Cost and operational context for national human papillomavirus (HPV) vaccine delivery in six low- and middle-income countries.

INTRODUCTION: There are concerns from immunization program planners about high delivery costs for human papillomavirus (HPV) vaccine. Most prior research evaluated costs of HPV vaccine delivery during demonstration projects or at introduction, showing relatively high costs, which may not reflect the costs beyond the pilot or introduction years. This study sought to understand the operational context and estimate delivery costs for HPV vaccine in six national programs, beyond their introduction years. METHODS: Operational research and microcosting methods were used to retrospectively collect primary data on HPV vaccination program activities in Ethiopia, Guyana, Rwanda, Senegal, Sri Lanka, and Uganda. Data were collected from the national level and a sample of subnational administrative offices and health facilities. Operational data collected were tabulated as percentages and frequencies. Financial costs (monetary outlays) and economic costs (financial plus opportunity costs) were estimated, as was the cost per HPV vaccine dose delivered. Costing was done from the health system perspective and reported in 2019 United States dollars (US$). RESULTS: Across the study countries, between 53 % and 99 % of HPV vaccination sessions were conducted in schools. Differences were observed in intensity and frequency with which program activities were conducted and resources used. Mean annual economic costs at health facilities in each country ranged from $1,207 to $3,190, while at the national level these ranged from $7,657 to $304,278. Mean annual HPV vaccine doses delivered per health facility in each country ranged from 162 to 761. Mean financial costs per dose per study country ranged from $0.27 to $3.32, while the economic cost per dose ranged from $3.09 to $17.20. CONCLUSION: HPV vaccine delivery costs were lower than at introduction in some study countries. There were differences in the activities carried out for HPV vaccine delivery and the number of doses delivered, impacting the cost estimates.

The Global Demand and Supply Balance of the Human Papillomavirus Vaccine: Implications for the Global Strategy for the Elimination of Cervical Cancer.

As of November 2023, 140 World Health Organization (WHO) member states had introduced human papillomavirus (HPV) vaccination in their routine immunization schedules. Despite a continuously increasing demand from countries across all income groups, supply constraints, COVID-19 pandemic disruptions, and other factors have slowed the pace of introduction, particularly in low-resource settings. Using a population-based forecasting methodology and leveraging the WHO's yearly vaccine supply data collection, we updated global demand and supply projections for the HPV vaccine for the period of 2022-2031. The analysis aimed at clarifying the magnitude of the challenges to bringing in equitable access to HPV vaccines, which can hinder the achievement of the Global Strategy for the Elimination of Cervical Cancer. The results of this analysis show that the risk of HPV shortages has significantly decreased, and global supply is now, under normal circumstances, sufficient to meet global demand. In the long term, HPV supply will be more than sufficient to meet the Global Strategy's goal of 90% of girls fully vaccinated with the HPV vaccine by the age of 15 years. Nonetheless, paying attention to the formulation of policies and carefully managing demand and supply will be required to ensure the long-term sustainability of the HPV vaccine program.

HPV vaccination coverage in three districts in Zimbabwe following national introduction of 0,12 month schedule among 10 to 14 year old girls.

BACKGROUND: Zimbabwe has one of the highest incidence rates of cervical cancer in the world - 61.7 per 100,000 women. The government of Zimbabwe introduced bivalent HPV vaccine with a 0,12 month schedule to all 10-14 year old girls using a pulsed-campaign approach in May 2018 (dose 1) and May 2019 (dose 2). METHODS: In August 2019, we conducted a population-based, two-stage cluster survey of households with girls who were eligible for the national HPV vaccination program to determine two-dose HPV vaccination coverage in three districts of Zimbabwe. All households with girls currently aged 11 to 15 years were line-listed through a census conducted in the pre-selected clusters from each district prior to survey administration. A simple random sample of eligible households was selected from these lists to estimate HPV vaccine coverage at sufficient power with a margin of error of +/- 5%. Criteria for district selection included estimated vaccine uptake (low, medium, high), rural/urban/peri-urban, geographic area, estimated number of girls not in school, and recent natural disasters or disease outbreaks. We oversampled households with girls aged 13 or 14 years at the time of dose 1. RESULTS: On-time dose 1 uptake ranged from 88 to 94% and two-dose HPV vaccine coverage ranged from 75 to 86% across the three districts. Nearly all vaccinations occurred in schools, and less than 2% of girls did not attend school. There were challenges assessing ages of girls at schools prior to vaccination - 9% of girls vaccinated were less than 10 years old at time of dose 1. DISCUSSION: Zimbabwe has demonstrated that high uptake and successful completion of 2-dose HPV vaccination can be achieved with an annual dosing schedule. Efforts going forward will need to focus on minimizing dropout between doses and routinizing annual vaccinations in schools for every subsequent new cohort of eligible girls in the country.

