FINAL REPORT. Start and end dates of the project January 1 to December 31, 2009 Time period covered by this progress report January to December 2009

Transcription

1 FINAL REPORT Project. DEVELOPING A MANAGEMENT MODEL FOR THE CERVICAL CANCER VACCINATION Amount of the donation 12,000 doses of Gardasil Start and end dates of the project January 1 to December 31, 2009 Time period covered by this progress report January to December 2009 La Paz, January 2010

2 SECTION I SUMMARY Every year, more than 288,000 women die worldwide from cervical cancer. In many regions cervical cancer disproportionately affects the poorest and most vulnerable women. At least 80% of these deaths occur in developing countries, and the majority occurs in the poorest areas of those countries. In the Plan Nacional de Cáncer Cérvico Uterino (National Plan Against Cervical Cancer), the Ministry of Health and Sports 1 established strategies, objectives, goals and action lines, including the need to develop projects to introduce the HPV vaccine. According to the MSD's National Plan Against Cervical Cancer, Bolivia has one of the highest rates of cervical cancer in the region, at 58.1/100,000, which is equal to 661 deaths per year due to cervical cancer. Each day, two women die of cervical cancer. The mortality rate is the highest in the Americas region. It is estimated that 25% of all deaths among women in Bolivia are due to cancer, and of those deaths, 63% are related to cervical cancer. In 2008, the Bolivian MSD and CIES Salud Sexual y Reproductiva implemented a project entitled Developing a Management Model for the Cervical Cancer Vaccination, which utilized a donation from Merck Laboratories, via International Planned Parenthood Federation, Western Hemisphere Region (IPPF/WHR) of 12,000 doses of the HPV vaccine, which were used to vaccinate 3,300 girls in Oruro, El Alto and Chaco Chuquisaqueño Departments with the goal of reducing the morbidity and mortality rate due to cervical cancer. The MSD and CIES, with technical assistance from IPPF/WHR, implemented an experimental pilot program to identify successful models for introducing the HPV vaccine. The project was designed to ensure the highest level of coverage of the HPV vaccine (three doses), using three different operational strategies: i) vaccinations in schools, ii) vaccinations at clinics in response to client requests, and iii) vaccinations through mobile health units to reach rural areas. The main goal was to improve acceptance of the vaccine by integrating efforts into broader programs to improve cervical cancer prevention and education. Results show 99.7%, 99.2% and 97.1% achievement of the goals for the first, second and third doses; 99% acceptance, 0.45% adverse reactions and a 0.01% loss of vaccines. 1 MSD: Ministry of Health and Sports 2

3 SECTION II BACKGROUND According to the MSD's National Plan Against Cervical Cancer, Bolivia has one of the highest rates of cervical cancer in the region at 58.1/100,000, which is equal to 661 deaths per year due to cervical cancer. Each day, two women die of cervical cancer. The mortality rate is the highest in the Americas region. It is estimated that 25% of all deaths among women in Bolivia are due to cancer, and of those deaths, 63% are related to cervical cancer. In response to the high rates of maternal morbidity and mortality in Bolivia due to cervical cancer, the MSD, with technical assistance from CIES, implemented the project Developing a Management Model for the Cervical Cancer Vaccination. This project is particularly relevant and timely. Bolivia is testing effective models for planning and expanding use of HPV vaccinations and is working to improve the results of its adolescent prevention and detection programs. There is also growing political support for and donor interest in reducing the unnecessary burden of cervical cancer in Bolivia. It is hoped that this program will help Bolivia radically improve cervical cancer rates as well as the efficiency and effectiveness of its efforts in this area by providing training, experience and viable models for the introduction of new technologies. SECTION III DESCRIPTION OF THE MODEL, ACTIVITIES, RESULTS AND CHALLENGES VACCINE ADMINISTRATION MODEL The HPV vaccine administration model was developed by CIES within the following framework: PLANNING MINISTRY OF HEALTH - CIES COORDINATION MINISTRY OF HEALTH SEDES SEDES HEALTH NETWORKS SEDUCA - SCHOOLDIRECTORS - TEACHERS - SCHOOL BOARD - PARENTS CIES - TECHNICAL MANAGEMENT - MEDICAL DEPARTMENT - 3

