-income countries (HICs) but are now increasingly being conducted in low-and-middle income countries (LMICs). In LMICs settings, HIS are likely to raise concerns among various stakeholders including participating populations and regulatory bodies, that are unfamiliar with this type of research. Deliberately infecting a healthy individual with a disease-causing pathogen seems to go against the normal practice of medicine of “do no harm”. Such types of studies can give rise to increased rumors and jeopardize research participation in study activities, including non-HIS research. Community engagement can be one approach to address particular issues that HIS studies raise through meaningfully engaging with communities, where views and voices inform the conduct of HIS studies. In addition, engagement can inform the ethical conduct and acceptability of HIS studies in LMICs settings and provide opportunities for sharing information, listening to, and responding to concerns and views from potential participants, and the larger community in which the study would be conducted. Despite community engagement being an important aspect to consider, very few published and gray literature cover the types of approaches that have been used, and lessons learnt in engagement for HIS. This article outlinesthe community engagement approaches that were used to engage stakeholders and communities for malaria HIS-controlled human malaria infection (CHMI), undertaken in Kilifi, Kenya. It outlines the engagement activities across the research cycle, from activities conducted during protocol development, to planning, and implementation of the study. We discuss the challenges experienced, lessons learnt, and provide some recommendations for engagement around HIS. |
| first_indexed | 2024-04-14T05:42:56Z |
| format | Article |
| id | doaj.art-52b830927c7f49c58453d86f3b97b98f |
| institution | Directory Open Access Journal |
| issn | 2296-2565 |
| language | English |
| last_indexed | 2024-04-14T05:42:56Z |
| publishDate | 2022-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Public Health |
| spelling | doaj.art-52b830927c7f49c58453d86f3b97b98f2022-12-22T02:09:22ZengFrontiers Media S.A.Frontiers in Public Health2296-25652022-04-011010.3389/fpubh.2022.793913793913Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons LearntNoni Mumba0Patricia Njuguna1Patricia Njuguna2Primus Chi3Vicki Marsh4Vicki Marsh5Esther Awuor6Mainga Hamaluba7Mainga Hamaluba8Cynthia Mauncho9Salim Mwalukore10Johnson Masha11Mary Mwangoma12Betty Kalama13Hassan Alphan14Juliana Wambua15Philip Bejon16Philip Bejon17Dorcas Kamuya18Dorcas Kamuya19Melissa C. Kapulu20Melissa C. Kapulu21Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaPATH Centre for Vaccine Innovation and Access, Nairobi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaCentre for Tropical Medicine and Global Health, Oxford University, Oxford, United KingdomKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaCentre for Tropical Medicine and Global Health, Oxford University, Oxford, United KingdomKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaCentre for Tropical Medicine and Global Health, Oxford University, Oxford, United KingdomKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaCentre for Tropical Medicine and Global Health, Oxford University, Oxford, United KingdomKenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme, Kilifi, KenyaCentre for Tropical Medicine and Global Health, Oxford University, Oxford, United KingdomHuman infection studies (HIS) involve deliberately infecting healthy volunteers with disease-causing pathogens under controlled conditions. These studies are “controlled” by way of using specific types of pathogens, including dose, and the availability of emergency medical facilities to research volunteers. Most HIS involve diseases whose treatment is known and are done to accelerate the development of novel therapeutics such as vaccines, to address emerging and existing infectious diseases. Traditionally, HIS have been conducted primarily in high-income countries (HICs) but are now increasingly being conducted in low-and-middle income countries (LMICs). In LMICs settings, HIS are likely to raise concerns among various stakeholders including participating populations and regulatory bodies, that are unfamiliar with this type of research. Deliberately infecting a healthy individual with a disease-causing pathogen seems to go against the normal practice of medicine of “do no harm”. Such types of studies can give rise to increased rumors and jeopardize research participation in study activities, including non-HIS research. Community engagement can be one approach to address particular issues that HIS studies raise through meaningfully engaging with communities, where views and voices inform the conduct of HIS studies. In addition, engagement can inform the ethical conduct and acceptability of HIS studies in LMICs settings and provide opportunities for sharing information, listening to, and responding to concerns and views from potential participants, and the larger community in which the study would be conducted. Despite community engagement being an important aspect to consider, very few published and gray literature cover the types of approaches that have been used, and lessons learnt in engagement for HIS. This article outlinesthe community engagement approaches that were used to engage stakeholders and communities for malaria HIS-controlled human malaria infection (CHMI), undertaken in Kilifi, Kenya. It outlines the engagement activities across the research cycle, from activities conducted during protocol development, to planning, and implementation of the study. We discuss the challenges experienced, lessons learnt, and provide some recommendations for engagement around HIS.https://www.frontiersin.org/articles/10.3389/fpubh.2022.793913/fullcommunity engagement approacheshuman infection studiesmalariastakeholder identificationchallenges and lessons |
| spellingShingle | Noni Mumba Patricia Njuguna Patricia Njuguna Primus Chi Vicki Marsh Vicki Marsh Esther Awuor Mainga Hamaluba Mainga Hamaluba Cynthia Mauncho Salim Mwalukore Johnson Masha Mary Mwangoma Betty Kalama Hassan Alphan Juliana Wambua Philip Bejon Philip Bejon Dorcas Kamuya Dorcas Kamuya Melissa C. Kapulu Melissa C. Kapulu Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt Frontiers in Public Health community engagement approaches human infection studies malaria stakeholder identification challenges and lessons |
| title | Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt |
| title_full | Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt |
| title_fullStr | Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt |
| title_full_unstemmed | Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt |
| title_short | Undertaking Community Engagement for a Controlled Human Malaria Infection Study in Kenya: Approaches and Lessons Learnt |
| title_sort | undertaking community engagement for a controlled human malaria infection study in kenya approaches and lessons learnt |
| topic | community engagement approaches human infection studies malaria stakeholder identification challenges and lessons |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2022.793913/full |
| work_keys_str_mv | AT nonimumba undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT patricianjuguna undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT patricianjuguna undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT primuschi undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT vickimarsh undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT vickimarsh undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT estherawuor undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT maingahamaluba undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT maingahamaluba undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT cynthiamauncho undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT salimmwalukore undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT johnsonmasha undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT marymwangoma undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT bettykalama undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT hassanalphan undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT julianawambua undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT philipbejon undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT philipbejon undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT dorcaskamuya undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT dorcaskamuya undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT melissackapulu undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt AT melissackapulu undertakingcommunityengagementforacontrolledhumanmalariainfectionstudyinkenyaapproachesandlessonslearnt |