Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention (MDI)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cebu, Philippines
- Minglanilla
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Quezon, Philippines
- Los Banos
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Quezon, Philippines
- Pagbilao Health Center
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-
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Ban Phon Ko, Thailand
- Ban Yuanlae District Health Center
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Nakhon Si Thammarat, Nakornsri, Thailand
- Ban Mai Daeng
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Nakhon Si Thammarat, Nakornsri, Thailand
- Ban Pai Ta Health Center
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Nakisron
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Nakhon Si Thammarat, Nakisron, Thailand
- Health promotion Clinic Number 11
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Nakornsri
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Nakhon Si Thammarat, Nakornsri, Thailand
- Ban Pak Poon Health Center
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Nakhon Si Thammarat, Nakornsri, Thailand
- Maharat Nakhonsithammarat Primary Care Unit
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Nakhon Si Thammarat, Nakornsri, Thailand
- Pak-Panung District Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 9-13 at first HPV vaccine dose
- Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
- Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses
Exclusion Criteria:
- Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
- Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
- Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
- Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
- Girls with a bleeding disorder or currently taking anticoagulants
- Girls that have received any other vaccinations in the past 4 weeks
- Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: HPV Vaccine
Eligible girls were offered 3 doses of the HPV vaccine
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HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination. FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains: 20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
Time Frame: 18 months
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The aim of the study to assess whether we can fully vaccinate (all 3 doses),50% of girls aged 9 -13 in the participating districts, in an 18-month period.
This corresponds to 4000 girls in Thailand and 4000 in Phillipines.
The study will seek to undertand if this level of population coverage (50%), can be achieved through encouraging women that recive cervical cancer screening to bring in their daughters or relatives for vaccination.
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18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: 1 year
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Data on mothers knowledge of the vaccine, and intention to have their daughters vaccinated will be collected for a period of 1 year (or when the target number of 700 women/guardians is reached, whatever comes first). Data will be collected on:
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1 year
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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
Time Frame: 2 years
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Programmatic data will be collected for the duration of the project, including but not limited to:
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilia Llave, MD, Cancer Institute Foundation, Phillipines
- Principal Investigator: Kobchitt Limpaphayom, MD, Chulalongkorn University, Thailand
- Principal Investigator: Enriquito Lu, MD, MPH, Jhpiego
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36448
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