Vaccine Demonstration Project Research Articles

A qualitative assessment of influenza vaccine uptake among children in Kenya

BackgroundInfluenza is a significant contributor to acute respiratory infections (ARI), and children < 5 years are at increased risk of severe influenza disease. In Kenya the influenza vaccine is not included in the Kenya Expanded Programme on Immunization (KEPI). To inform roll-out of a national influenza vaccination program, we implemented an influenza vaccine demonstration project in Nakuru and Mombasa counties in Kenya from 2019 to 2021 and set out to establish factors driving influenza vaccine acceptance and hesitancy among caregivers of children aged 6–23 months. MethodsUsing semi-structured questionnaires, we conducted eight focus group discussions among community members and twelve key informant interviews among healthcare workers to elicit both lay and expert opinions. Thematic analysis of the interviews was conducted using the World Health Organization’s “3 Cs” model of vaccine hesitancy to determine reasons for acceptance or hesitancy of the influenza vaccine. ResultsThe influenza vaccine was well received among community members and healthcare workers though concerns were raised. Vaccine hesitancy was fuelled by misconceptions about reasons for introducing the vaccine (confidence), perceptions that influenza was not a serious disease (complacency) and administrative fees required at some facilities (convenience). Despite the use of various advocacy, communication and social mobilisation strategies targeted at educating the community on the influenza disease and importance of vaccination, there remained a perception of inadequate reach of the sensitization among some community members. Contextual factors such as the COVID-19 pandemic affected uptake, and parents expressed concern over the growing number of vaccines recommended for children. ConclusionDespite lingering concerns, caregivers had their children vaccinated indicating that vaccine hesitancy exists, even among those who accepted the vaccine for their children. Efforts targeted at increasing confidence in and reducing misconceptions towards vaccines through effective communication strategies, are likely to lead to increased vaccine uptake.

Costs of seasonal influenza vaccine delivery in a pediatric demonstration project for children aged 6–23 months — Nakuru and Mombasa Counties, Kenya, 2019–2021

BackgroundDuring November 2019–October 2021, a pediatric influenza vaccination demonstration project was conducted in four sub-counties in Kenya. The demonstration piloted two different delivery strategies: year-round vaccination and a four-month vaccination campaign. Our objective was to compare the costs of both delivery strategies. MethodsCost data were collected using standardized questionnaires and extracted from government and project accounting records. We reported total costs and costs per vaccine dose administered by delivery strategy from the Kenyan government perspective in 2021 US$. Costs were separated into financial costs (monetary expenditures) and economic costs (financial costs plus the value of existing resources). We also separated costs by administrative level (national, regional, county, sub-county, and health facility) and program activity (advocacy and social mobilization; training; distribution, storage, and waste management; service delivery; monitoring; and supervision). ResultsThe total estimated cost of the pediatric influenza demonstration project was US$ 225,269 (financial) and US$ 326,691 (economic) for the year-round delivery strategy (30,397 vaccine doses administered), compared with US$ 214,753 (financial) and US$ 242,385 (economic) for the campaign strategy (25,404 doses administered). Vaccine purchase represented the largest proportion of costs for both strategies. Excluding vaccine purchase, the cost per dose administered was US$ 1.58 (financial) and US$ 5.84 (economic) for the year-round strategy and US$ 2.89 (financial) and US$ 4.56 (economic) for the campaign strategy. ConclusionsThe financial cost per dose was 83% higher for the campaign strategy than the year-round strategy due to larger expenditures for advocacy and social mobilization, training, and hiring of surge staff for service delivery. However, the economic cost per dose was more comparable for both strategies (year-round 22% higher than campaign), balanced by higher costs of operating equipment and monitoring activities for the year-round strategy. These delivery cost data provide real-world evidence to inform pediatric influenza vaccine introduction in Kenya.

