Gates Open Research最新文献

{"title":"How resilient were family planning programs during the COVID-19 pandemic? Evidence from 70 countries","authors":"Karen Hardee, Rebecca Rosenberg, John Ross, Imelda Zosa-Feranil","doi":"10.12688/gatesopenres.14856.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14856.1","url":null,"abstract":"<ns3:p><ns3:bold>Background: </ns3:bold>At the beginning of the COVID-19 pandemic fears of severe disruptions to family planning (FP) and access to services abounded. This paper uses a unique data source, a special Supplement added to the 2021 round of the National Composite Index for Family Planning (NCIFP), to assess in depth the resilience of FP programs in the face of the COVID-19 pandemic across 70 countries spanning six regions.</ns3:p><ns3:p> <ns3:bold>Methods: </ns3:bold>The 2021 NCIFP included 961 key informants who were asked questions to assess interference in the countries’ ability to achieve objectives, ability to maintain commitment to FP, and availability of information and services. Open ended responses added context.</ns3:p><ns3:p> <ns3:bold>Results: </ns3:bold>All programs were affected; the magnitude of effects varies by region and country. While the average resilience score, at 47 out of 100, implies middling levels of resilience, further analysis showed that despite interference in many components of programming, with some exceptions, the COVID-19 pandemic generally did not diminish government commitment to FP and programs remained resilient in providing access to services. Common themes mentioned by 178 respondents (18.5% of respondents) included: fear of infection; disruption of services / difficulty with lockdown and travel restrictions; staff / facilities diverted to COVID-19; access to reproductive health services and contraceptive methods affected; shifts in services / outreach; interference with logistics &amp; supplies, training &amp; supervision, and M&amp;E; lack of attention to FP/sexual reproductive health; financing reduced or diverted; and effects on existing partnerships. A strong enabling environment for FP, which the NCIFP is designed to measure, was positively correlated with continued government commitment and access to contraceptive methods during COVID-19.</ns3:p><ns3:p> <ns3:bold>Conclusion: </ns3:bold>These findings are instructive for programming: it will face challenges and ‘interference’ when unanticipated shocks like COVID-19 occur, with strong FP programs best prepared to exhibit resilience.</ns3:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135385655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Objective Structured Clinical Examination (OSCE) in a hybrid digital / in-person training for hormonal IUD in Nigeria: findings and applications of the approach","authors":"Ezechukwu Nwokoma, Helen Anyasi, Samantha Archie, Chinedu Onyezobi, Funmilola OlaOlorun, Jennifer Anyanti, Anthony Nwala, Kayode Afolabi, Kristen Little, Eden Demise, Kendal Danna, Kate Rademacher, Marya Plotkin","doi":"10.12688/gatesopenres.14695.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14695.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold>: The hormonal intrauterine device, a long-acting reversible contraceptive method, is being introduced to pilot sites in the private and public sector in Nigeria by the Nigerian Federal Ministry of Health since 2019. To inform training of health care providers, a study was conducted on a hybrid digital and in-person training which utilized Objective Structured Clinical Examination (OSCE) to assess competency of provider trainees. This study represents one of few documented experiences using OSCE to assess the effectiveness of a digital training.</ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold>: From September – October 2021, in Enugu, Kano and Oyo states of Nigeria, 62 health care providers from public and private sector health facilities were trained in hormonal IUD service provision using a hybrid digital / in-person training approach. Providers, who were skilled in provision of copper IUD, underwent a didactic component using digital modules, followed by an in-person practicum, and finally supervised service provision in the provider trainee’s workplace. Skills were assessed using OSCE during the one-day practicum. </ns4:p><ns4:p> <ns4:bold>Results</ns4:bold>: Use of the OSCE to assess skills provided valuable information to study team. The performance of provider trainees was high (average 94% correct completion of steps in the OSCE). </ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold>: OSCE was used as a research methodology as part of this pilot study; to date, OSCE has not been integrated into the training approach to be scaled up by FMOH. Uniformly high performance of provider trainees was seen on the OSCE, unsurprising since provider trainees were experienced in providing copper IUD. If and when training is rolled out to providers inexperienced with copper IUD, OSCE may have a more important role to assess skills before service provision. The role of OSCE in design of hybrid digital / in-person training approaches should be further explored in rollout of hormonal IUD and other contraceptive technologies.