The Human Papillomavirus (HPV) Transmission Pilot Study

NCT00823511 | Completed

• 2 other identifiers: MCC-14881USF IRB 104923
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

This transmission pilot study is a prospective study to determine feasibility of enrolling female partners into an international transmission study. Companion study to MCC-13930.

Conditions

Human Papillomavirus Infection

Keywords

HPV; Human Papillomavirus Infection; Cervix Uteri; Cancer Control; Risk Assessment, Detection & Intervention; Sexually Transmitted; Neoplasia; Carcinogenesis; Cervix

Outcome Measures

Primary Outcomes (1)

• Proportion of men in the HIM study willing to invite their female partner to participate in partner study, proportion of female partners who: a) contact clinic for enrollment in study b) are eligible to participate in the study c) enroll in study.

  2 year accrual period

Secondary Outcomes (1)

• Proportion of female partners who report being monogamous with the HIM partner, proportion of women that are both HPV sero negative and HPV DNA negative at enrollment, proportion of women who comply with study protocol over 2 years of follow up.

  2 years per participant

Study Arms (1)

Female Partners

Female partners of HIM Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female partners of HIM Study participants - Companion study to MCC-13930. Residents of Southern Florida.

You may qualify if:

• Female partners of HIM Study participants
• report no abnormal Pap smear during the past 6 months;
• have not had a hysterectomy
• have never been diagnosed with genital warts;
• are not pregnant;
• residents of southern Florida;
• are not and have not been enrolled in an HPV vaccine trial;
• willing to comply with scheduled visits every 6 months for 2 years.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Neoplasms; Carcinogenesis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Anna Giuliano

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: October 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

US (1)