Background

Cervical Cancer in the Philippines

In the Philippines, the age-standardized incidence rate of cervical cancer is approximately 20 per 100,000 women. According to the 2005 Philippine Cancer Facts and Estimates, 3,807 women died from cervical cancer in that year.

Secondary Prevention Intervention: CECAP Network Program

From October 2006 to June 2008, Jhpiego, an affiliate of Johns Hopkins University and Cancer Institute Foundation (CIF) implemented the Cervical Cancer Prevention Network Program (CECAP). This collaborative project offered low resource communities screening services for cervical cancer and immediate treatment of pre-cancer cervical lesion with cryotherapy in a Single Visit Approach (SVA). At present, CECAP has reached more than 50,000 women aged 25-45 and trained 30 master trainers in SVA clinical skills, who have since gone on to ttrain289 health providers from every province in the country.

Introducing Primary Prevention: HPV Vaccination

To complement secondary prevention of cervical cancer, a primary prevention method is now available. Gardasil® is Merck’s quadrivalent, human papillomavirus (types 6, 11, 16, 18) recombinant, inactivated vaccine. Gardasil was tested in over 11,000 women in the United States and around the world, and found to be safe and effective in preventing serious HPV-related diseases. The Food and Drug Administration (FDA) approved Gardasil® on June 8, 2006 for use in girls and women 9 - 26 years of age. In the Philippines, the government approved Gardasil® on October 19th, 2006.

Linking Primary and Secondary Prevention:
Mother Daughter Initiative in Cervical Cancer Prevention

Little is known about effective strategies for HPV vaccine delivery of prepubescent girls in low and middle-income countries. Demonstration projects in Peru, Uganda, Vietnam, and India are currently testing whether schools or outreach by professional platforms are good delivery platforms to reach adolescent girls with the HPV vaccine. There is also limited information on factors that are associated with mothers and daughters’ uptake of the HPV vaccine.

To introduce HPV vaccination to the community, three main challenges need to be overcome:

•Developing local partnerships,
•Ensuring community acceptability,
•And improving access to and up-take of services.

The main strategy of reaching girls with the vaccine based on initial contact with the mothers, female guardians and relatives during cervical pre-cancer screening and treatment services can potentially overcome these challenges.

In response to this, a study entitled, Mother-Daughter Initiative (MDI) in cervical cancer prevention, was implemented to test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in the Philippines by integrating the HPV vaccine for girls ages 9-13 into an already successful screening and treatment program for mothers.

Aims of the MDI Project
The MDI project has three main objectives.

Aim 1: Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers – the aim is to fully vaccinate 50% of girls aged 9-13 in participating districts, or 4,000 girls in the Philippines in a years time.

Aim 2: Assess mothers’ acceptability of having their daughters receive the full course of HPV vaccine after mothers receive screening and treatment services for cervical pre-cancer

Aim 3: Inform future programs that aim to introduce the HPV vaccine in the context of secondary screening for cervical cancer by determining the factors related to screened women bringing daughters for HPV vaccination and the costs of vaccine introduction

The MDI project will be conducted over a 2 year period. Enrollment will take place over the first year, 6 months to complete all third dose injections, and 6 months of data analysis and report writing, in three selected areas in the Philippines:

• Los Banos, Laguna
• Minglanilla, Cebu
• Pagbilao, Quezon

These areas have an established cervical cancer screening program initiated by the CECAP program. Thus, the HPV vaccination program will be introduced into the existing CECAP facilities and within communities that are familiar with cervical cancer screening.