4 IDENTIFICATION SELECTION OF SCHOOLS OPERATIONS TEACHERS TRAINING, INFORMATION AND SENSITIZATION BOYS - GIRLS PARENTS SCHOOL BOARD ADMINISTRATION OF THE VACCINE TO GIRLS 9 TO 13 EVALUATION OF THE PROCESS Messages according to target segment receiving sensitization, training and promotion of the vaccine against cervical cancer TARGET SEGMENT MESSAGES ACTIVITY MATERIALS Local Authorities Description of HPV; relationship between HPV and cancer and reasons why the vaccine is important; advantages, tolerance and limitations of the vaccination; benefits to adding it to the National SRH, Epidemiology and Cancer Programs; coordination and monitoring by MSD with CIES to advance this work; reasons for selecting certain schools and health centers; arguments for vaccinating girls of a certain age and convenience of the vaccine; the role of local authorities in supporting vaccination efforts. Meetings to introduce and disseminate information about the project; sensitization of authorities; involvement of local authorities in the implementation phase of the vaccination campaign by calling for the launch of the micro-campaigns. Project presentation (ppt), posters, brochures, booklets, merchandising. School Directors, Teachers and Parents Description of HPV; relationship between HPV and cancer and reasons why the vaccine is important; advantages, tolerance and limitations of the vaccination; arguments for vaccinating girls of Sensitizing school directors, teachers and parents related to the primary target segment. Informational videos, informational meetings with the 3 segments, banners, brochures, posters, 4

5 TARGET SEGMENT MESSAGES ACTIVITY MATERIALS a certain age and convenience of the vaccine; reasons for selecting schools; the role of parents in caring for their children; the right to informed decision making; the role of directors, teachers and parents in guaranteeing appropriate administration of the vaccine. Training teachers. merchandising materials (cases, key chains, etc.) Informational meetings, educational videos, brochures. Facilitator - Promoter Team Description of HPV; relationship between HPV and cancer and reasons why the vaccine is important; advantages, tolerance and limitations of the vaccination; arguments for vaccinating girls of a certain age; administration of the vaccine; importance of individualized follow-up and monitoring for each girl; the right to informed decision making. Sensitization of facilitator teams in each region. Training facilitator teams. Informational videos, merchandising, posters, banners Training guide for promoters, flip charts, booklets, brochures. Health Personnel The burden of cervical cancer that would be relieved with the HPV vaccine; visual inspection with acetic acid (VIA) for cervical cancer screening; HPV screening; cytologic examinations; creation and coordination of alliances between different programs and with the private sector; why screening continues to be important after the initial vaccination; expectations raised by the vaccine and the vaccination program; its impact in the short, medium and long term; methods of administration; importance of personalized follow-up with each child; reporting and documentation methods; coordination with other local authorities and institutions in the health network. Sensitization of participating health personnel. Training health personnel. Informational videos, merchandising, posters, banners. Training guide for promoters, flip charts, booklets, brochures. Technical Committee The burden of cervical cancer that will be relieved with the HPV vaccine; benefits to adding it to the National SRH, Epidemiology Sensitization and provision of information to the Technical Committee, which was Guide to possible questions and answers about cervical cancer and 5

6 TARGET SEGMENT MESSAGES ACTIVITY MATERIALS and Cancer Programs; visual inspection with acetic acid (VIA) for cervical cancer screening; HPV screening; cytologic examinations; creation and coordination of alliances between different programs and with the private sector; why screening continues to be important after the initial vaccination; expectations raised by the vaccine and the vaccination program; its impact in the short, medium and long term; planned sustainability mechanisms. created to respond to contingencies. the HPV vaccine. Meetings to exchange information. Dissemination of the most up-todate information on the issue. Girls at Selected Schools Description of HPV; relationship between HPV and cancer and reasons why the vaccine is important; advantages, tolerance and limitations of the vaccination; importance of vaccinating girls who have not had intercourse; the right to informed decision making. Sensitization and information. Informational video, training workshops, merchandising, brochures, posters, CDS with messages. I. PRE-VACCINATION Objective 1. Improve access to information in target communities and decision makers on the HPV vaccine policies in the context of an integrated approach to preventing cervical cancer. Past Activities Together with the MSD's technical team, CIES developed a communications strategy targeting concerned parties, including political leaders, educators, service providers, teachers and youth. 6