Comparing performance of year-round and campaign-mode influenza vaccination strategies among children aged 6–23 months in Kenya: 2019–2021

IntroductionIn 2016, the Kenya National Immunization Technical Advisory Group requested additional programmatic and cost effectiveness data to inform the choice of strategy for a national influenza vaccination program among children aged 6–23 months of age. In response, we conducted an influenza vaccine demonstration project to compare the performance of a year-round versus campaign-mode vaccination strategy. Findings from this demonstration project will help identify essential learning lessons for a national program. MethodsWe compared two vaccine delivery strategies: (i) a year-round vaccination strategy where influenza vaccines were administered throughout the year at health facilities. This strategy was implemented in Njoro sub-county in Nakuru (November 2019 to October 2021) and Jomvu sub-county in Mombasa (December 2019 to October 2021), (ii) a campaign-mode vaccination strategy where vaccines were available at health facilities over four months. This strategy was implemented in Nakuru North sub-county in Nakuru (June to September 2021) and Likoni sub-county in Mombasa (July to October 2021). We assessed differences in coverage, dropout rates, vaccine wastage, and operational needs. ResultsWe observed similar performance between strategies in coverage of the first dose of influenza vaccine (year-round strategy 59.7 %, campaign strategy 63.2 %). The coverage obtained in the year-round sub-counties was similar (Njoro 57.4 %; Jomvu 63.1 %); however, more marked differences between campaign sub-counties were observed (Nakuru North 73.4 %; Likoni 55.2 %). The campaign-mode strategy exceeded the cold chain capacity of participating health facilities, requiring thrice monthly instead of once monthly deliveries, and was associated with a two-fold increase in workload compared to the year-round strategy (168 vaccines administered per day in the campaign strategy versus 83 vaccines administered per day in the year-round strategy). ConclusionAlthough both strategies had similar coverage levels, the campaign-mode strategy was associated with considerable operational needs that could significantly impact the immunization program.

Promoting adolescent health through integrated human papillomavirus vaccination programs: The experience of Togo

The introduction of the Human papillomavirus (HPV) vaccine has shown potential to not only prevent cervical cancer but also drive adolescents’ access to other health care services, even in low-income countries. Few studies have been conducted to date to identify best practices and estimate the acceptance, operational challenges and benefits of including broader adolescent health interventions into immunization efforts, knowledge which is essential to supporting widespread integration. In this paper we review the efforts undertaken by the government of Togo to integrate adolescent health programming with the HPV vaccination roll out. With the support of partners (GAVI, WHO, UNFPA and UNICEF), the country successfully completed, in 2017, two years of an HPV vaccine demonstration project, which entailed vaccinating 10-year-old girls against HPV in two selected districts of the country and integrating a health education component focused on puberty education / menstrual hygiene and hand washing practice. Our study is a post-implementation program evaluation, using mixed methods to assess key questions of feasibility and acceptability of an integrated adolescent package of care. It showed that the HPV vaccination in conjunction with the health education sessions was well received by the majority of health care providers, teachers and parents. Our study confirmed that in Togo it proved feasible to combine education and HPV vaccination in school-based service delivery. However, more operational research is neded to understand how to increase the impact and sustainability of the co-delivery of interventions. We did not analyze the health impact and cost implications of the intervention, which will be an important consideration for scaling up such integration efforts alongside routine immunization.

Global health systems partnerships: a mixed methods analysis of Mozambique\u2019s HPV vaccine delivery network actors

BackgroundGlobal health partnerships have expanded exponentially in the last two decades with Gavi, the Vaccine Alliance considered the model’s pioneer and leader because of its vaccination programs’ implementation mechanism. Gavi, relies on diverse domestic and international partners to carry out the programs in low- and middle-income countries under a partnership engagement framework (PEF). In this study, we utilized mixed methods to examine Mozambique’s Gavi driven partnership network which delivered human papillomavirus (HPV) vaccine during the demonstration phase.MethodsQualitative tools gauged contextual factors, prerequisites, partner performance and practices while a social network analysis (SNA) survey measured the partnership structure and perceived added value in terms of effectiveness, efficiency and country ownership. Forty key informants who were interviewed included frontline Ministry of Health workers, Ministry of Education staff and supporting partner organization members, of whom 34 participated in the social network analysis survey.ResultsPartnership structure SNA connectivity measurement scores of reachability (100%) and average distance (2.5), were high, revealing a network of very well-connected HPV vaccination implementation collaborators. Such high scores reflect a network structure favorable for rapid and widespread diffusion of information, features necessary for engaging and handling multiple implementation scales. High SNA effectiveness and efficiency measures for structural holes (85%) and low redundancy (30%) coupled with high mean perceived effectiveness (97.6%) and efficiency (79.5%) network outcome scores were observed. Additionally, the tie strength average score of 4.1 on a scale of 5 denoted high professional trust. These are all markers of a collaborative partnership environment in which disparate institutions and organizations leveraged each entity’s comparative advantage. Lower perceived outcome scores for country ownership (24%) were found, with participants citing the prominent role of several out-of-country partner organizations as a major obstacle.ConclusionsWhile there is room for improvement on the country ownership aspects of the partnership, the expanded, diverse and inclusive collaboration of institutions and organizations that implemented the Mozambique HPV vaccine demonstration project was effective and efficient. We recommend that the country adapt a similar model during national scale up of HPV vaccination.