Methodology

To assess the feasibility and acceptability of the proposed strategy, the following will be conducted:

• Survey of 400 women aged 25-45 who were screened for cervical cancer to find out information on acceptability and factors related to bringing their daughters to receive the full course of the vaccine

• Provide 3 doses of the HPV vaccine to 4000 girls between the ages of 9-13

• Survey of 300 parents or guardians after the administration of the 1st dose of the HPV vaccination to the young girls

• Data collection of facility statistics on screening and HPV vaccination

There were three study populations involved:
• Women who received secondary screening for cervical pre-cancer (25-45)

• Girls between the ages of 9-13 receiving the HPV vaccine, and

• Parents or guardians who did not receive secondary screening but are interested in having their daughter receive HPV vaccine.

For this study, the confidentiality and consent process of study participants was guaranteed by project staff, following established guidelines approved by National Institutes of Health, University of the Philippines Manila, which also gave the ethical approval for the study.

MDI Project Team - Philippines

MDI project team in the Philippines was led by Dr. Cecilia Llave, who served as the project’s Co-Principal Investigator and Project Director. She is supported by the Project Manager, Marie Grace R. Mateo, Project Assistant, Venus Mendoza and Technical Assistant, Lorena Rolando. A coordinating center is located at the Cancer Institute Foundation Office in Philippine General Hospital.

Each MDI vaccine site was ran by a core team trained by Jhpiego and CIF. Municipal health officers were the assigned focal person for the project.

For each team, they also formed a small unit to comprise additional members to aid them in conducting the MDI project.

Project Results

Milestones

December 2010

Formal implementation of the MDI project. After receiving IRB approval in the Philippines on September 2010, Jhpiego and CIF officially signed a sub agreement for the MDI implementation.

January 2011

MDI Providers’ Training

Nine providers, three from each site, received a five day training from Jhpiego and CIF on the implementation process for the MDI project. After the training, the MDI site teams started providing HPV vaccination.

November 2011

Completion of MDI Surveys

The two surveys, HPV knowledge and Intention Interview and Post 1st Dose Interview, were completed by November 2011.

December 2011

Last batch of administering 1st Dose of the HPV vaccine

The project completed vaccinating the first dose of the HPV vaccine in 4,000 girls aged 9-13 in the three sites.

 July 2012

End of Follow up for 2nd and 3rd Dose schedule and Data Collection

For the study, health providers followed up the young girls on schedule to receive either the 2nd or 3rd dose.  The last girl received her third dose in July 2012. During the same month collection of Vaccine Eligibility, Screening and Injection (MDI 1) forms were concluded. Additional forms like MDI 3 Patient Contact Information Form were also collected from all the three sites.

Table 1 shows the completion of the three dose schedules of the young girls for the three sites.

Table 1. HPV Vaccine Dose Schedule Completion

 

MDI Sites

Dose 1

Dose 2

Dose 3

LB

1333

1301

1278

MN

1334

1334

1334

PB

1333

1212

912

TOTAL

100.0%

(4000)

96.18% (3847)

88.1% (3524)

 

August 2012

Submission of Final Database

After a series of data checking, cleaning and verification of forms, the MDI database was submitted to Jhpiego personnel on August 2012 for analysis. 

September 2012

Preparation for Close out of Project

All financial and reporting requirements were prepared for the wrap up of the MDI project. The work plan was reviewed to check the remaining activities that needed to be completed and that all the project inputs wherein line with the accomplishments.

October 2012

Formal end of MDI project and turnover of project documents to CIF-CECAP

October marked the close out period for the MDI project. Project documents were turned over to CECAP who is in charge of safe keeping of the complete data collection tools  for one year.

 

Table 2. Other MDI Project Indicators:

Feb 2011-June 2012

MDI Indicators

LB

MN

PB

Total

No. of Women screened for cervical cancer

3867

1747

1696

7310

No of women treated for pre cancerous lesion

10

5

5

20

No. of participants during CECAP promotion activities

13674

1858

2441

17973

Aside from information on HPV vaccination, data on cervical cancer screening and participation in CECAP promotion activities were also collected. Table 2 shows that for the period of February 2011 up to June 2012, more than 7,000 women were screened for cervical cancer and CECAP promotional activities were attended by almost  18,000 individuals. 