7 Phases for this process included: Phase I Organization and Creation of IEC Materials and Documentation Forms Collect and adapt IEC materials developed by PATH/Peru on cervical cancer and the HPV vaccine OBJECTIVE ACTIVITIES SEGMENTS I.1 Meetings to coordinate with MSD and cooperating to collect documentation forms and IEC materials I.2 Adapting materials produced by PATH/Peru I.3 Creating needed materials that did not already exist 1.4 Education/dissemination Technical Committee - Communications and Promotion Committee assembled Phase II Internal Sensitization External Sensitization Provide information about the benefits of the vaccine against cervical cancer, SRH and maternal health, using messages integrating the 3 components and responding to possible myths and mistaken beliefs II.1 Assemble technical team to sensitize health personnel and educational promoters II.2 Informational and sensitization meetings with health and educational personnel in each region Sensitizing technical team, MSD health personnel, CIES health personnel, health promoters, CIES educators Provide information on the importance of using the vaccine to fight cervical cancer as an integral component of maternal health and sexual and reproductive health II.1 Identify team of facilitators/promoters for sensitization processes regionally II.2 Contact local authorities in each region II.3 Identify schools/directors and teachers for sensitization trainings II.4 Identify population to be vaccinated according to selection of schools by region III.5 Identify number of parents to target with sensitization strategies Local authorities, directors, teachers, parents board, parents of girls, girls/boys in selected grades RESOURCES a. Documentation forms developed by MSD for vaccinations b. Protocols/guides for administering and use of vaccines c. Sensitization and Training Guide for health and educational personnel d. Adapted and new IEC a. Informational audiovisual materials with basic repeating messages (video, posters, banners, brochures) b. Graphics and merchandising materials for reinforcement and support 7

8 Phase I Organization and Creation of IEC Materials and Documentation Forms materials e. Vaccine distribution and storage Phase II Internal Sensitization External Sensitization Objective 2. Increase knowledge of and create demand for the vaccine among parents, girls and teachers. Past Activities Information, education and communication with girls, youth, educators and teachers about cervical cancer, HPV vaccines, benefits and possible side effects were conducted. Sensitization of parents so that they can act as facilitators and promoters of the vaccine with their daughters. During the life of the project parents were sensitized. Trainings were held with CIES staff and health personnel from the Ministry of Health and Sports on cervical cancer, the HPV vaccine, implementation model, using the vaccine, protocols, how to use support materials and adverse effects (see appendices). Fifty two CIES staff including medical providers, nurses and educators was trained. The training took place from April 27 to 30 th Ninety six Ministry of Health personnel were trained from 5-10 of May in El Alto, Oruro and Monteagudo. Personnel include medical providers and staff in charge of vaccination. Sensitizing Teachers During the sensitization and information phase, an informational session about the cervical cancer vaccine was held with teachers in each of the selected schools to make it possible for the teachers to provide this information on their own to students and parents. A total of 597 teachers were sensitized on HPV. 8

9 Results: 100% of the teachers in 21 schools and 16 educational institutions informed about the topic. Sensitizing Parents In accordance with the action plan, information was provided to the parents of boys and girls. The information was divided in two parts: 1. Cervical cancer 2. Prevention: Pap smears, HPV vaccine Results: 3,321 parents informed about cervical cancer and the HPV vaccine. Information for Girls and Boys at Selected Schools During the sensitization and information phase, a session providing information about the cervical cancer vaccine was held with students in each of the schools. Results: 6,494 girls and boys received information and educational materials. Boys and girls share the same room and the sensitization reached both of them at during the school class. Objective 3. Improve knowledge and skills among service providers at CIES and the Ministry of Health and Sports regarding the HPV vaccine and its safe and effective administration. Past Activities Develop education programs for service providers and educators Hold trainings on the HPV vaccine and related protocols with CIES and the Ministry of Health and Sports As planned, information, education and sensitization sessions were held with the target population (3 health department directors, 3 department chiefs for the Programa Ampliado de Inmunizaciones (Extended Immunization Program), 5 health district directors and staff members at health centers where the vaccine was administered) Objective 4. Guarantee effective logistics in the provision and storage of vaccines to health centers and vaccination sites. Past Activities 9