Community stakeholder engagement during a vaccine demonstration project in Nigeria: lessons on implementation of the good participatory practice guidelines.

IntroductionTo report on the successes and challenges with implementing the good participatory practice guidelines for the Nigerian Canadian Collaboration on AIDS Vaccine (NICCAV) project.MethodsAn open and close ended questionnaire was administered to 25 randomly selected community stakeholders on the project. The questions sought information on perception about the community entry, constitution and function of the community advisory board (CAB) and community based organization (CBO), media engagement process, and research literacy programmes. The quantitative and qualitative data were analysed and findings triangulated.ResultsThe project exceeded its targets on CBO engagement and community members reached. Stakeholders had significant improvement in knowledge about HIV vaccine research design and implementation (p=0.004). All respondents felt satisfied with the community entry, CAB constitution process, function and level of media engagement; 40% were satisfied with the financial support provided; 70% felt the community awareness and education coverage was satisfactory; and 40% raised concerns about the study site selection with implications for study participants' recruitment.ConclusionThe NICCAV community stakeholder engagement model produced satisfactory outcomes for both researchers and community stakeholders. The inclusion of an advocacy and monitoring plan enabled it to identify important challenges that were of ethical concerns for the study.

Implementation strategy and cost of Mozambique\u2019s HPV vaccine demonstration project

BackgroundCost is an important determinant of health program implementation. In this study, we conducted a comprehensive evaluation of the implementation strategy of Mozambique’s school-based HPV vaccine demonstration project. We sought to estimate the total costs for the program, cost per fully immunized girl (FIG), and compute projections for the total cost of implementing a similar national level vaccination program.MethodsWe collected primary data through document review, participatory observation, and key informant interviews at all levels of the national health system and Ministry of Education. We used a combination of micro-costing methods—identification and measurement of resource quantities and valuation by application of unit costs, and gross costing—for consideration of resource bundles as they apply to the number of vaccinated girls. We extrapolated the cost per FIG to the HPV-vaccine-eligible population of Mozambique, to demonstrate the projected total annual cost for two scenarios of a similarly executed HPV vaccine program.ResultsThe total cost of the Mozambique HPV vaccine demonstration project was $523,602. The mean cost per FIG was $72 (Credibility Intervals (CI): $62 - $83) in year one, $38 (CI: $37 - $40) in year two, and $54 CI: $49 - $61) for years one and two. The mean cost per FIG with the third HPV vaccine dose excluded from consideration was $60 (CI: $50 - $72) in year one, $38 (CI: $31 - $46) in year two, and $48 (CI: $42 - $55) for years one and two. The mean cost per FIG when only one HPV vaccine dose is considered was $30 (CI: $27 - $33)) in year one, $19 (CI: $15–$23) in year two, and $24 (CI: $22–$27) for both years. The projected annual cost of a two-and one-dose vaccine program targeting all 10-year-old girls in the country was $18.2 m (CI: $15.9 m - $20.7 m) and $9 m (CI: $8 m - $10 m) respectively.ConclusionNational adaptation and scale-up of Mozambique’s school-based HPV vaccine strategy may result in substantial costs depending on dosing. For sustainability, stakeholders will need to negotiate vaccine price and achieve higher efficiency in startup activities and demand creation.