The projected cost-effectiveness and budget impact of HPV vaccine introduction in Ghana.

BACKGROUND: Cervical cancer is responsible for around one-quarter of all cancer deaths among Ghanaian women. Between 2013 and 2015, Ghana conducted a pilot of HPV vaccination among 10-14-year-old girls in four regions; however, the country has yet to introduce the vaccine nationally. This study projected the cost-effectiveness and budget impact of adding HPV vaccination into Ghana's national immunization program. METHODS: We used a proportional outcomes model (UNIVAC, version 1.4) to evaluate the cost-effectiveness of introduction with bivalent (Cervarix™) and quadrivalent (Gardasil®) vaccines from government and societal perspectives. Vaccine introduction was modeled to start in 2022 and continue over ten birth cohorts using a combined delivery strategy of school (80%) and community outreach (20%). We modeled vaccination in a single age cohort of 9-year-old girls vs. a multi-age cohort of 9-year-old girls (routine) and 10-14-year-old girls (one-time campaign) compared to no vaccination. Health outcomes included cervical cancer cases, hospitalizations, deaths, and disability-adjusted life years (DALYs). We applied a discount rate of 3% to costs and outcomes. All monetary units are reported in USD 2018. RESULTS: National HPV vaccination in Ghana was projected to be cost-effective compared to no vaccination in all scenarios evaluated. The most cost-effective and dominant strategy was vaccination among 9-year-old girls, plus a one-time campaign among 10-14-year-old with the bivalent vaccine ($158/DALY averted from the government perspective; 95% credible range: $19-$280/DALY averted). Projected average annual costs of the vaccine program ranged from $11.2 to $15.4 M, depending on strategy. This represents 11-15% of the estimated total immunization costs for 2022 ($100,857,875 based on Ghana's comprehensive Multi-Year Plan for Immunization, 2020-2024). DISCUSSION: Our model suggests that introducing HPV vaccination would be cost-effective in Ghana under any strategy when willingness-to-pay is at least 40% GDP per capita ($881). Inclusion of a one-time catch-up campaign is shown to create greater value for money than routine immunization alone but would incur greater program costs.

Priorities for sexually transmitted infection vaccine research and development: Results from a survey of global leaders and representatives.

OBJECTIVE: To determine the sexually transmitted infection (STI) vaccine research priorities of global leaders in STI vaccine research, development, and service provision. METHODS: Global representatives attending the STI Vaccines: Opportunities for Research, Development, and Implementation symposium preceding the STI & HIV World Congress in 2019 were invited to complete an electronic survey. We asked participants to rank items by importance/priority for STI vaccine development for the following areas of focus: specific STIs (gonorrhea, chlamydia, syphilis, herpes, and trichomoniasis), broad research domains (basic science, funding, communication, program planning, and vaccine hesitancy), and specific research activities related to these domains. We calculated weighted value scores based on the ranking (e.g., first, second, third) and the total number of responses in order to produce a ranked list of the priorities. RESULTS: A total of 46 out of 97 (44%) symposium attendees responded to the survey. Gonorrhea was identified as the STI that should be prioritized for vaccine development, followed by syphilis with weighted value scores of 3.82 and 3.37, respectively, out of a maximum of five. Basic science (and vaccine development) was the domain ranked with the highest priority with a weighted value score of 4.78 out of six. Research activities related to basic science and vaccine development (including pre-clinical and clinical trials, and surveillance measures) and increased funding opportunities were the most highly ranked activities in the "STI vaccine development" and "research domains and activities" categories. CONCLUSION: Global leaders in attendance at the STI Vaccines symposium prioritized continued scientific work in vaccine development and program planning. Gonorrhea was identified as the highest priority infection, followed by syphilis.

