challenges and lessons learned during the planning and early implementation of the CORD-Papers-2022-06-02 (Version 1)

Title: Challenges and lessons learned during the planning and early implementation of the RTSS/AS01(E) malaria vaccine in three regions of Ghana: a qualitative study
Abstract: BACKGROUND: In 2019 the RTSS/AS01(E) malaria vaccine was introduced on a pilot basis in six regions of Ghana by the Ministry of Health/Ghana Health Service as part of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP). This is the first time a malaria vaccination programme has been implemented in any country. This paper describes the challenges faced and lessons learned during the planning and early implementation of the RTSS/AS01(E) vaccine in three out of the six regions that implemented the programme in Ghana. METHODS: Twenty-one in-depth interviews were conducted with regional and district health service managers and frontline health workers three months after the start of MVIP in May 2019. Data were coded using NVivo software version 12 and a coding framework was developed to support thematic analysis to identify the challenges and lessons learned during the RTSS/AS01(E) implementation pilot which were also categorized into the Consolidated Framework for Implementation Research (CFIR). RESULTS: Participants reported challenges related to the characteristics of the intervention such as issues with the vaccine schedule and eligibility criteria and challenges related to how it was implemented as a pilot programme. Additionally major challenges were faced due to the spread of rumours leading to vaccine refusals; thus the outer setting of the CFIR was adapted to accommodate rumours within the community context. Health service managers and frontline health workers also experienced challenges with the process of implementing RTSS/AS01(E) including inadequate sensitization and training as well as issues with the timeline. They also experienced challenges associated with the features of the systems within which the vaccine was being implemented including inadequate resources for cold-chain at the health facility level and transportation at the district and health facility levels. This study identified the need for a longer more intensive and sustained delivery of contextually-appropriate sensitization prior to implementation of a programme such as MVIP. CONCLUSIONS: This study identified 12 main challenges and lessons learned by health service managers and health workers during the planning and early implementation phases of the RTSS/AS01(E) pilot introduction in Ghana. These findings are highly relevant to the likely scale-up of RTSS/AS01(E) within Ghana and possible implementation in other African countries as well as to other future introductions of novel vaccines.
Published: 2022-05-12
Journal: Malar J
DOI: 10.1186/s12936-022-04168-9
DOI_URL: http://doi.org/10.1186/s12936-022-04168-9
Author Name: Grant Jane
Author link: https://covid19-data.nist.gov/pid/rest/local/author/grant_jane
Author Name: Gyan Thomas
Author link: https://covid19-data.nist.gov/pid/rest/local/author/gyan_thomas
Author Name: Agbokey Francis
Author link: https://covid19-data.nist.gov/pid/rest/local/author/agbokey_francis
Author Name: Webster Jayne
Author link: https://covid19-data.nist.gov/pid/rest/local/author/webster_jayne
Author Name: Greenwood Brian
Author link: https://covid19-data.nist.gov/pid/rest/local/author/greenwood_brian
Author Name: Asante Kwaku Poku
Author link: https://covid19-data.nist.gov/pid/rest/local/author/asante_kwaku_poku
sha: 4f436a6b8326d114d848481a1d86ecfe732ec0fd
license: cc-by
license_url: https://creativecommons.org/licenses/by/4.0/
source_x: Medline; PMC
source_x_url: https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 35550113
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/35550113
pmcid: PMC9096766
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9096766
url: https://doi.org/10.1186/s12936-022-04168-9 https://www.ncbi.nlm.nih.gov/pubmed/35550113/
has_full_text: TRUE
Keywords Extracted from Text Content: MVIP S/ AS01 E vaccine outer vaccine Vaccine RTS S/AS01 E Health/Ghana Health Service individuals IDI-17 Mosquirix© IDI-21 MVIP outer participants RTS volunteers country-led S/AS01 E doses 1 and artemisinin-based KHRC MCV-2 EPI IDI-04 IDI-10 locally-appropriate let's Ghana [30] vaccine Escoffery left Rumours Ghana Health Service recipients children ITNs EPI vaccines FDA Ghana [21, 22] vitamin A people IDI-08 ...people ... guinea pigs IDI-06 S/ AS01 E S/AS01 E Health/Ghana Health Service inner S/AS01 E vaccine LMICs 2,660,648 IDI-07 funds EPI vaccine measles Measles Food Vaccine vaccine... COVID-19 Ghana [9] children JG MVIP participants RTS BG Ghana Health Service S/AS01 E FA S/AS01 E vaccine