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135879731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preferences for services in a patient’s first six months on antiretroviral therapy for HIV in South Africa and Zambia (PREFER): research protocol for a prospective observational cohort study","authors":"Mhairi Maskew, Vinolia Ntjikelane, Allison Juntunen, Nancy Scott, Mariet Benade, Linda Sande, Pamfred Hasweeka, Prudence Haimbe, Priscilla Lumano-Mulenga, Hilda Shakewelele, Mpande Mukumbwa-Mwenechanya, Sydney Rosen","doi":"10.12688/gatesopenres.14682.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14682.1","url":null,"abstract":"<ns4:p><ns4:bold>Background</ns4:bold></ns4:p><ns4:p> </ns4:p><ns4:p> For patients on HIV treatment in sub-Saharan Africa (SSA), the highest risk for loss from care consistently remains the first six months after antiretroviral (ART) initiation, when patients are not yet eligible for most existing differentiated service delivery (DSD) models. To reduce disengagement from care during this period, we must gain a comprehensive understanding of patients’ needs, concerns, resources, and preferences for service delivery during this period. The PREFER study will use a sequential mixed-methods approach to survey a sample of patients in South Africa and Zambia 0-6 months after ART initiation to develop a detailed profile of patient characteristics and needs.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Protocol</ns4:bold></ns4:p><ns4:p> </ns4:p><ns4:p> PREFER is an observational, prospective cohort study of adult patients on ART for ≤6 months at 12 public sector healthcare facilities in Zambia and 18 in South Africa that aims to inform the design of DSD models for the early HIV treatment period. It has four components: 1) survey of clients 0-6 months after ART initiation; 2) follow up through routinely collected medical records for <12 or <24 months after enrollment; 3) focus group discussions to explore specific issues raised in the survey; and 4) in South Africa only, collection of blood samples self-reported naïve participants to assess the prevalence of ARV metabolites indicating prior ART use. Results will include demographic and clinical characteristics of patients, self-reported HIV care histories, preferences for treatment delivery, and predictors of disengagement.</ns4:p><ns4:p> </ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold></ns4:p><ns4:p> </ns4:p><ns4:p> PREFER aims to understand why the early treatment period is so challenging and how service delivery can be amended to address the obstacles that lead to early disengagement from care and to distinguish the barriers encountered by naïve patients to those facing re-initiators. The information collected by PREFER will help respond to patients’ needs and design better strategies for service delivery and improve resource allocation going forward.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135826261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drivers of future population growth in six most populous countries: Effect of demographic components on the population growth using decomposition analysis","authors":"Jayachandran A A, John Stover","doi":"10.12688/gatesopenres.14741.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14741.1","url":null,"abstract":"Background: Long-term population projections are useful exercises to help us study population dynamics and set up suitable policies and programmes. Release of the UN 2022 world population prospects data enables us to estimate the effects of demographic factors on future population growth. Methods: Relative contributions of demographic factors influencing future population growth are routinely identified using decomposition technique and that has been used in this paper. Six most populous countries have been considered for the analysis and the recently released 2022 Revision of World Population Prospects data used. Results: Results of decomposition analysis of population growth in six most populous countries and the total population suggest that population momentum continues to influence the population growth in the six most populous countries of the world in coming decades. However, influence of fertility on population growth has started to reverse in China, India, and Indonesia while it continues to be a significant factor in population growth in Nigeria and Pakistan. Gains in mortality steadily gather momentum in increase of population growth in all the six countries in coming decades. Migration marginally effects India’s population decrease whereas, it positively influences the USA’s population. Conclusions: The decomposition of variation in population growth into the relative contributions from different demographic rates has multiple uses in demography and formulating population policies.  