Introducing HPV vaccines in the community: Challenges and Lessons Learned

A number of challenges and lessons learned were noted as the MDI project was implemented in the three sites in the Philippines.

 

Existing myths and misconceptions on HPV vaccine

At the onset of MDI project implementation, myths and misconceptions on HPV vaccines were communicated in some areas. Rumours that HPV vaccines were an abortifacient and could cause infertility were raise by  parents of the HPV vaccine recipients and also the project implementers.

To address these issues, MDI providers talked to those who had heard about the myths and carefully explained to them that such issues are just misconceptions and that the HPV vaccine has been proven safe and effective. The providers also asked where they got the information and asked them how reliable the source of the information was.

 

Getting consent from legal guardians

It was important that parents and legal guardians personally accompanied the daughters during their first visit to ensure the project received  written consent prior to HPV vaccination of the minor. In settings where the parents were not available, the project site staff requested their next of kin to accompany the daughter to the health center.

This posed some difficulty because legal guardianship is loosely defined in the Philippines. Oftentimes, parents do not secure formal guardianship for their children should they leave the country or migrate to another province leaving their child either with the grandmother or aunt.

Initially, this was a challenge for the MDI providers since they need to secure consent. There a number of cases that the young girl comes with the grandmother or aunt and there is no legal document to show legal guardianship.

To adapt to the situation and taking into account what is the cultural norm in the Philippines, even without a legal document screening questions were asked to ensure that the daughter is accompanied by a legal guardian. Under the MDI project, it was accepted that parent's can assign their close relatives (e.g. aunts, grandmothers) as their child’s legal guardian. This case holds true for parents not residing in the same community as their daughter or both parents working abroad.

For children whose parents are deceased, the one who is currently taking care of the child assumes legal guardianship. No official documentation is required especially for availing health services such as HPV vaccination. To validate this kind of guardianship during screening for HPV vaccination, the assigned health provider asked the guardian about her relationship with the young girl. An example of question asked is “Sa iyo ba nakatira ung bata?” (Is the child living with you?) There were follow up questions which delve s into the living arrangement of the child and what condition prompted the current arrangement so as to ensure the nature of relationship between the child and the guardian. In other instances, health providers asked the midwife in the area where the legal guardian is residing to vouch for the validity of guardianship since they are likely to know this information.

 

HPV vaccination schedules coincided with the school day

The target age of the girls to be given HPV vaccine was from 9-13 years old under the MDI project which corresponds to the same age group of girls attending school.  Given that HPV vaccination schedule often falls during school days, girls are likely to miss school should they get their HPV vaccination.

During the 1st dose administration of the HPV vaccination, the young girls missed school as to get their HPV vaccination. With a limited supply of the vaccines, mothers together with their daughters lined up the clinics for the opportunity of having their daughters vaccinated.

However, during succeeding dose schedules, the young girls preferred to not miss school so some doses were given outside of the exact date to return.

Faced with this dilemma, the health providers found solutions to adapt to the situation. They offered weekend schedules for those daughters who missed their scheduled vaccination. The municipal health officer also discussed with teachers if the girls could be excused during recess or lunch breaks so that they could  be vaccinated. In some instances, the physician wrote an excuse letter to the teacher as proof to excuse the girl from the absence. There were also times that the HPV vaccination card was presented to the teacher to show that they received the vaccine that day to explain why they were late in coming into class.

 

Competing Tasks of Health Providers

In developing countries like the Philippines, many of the health providers are carrying out multiple services and have lots of responsibilities at health facilities.

Adding a “new responsibility” is often times seen as a burden to the health provider. Given that each health provider is overworked and undercompensated, she or he may not feel that the new project is a priority. The project team had to build rapport with each MDI site to overcome this challenge. Since MDI implementation  required not only the services of the core team but also other members of the health facility, it was best to and explain the importance and benefits of the project to the community and the providers. With careful planning within members of the health facility, strategies were put forward on how introducing an HPV vaccination program may be feasible in their clinic and community.

