Brief Title
The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru
Official Title
The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)
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.
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru.
Condition
Cervical Intraepithelial Neoplasia
Intervention
Gardasil
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
642
Start Date
May 2011
Completion Date
April 2012
Primary Completion Date
April 2012
Eligibility Criteria
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
Gender
Female
Ages
30 Years - 45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jerome L Belinson, MD, ,
Location Countries
Peru
Location Countries
Peru
Administrative Informations
NCT ID
NCT01338051
Organization ID
PERCAPS I
Responsible Party
Principal Investigator
Study Sponsor
Preventive Oncology International, Inc.
Collaborators
Peru Instituto Nacional de Enfermadades Neoplasticas (INEN)
Study Sponsor
Jerome L Belinson, MD, Principal Investigator, Preventive Oncology International
Verification Date
April 2014