National implementation of HPV vaccination programs in low-resource countries: Lessons, challenges, and future prospects.

More than 90% of cervical cancer deaths occur in low- and middle-income countries (LMICs), which have limited capacity to mount the comprehensive national screening and precancer treatment programs that could prevent most of these deaths. The development of vaccines against the human papillomavirus (HPV) has dramatically altered the landscape of cervical cancer prevention. As of mid-2020, 56 LMICs (41% of all LMICs) have initiated national HPV vaccination programs. This paper reviews the experience of LMICs that have introduced HPV vaccine into their national programs, key lessons learned, HPV vaccination sustainability and scale-up challenges, and future mitigation measures. As international guidance evolved and countries accumulated experience, strategies for national introduction shifted with regard to target groups, delivery site and timing, preparation and planning, communications and social mobilization, and ultimately monitoring, supervision and evaluation. Despite the successes that LMICs have been able to achieve in reaching large proportions of eligible girls, there are still considerable challenges countries encounter in overcoming rumors, reaching out-of-school girls, completing the vaccine series, estimating target populations, monitoring program performance, and assuring vaccination sustainability. New opportunities, such as the entry of additional vaccine manufacturers and ongoing studies to evaluate one-dose delivery, could help overcome the outstanding barriers to higher coverage and financial sustainability. Effective use of the experience to date and advances on the horizon could enable all LMICs to move towards the coverage levels that are needed to achieve eventual elimination.

HPV vaccination introduction worldwide and WHO and UNICEF estimates of national HPV immunization coverage 2010-2019.

WHO/UNICEF estimates for HPV vaccination coverage from 2010 to 2019 are analyzed against the backdrop of the 90% coverage target for HPV vaccination by 2030 set in the recently approved global strategy for cervical cancer elimination as a public health problem. As of June 2020, 107 (55%) of the 194 WHO Member States have introduced HPV vaccination. The Americas and Europe are by far the WHO regions with the most introductions, 85% and 77% of their countries having already introduced respectively. A record number of introductions was observed in 2019, most of which in low- and middle- income countries (LMIC) where access has been limited. Programs had an average performance coverage of around 67% for the first dose and 53% for the final dose of HPV. LMICs performed on average better than high- income countries for the first dose, but worse for the last dose due to higher dropout. Only 5 (6%) countries achieved coverages with the final dose of more than 90%, 22 countries (21%) achieved coverages of 75% or higher while 35 (40%) had a final dose coverage of 50% or less. When expressed as world population coverage (i.e., weighted by population size), global coverage of the final HPV dose for 2019 is estimated at 15%. There is a long way to go to meet the 2030 elimination target of 90%. In the post-COVID era attention should be paid to maintain the pace of introductions, specially ensuring the most populous countries introduce, and further improving program performance globally.

Risk of childhood mortality associated with death of a mother in low-and-middle-income countries: a systematic review and meta-analysis.