Such studies are important in assessing countries’ positions in demographic transition in taking appropriate policy decisions. This century is going to witness unprecedent demographic transitions at varying levels with some countries struggling to manage ultra-low fertility leading to decline in population scenario to countries with high fertility leading to doubling of population size.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47246077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP – TT)","authors":"R. Harding, E. Moya, Ricardo Ataíde, Z. Truwah, G. Mzembe, Gomezgani Mhango, Ayşe V. Demir, William Stones, Louise Randall, Marc Seal, Katherine Johnson, Stefan Bode, M. Mwangi, S. Pasricha, S. Braat, K. Phiri","doi":"10.12688/gatesopenres.14710.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14710.1","url":null,"abstract":"Background: Anemia affects 40% of pregnant women globally, leading to maternal mortality, premature birth, low birth weight, and poor baby development. Iron deficiency causes over 40% of anemia cases in Africa. Oral iron supplementation is insufficient for Low-and-Middle-Income-Countries (LMICs) to meet current WHO targets. We hypothesized that a single intravenous dose of Ferric Carboxymaltose (FCM) may be more effective than oral iron treatment for anemia recovery, particularly in these settings where women present late for antenatal care. Methods: This is a two-arm parallel open-label individual-randomized controlled trial in third trimester, in malaria Rapid Diagnostic Test-negative pregnant women with moderate or severe anemia - capillary hemoglobin <10 g/dL – who are randomized to receive either parenteral iron – with FCM – or standard-of-care oral iron for the remainder of pregnancy. This is the sister trial to the second-trimester REVAMP trial, funded by the Bill and Melinda Gates Foundation (trial registration ACTRN12618001268235, Gates Grant number INV-010612). In REVAMP-TT, recruitment and treatment are performed within primary health centers. The trial will recruit 590 women across Zomba district, Malawi. The primary outcome is the proportion of anemic women - venous hemoglobin <11 g/dL - at 36 weeks’ gestation or delivery (whichever occurs first). Other pre-specified key secondary clinical and safety outcomes include maternal iron-status and hypophosphatemia, neonate birth weight, infant growth and infant iron and hematological parameters. Discussion: This study will determine whether FCM, delivered within primary health centers, is effective, safe and feasible for treating moderate to severe anemia in third-trimester pregnant Malawian women. This intervention could have long-term benefits for maternal and child health, resulting in improved survival and child development.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41698657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Programmatic mapping and estimating the population size of female sex workers, men who have sex with men, people who inject drugs and transgender populations in Kenya","authors":"Janet Musimbi, Helgar Musyoki, Mary Mugambi, Shem Kaosa, Japheth Kioko, Diane Aluko, Waruiru Wanjiru, Solomon Wambua, Ravi Prakash, Shajy Isac, Parinita Bhattacharjee, Faran Emmanuel","doi":"10.12688/gatesopenres.13623.2","DOIUrl":"https://doi.org/10.12688/gatesopenres.13623.2","url":null,"abstract":"<ns4:p>Introduction: Effective coverage of Human Immunodeficiency Virus prevention services for Key Populations (KPs) including female sex workers (FSWs), men who have sex with men (MSM), people who inject drugs (PWID) and transgender (TG) people necessitates periodic validation of physical venues and size estimates. Kenya conducted a robust size estimation of KPs in 2012 and a repeat mapping and size estimation exercise was conducted in 2018 to update KP Size Estimates and sub-typologies within each County for calculation of realistic program indicators. </ns4:p><ns4:p> Methods: A prospective mixed methods programmatic mapping approach adopted comprised two steps. The first step involved consolidating and documenting all known venues where KPs congregate while the second step included visiting and validating these venues confirming their active status. Data were collected in 34 out of 47 Counties in Kenya between January and March 2018. Data collected included estimated number of KPs (range), venue typology and