10 Review and adapt logistics and storage and transportation protocols for HPV vaccines Disseminate protocols to centers and those administering the vaccine, including schools Monitor compliance with the protocols These activities followed the Programa Ampliado de Inmunizaciones (PAI) regulations. The process was as follows: Internal Training PHASE III External Training OBJECTIVE Strengthen knowledge and provide tools to medical personnel, teachers and promoters to replicate training about benefits, administration and follow-up documentation for the HPV vaccine ACTIVITIES SEGMENTS RESOURCES III.1 Create a timetable to train promoter/facilitator teams III.2 Train the 3 assembled promoter teams and choose appropriate personnel for replication Facilitating team of promoters, training promoters (educators, CIES youth leaders, doctors) a. Training guides for facilitator/promoter teams b. Informational video and printed support materials III.1 Create a training timetable with directors/teachers/parent board in selected schools III.2 Create a timetable to train health personnel III.3 Train designated health personnel (CIES health centers and clinics) on the use, administration, management of and documentation for vaccinations III.4 Train teachers and girls/boys from selected grades and schools on benefits, procedure and importance of the vaccine in preventing cervical cancer III.5 Identify dates and timetable for administration of the vaccine with directors/teachers/parents Directors, teachers, parents board, health personnel, girls/boys in selected schools a. Audiovisual material, printed support materials and merchandising b. Supplies for trainings (flipcharts, DVD, television, markers, etc.) 10

11 II. PROVIDING SAFE AND EFFECTIVE VACCINATIONS Objective 1. Provide access to the HPV vaccine to girls in selected public schools in rural and urban areas. Past Activities Establish a vaccination calendar in the selected public schools in rural and urban areas. Administer three doses of the HPV vaccine to girls in the selected schools. Operational Strategies The following strategies were used to coordinate the work for optimal results in administering the HPV vaccine: Identify dates to administer the first, second and third doses after establishing agreements with the Ministry of Health and Sports to manage the access of personnel administrating the vaccine to the schools. As planned, individuals assigned to different schools coordinated, with directors and advisors at different institutions, communication methods and assistance strategies for the girls receiving the vaccines. The directors, in coordination with the grade advisors, assigned classrooms for the vaccination day(s) to be used for relaxation exercises and to follow protocol with the girls before vaccination. The grade advisors, in coordination with the heads of schools, informed the girls about the dates for the HPV vaccination and urged the girls to bring their vaccination cards. When the girls in each grade were given information about the vaccination, they were also asked to think about the importance of getting all three doses so that the HPV vaccine would be effective. The girls were reminded of the importance of telling their fathers, mothers or guardians about the vaccination so they could be a part of the process. The personnel administering the vaccination recorded the telephone numbers and addresses of girls who were vaccinated in order to make it easier to locate them and prevent them from missing school. The medical personnel always had emergency equipment such as stethoscopes, a first-aid kit and an ambulance available so if any girls experienced adverse effects they could be treated immediately. Given the experience with the first dose, starting with the second dose, the girls who were vaccinated were given a snack and kept under observation for a few minutes. 11

12 On the girls' vaccination record cards, we added the code OR, LP or CH to indicate that each girl belonged to one of the departments selected for the program (Oruro, La Paz or Chuquisaca) to improve follow-up in subsequent years. We also created a national database with information about the girls who were vaccinated to improve monitoring and, in the future, collect data on the protection provided by and the effectiveness of the vaccination in Bolivia. Medical personnel wore masks and an identifying vest for the vaccination days. GARDASIL VACCINATION INFORMATION No. of No. of girls vaccinated Region girls scheduled for the vaccine 1st dose 2nd dose 3rd dose 2nd dose compared to the 1st Achievement of goals 3rd dose compared to the 2nd 3rd dose compared to all girls selected Follow-up percentage Between 1st and 2nd doses Between 2nd and 3rd doses Vaccination Coverage EL ALTO ORURO UMOSAS Total As shown, 95.9% of the 3,900 girls scheduled to be vaccinated received the third dose. Follow-up between the first and second doses and the second and third doses ranged from 99.7% to 99.2%. If the third dose had not been scheduled during the year-end school vacation, this percentage would have been much higher. One of the three regions used the model in rural areas, in hard-to-reach communities, with the strong support of educators, who unfortunately were away from school because of the break at the time of the third dose. Difference Between the 2nd and 1st Doses Between the 3rd and 2nd Doses El Alto Oruro UMOSAS Total As shown, 149 girls who received the first dose did not return for the second and third doses. However, their absence was not due to adverse reactions or factors or perceptions related to the vaccine. They did not return due to seasonal illnesses or because they had moved to another department. 12