Human papillomavirus (HPV) vaccine coverage achievements in low and middle-income countries 2007–2016

IntroductionSince 2007, HPV vaccine has been available to low and middle income countries (LAMIC) for small-scale ‘demonstration projects’, or national programmes. We analysed coverage achieved in HPV vaccine demonstration projects and national programmes that had completed at least 6 months of implementation between January 2007–2016. MethodsA mapping exercise identified 45 LAMICs with HPV vaccine delivery experience. Estimates of coverage and factors influencing coverage were obtained from 56 key informant interviews, a systematic published literature search of 5 databases that identified 61 relevant full texts and 188 solicited unpublished documents, including coverage surveys. Coverage achievements were analysed descriptively against country or project/programme characteristics. Heterogeneity in data, funder requirements, and project/programme design precluded multivariate analysis. ResultsEstimates of uptake, schedule completion rates and/or final dose coverage were available from 41 of 45 LAMICs included in the study. Only 17 estimates from 13 countries were from coverage surveys, most were administrative data. Final dose coverage estimates were all over 50% with most between 70% and 90%, and showed no trend over time. The majority of delivery strategies included schools as a vaccination venue. In countries with school enrolment rates below 90%, inclusion of strategies to reach out-of-school girls contributed to obtaining high coverage compared to school-only strategies. There was no correlation between final dose coverage and estimated recurrent financial costs of delivery from cost analyses. Coverage achieved during joint delivery of HPV vaccine combined with another intervention was variable with little/no evaluation of the correlates of success. ConclusionsThis is the most comprehensive descriptive analysis of HPV vaccine coverage in LAMICs to date. It is possible to deliver HPV vaccine with excellent coverage in LAMICs. Further good quality data are needed from health facility based delivery strategies and national programmes to aid policymakers to effectively and sustainably scale-up HPV vaccination.

Implementation of a human papillomavirus vaccination demonstration project in Malawi: successes and challenges

BackgroundCervical cancer is a major public health problem in Malawi. The age-standardized incidence and mortality rates are estimated to be 75.9 and 49.8 per 100,000 population, respectively. The availability of the human papillomavirus (HPV) vaccine presents an opportunity to reduce the morbidity and mortality associated with cervical cancer. In 2013, the country introduced a school-class-based HPV vaccination pilot project in two districts. The aim of this study was to evaluate HPV vaccine coverage, lessons learnt and challenges identified during the first three years of implementation.MethodsThis was an evaluation of the HPV vaccination project targeting adolescent girls aged 9–13 years conducted in Malawi from 2013 to 2016. We analysed programme data, supportive supervision reports and minutes of National HPV Task Force meetings to determine HPV vaccine coverage, reasons for partial or no vaccination and challenges. Administrative coverage was validated using a community-based coverage survey.ResultsA total of 26,766 in-school adolescent girls were fully vaccinated in the two pilot districts during the first three years of the programme. Of these; 2051 (7.7%) were under the age of 9 years, 884 (3.3%) were over the age of 13 years, and 23,831 (89.0%) were aged 9–13 years (the recommended age group). Of the 765 out-of-school adolescent girls aged 9–13 who were identified during the period, only 403 (52.7%) were fully vaccinated. In Zomba district, the coverage rates of fully vaccinated were 84.7%, 87.6% and 83.3% in year 1, year 2 and year 3 of the project, respectively. The overall coverage for the first three years was 82.7%, and the dropout rate was 7.7%. In Rumphi district, the rates of fully vaccinated coverage were 90.2% and 96.2% in year 1 and year 2, respectively, while the overall coverage was 91.3%, and the dropout rate was 4.9%. Administrative (facility-based) coverage for the first year was validated using a community-based cluster coverage survey. The majority of the coverage results were statistically similar, except for in Rumphi district, where community-based 3-dose coverage was higher than the corresponding administrative-coverage (94.2% vs 90.2%, p < 0.05), and overall (in both districts), facility-based 1-dose coverage was higher than the corresponding community-based (94.6% vs 92.6%, p < 0.05). Transferring out of the district, dropping out of school and refusal were some of the reasons for partial or no uptake of the vaccine.ConclusionIn Malawi, the implementation of a school-class-based HPV vaccination strategy was feasible and produced high (>80%) coverage. However, this strategy may be associated with the vaccination of under- and over-aged adolescent girls who are outside of the vaccine manufacturer’s stipulated age group (9–13 years). The health facility-based coverage for out-of-school adolescent girls produced low coverage, with only half of the target population being fully vaccinated. These findings highlight the need to assess the immunogenicity associated with the administration of a two-dose schedule to adolescent girls younger or older than 9–13 years and effectiveness of health facility-based strategy before rolling out the programme.

