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1.
N Engl J Med ; 387(26): 2411-2424, 2022 12 29.
Artículo en Inglés | MEDLINE | ID: mdl-36516078

RESUMEN

BACKGROUND: Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease. METHODS: We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4. RESULTS: A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14. CONCLUSIONS: No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.).


Asunto(s)
Vacunas contra el Virus del Ébola , Ebolavirus , Fiebre Hemorrágica Ebola , Adulto , Niño , Humanos , Anticuerpos Antivirales , República Democrática del Congo , Vacunas contra el Virus del Ébola/uso terapéutico , Fiebre Hemorrágica Ebola/prevención & control
2.
Clin Infect Dis ; 78(4): 870-879, 2024 Apr 10.
Artículo en Inglés | MEDLINE | ID: mdl-37967326

RESUMEN

BACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).


Asunto(s)
Vacunas contra el Virus del Ébola , Ebolavirus , Fiebre Hemorrágica Ebola , Adulto , Niño , Humanos , Anticuerpos Antivirales , Proteínas del Envoltorio Viral , Vacunas Sintéticas , Vacunación/métodos , Vacunas Atenuadas , Inmunogenicidad Vacunal
3.
BMC Public Health ; 24(1): 143, 2024 01 10.
Artículo en Inglés | MEDLINE | ID: mdl-38200476

RESUMEN

BACKGROUND: Routine childhood immunisation is one of the most important life-saving public health interventions. However, many children still have inadequate access to these vaccines and millions remain (partially) unvaccinated globally. As the COVID-19 pandemic disrupted health systems worldwide, its effects on immunisation have become apparent. This study aimed to estimate routine immunisation coverage among children under two in Sierra Leone and to identify factors associated with incomplete immunisation during the COVID-19 pandemic. METHODS: A cross-sectional household survey was conducted in three districts in Sierra Leone: Bombali, Tonkolili and Port Loko. A three-stage cluster sampling method was followed to enrol children aged 10-23 months. Information regarding immunisation status was based on vaccination cards or caretaker's recall. Using WHO's definition, a fully immunised child received one BCG dose, three oral polio vaccine doses, three pentavalent vaccine doses and one measles-containing vaccine dose. Following the national schedule, full immunisation status can be achieved at 9 months of age. Data were weighted to reflect the survey's sampling design. Associations between incomplete immunisation and sociodemographic characteristics were assessed through multivariable logistic regression. RESULTS: A total of 720 children were enrolled between November and December 2021. Full vaccination coverage was estimated at 65.8% (95% CI 60.3%-71.0%). Coverage estimates were highest for vaccines administered at birth and decreased with doses administered subsequently. Adjusting for age, the lowest estimated coverage was 40.7% (95% CI 34.5%-47.2%) for the second dose of the measles-containing vaccine. Factors found to be associated with incomplete immunisation status were: living in Port Loko district (aOR = 3.47, 95% CI = 2.00-6.06; p-value < 0.001), the interviewed caretaker being Muslim (aOR = 1.94, 95% CI = 1.25-3.02; p-value = 0.015) and the interviewed caretaker being male (aOR = 1.93, 95% CI = 1.03-3.59, p-value = 0.039). CONCLUSION: Though full immunisation coverage at district level improved compared with pre-pandemic district estimates from 2019, around one in three surveyed children had missed at least one basic routine vaccination and over half of eligible children had not received the recommended two doses of a measles-containing vaccine. These findings highlight the need to strengthen health systems to improve vaccination uptake in Sierra Leone, and to further explore barriers that may jeopardise equitable access to these life-saving interventions.


Asunto(s)
COVID-19 , Sarampión , Recién Nacido , Niño , Masculino , Humanos , Femenino , Cobertura de Vacunación , Pandemias , Sierra Leona/epidemiología , Estudios Transversales , COVID-19/epidemiología , COVID-19/prevención & control , Vacunación , Inmunización , Vacuna Antisarampión
4.
Malar J ; 22(1): 357, 2023 Nov 21.
Artículo en Inglés | MEDLINE | ID: mdl-37990324

