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Completed

NCT Number: NCT00823511

The Human Papillomavirus (HPV) Transmission Pilot Study

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.

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Key information

Conditions

Human Papillomavirus Infection Carcinogenesis Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Neoplasms Neoplastic Processes Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

About this study

We planned to enroll 150 female sexual partners, 75 per year for 2 years, of male study participants in the HPV Infection in Men (HIM) Study. The enrollment period is from June 2006 through May 2008 and participants will be followed through May 2010. At all study visits participants will undergo interviews, a physical exam and laboratory analysis for HPV for a total of 5 clinical visits scheduled every 6 months over 2 years of follow-up. In addition, at each study visit, participants will provide blood for HPV antibody analyses. At enrollment, visit 3 and visit 5 a Pap smear test will be done. At the enrollment visit, study participants will complete a questionnaire designed to assess social and behavioral risk factors for the acquisition of HPV. At each subsequent study visit, participants will be asked to provide updated information to assess changes in risk behaviors such as condom use, relations with new partners, and tobacco use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Do not meet the Inclusion Criteria.

Treatment and study plan

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.

    Time frame: 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.

    Time frame: 2 years per participant

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Jan 15, 2009
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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