timing of operation of each venue. </ns4:p><ns4:p> Results: We estimated a total number of 167,940 (129,271 to 206,609) FSWs; 32,580 (24,704 to 40,455) MSM; 16,063 (12,426 to 19,691) PWIDs; 10,951 (8,160 to 13,742) and 4,305 (2,826 to 5,783) transgender people congregating at 10,250, 1,729, 401 and 1,218 venues respectively. Majority of the venues for FSW (81%), MSM (64%) and transgender people (67%) were bars with and without lodging, PWIDs were mostly found on streets and injecting dens (70%). Around 9% of FSW and MSM and11% of PWIDs were below the age of 18 years. </ns4:p><ns4:p> Conclusion: This study provided information on young KPs, female PWIDs, MSWs and for the first time, TG people in Kenya. The exercise updated size estimates of KPs by typology and provided new evidence for resource allocation, planning of interventions and targets. Programmatic mapping continues to be a useful approach supporting programs to achieve high levels of coverage and prioritize resources.</ns4:p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"177 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136020704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strengths and weaknesses of the South-South Learning Exchange: a qualitative analysis of experts’ perspectives","authors":"I. Triulzi, R. Kabra, K. Allagh, J. Kiarie","doi":"10.12688/gatesopenres.14699.1","DOIUrl":"https://doi.org/10.12688/gatesopenres.14699.1","url":null,"abstract":"Background:  South-South learning exchange (SSLE) refers to an interactive learning process where peers exchange knowledge and experience to work towards a beneficial change. Despite organizations having recently increased the opportunity to run SSLEs, the SSLE support mechanisms and processes are not well documented in the scientific literature. This study explored experts’ perspective on SSLEs, strengths, weaknesses and mechanisms leading to outcomes.  Methods:  We conducted a qualitative study using semi-structured interviews on experience of participants and organizers of SSLEs. Data were collected between 1st September 2021 to 26th November 2021. All data were digitally recorded, transcribed verbatim, and analysed. In the analysis, we adopted an inductive approach derived from thematic analysis.  Results:  Sixteen experts who have participated in or facilitated one or more SSLE were interviewed. Experts’ accounts demonstrated an appreciation of participants’ empowerment, positive peer-to-peer “mind change” and convincing and powerful hands-on learning of this approach as strengths in the successful implementation of the SSLE. Being resource heavy, participant reluctance and absence of a validated methodology emerged as main weaknesses of the South-South learning approach, which could impair the effectiveness of this scheme.   Conclusions:  The SSLE is a promising approach to exchange knowledge and experience to work toward a desired change. This study suggested that this approach could gain robustness and credibility adopting a validated and systematic methodology. Furthermore, national and international funds improve availability of and accessibility to learning on the SSLE.","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45005212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adult malaria mortality during 2019 at Bo Government Hospital, Sierra Leone.","authors":"Satta Sylvia T K Kpagoi, Ashley Aimone, Rashid Ansumana, Ibrahim Swaray, Hellen Gelband, John W Eikelboom, Prabhat Jha, Isaac I Bogoch","doi":"10.12688/gatesopenres.14396.2","DOIUrl":"10.12688/gatesopenres.14396.2","url":null,"abstract":"<p><p>It is uncertain whether malaria is an important cause of death among adults in endemic areas. We performed a chart review of adults admitted to Bo Government Hospital during 2019. Of 893 admissions, 149 (59% female, mean age 58.5 years) had a laboratory diagnosis of malaria and 22 (14.8%) died. Mortality was significantly higher among patients with severe malaria compared with those who had non-severe malaria (6/20 [30%] versus 16/129 [12.4%], <i>p</i>=0.031).  Our results suggest that malaria is a common cause of death in hospitalized Sierra Leonian adults.