RESUMEN

BACKGROUND: Malaria remains the leading cause of mortality and morbidity in young children in sub-Saharan Africa. To prevent malaria in children living in moderate-to-high malaria transmission areas, the World Health Organization has recommended perennial malaria chemoprevention (PMC). Prior to piloting PMC implementation in southern Togo, a household survey was conducted to estimate malaria infection prevalence in children under 2 years of age (U2). METHODS: A cross-sectional community-based household survey was conducted in the Haho district in the Togo Plateaux region. A three-stage random sampling method was used to select study participants aged 10-23 months whose caretakers gave informed consent. The prevalence of Plasmodium infection, defined as a positive rapid diagnostic test (RDT), was estimated with 95% confidence interval (CI). Clinical malaria was defined as having a positive RDT plus fever (≥ 37.5 °C) or history of fever in the last 24 h. Mixed-effects logistic regression models were used to assess the child's, caretaker's, and household's factors associated with malaria infection. RESULTS: A total of 685 children were included in the survey conducted January-February in 2022 (dry season). Median age was 17 months (interquartile range: 13-21). About 80% of the children slept under a bed net the night before the interview. Malaria infection prevalence was 32.1% (95% CI 27.7-37.0) with significant area variation (cluster range: 0.0-73.3). Prevalence of clinical malaria was 15.4% (95% CI 12.2-19.2). Children whose caretakers were animist (aOR: 1.71, 95% CI 1.19-2.46) and those living in mother-headed households (aOR: 2.39, 95% CI 1.43-3.99) were more likely to have a positive RDT. Living more than 5 km away from the nearest health facility (aOR: 1.60, 95% CI 1.04-2.44) and presence of two or more under-5-years children in the household (aOR: 1.44, 95% CI 1.01-2.07) were also associated with increased risk of infection. CONCLUSION: One-third of the children U2 who participated in this survey had malaria infection, thus PMC could be a promising strategy to reduce malaria burden in young children in Plateaux region. Reinforcement of outreach services and targeting the poorest households should be prioritized to reduce the inequity in malaria prevention in children exposed to the infection.


Asunto(s)
Malaria , Humanos , Niño , Lactante , Preescolar , Prevalencia , Estudios Transversales , Togo/epidemiología , Malaria/epidemiología , Malaria/prevención & control , Factores de Riesgo , Quimioprevención
5.
Malar J ; 22(1): 145, 2023 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-37127633

RESUMEN

BACKGROUND: Intermittent Preventive Treatment of malaria in infants (IPTi) is a malaria control strategy consisting of the administration of an anti-malarial drug alongside routine immunizations. So far, this is being implemented nationwide in Sierra Leone only. IPTi has been renamed as Perennial Malaria Chemoprevention -PMC-, accounting for its recently recommended expansion into the second year of life. Before starting a pilot implementation on PMC, the currently implemented strategy and malaria prevalence were assessed in young children in selected areas of Sierra Leone. METHODS: A cross-sectional, community-based, multi-stage cluster household survey was conducted from November to December 2021 in selected districts of the Northern and northwestern provinces of Sierra Leone among 10-23 months old children, whose caretakers gave written informed consent to participate in the survey. Coverage of IPTi and malaria prevalence-assessed with rapid diagnostic tests-were calculated using percentages and 95% confidence intervals weighted for the sampling design and adjusted for non-response within clusters. Factors associated with RDT + and iPTi coverage were also assessed. RESULTS: A total of 720 children were recruited. Coverage of three IPTi doses was 50.57% (368/707; 95% CI 45.38-55.75), while prevalence of malaria infection was 28.19% (95% CI 24.81-31.84). Most children had received IPTi1 (80.26%, 574/707; 95% CI 75.30-84.44), and IPTi2 (80.09%, 577/707; 95% CI 76.30-83.40) and over half of the children also received IPTi3 (57.72%, 420/707; 95% CI 53.20-62.11). The uptake of each IPTi dose was lower than that of the vaccines administered at the same timepoint at all contacts. CONCLUSION: In Sierra Leone, half of the children received the three recommended doses of IPTi indicating an increase in its uptake compared to previous data of just a third of children receiving the intervention. However, efforts need to be made in improving IPTi coverage, especially in the planned expansion of the strategy into the second year of life following recent WHO guidelines.


