Clinical trial NCT00823511: The Human Papillomavirus (HPV) Transmission Pilot Study
Official title: The Human Papillomavirus (HPV) Transmission Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Keywords: HPV
Human Papillomavirus Infection
Cervix Uteri
Cancer Control
Risk Assessment, Detection & Intervention
Sexually Transmitted
Neoplasia
Carcinogenesis
Cervix
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female partners of HIM Study participants - Companion study to MCC-13930. Residents of Southern Florida.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 year accrual period
Secondary outcomes:
measure: 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.
timeFrame: 2 years per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center & Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Anna Giuliano
role: PRINCIPAL_INVESTIGATOR
References: