Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Biological: HPV Vaccine (Gardasil)

• Registration Number: NCT01096134
• Lead Sponsor: Jhpiego

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 available

Study Timeline

• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2011-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPV Vaccine	HPV Vaccine (Gardasil)	Eligible girls were offered 3 doses of the HPV vaccine

Primary Outcome Measures

Name	Time	Method
Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers	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

Name	Time	Method
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	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	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

Trial Locations

Locations (10)

Minglanilla; 🇵🇭 Cebu, Philippines

Los Banos; 🇵🇭 Quezon, Philippines

Ban Pak Poon Health Center; 🇹🇭 Nakhon Si Thammarat, Nakornsri, Thailand

Pagbilao Health Center; 🇵🇭 Quezon, Philippines

Health promotion Clinic Number 11; 🇹🇭 Nakhon Si Thammarat, Nakisron, Thailand

Pak-Panung District Health Center; 🇹🇭 Nakhon Si Thammarat, Nakornsri, Thailand

Maharat Nakhonsithammarat Primary Care Unit; 🇹🇭 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