BACKGROUND: Death of a mother at an early age of the child may result in an increased risk of childhood mortality, especially in low-and-middle-income countries. This study aims to synthesize estimates of the association between a mother's death and the risk of childhood mortality at different age ranges from birth to 18 years in these settings. METHODS: Various MEDLINE databases, EMBASE, and Global Health databases were searched for population-based cohort and case-control studies published from 1980 to 2017. Studies were included if they reported the risk of childhood mortality for children whose mother had died relative to those whose mothers were alive. Random-effects meta-analyses were used to pool effect estimates, stratified by various exposures (child's age when mother died, time since mother's death) and outcomes (child's age at risk of child death). RESULTS: A total of 62 stratified risk estimates were extracted from 12 original studies. Childhood mortality was associated with child's age at time of death of a mother and time since a mother's death. For children whose mother died when they were ≤ 42 days, the relative risk (RR) of dying within the first 1-6 months of the child's life was 35.5(95%CI:9.7-130.5, p [het] = 0.05) compared to children whose mother did not die; by 6-12 months this risk dropped to 2.8(95%CI:0.7-10.7). For children whose mother died when they were ≤ 1 year, the subsequent RR of dying in that year was 15.9(95%CI:2.2-116.1,p [het] = 0.02), compared to children whose mother lived. For children whose mother died when they were ≤ 5 years of age, the RR of dying before aged 12 was 4.1(95%CI:3.0-5.7),p [het] = 0.83. Mortality was also elevated in specific analysis  among children whose mother died when child was older than 42 days. Overall, for children whose mother died < 6 and 6+ months ago, RRs of dying before reaching adulthood (≤18 years) were 4.7(95%CI:2.6-8.7,p [het] = 0.2) and 2.1(95%CI:1.3-3.4,p [het] = 0.7), respectively, compared to children whose mother lived. CONCLUSIONS: There is evidence of an association between the death of a mother and childhood mortality in lower resource settings. These findings emphasize the critical importance of women in family outcomes and the importance of health care for women during the intrapartum and postpartum periods and throughout their child rearing years.

Human papillomavirus vaccine disease impact beyond expectations.

Since 2006, 115 countries and territories have introduced human papillomavirus (HPV) vaccination programs. Several efforts have been undertaken to evaluate the impact of HPV vaccines. Many countries, mainly high-income and with high screening coverage, are already reporting a visible impact of the HPV vaccine on HPV-related diseases. Others, largely low-income and middle-income countries, are introducing HPV vaccine to control HPV diseases that will undoubtedly generate a similar impact. In this review, we will summarize the compelling evidence of the impact of vaccines in reducing the burden of HPV-related disease. The data support additional efforts to make HPV vaccines widely available to adolescent girls in the countries that bear the vast majority of cervical cancer-related morbidity and mortality.

The burden of cervical cancer in Vietnam: Synthesis of the evidence.

There is currently no national cervical screening or HPV immunization program in Vietnam. This study aims to synthesize available data on the burden of disease and to project the burden of cervical cancer to 2049 if no major interventions are implemented. We reviewed published data sources on risk factors for HPV prevalence, high-grade lesions, cervical cancer incidence and mortality in Vietnam from 1990 to 2017. We then used the available data to project the number of new cervical cancer cases for the period 2013-2049. Data on cervical cancer incidence and mortality in Vietnam are limited; two Vietnamese cancer registries have been reported on by the International Agency for Research on Cancer, which cover urban populations representing ∼20% of the national population. The reported age-standardized cervical cancer incidence in Hanoi was 6.7 (1993-1997), compared to 28.8 and 14.1 per 100,000 women in Ho Chi Minh City (1995-1998 and 2009-2012, respectively). Cancer mortality data are not uniformly available from cancer registries or mortality surveys in Vietnam because cause of death has not been routinely ascertained. Based on available urban population registry data, estimated rates in the rural population, and forward projection of existing trends, we estimate that without any further intervention, the number of new cases will increase from 6930 (range 5671-8493) in 2012 to 8562 (range 5775-12,762) in 2049, giving a total of 379,617 (range 276,879-542,941) new cases over the period 2013-2049. These findings help underpin the case for the delivery of HPV vaccination and cervical screening in Vietnam, and support similar initiatives in other low- and middle-income countries.

What works for human papillomavirus vaccine introduction in low and middle-income countries?

Since 2007, low and middle-income countries (LMICs) have gained experience delivering HPV vaccines through HPV vaccination pilots, demonstration projects and national programmes. This commentary summarises lessons from HPV vaccination experiences in 45 LMICs and what works for HPV vaccination introduction. Methods included a systematic literature review, unpublished document review, and key informant interviews. Data were extracted from 61 peer-reviewed articles, 11 conference abstracts, 188 technical reports, and 56 interviews, with quantitative data analysed descriptively and qualitative data analysed thematically. Key lessons are described under five themes of preparation, communications, delivery, coverage achievements, and sustainability. Lessons learnt were generally consistent across countries and projects and sufficient lessons have been learnt for countries to deliver HPV vaccine through phased national rollout rather than demonstration projects. However, challenges remain in securing the political will and financial resources necessary to implement successful national programmes.