Extracted Text Content in Record: First 5000 Characters:Background: In 2019, the RTS,S/AS01 E malaria vaccine was introduced on a pilot basis in six regions of Ghana by the Ministry of Health/Ghana Health Service as part of the WHO-coordinated Malaria Vaccine Implementation Programme (MVIP). This is the first time a malaria vaccination programme has been implemented in any country. This paper describes the challenges faced, and lessons learned, during the planning and early implementation of the RTS,S/ AS01 E vaccine in three out of the six regions that implemented the programme in Ghana. Methods: Twenty-one in-depth interviews were conducted with regional and district health service managers and frontline health workers three months after the start of MVIP in May 2019. Data were coded using NVivo software version 12 and a coding framework was developed to support thematic analysis to identify the challenges and lessons learned during the RTS,S/AS01 E implementation pilot, which were also categorized into the Consolidated Framework for Implementation Research (CFIR). Results: Participants reported challenges related to the characteristics of the intervention, such as issues with the vaccine schedule and eligibility criteria, and challenges related to how it was implemented as a pilot programme. Additionally, major challenges were faced due to the spread of rumours leading to vaccine refusals; thus, the outer setting of the CFIR was adapted to accommodate rumours within the community context. Health service managers and frontline health workers also experienced challenges with the process of implementing RTS,S/AS01 E , including inadequate sensitization and training, as well as issues with the timeline. They also experienced challenges associated with the features of the systems within which the vaccine was being implemented, including inadequate resources for cold-chain at the health facility level and transportation at the district and health facility levels. This study identified the need for a longer, more intensive and sustained delivery of contextually-appropriate sensitization prior to implementation of a programme such as MVIP. Conclusions: This study identified 12 main challenges and lessons learned by health service managers and health workers during the planning and early implementation phases of the RTS,S/AS01 E pilot introduction in Ghana. These findings are highly relevant to the likely scale-up of RTS,S/AS01 E within Ghana and possible implementation in other African countries, as well as to other future introductions of novel vaccines. In 2019, an estimated 229 million malaria cases resulted in 409,000 deaths, the majority of these deaths occurring in young sub-Saharan African children [1] . These deaths occurred despite significant progress in malaria control since the year 2000, with the implementation and scaleup of multiple preventative and curative interventions. In recent years, progress in malaria control has plateaued in several countries, creating an urgent need to develop and implement new strategies [1] . The RTS,S/AS01 E is the first malaria vaccine to be deployed widely and has been shown to provide partial protection against uncomplicated and severe malaria in young children in a phase 3 trial [2] . In 2016, the World Health Organization (WHO) recognized the potential public health impact of RTS,S/AS01 E and recommended the pilot implementation of the vaccine in three to five sub-Saharan African settings [3] . Following this recommendation, a country-led, WHO-coordinated Malaria Vaccine Implementation Programme (MVIP) was established to support the pilot implementation of the vaccine in routine settings. Ghana, Kenya and Malawi were selected to introduce RTS,S/AS01 E through their national immunization programmes, reaching 360,000 children per year [4] . In April 2019, the Ghanaian Ministry of Health/Ghana Health Service launched the MVIP in Ghana, with administration of the vaccine through the Expanded Programme on Immunization (EPI) into six regions starting on May 1st 2019 [5] . Alongside the introduction of the vaccine into the routine immunization system, a team of WHO and in-country and international researchers are evaluating the programme to assess the feasibility, safety and impact of the RTS,S/AS01 E introduction. As part of the evaluation, only selected areas within the regions introduced the vaccine, while other districts served as comparison areas. The findings from the MVIP were reviewed in 2021 and WHO formally recommended the use of the RTS,S/AS01 E vaccine for children living in regions with moderate to high malaria transmission [6] . In Ghana, four doses of RTS,S/AS01 E are given at 6, 7, 9 and 24 months of age, co-administered with vitamin A at 6 and 24 months, and with measles and yellow fever vaccine at 9 months [7] . Ghana has a well-functioning EPI, with 97% national coverage for the third dose of pentavalent vaccine. However, vaccine coverage after the first year of life has proved a challenge, with coverage o
Keywords Extracted from PMC Text: outer people understood."What " IDI-14 FDA locally-appropriate Mosquirix© Ghanaians Ghana [30] vitamin A EPI vaccine transitional zone inner EPI vaccines S/AS01E vaccine Ghana guinea pigs LMICs ... vaccine... [23–25] EPI recipients ITNs left Measles MVIP IDI-07 Food Ghana [21, 22] months."The " country-led RTS low- Sunyani funds level."I correct."districts [9] " IDI-17 individuals 's " IDI-04 MCV-2 COVID-19 participants vaccine S/AS01E doses 1 and children ...people ineligible."That let's S/AS01E 2,660,648 " IDI-21 cold-chain Volta lake Escoffery IDI-17 Rumours Ghana Health Service neglected."Most volunteers KHRC Vaccine artemisinin-based S/AS01E dose 4 measles Health/Ghana Health Service