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"7 ","pages":"48"},"PeriodicalIF":0.0,"publicationDate":"2023-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10465729/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10153671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Incentives and disincentives to private sector reporting on family planning in Kenya: <i>why these matter, and how they may change over time</i>.","authors":"Gabrielle Appleford, Daniel Mumbia, Priya Emmart","doi":"10.12688/gatesopenres.13909.2","DOIUrl":"10.12688/gatesopenres.13909.2","url":null,"abstract":"<p><p><b>Background:</b> This study sought to understand private sector reporting on family planning in Kenya's health information system (KHIS). We approached this through three lenses: governance, procedural and technical. Our study looked at these areas of interest in Kenya, complemented by deeper exploration in Nairobi County. <b>Methods:</b> The study used mixed methods drawing on analysis from the KHIS and surveys, complemented by desk review. The qualitative research entailed group discussions with public sector personnel while more in-depth qualitative interviews were done with public and private sector respondents. A framework matrix was developed for the qualitative analysis. The study was approved by the Ministry of Health in March 2022 and conducted over the period March - May 2022.  <b>Results:</b> From a governance lens, private sector respondents recognised the importance of registry and reporting as a government policy requirement. From a procedural lens, private sector respondents saw reporting procedures as duplicative and parallel processes as reports are not generated through digitised information systems. From a technical lens, private sector reporting rates have improved over time however other data quality issues remain, which include over- and under-reporting of family planning services into KHIS. Secondary analysis for Nairobi County shows that the private facility contribution to family planning has declined over time while family planning access through pharmacies have grown over the same period; there is no visibility on this shift within the KHIS. Changes in private sector family service provision have implications for assumptions underpinning modern contraceptive modelled estimates and programmatic decision-making. <b>Conclusions:</b> There is limited monitoring of the incentives and disincentives for reporting by private health facilities into the KHIS. These have changed over time and place. Sustained private sector engagement is important to align incentives for reporting as is greater visibility on the role of pharmacies in family planning.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"6 ","pages":"124"},"PeriodicalIF":0.0,"publicationDate":"2023-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10520241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41109416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the effect of reduced-dose pneumococcal conjugate vaccine schedules on vaccine serotype carriage in children and their caretakers in a naïve population in Vietnam: Protocol for a cluster randomized non-inferiority trial.","authors":"Lay-Myint Yoshida, Stefan Flasche, Kim Mulholland, Hien-Anh Nguyen, Cattram Nguyen, Michiko Toizumi, Duc-Anh Dang","doi":"10.12688/gatesopenres.14742.1","DOIUrl":"10.12688/gatesopenres.14742.1","url":null,"abstract":"<p><p><b>Introduction:</b> The WHO currently recommends giving pneumococcal conjugate vaccines (PCVs) as three doses - either three doses in infancy with Pentavalent vaccine (3p+0), or two doses in infancy followed by a booster around 12 months (2p+1). However, their high price is a barrier to introduction and sustainability in low and middle-income countries. We hypothesize that a schedule with a single priming and a booster dose (1p+1) may maintain similar levels of protection for the community by sustaining herd immunity, once circulation of vaccine types has been controlled. <b>Methods and analysis:</b> We will conduct a cluster randomized trial with four intervention arms (1p+1, 0p+1, 2p+1, 3p+0) and three unvaccinated clusters in the 27 communes of Nha Trang, central Vietnam. A PCV catch-up vaccination campaign to all children under three years of age will be performed at the start of the trial. The primary endpoint is non-inferiority of the1p+1 schedule if compared to the WHO standard 2p+1 and 3p+0 schedules in reducing vaccine serotype carriage prevalence in infants. We will also explore impact of 0p+1 schedule. A baseline and annual pneumococcal carriage surveys of 6480 participants per survey covering infants, toddlers and their mothers will be conducted. <b>Ethics and dissemination:</b> Ethical approvals were obtained from the ethical review committees of Institute of Tropical Medicine, Nagasaki University (151203149-2) and the Ministry of Health, Vietnam (1915/QD-BYT). The results, interpretation and conclusions will be presented at national and international conferences, and published in peer-reviewed open access journals. <b>Trial registration number:</b> NCT02961231.</p>","PeriodicalId":12593,"journal":{"name":"Gates Open Research","volume":"7 ","pages":"110"},"PeriodicalIF":0.0,"publicationDate":"2023-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10539539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41117157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}