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

April 16, 2014 updated by: Jerome Belinson, Preventive Oncology International, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our research group has recently demonstrated that a self-collected cervico-vaginal sample tested with a very high throughput HR-HPV assay is as sensitive has a direct endocervical physician collected sample. Teamed with a non-liquid transport media the investigators believe the technology is solved to reach large populations in a short period of time. With the majority of the world's medically underserved now living in middle income countries it is not necessary to think simple and small to reach the Earth's needy. The investigators can think high tech and high throughput. The massive volumes possible, with proper organization, will control the per/patient cost. The investigators will think "events", not continuous care. Clearly continuous care is the only way to adequately provide the needed care for many problems. However, many interventions can be confined to events which organize large screening or vaccination days and only when positives are identified from the detection algorithm does the healthcare staff become involved for management. The investigators spend an enormous amount of resources identifying the majority of people who will ultimately test negative. The more local the paradigms and the more involved the community in designing the program, the greater will be the participation and the lost to follow-up segment will shrink. This mother, child, screen, treat and vaccinate program will use cervical cancer prevention as the target preventive healthcare intervention. Using community based research orientation the project will begin with a 3 day education program and collaborative meeting with the women leaders of the communities (promotoras). Collectively the investigators will develop the model for the community to advertise, educate, recruit, register, self-collect the specimens, deliver the samples, and report the results. In addition the logistics of the 3 vaccination schedule for the female children will be organized. The medical staff will be involved only with the management of the positives and the vaccine administration. The observational measures will focus on assessing how effectively each of the steps was accomplished.

Study Type

Interventional

Enrollment (Actual)

642

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
    • Lima
      • Manchay, Lima, Peru
        • Centro de Salud Portada de Manchay
    • Loreto
      • Iquitos, Loreto, Peru, 065
        • Centro de Salud Bellavista Nanay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Inclusion criteria (adult)

  1. 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.
  2. No screening or knowledge of the results of a Pap Test in the last 5 years
  3. No hysterectomy
  4. No prior pelvic radiation.
  5. Willing to sign consent form

Inclusion criteria (children)

  1. Female children and grandchildren of a participating women ages 10-13 years
  2. No acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
  3. No previous vaccination with Gardasil
  4. No reactions to previous dose in their vaccination series
  5. No known yeast allergy
  6. Willing to participate

Exclusion Criteria:

Exclusion criteria (adults)

Patients will be excluded in the study based on the following criteria:

  1. Males
  2. Women younger than 30 years old and older than 45 years old.
  3. 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.
  4. Pregnant women.
  5. Patients with known history of hysterectomy or radiation for a pelvic cancer.
  6. Refusal to participate

Exclusion criteria (Children)

  1. Males
  2. Girls younger than 10 years old, and older than 13 years.
  3. acute illnesses (clinically evident according to vaccinating staff) - such as fever, nausea, vomiting, diarrhea
  4. previous vaccination with Gardasil
  5. reactions to a previous dose in their vaccination series
  6. known yeast allergy
  7. Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Interview with participants will occur at approximately one month after 2nd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Preventive Oncology International, Inc.

Collaborators

Merck Sharp & Dohme LLC
Peru Instituto Nacional de Enfermadades Neoplasticas (INEN)

Investigators

  • Principal Investigator: Jerome L Belinson, MD, Preventive Oncology International
  • Principal Investigator: Carlos Vallejos Sologuren, MD, Instituto Nacional de Enfermadades Neoplasticas (INEN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 16, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERCAPS I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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