Extracted PMC Text Content in Record: First 5000 Characters:In 2019, an estimated 229 million malaria cases resulted in 409,000 deaths, the majority of these deaths occurring in young sub-Saharan African children [1]. These deaths occurred despite significant progress in malaria control since the year 2000, with the implementation and scale-up of multiple preventative and curative interventions. In recent years, progress in malaria control has plateaued in several countries, creating an urgent need to develop and implement new strategies [1]. The RTS,S/AS01E is the first malaria vaccine to be deployed widely and has been shown to provide partial protection against uncomplicated and severe malaria in young children in a phase 3 trial [2]. In 2016, the World Health Organization (WHO) recognized the potential public health impact of RTS,S/AS01E and recommended the pilot implementation of the vaccine in three to five sub-Saharan African settings [3]. Following this recommendation, a country-led, WHO-coordinated Malaria Vaccine Implementation Programme (MVIP) was established to support the pilot implementation of the vaccine in routine settings. Ghana, Kenya and Malawi were selected to introduce RTS,S/AS01E through their national immunization programmes, reaching 360,000 children per year [4]. In April 2019, the Ghanaian Ministry of Health/Ghana Health Service launched the MVIP in Ghana, with administration of the vaccine through the Expanded Programme on Immunization (EPI) into six regions starting on May 1st 2019 [5]. Alongside the introduction of the vaccine into the routine immunization system, a team of WHO and in-country and international researchers are evaluating the programme to assess the feasibility, safety and impact of the RTS,S/AS01E introduction. As part of the evaluation, only selected areas within the regions introduced the vaccine, while other districts served as comparison areas. The findings from the MVIP were reviewed in 2021 and WHO formally recommended the use of the RTS,S/AS01E vaccine for children living in regions with moderate to high malaria transmission [6]. In Ghana, four doses of RTS,S/AS01E are given at 6, 7, 9 and 24 months of age, co-administered with vitamin A at 6 and 24 months, and with measles and yellow fever vaccine at 9 months [7]. Ghana has a well-functioning EPI, with 97% national coverage for the third dose of pentavalent vaccine. However, vaccine coverage after the first year of life has proved a challenge, with coverage of Measles Containing Vaccine second dose (MCV-2), given at 18 months, currently reported at 83% [8]. This study aimed to document the challenges and lessons learned during the planning and early implementation phases of the RTS,S/AS01E introduction, according to the regional and district level health service managers and frontline health workers who planned and delivered the vaccine, to assist future wider distribution of the vaccine in Ghana and elsewhere in Africa. The study area lies in the forest transitional zone of Ghana with an estimated population of 2,660,648, whose major occupation is agriculture and related activities [9]. Malaria is endemic and perennial in the area, with a peak in transmission between April and October [10]. In 2019, the prevalence of malaria in children under five years of age in the region was estimated at 17% [11]. This burden is despite a high reported use of insecticide-treated bed nets (ITNs), with 80% of households in the region reporting ownership of at least one ITN, and 69% of children under five reported having slept under an ITN the night before the Malaria Indicator Survey in 2019 [11]. Under the national guidelines, all cases of suspected malaria are confirmed via microscopy or rapid diagnostic test, and treated using artemisinin-based combination therapy. The health facilities in the study area which provide curative and preventive services include hospitals (29), poly-clinics (6), health centres (84), clinics (113), private maternity homes (42), community-based health planning and services centres (190) and outreach points (1393) [12]. EPI services are provided as part of reproductive and child health services at all health facilities, mainly by Community Health Nurses (CHNs). Health professionals including specialist doctors, general practitioners, midwives, nurses, laboratory workers, administrative and support staff provide both curative and preventive services at the various health facilities. The study area has a total of 21 sub-regional districts (10 implementing districts/11 comparator districts) participating in the MVIP. For this study, IDIs were conducted at the regional level and in two districts. Two of the 10 implementing districts were randomly selected using the random number generator function in Microsoft Excel. Within each selected district, one community health facility was selected using convenience sampling. Purposive sampling was used to select health service managers involved in the planning and delivery of the RTS,S/AS01E vaccine at the reg
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