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

Cervical Cancer Clinical Trial

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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT01338051
• Study type: Interventional
• Source: Preventive Oncology International, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 2011
• Completion date: April 2012