Lessons learnt from human papillomavirus (HPV) vaccination in 45 low- and middle-income countries.

ObjectiveTo synthesise lessons learnt and determinants of success from human papillomavirus (HPV) vaccine demonstration projects and national programmes in low- and middle-income countries (LAMICs).MethodsInterviews were conducted with 56 key informants. A systematic literature review identified 2936 abstracts from five databases; after screening 61 full texts were included. Unpublished literature, including evaluation reports, was solicited from country representatives; 188 documents were received. A data extraction tool and interview topic guide outlining key areas of inquiry were informed by World Health Organization guidelines for new vaccine introduction. Results were synthesised thematically.ResultsData were analysed from 12 national programmes and 66 demonstration projects in 46 countries. Among demonstration projects, 30 were supported by the GARDASIL® Access Program, 20 by Gavi, four by PATH and 12 by other means. School-based vaccine delivery supplemented with health facility-based delivery for out-of-school girls attained high coverage. There were limited data on facility-only strategies and little evaluation of strategies to reach out-of-school girls. Early engagement of teachers as partners in social mobilisation, consent, vaccination day coordination, follow-up of non-completers and adverse events was considered invaluable. Micro-planning using school/ facility registers most effectively enumerated target populations; other estimates proved inaccurate, leading to vaccine under- or over-estimation. Refresher training on adverse events and safe injection procedures was usually necessary.ConclusionConsiderable experience in HPV vaccine delivery in LAMICs is available. Lessons are generally consistent across countries and dissemination of these could improve HPV vaccine introduction.

Implementation of an HPV vaccination program in Eldoret, Kenya: results from a qualitative assessment by key stakeholders.

BackgroundCervical cancer strikes hard in low-resource regions yet primary prevention is still rare. Pilot projects have however showed that Human Papillomavirus (HPV) vaccination programs can attain high uptake. Nevertheless, a study accompanying a vaccination demonstration project in Eldoret, Kenya, revealed less encouraging outcomes: uptake during an initial phase targeting ten schools (i.e., 4000 eligible girls), was low and more schools had to be included to reach the proposed number of 3000 vaccinated girls. The previously conducted study also revealed that many mothers had not received promotional information which had to reach them through schools: teachers were sensitized by health staff and asked to invite students and parents for HPV vaccination in the referral hospital. In this qualitative study, we investigate factors that hampered promotion and vaccine uptake.MethodsFocus group discussions (FGD) with teachers (4) and fathers (3) were organized to assess awareness and attitudes towards the vaccination program, cervical cancer and the HPV vaccine, as well as a FGD with the vaccinators (1) to discuss the course of the program and potential improvements. Discussions were recorded, transcribed, translated, and analyzed using thematic analysis In addition, a meeting with the program coordinator was set up to reflect upon the program and the results of the FGD, and to formulate recommendations for future programs.ResultsCervical cancer was poorly understood by fathers and teachers and mainly linked with nonconforming sexual behavior and modern lifestyle. Few had heard about the vaccination opportunity: feeling uncomfortable to discuss cervical cancer and not considering it as important had hampered information flow. Teachers requested more support from health staff to address unexpected questions from parents. Non-uptake was also the result of distrust towards new vaccines. Schools entering the program in the second phase reacted faster: they were better organized, e.g., in terms of transport, while the community was already more familiarized with the vaccine.ConclusionsClose collaboration between teachers and health staff is crucial to obtain high HPV vaccine uptake among schoolgirls. Promotional messages should, besides providing correct information, tackle misbeliefs, address stigma and stress the priority to vaccinate all, regardless of lifestyle. Monitoring activities and continuous communication could allow for detection of rumors and unequal uptake in the community.