Asunto(s)
Malaria , Pirimetamina , Niño , Humanos , Lactante , Preescolar , Pirimetamina/uso terapéutico , Sulfadoxina/uso terapéutico , Estudios Transversales , Sierra Leona , Combinación de Medicamentos , Malaria/prevención & control
6.
BMC Health Serv Res ; 22(1): 1327, 2022 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-36348488

RESUMEN

BACKGROUND: Antiretroviral therapy (ART) is the primary mode of treatment for Human Immunodeficiency Virus (HIV). It slows disease progression and reduces the spread of infection. HIV treatment is also known to require a high level of adherence of over 90% to achieve good treatment outcomes and viral load suppression. In Sierra Leone, about 70% of People Living with HIV (PLHIV) are non-adherent in their first year of treatment. Understanding the reasons behind this high rate of non-adherence from the perspectives of both PLHIV and health workers is critical for developing strategies to improve adherence. This qualitative study is rooted in the field of public health services. It identifies the barriers and facilitators influencing adherence to antiretroviral treatment in Sierra Leone.  METHODS: A qualitative study design using in-depth interviews of four healthcare workers and 16 PLHIV in two districts in Sierra Leone- Freetown and Bo. The interviews were analyzed using a grounded theory approach to identify emerging themes from the data. RESULTS: The study identified several facilitators and barriers to ART adherence at the personal, community, and health system levels. The facilitators included perceived benefits of ART, family support, having an informal caregiver, receiving free ART medicines, and belonging to peer support groups. The identified barriers were stigma and discrimination, frequency of medication, use of traditional medicine, lack of money for food and transport, work barriers, inadequate medicines and test kits, limited health workers, and long distances to clinics. CONCLUSIONS: Our study emphasized the need for implementing behavioural change communication programmes and activities to reduce stigma and discrimination in the community. Knowledge of the facilitators and barriers to antiretroviral therapy could provide relevant information for more responsive and equitable programmes supporting adherence implementation in low- and middle-income countries. This study also identifies the vital need for community integration of HIV treatment services.


Asunto(s)
Infecciones por VIH , Cumplimiento de la Medicación , Humanos , Sierra Leona , Antirretrovirales/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Investigación Cualitativa , Personal de Salud
7.
J Infect Dis ; 224(11): 1907-1915, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-34013349

RESUMEN

BACKGROUND: The effect of malaria infection on the immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein (GP) vaccine (rVSVΔG-ZEBOV-GP) (ERVEBO) is unknown. METHODS: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) vaccinated 7998 asymptomatic adults with rVSVΔG-ZEBOV-GP during the 2014-2016 Ebola epidemic. In STRIVE's immunogenicity substudy, participants provided blood samples at baseline and at 1, 6, and 9-12 months. Anti-GP binding and neutralizing antibodies were measured using validated assays. Baseline samples were tested for malaria parasites by polymerase chain reaction. RESULTS: Overall, 506 participants enrolled in the immunogenicity substudy and had ≥1 postvaccination antibody titer. Of 499 participants with a result, baseline malaria parasitemia was detected in 73 (14.6%). All GP enzyme-linked immunosorbent assay (ELISA) and plaque reduction neutralization test (PRNT) geometric mean titers (GMTs) at 1, 6, and 9-12 months were above baseline, and 94.1% of participants showed seroresponse by GP-ELISA (≥2-fold rise and ≥200 ELISA units/mL), while 81.5% showed seroresponse by PRNT (≥4-fold rise) at ≥1 postvaccination assessment. In participants with baseline malaria parasitemia, the PRNT seroresponse proportion was lower, while PRNT GMTs and GP-ELISA seroresponse and GMTs showed a trend toward lower responses at 6 and 9-12 months. CONCLUSION: Asymptomatic adults with or without malaria parasitemia had robust immune responses to rVSVΔG-ZEBOV-GP, persisting for 9-12 months. Responses in those with malaria parasitemia were somewhat lower.


Asunto(s)
Vacunas contra el Virus del Ébola/inmunología , Ebolavirus , Fiebre Hemorrágica Ebola/prevención & control , Inmunogenicidad Vacunal , Estomatitis Vesicular/inmunología , Proteínas del Envoltorio Viral/inmunología , Adolescente , Adulto , Anciano , Animales , Anticuerpos Antivirales/sangre , Infecciones Asintomáticas , Vacunas contra el Virus del Ébola/administración & dosificación , Vacunas contra el Virus del Ébola/efectos adversos , Ebolavirus/genética , Ebolavirus/aislamiento & purificación , Ensayo de Inmunoadsorción Enzimática , Femenino , Fiebre Hemorrágica Ebola/inmunología , Humanos , Malaria , Masculino , Persona de Mediana Edad , Parasitemia/prevención & control , Proteínas Recombinantes , Sierra Leona , Proteínas del Envoltorio Viral/efectos adversos
8.
Emerg Infect Dis ; 26(3): 541-548, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-32017677

RESUMEN

Little information exists regarding Ebola vaccine rVSVΔG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.