To overcome this challenge many health facilities scheduled a dedicated HPV vaccination day each week similar to what they do with their expanded immunization program. This way the health providers had ample time for their other responsibilities.

 

Reaching young girls in geographically isolated areas

Some of the young girls live in remote areas where the only means of transportation was by foot. In areas like this, young girls didn’t have access to the main health center where the HPV vaccines were available. When this situation arose, health providers went to these barangays so that young girls could get their HPV vaccination. They did this through outreach. An outreach is a mobile activity where health providers bring into a place a health service which is not readily available in their locale. This is done to almost every health program in the community to make the services accessible to everyone Outreaches posed many pros and cons.The advantage is that the target client gets ready access to the health  service. In this case, young girls no longer needed to travel to the health center to get the HPV vaccine. The disadvantage is that it is labor intensive. Manpower at the health center is reduced with each outreach; requiring proper coordination at the clinic, community, and outreach venue so that young girls and their mothers are properly informed of the time, date and place where the outreach will take place.

To be more cost effective, HPV vaccination outreaches are done simultaneously with cervical cancer screening outreach as much as possible. This way mothers who bring their daughters can get the screening if they have not been screened previously.

 

Severe Weather Conditions falling on HPV vaccination schedule

The Philippines typically experiences more than 20 typhoons annually. At times the HPV vaccination scheduled outreaches and clinic vaccination days had to be cancelled due to was cancelled typhoons or flooding.  Health providers had to make the necessary adjustment to accommodate young girls when they missed their scheduled vaccinations.

 

Dealing with adverse events or pregnancy cases

During the MID project some health providers had to deal with events and cases of  pregnant girls., The health providers’ had to follow the assigned protocol for such events. When such situations occurred, prompt reporting was expected from the health providers to the MDI team. The experience of reporting adverse events and a pregnancy case was a  provided lesson learned for health providers to efficiently document what has happened, do an investigation and report immediately the findings. The health providers also realized that they needed to persistently follow up the client who reported the event to ensure their safety.

Because of these events, the sites reinforced their counselling to put emphasis on not becoming pregnant as it is a contraindication of HPV vaccination and asked that the girls (and mothers / guardians) promptly report if the young girl who received the HPV vaccine felt unpleasant.


Best Practices from MDI implementation experience

Aside from lessons learned documented during project implementation above, there were best practices being delivered. The following practices showcased the strengths observed in the sites where the project was piloted.

 

Initiated creative information dissemination opportunities

Disseminating information to reach the target audience was not an easy task. For MDI, the target audience was both the parents and young girls aged 9-13. Reaching these audiences required more than waiting for them to come by the health center. For the MDI sites, they employed various active information dissemination activities.

During a charity walk for cervical cancer prevention program in Los Baños, Laguna, MDI providers gave out leaflets about the MDI project, indicating when the HPV vaccination was available and who can get vaccinated.

Project sites  also collaborated with a local cable company to have a few minutes of airtime for free advertisement of the availability of HPV vaccination and the cervical cancer screening program in the area.

In Pagbilao, Quezon, the MDI providers’ approach was to have a dialogue with the parents during Parent - Teacher meeting. They usually give a short lecture about cervical cancer prevention to include HPV vaccination and then announce the HPV vaccination schedule in the area. In some cases, they joined microfinancing organization’s monthly meeting as most of its members were mothers to inform them of the available HPV vaccination in the health center.

For Minglanilla, Cebu, MDI providers coordinated with the school principal of the local elementary public school and requested for a short lecture for school graders 3, 4, 5 and 6. They gave a lecture tailored to young girls about cervical cancer prevention. At the end of each lecture, young girls between the ages 9-13 are asked to bring their parents to the designated health center if the girls wanted to get the HPV vaccination.