13 Location Received Administered Vaccines broken, lost or missing Balance EL ALTO ORURO UMOSAS Total Only one dose arrived damaged and one dose was lost during transportation and administration of the vaccines. No. of adverse reactions 1st dose No. % Thirty percent of the girls who were vaccinated reported discomfort immediately after the vaccination, specifically, slight pain, heat, redness or some bleeding at the vaccination point. Some girls, who had not eaten breakfast, felt nauseated. The discomfort quickly passed without the need for treatment, merely monitoring by the school medical teams that were available on site. The girls were counseled to go to the nearest health center to report any adverse effects; at the time of this report no such cases were registered. UMOSAS ORURO EL ALTO Reasons Girls Did Not Receive the Second Dose: Death or illness not related to the vaccination, having moved and school vacation. Seasonal illnesses. Seasonal illnesses, surgery or having moved. Cold Chain - Biologics (Vaccines) During the vaccination campaign, the cold chain was maintained by observing the steps established by the Programa Ampliado de Inmunización for protecting and storing biologics. The program complied with the processes for receipt of, delivery and distribution of biologics. The program followed these steps: First Step Receipt of biologics at Bolivian Customs with PAI Nacional. Deposited in Bolivian warehouses following cold chain procedures. Inventory and storage confirmed, paperwork completed in accordance with the requirements of the manufacturer and returned. 13

14 Delivery of the vaccines by the MSD National Office to the regions. Delivery accepted by the appropriate person in each region. Second Step Condition of the vaccines verified, delivered to storage by SEDES authorities. Third Step Distribution of biologics on vaccination date. Delivery. Gerencia de Red responsible for receipt of and signing for biologics. Gerencia de Red PAI responsible for overseeing distribution of the biologic. Distribution and delivery of biologics to the vaccination teams. Fourth Step Distribution of biologics to different communities and schools. III. CREATING AN INTEGRATED FOCUS IN CANCER PREVENTION EFFORTS Objective 1. Increase demand for cervical cancer and prostate cancer screening at CIES through education and sensitization activities in schools. Past Activities Education and sensitization activities in schools for parents. The education process relied on materials specifically designed for the program and on the ongoing information and education activities held through the program. The target population was reached in all grades, schools and educational centers where the model was implemented. IV. ROLE OF THE PILOT PROJECT IN PROMOTING THE INSTITUTIONALIZATION OF THE HPV VACCINE NATIONALLY Objective 1. Create strategic alliances with the authorities in the public health and education sectors and non-governmental organizations to disseminate lessons learned and best practices based on the pilot program in order to extend it throughout the country. Past Activities Involve key actors from the health and education sectors and NGOs in each of the steps to develop the pilot project. 14

15 Establish collaboration agreements and alliances to expand the project. Assemble national and regional committees to advocate for expansion of the project. An alliance was established with the media, which followed the three stages of the vaccination campaign against HPV. Their involvement was vital and they became a strategic ally. To publicize the results of the third and last dose to the community, a press conference was held at SEDES with the departmental coordinating committee, SEDES representatives and the operations team that had participated in creating the model. In the department, all press outlets, including print, radio and television, carried news about the administration of the Gardasil vaccine against the human papillomavirus. Objective 2. Identify best practices for introducing new technologies for primary and secondary prevention of cervical cancer, including the HPV vaccine in rural and urban areas. Past Activities Document pre-vaccination activities, vaccination and follow-up during the first year that the vaccine was introduced. Write a technical report describing the process and the results. Develop and disseminate a technical report describing best practices and recommendations to expand coverage. SECTION IV LESSONS LEARNED The content of training and information sessions were adequate, however, they should provide more in-depth emphasis on cervical cancer. Ongoing training on implementation and development provided by PAI has made adequate management of protocols and standards possible. The successes achieved were due to scheduling activities and holding them on the given dates. Beneficiaries have more confidence if they are provided with timely sensitization and information. Confidence in and acceptance of new vaccines is achieved with processes that facilitate voluntary decision making about whether to participate, which is expressed by signing informed consent forms. Providing supplies and the vaccines in advance (5 days) guarantees the success of the vaccination campaign. 15

16 Continuing to provide information and ongoing communication with beneficiaries results in better performance during implementation of the second and third stages of the project. The participation of key actors (MSD, SEDES, towns, users) gives legitimacy to the process. Harmonizing policies, regulations and protocols supports institutional and technical sustainability. SECTION V FUTURE ACTION AND RECOMMENDATIONS 1. Implement and develop the second phase and vaccinate 30,000 girls. 2. Research acceptance of the HPV vaccine among the general population. 3. Establish strategic alliances to create and implement an epidemiological monitoring system for cervical cancer. 4. Obtain MSD's approval and disseminate throughout the country the manual on HPV vaccination procedures. SECTION VI APPENDICES During this phase, we received technical assistance from IPPF in the form of consulting services. Attached: a. Digital photo album 16