Asunto(s)
Vacunas contra el Virus del Ébola/inmunología , Fiebre Hemorrágica Ebola/epidemiología , Complicaciones Infecciosas del Embarazo/epidemiología , Atención Prenatal , Adulto , Método Doble Ciego , Vacunas contra el Virus del Ébola/efectos adversos , Femenino , Fiebre Hemorrágica Ebola/prevención & control , Humanos , Embarazo , Complicaciones Infecciosas del Embarazo/prevención & control , Resultado del Embarazo , Sierra Leona/epidemiología , Vacunación , Adulto Joven
9.
BMC Pediatr ; 20(1): 286, 2020 06 09.
Artículo en Inglés | MEDLINE | ID: mdl-32517722

RESUMEN

BACKGROUND: Poor compliance to highly active antiretroviral therapy (HAART) can result in the poor quality of life in children living with Human immunodeficiency virus/Acquired immunodeficiency syndrome (HIV/AIDS) because of low plasma drug concentration and the possibility of drug resistance. This study evaluates the response of caregivers for determination of adherence and the four quality of life domains in children (aged 14 years and under) on HAART. METHODS: We conducted a cross-sectional study of 188 children, each accompanied by their caregivers at Ola During Children's Hospital and Makeni Government Hospital between September and November 2016. Adherence to HAART and Quality of life was assessed using the WHO Quality of life summary questionnaire (WHOQOL-BREF). We obtained ethical approval from the Sierra Leone Ethics and Scientific Review Committee. RESULTS: The study revealed 5.9% adherence amongst paediatric patients, and a strong association of adherent patients(p = 0.019*) to the physical health domain (mean = 64.61 SD = 8.1). Caregiver HIV status showed a strong association with the physical (mean = 58.3, SD = 11.7 and p = 0.024*), and psychological health domains (mean = 68.2, SD = 14.7 and p = 0.001). Caregiver type (mother/father/sibling) accompanying child to hospital also showed strong associated with the physical (mean = 58.0, SD = 10.6, p <  0.001), psychological (mean 68.2 SD = 14.81 p <  0.001) and environmental health domains (mean = 59.7, SD = 13.47, p <  0.001). Further regression analysis showed a strong association with physical health domain for HIV positive caregivers (p = 0.014) and adherent paediatric patients (p = 0.005). Nuclear family also showed a strong association with psychological (p <  0.001) and environmental (p = 0.001) health domains. CONCLUSION: This study showed a strong association between the quality of life domains and the involvement of nuclear family caregiver, HIV-positive caregiver and adherence to HAART. Our study suggests that the involvement of any member of the nuclear family, HIV positive parents and patient adherence to therapy can improve the quality of life of paediatric HIV/AIDS patients on highly active antiretroviral therapy in the two hospitals.


Asunto(s)
Cuidadores , Infecciones por VIH , Adolescente , Terapia Antirretroviral Altamente Activa , Niño , Estudios Transversales , Infecciones por VIH/tratamiento farmacológico , Humanos , Cumplimiento de la Medicación , Calidad de Vida , Sierra Leona , Encuestas y Cuestionarios
16.
J Infect Dis ; 217(suppl_1): S16-S23, 2018 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-29788343

RESUMEN

The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE), a phase 2/3 trial of investigational rVSV∆G-ZEBOV-GP vaccine, was conducted during an unprecedented Ebola epidemic. More than 8600 eligible healthcare and frontline response workers were individually randomized to immediate (within 7 days) or deferred (within 18-24 weeks) vaccination and followed for 6 months after vaccination for serious adverse events and Ebola virus infection. Key challenges included limited infrastructure to support trial activities, unreliable electricity, and staff with limited clinical trial experience. Study staff made substantial infrastructure investments, including renovation of enrollment sites, laboratories, and government cold chain facilities, and imported equipment to store and transport vaccine at ≤-60oC. STRIVE built capacity by providing didactic and practical research training to >350 staff, which was reinforced with daily review and feedback meetings. The operational challenges of safety follow-up were addressed by issuing mobile telephones to participants, making home visits, and establishing a nurse triage hotline. Before the Ebola outbreak, Sierra Leone had limited infrastructure and staff to conduct clinical trials. Without interfering with the outbreak response, STRIVE responded to an urgent need and helped build this capacity. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].


