Clinical trial · Observational
Community Awareness, Resources and Education (CARE II): Project 3
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Researchers at The Ohio State University and the University of Michigan are working together to understand cancer of the cervix. One of the areas they are studying is how stress you may experience in your life effects the way you respond to GARDASIL®. GARDASIL® is a vaccine approved by the Food and Drug Administration (FDA) to prevent some types of Human Papillomavirus (HPV) infection which can cause cancer of the cervix. Participants are being recruited from the Appalachian region of Ohio.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- serum antibody levels for HPV 6,11,16 and 18
- timeFrame
- 12 months
Secondary outcomes (3)
- measure
- serum antibody levels for Epstein-Barr Virus (EBV)
- timeFrame
- baseline
- measure
- Center for Epidemiological Studies - Depression (CES-D) Scale Score
- timeFrame
- 12 months
- measure
- perceived stress
- timeFrame
- 12-months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 18-26 years of age * Resident of an Appalachian county * Intact cervix * Able to read and understand English * Cognitively able to provide informed consent * Willing to come for four clinic visits Exclusion Criteria: * Prior history of cervical cancer * Prior history of a cervical lesion treated with cryotherapy or any form of surgical removal of a portion of the cervix to treat CIN * No cervix * Pregnant or planning to become pregnant in the next year * History of immune disorder: auto-immune, primary immune or acquired * Any contra-indications for the GARDASIL® vaccine series * Taking immune suppressive medications * Any prior exposure to an HPV vaccine of any type * Planning to move out of the immediate area in the next year
References
Publications (0)
Data not yet available