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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 Corp.
Information provided by (Responsible Party):
Sharon Kibwana, Jhpiego

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Official Title  ICMJE Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cervical Cancer
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: HPV Vaccine
Eligible girls were offered 3 doses of the HPV vaccine
Intervention: Biological: HPV Vaccine (Gardasil)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2010)
8000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 9 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096134
Other Study ID Numbers  ICMJE 36448
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sharon Kibwana, Jhpiego
Study Sponsor  ICMJE Jhpiego
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Cecilia Llave, MD Cancer Institute Foundation, Phillipines
Principal Investigator: Kobchitt Limpaphayom, MD Chulalongkorn University, Thailand
Principal Investigator: Enriquito Lu, MD, MPH Jhpiego
PRS Account Jhpiego
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP