The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Cervical Neoplasm; Cervical Dysplasia; Human Papillomavirus
MeSH terms: Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Gardasil
Intervention type(s): Biological
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Community based participatory research