Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers

Completed

• Conditions: Human Papillomavirus Viruses

• Registration Number: NCT02895399
• Lead Sponsor: Centre Hospitalier de Cayenne

Brief Summary

Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection.

Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-09
• Study Completion: 2014-10
• Status Verified: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Last Update Submitted: 2016-09-08
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 643

Inclusion Criteria

• Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )
• Having already had sexual intercourse
• Having given after information , consent to the inclusion in the study

Exclusion Criteria

• Age < 20 or age> 65 years
• Being pregnant more than 3 months
• Have had a hysterectomy
• Denial of participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and distribution of Human Papillomaviruses genotypes	At the time of inclusion (baseline)