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

Cervical Cancer Clinical Trial

— PERCAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338051
• Other study ID #: PERCAPS I
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2011
• Last updated: April 16, 2014
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: Preventive Oncology International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardPeru: Instituto Nacional de SaludPeru: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Cervical Neoplasm
• Human Papillomavirus
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Peru	Centro de Salud Bellavista Nanay	Iquitos	Loreto
Peru	Centro de Salud Portada de Manchay	Manchay	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Preventive Oncology International, Inc.	Merck Sharp & Dohme Corp., Peru Instituto Nacional de Enfermadades Neoplasticas (INEN)

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Preventive Oncology International