The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)
30 Years
45 Years
Female
Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervical Neoplasm, Cervical Dysplasia, Human Papillomavirus
Trial Information
The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru (PERCAPS)
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Evaluation of key study processes used in the process of implementing a mother/child screen, treat and vaccinate program in Iquitos, Peru.
Outcome Description:
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.
Outcome Time Frame:
Interview with participants will occur at approximately one month after 2nd vaccination
Safety Issue:
No
Principal Investigator
Jerome L Belinson, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Preventive Oncology International
Authority:
United States: Institutional Review Board
Study ID:
PERCAPS I
NCT ID:
NCT01338051
Start Date:
May 2011
Completion Date:
April 2012
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Cervical Cancer
- Cervical Neoplasm
- Cervical Dysplasia
- Human Papillomavirus
- Community based participatory research
- Neoplasms
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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