Overweight, obesity, underweight and stunting in female primary school learners in rural KwaZulu-Natal, South Africa

Malnutrition substantially impacts the health outcomes of children. Globally, the childhood prevalence of overweight and obesity has increased, while underweight and stunting (though decreasing) continues to pose a major public health challenge. In low- to middle-income countries, a mixed pattern of over- and undernutrition (nutritional transition) can exist in communities. To describe the prevalence of malnutrition among female learners in the Nongoma and Ceza districts in Zululand, KwaZulu-Natal (KZN). We performed a secondary analysis of anthropometric data collected during the 2011 HPV Vaccination Demonstration Project. School health teams, comprising trained nurses, measured the height (in cm) and weight (in kg) of 963 female learners in 31 primary schools. Internationally accepted standardised measures were used as cut-offs for defining overweight, obesity, underweight and stunting. We found evidence of both under- and overnutrition. Overall, 9% of female learners were overweight, 3.8% obese, 4% underweight and 9.2% stunted (using WHO/NCHS criteria). The highest levels of stunting were in the 11 - 12-year age groups, of underweight in the 10-year age group, of overweight and obesity in the 9 - 10-year age groups. Moreover, a proportion of underweight (17.4%), overweight (11.1%) and obese (22.9%) learners were also stunted. Our study describes the prevalence of overweight and obesity, wasting and stunting of female learners in KZN and suggests the presence of a nutritional transition in these rural communities; however, further studies are needed. Our findings emphasise the need for health promotion and education programs in schools.

Influences on parental acceptance of HPV vaccination in demonstration projects in Uganda and Vietnam

This study investigates the effect of communication strategies on human papillomavirus (HPV) vaccine uptake in HPV vaccine demonstration projects in Uganda and Vietnam. Secondary analysis was conducted on data from surveys of a representative sample of parents and guardians of girls eligible for HPV vaccine, measuring three-dose coverage achieved in demonstration projects in 2008–2010. Univariate and multivariate logistic regression analysis calculated the unadjusted and adjusted odds of receiving at least one dose of HPV vaccine depending on exposure to community influencers; information, education, and communication (IEC) channels; and demographic factors. This study found that exposure to community influencers was associated with HPV vaccine uptake in a multivariate model controlling for other factors. Exposure to non-interactive IEC channels was only marginally associated with HPV vaccine uptake. These results underscore the need of HPV vaccine programs in low- and middle-income countries to involve and utilize key community influencers and stakeholders to maximize HPV vaccine uptake.

Paradigm shift needed for cervical cancer: HPV infection is the real epidemic

In South Africa (SA) the prevalence of cervical cancer is alarmingly high, presentation is late and survival rates are poor. High-risk human papillomavirus (hrHPV) has been established as a prerequisite for the development of cervical cancer, and prevention programmes in many developed countries include primary prevention through immunisation against types 16 and 18 before hrHPV exposure. Two articles in this issue of SAMJ report the outcome of a vaccine demonstration project in rural KwaZulu-Natal (KZN), and high hrHPV prevalence among a large sample of SA women. The editorial discusses optimal cervical cancer prevention programme for a middle-resourced country with an extremely high burden of HPV-associated disease like SA, and proposes initiation of primary school-based HPV vaccination as soon as possible, 10-yearly HPV-based screening, and effective treatment of women with positive screening tests.

High uptake of Gardasil vaccine among 9 - 12-year-old schoolgirls participating in an HPV vaccination demonstration project in KwaZulu-Natal Province

Cervical cancer is linked to infection of the cervix by oncogenic human papillomavirus (HPV) subtypes. The quadrivalent Gardasil vaccine (against HPV types 6, 11, 16, 18), recommended in girls 9 - 12 years of age, has been shown to be safe, immunogenic and efficacious, with minimal or no side-effects. To demonstrate the capacity of school health teams to carry out vaccinations within a school environment. To assess the uptake of 3 doses of the vaccine, document lessons learnt and provide recommendations for a national rollout of school-based HPV vaccination for learners. Female learners (age 9 - 12 years) from 31 primary schools in Nongoma and Ceza districts (KwaZulu-Natal province, South Africa) were identified for inclusion in the vaccination programme. The 3 doses of vaccine were administered by existing school health teams. Education and training sessions were held with all stakeholders: provincial departments of health and education; school health teams; primary healthcare nurses; hospital doctors and nurses; private practitioners; school principals, teachers and governing bodies; parents; and community and traditional leaders. The overall uptake of the vaccine was found to be high: 99.7%, 97.9% and 97.8% for the first, second and third doses respectively (N = 963). No adverse events were attributed to the HPV vaccine. This project demonstrated the successful implementation of HPV vaccination among learners (ages 9 - 12 years) using school health teams.

