Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Jhpiego.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Jhpiego
ClinicalTrials.gov Identifier:
NCT01096134
First received: March 23, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention
Cervical Cancer
Biological: HPV Vaccine (Gardasil)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

Resource links provided by NLM:


Further study details as provided by Jhpiego:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 8000
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Eligibility

Ages Eligible for Study:   9 Years to 13 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096134

Contacts
Contact: Enriquito Lu, MD, MPH 410-537-1824 rlu@jhpiego.net
Contact: Sharon Kibwana, MPH 410-537-1922 skibwana@jhpiego.net

Locations
Philippines
Minglanilla Recruiting
Cebu, Philippines
Pagbilao Health Center Recruiting
Quezon, Philippines
Los Banos Recruiting
Quezon, Philippines
Thailand
Health promotion Clinic Number 11 Recruiting
Nakhon Si Thammarat, Nakisron, Thailand
Ban Pak Poon Health Center Recruiting
Nakhon Si Thammarat, Nakornsri, Thailand
Maharat Nakhonsithammarat Primary Care Unit Recruiting
Nakhon Si Thammarat, Nakornsri, Thailand
Pak-Panung District Health Center Recruiting
Nakhon Si Thammarat, Nakornsri, Thailand
Ban Yuanlae District Health Center Not yet recruiting
Ban Phon Ko, Thailand
Ban Mai Daeng Recruiting
Nakhon Si Thammarat, Nakornsri, Thailand
Ban Pai Ta Health Center Recruiting
Nakhon Si Thammarat, Nakornsri, Thailand
Sponsors and Collaborators
Jhpiego
Merck Sharp & Dohme Corp.
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
  More Information

No publications provided

Responsible Party: Dr. Enriquito Lu, Director of Family Planning and Reproductive Health, Jhpiego
ClinicalTrials.gov Identifier: NCT01096134     History of Changes
Other Study ID Numbers: 36448
Study First Received: March 23, 2010
Last Updated: June 21, 2011
Health Authority: United States: Johns Hopkins School of Public Helath Institutional Review Board
Thailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health
Phillpines: Philippine Council for Health Research & Development

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 22, 2014