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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HPV Vaccine (Gardasil)
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

9 Years - 13 Years (Child)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Minglanilla
  • Los Banos
  • Pagbilao Health Center
  • Health promotion Clinic Number 11
  • Ban Pak Poon Health Center
  • Maharat Nakhonsithammarat Primary Care Unit
  • Pak-Panung District Health Center
  • Ban Yuanlae District Health Center
  • Ban Mai Daeng
  • Ban Pai Ta Health Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HPV Vaccine

Arm Description

Eligible girls were offered 3 doses of the HPV vaccine

Outcomes

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
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
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
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

Full Information

First Posted
March 23, 2010
Last Updated
October 9, 2015
Sponsor
Jhpiego
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01096134
Brief Title
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Acronym
MDI
Official Title
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jhpiego
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPV Vaccine
Arm Type
Experimental
Arm Description
Eligible girls were offered 3 doses of the HPV vaccine
Intervention Type
Biological
Intervention Name(s)
HPV Vaccine (Gardasil)
Intervention Description
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 Outcome Measure Information:
Title
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
1 year
Title
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
Description
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
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Llave, MD
Organizational Affiliation
Cancer Institute Foundation, Phillipines
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kobchitt Limpaphayom, MD
Organizational Affiliation
Chulalongkorn University, Thailand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enriquito Lu, MD, MPH
Organizational Affiliation
Jhpiego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minglanilla
City
Cebu
Country
Philippines
Facility Name
Los Banos
City
Quezon
Country
Philippines
Facility Name
Pagbilao Health Center
City
Quezon
Country
Philippines
Facility Name
Health promotion Clinic Number 11
City
Nakhon Si Thammarat
State/Province
Nakisron
Country
Thailand
Facility Name
Ban Pak Poon Health Center
City
Nakhon Si Thammarat
State/Province
Nakornsri
Country
Thailand
Facility Name
Maharat Nakhonsithammarat Primary Care Unit
City
Nakhon Si Thammarat
State/Province
Nakornsri
Country
Thailand
Facility Name
Pak-Panung District Health Center
City
Nakhon Si Thammarat
State/Province
Nakornsri
Country
Thailand
Facility Name
Ban Yuanlae District Health Center
City
Ban Phon Ko
Country
Thailand
Facility Name
Ban Mai Daeng
City
Nakhon Si Thammarat, Nakornsri
Country
Thailand
Facility Name
Ban Pai Ta Health Center
City
Nakhon Si Thammarat, Nakornsri
Country
Thailand

12. IPD Sharing Statement

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Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

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