Monitoring adverse events following immunisation in developing countries: experience from human papillomavirus vaccination demonstration projects

Surveillance of adverse events following immunisation (AEFIs) is important for maintaining trust in vaccination. This paper discusses retrospective reports by parents and guardians of girls experiencing AEFIs during human papillomavirus (HPV) vaccine demonstration projects in Uganda and Vietnam. A secondary analysis of data from a population-based survey measuring HPV vaccine coverage of eligible girls and acceptability among parents and guardians was conducted. Survey data from parents were analysed for frequency and type of AEFI and actions taken. Of the 1700 eligible households contacted, all responded to the survey; of those, 1313 respondents had an eligible child who had received at least one dose of the HPV vaccine. Data were missing from 49 respondents, resulting in 1264 surveys. Twenty-five percent reported an AEFI, with fever (29.1%) and pain or swelling at the injection site (62.0%) being the most common. Events totalled 386 (10.5%) of the 3684 doses administered. Most parents reported that they took no action (63.9%) or cared for girls at home (16.1%) following an AEFI. Thirty-three parents sought advice from health workers or attended a clinic for 46 events (0.8% of all doses). Frequency of reporting varied by respondent identity, geographic location and vaccination location. AEFIs reported were similar to Phase III vaccine trials. Most parents reporting AEFIs took no action or treated the girl at home, suggesting that most AEFIs were not serious enough to contact the health system. AEFI reports were more frequent when solicited in surveys compared with reports from routine monitoring.

Health and economic impact of human papillomavirus 16 and 18 vaccination of preadolescent girls and cervical cancer screening of adult women in Peru

To estimate the benefits, cost-effectiveness (i.e., value for money), and required financial costs (e.g., affordability) of adding human papillomavirus (HPV) vaccination to Peru's cervical cancer screening program. Evidence (e.g., coverage, delivery costs) from an HPV vaccination demonstration project conducted in Peru was combined with epidemiological data in an empirically calibrated mathematical model to assess screening (HPV DNA testing three to five times per lifetime) and HPV vaccination under different cost, coverage, and efficacy assumptions. Model outcomes included lifetime risk of cancer reduction, cancer cases averted, lives saved, average life expectancy gains, short-term financial costs, and discounted long-term economic costs. Status quo low levels of screening (e.g., cytologic screening at 10.0% coverage) reduced lifetime risk of cervical cancer by 11.9%, compared to not screening. Adding vaccination of preadolescent girls at a coverage achieved in the demonstration program (82.0%) produced an additional 46.1% reduction, and would cost less than US$ 500 per year of life saved (YLS) at ~US$ 7/dose or ~US$ 1 300 at ~US$ 20/dose. One year of vaccination was estimated to cost ~US$ 5 million at ~US$ 5/dose or ~US$ 16 million at ~US$ 20/dose, including programmatic costs. Enhanced screening in adult women combined with preadolescent vaccination had incremental cost-effectiveness ratios lower than Peru's 2005 per capita gross domestic product (GDP; US$ 2 852, in 2009 US$), and would be considered cost-effective. Preadolescent HPV vaccination, followed by enhanced HPV DNA screening in adult women, could prevent two out of three cervical cancer deaths. Several strategies would be considered "good value" for resources invested, provided vaccine prices are low. While financial costs imply substantial immediate investments, the high-value payoff should motivate creative mechanisms for financing and scale-up of delivery programs.

Health and economic impact of human papillomavirus 16 and 18 vaccination of preadolescent girls and cervical cancer screening of adult women in Peru