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

INTRODUCTION: Since 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. METHODS: A 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. RESULTS: Estimates 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. CONCLUSIONS: This 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.

Progress in HPV vaccination in low- and lower-middle-income countries.

The past 10 years have seen remarkable progress in the global scale-up of human papillomavirus (HPV) vaccinations. Forty-three low- and lower-middle-income countries (LLMICs) have gained experience in delivering this vaccine to young adolescent girls through pilot programs, demonstration programs, and national introductions and most of these have occurred in the last 4 years. The experience of Senegal is summarized as an illustrative country case study. Publication of numerous delivery experiences and lessons learned has demonstrated the acceptability and feasibility of HPV vaccinations in LLMICs. Four areas require dedicated action to overcome remaining challenges to national scaling-up: maintaining momentum politically, planning successfully, securing financing, and fostering sustainability. Advances in policy, programming, and science may help accelerate reaching 30 million girls in LLMICs with HPV vaccine by 2020.

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

OBJECTIVE: To synthesise lessons learnt and determinants of success from human papillomavirus (HPV) vaccine demonstration projects and national programmes in low- and middle-income countries (LAMICs). METHODS: Interviews 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. RESULTS: Data 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. CONCLUSION: Considerable experience in HPV vaccine delivery in LAMICs is available. Lessons are generally consistent across countries and dissemination of these could improve HPV vaccine introduction.

Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

BACKGROUND: Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. METHODS: A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90-70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. RESULTS: All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. CONCLUSIONS: Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.

Feasibility of delivering HPV vaccine to girls aged 10 to 15 years in Uganda.

BACKGROUND: Cervical cancer is a leading cause of mortality among women in Uganda. The availability of the human papillomavirus (HPV) vaccine presents an opportunity to prevent cervical cancer. The Government of Uganda conducted a demonstration project exploring the feasibility of two delivery strategies. OBJECTIVE: To explore the feasibility of two HPV vaccine delivery strategies: 1) a stand-alone school-based strategy that selected girls based on their enrolment in grade 5 (known as the "grade-based" strategy; and 2) an age-based strategy that delivered the HPV vaccine based on the girls' age (10-year-olds). This strategy combined the delivery of the vaccine with the distribution of deworming medication and vitamin A through an existing Child Days Plus program. METHODS: A qualitative study that explored the feasibility of the two delivery strategies from the perspective of health workers, district leaders, and staff of the Uganda National Expanded Programme on Immunization, utilizing in-depth interviews and focus group discussions. RESULTS: Coverage data showed that more girls (88%) were vaccinated using the grade-based strategy and completed all three doses compared to those (73%) vaccinated using the age-based strategy. Health workers and teachers indicated that determining vaccination eligibility was easier by grade than by age and there were minor disruptions to health services and school programs during vaccinations, as reported by health workers and teachers using the grade-based strategy. CONCLUSION: HPV vaccine delivery at schools using grade eligibility was more feasible than selecting girls by age. Lessons learned in Uganda could be relevant for countries considering implementing HPV vaccinations.

Immunogenicity of bivalent HPV vaccine among partially vaccinated young adolescent girls in Uganda.

