The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01338051|
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia Cervical Cancer Cervical Neoplasm Cervical Dysplasia Human Papillomavirus||Biological: Gardasil||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||642 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
- Biological: Gardasil
Gardasil will be administered to 10-13 year old daughters and granddaughters of study participants according to manufacturers recommended schedule of administration. Gardasil is supplied as 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.
DOSAGE FORMS AND STRENGTHS • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe.
- Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru. [ Time Frame: Interview with participants will occur at approximately one month after 2nd vaccination ]The investigators will evaluate community participation, lost to follow up and potential sustainability. One on one interviews with participants will be conducted by trained medical staff. Additional measures to success will be gathered from interviews with promotoras, participating health services staff and recoeded observation. These analyses are descriptive in nature.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338051
|Centro de Salud Portada de Manchay|
|Manchay, Lima, Peru|
|Centro de Salud Bellavista Nanay|
|Iquitos, Loreto, Peru, 065|
|Principal Investigator:||Jerome L Belinson, MD||Preventive Oncology International|
|Principal Investigator:||Carlos Vallejos Sologuren, MD||Instituto Nacional de Enfermadades Neoplasticas (INEN)|