 

Effective Barangay Health Workers (BHW)

 The barangay health workers (BHW) play a big role on disseminating information about new health programs in the community. Hence, the availability of HPV vaccination as part of the cervical cancer prevention efforts in the community is quickly dispersed. In addition to this, outreach activities heavily rely on the diligence of the BHWs of informing the people in the barangay about outreach for HPV vaccination and cervical cancer screening.

Given that MDI is a research study, the role of BHWs is dedicated only for cervical cancer prevention promotion. They are tasked to inform the availability of HPV vaccination and cervical cancer screening services in the health center. From a programmatic standpoint, BHWs can be fully utilized as “Prompters” for young girls to get their HPV vaccines especially for succeeding doses should the HPV vaccination becomes an integrated program in the health services in a community.

 

Efficient Record Keeping system

As the MDI project heavily relied on the information that was collected from the surveys and forms completed by the mothers and daughters, a reliable system of organized record was needed. The MDI sites modified the proposed record system to suit their existing set up. Over time, monitors from the project team found each of the sites’ record keeping methods efficient as forms were easily accessed and data review and cleaning was efficiently performed.


Summary, Recommendations and Future Directions

In summary, the implementation phase of the MDI project in the Philippines was satisfactorily completed. The major outputs of the project whereas follows:

· 4,000 young girls received HPV vaccines. With 88% of the girls that received the first dose also completing the full three dose schedule.

· Completion of 300 HPV Knowledge and Intention Interview and 400 Post Dose HPV Vaccine Interview

· 17,973 individuals participated in CECAP awareness campaign activities.

· 7,310 women aged 25-45 went for cervical cancer screening and 20 received treatment for precancerous lesion.

Based on the lessons learned and best practices at the study facilities, some recommendations are presented below that may be helpful in implementing an HPV vaccination in other communities

1. Know the HPV vaccination facts and be patient in addressing myths and conceptions about the HPV vaccination. Be careful about sounding defensive and appearing that you are hiding something.

2. Legal guardianship is loosely defined and highly dependent on cultural interpretation. In the Philippines, when you start HPV vaccination and it requires consent of legal guardian if parents are not around, provide the parameters to identify legal guardianship for clarity.

3. Talk to health providers and seek their feedback as to how HPV vaccination can be smoothly integrated into their existing work load.  Allow them to feel that they are contributing to the welfare of the community by providing HPV vaccination.

4. While making HPV vaccination available in main health centers is a must, not everyone in the community will have access to the service as some live in far places. Doing  outreach can help you reach young girls in geographically isolated areas.

5. Be prepared to provide a prompt response and quick action to situations like adverse events or pregnancy cases or even severe weather conditions that may affect the implementation of the HPV vaccination program.

6. While the MDI strategy meant reaching the objective of vaccinating 4,000 young girls with HPV vaccines, 1. the completion of the three-dose schedule was not at 100 percent. This was primarily due to scheduling difficulty around school schedules and the desire of the young girls to not miss  school It is recommended that modifying the MDI strategy to complement health center based vaccination with school based one especially for the 2nd and 3rd dose schedule. For the 1st vaccination dose, it is still recommended to be done at the health center to encourage mothers to go for cervical cancer screening as they accompany their daughters for their HPV vaccination.

The future of HPV vaccination to be publicly available at the national level is still bleak at the moment because the high cost of the vaccine remains to be a great barrier to overcome as expressed by the Department of Health in a recent statement issued during an HPV Summit on September 19, 2012. However, at the local level because of decentralisation of health services, municipalities can start their own initiative to provide HPV vaccination if not free or through cost recovery scheme. The cost of the HPV vaccines will eventually go down similarly to other vaccines introduced. Until then we cannot stop our efforts to prevent cervical cancer as we are waiting for a national HPV vaccination program. We can still save women’s lives by catching the disease early. Another way to do this is to make safe, effective and affordable cervical cancer screening and treatment options available to women.