BACKGROUND: Investigations of vaccine efficacy and immunogenicity for adult females receiving fewer than three doses of human papillomavirus (HPV) vaccine have suggested protection against infection and precancerous lesions. We investigated the immunogenicity of bivalent HPV vaccines among adolescent girls from Uganda who received one, two, or three vaccine doses. METHODS: Young girls vaccinated through a government program in Uganda were invited to participate. HPV16- and HPV18-specific antibodies were measured at ≥24 months after the last vaccine dose using an enzyme linked immunoassay in girls who received one (n=36), two (n=145), or three (n=195) doses. RESULTS: Nearly all subjects (99%) were HPV16 and HPV18 seropositive at the time of blood-draw. Geometric mean antibody levels (GMTs) were: HPV161-dose=230 EU/mL, HPV162-dose=808 EU/mL, and HPV163-dose=1607 EU/mL; HPV181-dose=87 EU/mL, HPV182-dose=270 EU/mL, and HPV183-dose=296 EU/mL. The GMT ratio for 2:3 doses was 0.50 (HPV16) and 0.68 (HPV18) and did not meet the non-inferiority criteria (i.e., lower bound of 97.5% confidence interval of the GMT ratio greater than 0.50). The GMT ratio for 1:3 doses for HPV16 and HPV18 was inferior, but absolute GMTs for one dose were higher than adult women who received one dose (HPV16=124 EU/mL, HPV18=69 EU/mL) where efficacy has been demonstrated. CONCLUSIONS: Even though immunogenicity with less than three doses did not meet a priori non-inferiority thresholds, antibody levels measured ≥24 months after last dose were similar to those of adult women who have been followed for more than eight years for efficacy.

Lessons learned from HPV vaccine delivery in low-resource settings and opportunities for HIV prevention, treatment, and care among adolescents.

BACKGROUND: Human papillomavirus (HPV) vaccines to prevent cervical cancer have become available in recent years and presented a new challenge to health systems, since they prevent a sexually transmitted virus and are most effective if they are delivered to young adolescent girls, a group not widely served by other health programs. Demonstration and pilot HPV vaccination programs undertaken in the past 7-8 years in low-resource settings have produced lessons that may be more broadly applied to other adolescent health interventions, particularly to those that attempt to reduce human immunodeficiency virus (HIV) infection. METHODS: A systematic literature review was undertaken to identify formal and informal evaluations of HPV vaccine use in low- and middle-income countries. Special attention was devoted to the detailed evaluations carried out on large demonstration projects in India, Peru, Uganda, and Vietnam. RESULTS: These lessons fall into 2 main categories: service delivery operations and community outreach and mobilization. Operational issues included venue and timing of vaccinations, definition of target population, micro-planning and coordination, integration with other services, and training. Community issues included consent, messages and channels, endorsement and support, and timing of mobilization efforts. DISCUSSION: Careful planning, good coordination across sectors and levels, and sensitive attention to the expressed needs for information and preferences for communication channels among youth, parents, and communities more broadly were among the key lessons that are relevant for HIV interventions, but many of the smaller details were also important. CONCLUSIONS: Applying or adapting these lessons to adolescent HIV services could accelerate effective program design and enhance success.

Qualitative study of the feasibility of HPV vaccine delivery to young adolescent girls in Vietnam: evidence from a government-implemented demonstration program.

BACKGROUND: Introduction of human papillomavirus (HPV) vaccine in national programs has proceeded apace since 2006, mostly in high-income countries. Recently concluded pilots of HPV vaccination in low-income countries have provided important lessons learned for these settings; however, rigorous evaluations of the feasibility of these delivery strategies that effectively reach young adolescents have been few. This paper presents results from a qualitative evaluation of a demonstration program which implemented school-based and health center-based HPV vaccinations to all girls in grade 6, or 11 years of age, for two years in four districts of Vietnam. METHODS: Using semi-structured interviews of 131 health and education staff from local, district, province, and national levels and 26 focus-group discussions with local project implementers (n = 153), we conducted a qualitative two-year evaluation to measure the impact of HPV vaccinations on the health and education systems. RESULTS: HPV vaccine delivery at schools or health centers was made feasible by: a. close collaboration between the health and education sectors, b. detailed planning for implementation, c. clearly defined roles and responsibilities for project implementers, d. effective management and supervision of vaccinations during delivery, and e. engagement with community organizations for support. Both the health and education systems were temporarily challenged with the extra workload, but the disruptions were short-lived (a few days for each of three doses) and perceived as worth the longer-term benefit of cervical cancer prevention. CONCLUSION: The learning from Vietnam has identified critical elements for successful vaccine delivery that can provide a model for other countries to consider during their planning of national rollout of HPV vaccine.