Clinical trial NCT01096134: Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Official title: Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-03-30
Enrollment: 8000
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.


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.

Primary outcomes:
measure: Determine the population coverage of HPV vaccination of girls aged 9-13 offered within the context of cervical cancer screening and treatment of mothers
timeFrame: 18 months
Secondary outcomes:
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Cebu
country: Philippines
facility: Minglanilla
city: Quezon
country: Philippines
facility: Los Banos
city: Quezon
country: Philippines
facility: Pagbilao Health Center
city: Nakhon Si Thammarat
country: Thailand
facility: Health promotion Clinic Number 11
state: Nakisron
city: Nakhon Si Thammarat
country: Thailand
facility: Ban Pak Poon Health Center
state: Nakornsri
city: Nakhon Si Thammarat
country: Thailand
facility: Maharat Nakhonsithammarat Primary Care Unit
state: Nakornsri
city: Nakhon Si Thammarat
country: Thailand
facility: Pak-Panung District Health Center
state: Nakornsri
city: Ban Phon Ko
country: Thailand
facility: Ban Yuanlae District Health Center
city: Nakhon Si Thammarat, Nakornsri
country: Thailand
facility: Ban Mai Daeng
city: Nakhon Si Thammarat, Nakornsri
country: Thailand
facility: Ban Pai Ta Health Center
Study officials:
affiliation: Cancer Institute Foundation, Phillipines
name: Cecilia Llave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University, Thailand
name: Kobchitt Limpaphayom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jhpiego
name: Enriquito Lu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: