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Completed

NCT Number: NCT01096134

Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

9 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Minglanilla, Cebu, Philippines

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HPV Vaccine (Gardasil)

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: MDI

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 30, 2010
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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