Asunto(s)
Brotes de Enfermedades , Vacunas contra el Virus del Ébola/administración & dosificación , Vacunas contra el Virus del Ébola/efectos adversos , Fiebre Hemorrágica Ebola/epidemiología , Fiebre Hemorrágica Ebola/prevención & control , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Femenino , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Sierra Leona/epidemiología , Vacunas Sintéticas/administración & dosificación , Vacunas Sintéticas/efectos adversos
17.
J Infect Dis ; 217(suppl_1): S6-S15, 2018 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-29788345
19.
Clin Trials ; 15(5): 436-443, 2018 10.
Artículo en Inglés | MEDLINE | ID: mdl-29895178

RESUMEN

Background/aims During the 2014-2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. Methods This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations. Results Establishing a clinical trial during an outbreak brought some unique challenges, including those related to trial design and the regulatory environment, operational issues, and community engagement. The situation was further complicated by the weak infrastructure and limited experience of clinical trials in Sierra Leone. However, operating in an outbreak context also brought some benefits to the research team, including strong stakeholder support. The EBOVAC-Salone study recruited participants both during and after the outbreak, leading to additional challenges to trial implementation during the post-outbreak transition. Conclusion Many lessons have been learned about setting up and implementing a clinical trial during a devastating Ebola epidemic, and some of the experiences of the EBOVAC-Salone team were mirrored by those of other researchers operating in the region. Common to several of these research groups is a recommendation that research should be more closely incorporated into outbreak response planning, which could expedite the establishment of timely and appropriate research projects. We recommend that the lessons learned by researchers during the West African Ebola epidemic are built into programmes and strategies to improve the responses to future epidemics, wherever they occur.


Asunto(s)
Ensayos Clínicos como Asunto , Vacunas contra el Virus del Ébola/inmunología , Adulto , Epidemias/prevención & control , Femenino , Fiebre Hemorrágica Ebola/epidemiología , Humanos , Masculino , Selección de Paciente , Sierra Leona/epidemiología
20.
Global Health ; 14(1): 99, 2018 10 20.
Artículo en Inglés | MEDLINE | ID: mdl-30342544

RESUMEN

BACKGROUND: As performance-based financing (PBF) has been increasingly implemented in low-income countries, a growing literature has developed, assessing its effectiveness and, more recently, focussing on the political dynamics of PBF introduction and implementation. This study contributes to the latter body of literature by exploring decision-making processes on PBF in Sierra Leone during the 2010-2017 period. Sierra Leone presents an interesting case because of the 'start-stop-start' trajectory of PBF. METHODS: The qualitative case study is based on a document review and 25 key informant interviews with national stakeholders and international actors. Documents and interviews were analysed based on a political economy framework focusing on actors and structure, but also making use of concepts drawn from interpretive policy analysis to look at frames. RESULTS: Our analysis describes the process of negotiation and re-negotiation of PBF in Sierra Leone, highlighting the role of different players, both internal and external, their ideas, capacity and power relations, and the shifting narratives around PBF. It is shown that external actors driving the debate make use of 'frames', both actual (i.e., defining the timing and pace of the discussions, the funding available, etc.) and metaphorical (i.e., how PBF is interpreted, defined and understood) to fit in and influence the debate. This is facilitated by the lack of capacity and resources in the fragile setting. Other strategies, such as 'venue shopping' are employed, though they may add to fragmentation in the volatile context. CONCLUSIONS: The retrospective view of the study has an analytical advantage, but findings are also relevant to guide practice. Although power relations and rent-seeking issues are difficult to overcome in resource and capacity-constrained settings, more attention could be paid to other elements. In particular, adopting shared frames to ensure a common and inclusive understanding of technical concepts such as PBF may be useful to ensure the political sustainability of reforms. Also, the 'actual frames' which define negotiation and implementation should remain flexible, allowing for disrupting events (e.g., the Ebola epidemic in Sierra Leone) as well as for time to develop national capacity and ownership in order to ensure longer-term political support and better health system integration.


Asunto(s)
Política de Salud , Financiación de la Atención de la Salud , Reembolso de Incentivo/organización & administración , Humanos , Estudios de Casos Organizacionales , Formulación de Políticas , Investigación Cualitativa , Estudios Retrospectivos , Sierra Leona
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