OBJECTIVE: To estimate the benefits, cost-effectiveness (i.e., value for money), and required financial costs (e.g., affordability) of adding human papillomavirus (HPV) vaccination to Peru's cervical cancer screening program. METHODS: Evidence (e.g., coverage, delivery costs) from an HPV vaccination demonstration project conducted in Peru was combined with epidemiological data in an empirically calibrated mathematical model to assess screening (HPV DNA testing three to five times per lifetime) and HPV vaccination under different cost, coverage, and efficacy assumptions. Model outcomes included lifetime risk of cancer reduction, cancer cases averted, lives saved, average life expectancy gains, short-term financial costs, and discounted long-term economic costs. RESULTS: Status quo low levels of screening (e.g., cytologic screening at 10.0% coverage) reduced lifetime risk of cervical cancer by 11.9%, compared to not screening. Adding vaccination of preadolescent girls at a coverage achieved in the demonstration program (82.0%) produced an additional 46.1% reduction, and would cost less than US$ 500 per year of life saved (YLS) at ~US$ 7/dose or ~US$ 1 300 at ~US$ 20/dose. One year of vaccination was estimated to cost ~US$ 5 million at ~US$ 5/dose or ~US$ 16 million at ~US$ 20/dose, including programmatic costs. Enhanced screening in adult women combined with preadolescent vaccination had incremental cost-effectiveness ratios lower than Peru's 2005 per capita gross domestic product (GDP; US$ 2 852, in 2009 US$), and would be considered cost-effective. CONCLUSIONS: Preadolescent HPV vaccination, followed by enhanced HPV DNA screening in adult women, could prevent two out of three cervical cancer deaths. Several strategies would be considered "good value" for resources invested, provided vaccine prices are low. While financial costs imply substantial immediate investments, the high-value payoff should motivate creative mechanisms for financing and scale-up of delivery programs.

Acceptance patterns and decision-making for human papillomavirus vaccination among parents in Vietnam: an in-depth qualitative study post-vaccination.

BackgroundThe GAVI Alliance’s decision in late 2011 to invite developing countries to apply for funding for human papillomavirus (HPV) vaccine introduction underscores the importance of understanding levels of HPV vaccine acceptance in developing country settings. In this paper, we present findings from qualitative research on parents’ rationales for vaccinating or not vaccinating their daughters (vaccine acceptance) and their decision-making process in the context of an HPV vaccination demonstration project in Vietnam (2008–2009).MethodsWe designed a descriptive qualitative study of HPV vaccine acceptability among parents of girls eligible for vaccination in four districts of two provinces in Vietnama. The study was implemented after each of two years of vaccinations was completed. In total, 133 parents participated in 16 focus group discussions and 27 semi-structured interviews.ResultsFocus group discussions and in-depth interviews with parents of girls vaccinated revealed that they were generally very supportive of immunization for disease prevention and of vaccinating girls against HPV. The involvement of the National Expanded Program of Immunization in the demonstration project lent credibility to the HPV vaccine, contributing to high levels of acceptance. For parents who declined participation, concerns about side effects, the possibility that the vaccine was experimental, and the possible impact of the vaccine on future fertility rose to the surface. In terms of the decision-making process, many parents exhibited ‘active decision-making,’ reaching out to friends, family, and opinion leaders for guidance prior to making their decision.ConclusionVietnam’s HPV vaccination experience speaks to the importance of close collaboration with the government to make the most of high levels of trust, and to reduce suspicions about new vaccines that may arise in the context of vaccine introduction in developing country settings.

Knowledge of Cervical Cancer and HPV Vaccine Post-Vaccination among Mothers and Daughters in Vietnam

Limited human papillomavirus (HPV) related knowledge might be a barrier to future vaccine acceptance. From 2008-2010, PATH conducted an HPV vaccination demonstration project in partnership with the government immunization program in Vietnam, which included awareness campaigns prior to vaccination. To assess and compare knowledge and attitudes about cervical cancer and HPV vaccines between mothers and daughters, and whether knowledge was associated with vaccination status. We analyzed HPV-related knowledge and attitude data from mother-daughter paired responses to a cross-sectional household survey. After parents completed the survey, daughters were asked the same questions. We calculated the frequency of responses for each question and devised a scaled composite measure for knowledge. Participants believed they had received enough information about cervical cancer and HPV vaccines and it was sufficient to make a decision about vaccination. Fifty percent of the participants knew HPV causes cervical cancer and 80% knew the HPV vaccine prevented cervical cancer. Mothers had more knowledge about cervical cancer and HPV infection (p<0.01), compared to daughters, who had more vaccine specific knowledge (p<0.01). However, the total mean knowledge score was similar for the groups. Girls not fully vaccinated had a lower mean knowledge score than fully vaccinated girls (p<0.001). Our results suggest that the purpose of the HPV vaccine was clearly messaged; however, some misconceptions about cervical cancer and HPV still exist. Limited knowledge about the magnitude of cervical cancer, HPV as a cause of cervical cancer, and HPV vaccines may have contributed to incomplete vaccination.