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Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention (MDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096134
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Sharon Kibwana, Jhpiego

Study Description
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Brief Summary:
The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.

Condition or disease Intervention/treatment Phase
Cervical Cancer Biological: HPV Vaccine (Gardasil) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HPV Vaccine
Eligible girls were offered 3 doses of the HPV vaccine
 Biological: HPV Vaccine (Gardasil)

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


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. 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 ]

    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:

    • Proportion of women with daughters who intend to vaccinate their daughters.
    • Proportion of daughters of screened mothers who return to receive the vaccine.
    • Proportion of girls who receive the first vaccine dose and are brought to the facility by a guardian/mother who did NOT recieve cervical cancer screening

  2. 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 ]

    Programmatic data will be collected for the duration of the project, including but not limited to:

    • Cost required to implement the program
    • Logistics required to ensure supply and appropriate maintenance of vaccine
    • Human resources required to effectively adminster the vaccine as part of routine services.
    • Key communication and outreach messages that effectively educate the community


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096134


Locations
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Philippines
Minglanilla
Cebu, Philippines
Los Banos
Quezon, Philippines
Pagbilao Health Center
Quezon, Philippines
Thailand
Health promotion Clinic Number 11
Nakhon Si Thammarat, Nakisron, Thailand
Ban Pak Poon Health Center
Nakhon Si Thammarat, Nakornsri, Thailand
Maharat Nakhonsithammarat Primary Care Unit
Nakhon Si Thammarat, Nakornsri, Thailand
Pak-Panung District Health Center
Nakhon Si Thammarat, Nakornsri, Thailand
Ban Yuanlae District Health Center
Ban Phon Ko, Thailand
Ban Mai Daeng
Nakhon Si Thammarat, Nakornsri, Thailand
Ban Pai Ta Health Center
Nakhon Si Thammarat, Nakornsri, Thailand
Sponsors and Collaborators
Jhpiego
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Cecilia Llave, MD Cancer Institute Foundation, Phillipines
Principal Investigator: Kobchitt Limpaphayom, MD Chulalongkorn University, Thailand
Principal Investigator: Enriquito Lu, MD, MPH Jhpiego
More Information
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Responsible Party: Sharon Kibwana, Senior Program Officer, Jhpiego
ClinicalTrials.gov Identifier: NCT01096134    
Other Study ID Numbers: 36448
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases