The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru

NCT01338051 | Completed Phase 1

• 1 other identifier: PERCAPS I
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 2

Brief Summary

This project will use a community based participatory research orientation to develop a model for large scale "campaign" preventive healthcare interventions. The investigators have considerable expertise with cervical cancer screening and HPV vaccination. The investigators also have well tested methodologies for cervical cancer screening that are highly effective, including self-sampling for HPV and improved specimen transport systems. Therefore, the investigators will use these medical interventions as the model preventive health interventions for this project.

Conditions

Cervical Intraepithelial Neoplasia; Cervical Cancer; Cervical Neoplasm; Cervical Dysplasia; Human Papillomavirus

Keywords

Community based participatory research

Outcome Measures

Primary Outcomes (1)

• Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru.

  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.

  Interview with participants will occur at approximately one month after 2nd vaccination

Interventions

Gardasil BIOLOGICAL

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.

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non pregnant women 30-45 years of age in Manchay, and in Iquitos, with female children or grandchildren ages 10-13 who they are willing to enroll in the study to receive Gardasil vaccination.
• No screening or knowledge of the results of a Pap Test in the last 5 years
• No hysterectomy
• No prior pelvic radiation.
• Willing to sign consent form
• Female children and grandchildren of a participating women ages 10-13 years
• No acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
• No previous vaccination with Gardasil
• No reactions to previous dose in their vaccination series
• No known yeast allergy
• Willing to participate

You may not qualify if:

• Patients will be excluded in the study based on the following criteria:
• Males
• Women younger than 30 years old and older than 45 years old.
• Women without female children or grandchildren age 10-13 or who are unwilling to enroll their 10-13 year old female children or grandchildren to receive Gardasil.
• Pregnant women.
• Patients with known history of hysterectomy or radiation for a pelvic cancer.
• Refusal to participate
• Males
• Girls younger than 10 years old, and older than 13 years.
• acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
• previous vaccination with Gardasil
• reactions to a previous dose in their vaccination series
• known yeast allergy
• Refusal to participate

Sponsors & Collaborators

• Preventive Oncology International, Inc.: lead
• Peru Instituto Nacional de Enfermadades Neoplasticas (INEN): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Centro de Salud Portada de Manchay

Manchay, Lima region, Peru

Location

Centro de Salud Bellavista Nanay

Iquitos, Loreto, 065, Peru

Location

Related Publications (1)

• Levinson KL, Abuelo C, Salmeron J, Chyung E, Zou J, Belinson SE, Wang G, Ortiz CS, Vallejos CS, Belinson JL. The Peru Cervical Cancer Prevention Study (PERCAPS): the technology to make screening accessible. Gynecol Oncol. 2013 May;129(2):318-23. doi: 10.1016/j.ygyno.2013.01.026. Epub 2013 Feb 4.

  PMID: 23385153 DERIVED

Related Links

• Preventive Oncology International

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Jerome L Belinson, MD

  Preventive Oncology International

  PRINCIPAL INVESTIGATOR

• Carlos Vallejos Sologuren, MD

  Instituto Nacional de Enfermadades Neoplasticas (INEN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jerome Belinson MD, president

Study Record Dates

• First Submitted: April 16, 2011
• First Posted: April 19, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

PE (2)