Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

Cervical Cancer Clinical Trial

— MDI  

Official title:

Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096134
• Other study ID #: 36448
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: October 9, 2015
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2015
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Johns Hopkins School of Public Helath Institutional Review BoardThailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public HealthPhillpines: Philippine Council for Health Research & Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 13 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Philippines	Minglanilla	Cebu
Philippines	Los Banos	Quezon
Philippines	Pagbilao Health Center	Quezon
Thailand	Ban Yuanlae District Health Center	Ban Phon Ko
Thailand	Ban Pak Poon Health Center	Nakhon Si Thammarat	Nakornsri
Thailand	Health promotion Clinic Number 11	Nakhon Si Thammarat	Nakisron
Thailand	Maharat Nakhonsithammarat Primary Care Unit	Nakhon Si Thammarat	Nakornsri
Thailand	Pak-Panung District Health Center	Nakhon Si Thammarat	Nakornsri
Thailand	Ban Mai Daeng	Nakhon Si Thammarat, Nakornsri
Thailand	Ban Pai Ta Health Center	Nakhon Si Thammarat, Nakornsri

Sponsors (2)

Lead Sponsor	Collaborator
Jhpiego	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	No
Secondary	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	1 year	No
Secondary	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	2 years	No