HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study

Completed

• Conditions: Cervical Cancer

• Registration Number: NCT01792973
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief Summary

HIV-infected women are at high risk of developing cervical cancer. This is a 3-year cohort study nested in the already existing Program for HIV Prevention and Treatment (PHPT) cohort of HIV-infected patients in Thailand (NCT 00433030). The main objective is to assess the prevalence, incidence, and clearance rate of HPV cervical infection and associated cervical lesion. The study will also provide the distribution of the HPV genotypes involved as well as other risk factors of cervical lesions. HIV-infected women receiving antiretrovirals, older than18 years of age, followed in the PHPT cohort or in the same hospitals are proposed to participate. An annual gynecological examination with a Pap-smear and a sampling for HPV testing is performed. Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection receive a more intensive follow-up with a colposcopy and a biopsy if necessary. Treatment is provided according to the National Guidelines.

Detailed Description

Title of the study: HPV Infection and Cervical Lesions in HIV infected Thai Women - A Prospective Study Country: Thailand Study period: 3 years Planned enrollment duration: 6 months

Primary objectives:

1. To evaluate the prevalence, the incidence, the persistence rate and the clearance rate of HPV cervical infection, of genotypes involved and of multiple infections.

2. To evaluate the prevalence, the incidence, the progression rate and the regression rate of cyto-histological abnormalities

3. To assess the efficacy of different screening algorithms using pap smear alone, pap-smear associated with HPV and HPV alone

Secondary objectives:

1. To determine the risk factors of high grade lesions (Cervical intraepithelial neoplasia (CIN)2 or higher) in HIV infected Thai women

2. To evaluate cyto-histology performances at different hospital levels Methods: A multicenter prospective cohort study nested in the PHPT cohort.

Inclusion criteria: HIV infected women, older than18 years of age, followed in the PHPT cohort or in the same hospitals.

Exclusion criteria: Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial Planned number of patients to be enrolled: 884

Follow-up procedures:

Annual gynecological examination with a Pap-smear and a sampling for HPV testing is planned.

Women with abnormal Pap-smear or with High-Risk HPV (HR-HPV) infection will be referred to a colposcopist.

In case of abnormalities at the colposcopy, a biopsy will be performed.

* If the biopsy is normal or shows a CIN1, the women will be referred for a new colposcopic examination 6 months later.

* If the biopsy shows CIN2 or more, treatment will be provided -LEEP or conisation, or hysterectomy, and the women will be referred for a new colposcopic examination 6 months later.

Biological and pathological procedures:

* Pap-smears will be read by local pathologists in participating hospital.

* Biopsies will be read by local pathologists in participating hospital.

* HPV tests will all be performed in the PHPT virological laboratory in Chiang Mai.

Statistical methodology:

Descriptive statistics, univariate and multivariate analyses.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 829

Inclusion Criteria

• HIV infected women, older than 18 years of age, followed in the PHPT cohort

Exclusion Criteria

• Virginity, total hysterectomy, pregnancy after 3rd month, inclusion in a HPV vaccination trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High grade cervical lesions	Up to 3 years	Cervical intraepithelial neoplasia grade 2 or higher (CIN2+) in histology, and high grade squamous intraepithelial lesions or higher (HSIL+) in cytology
High risk HPV infection	January 2015	HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, HPV68

Trial Locations

Locations (24)

Lamphun Hospital; 🇹🇭 Lamphun, Chiang Mai, Thailand

Mae Sai Hospital; 🇹🇭 Mae Sai, Chiang Rai, Thailand

Chonburi Hospital; 🇹🇭 Chon Buri, Chonburi, Thailand

Prapokklao Hospital; 🇹🇭 Chanthaburi, Chantaburi, Thailand

Sanpatong Hospital; 🇹🇭 San Pa Tong, Chiang Mai, Thailand

Samutprakarn Hospital; 🇹🇭 Samut Prakan, Samutprakarn, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Bhuddasothorn Hospital; 🇹🇭 Chachoengsao, Thailand

Chiang Kham Hospital; 🇹🇭 Chiang Kham, Phayao, Thailand

Nakornping Hospital; 🇹🇭 Mae Rim, Chiang Mai, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang Rai, Chiangrai, Thailand

Mahasarakam Hospital; 🇹🇭 Maha Sarakham, Mahasarakam, Thailand

Nakhonpathom Hospital; 🇹🇭 Nakhon Pathom, Nakhonpathom, Thailand

Maharat Nakhon Ratchasima Hospital; 🇹🇭 Nakhon Ratchasima, Thailand

Phan Hospital; 🇹🇭 Phan, Chiang Rai, Thailand

Buddhachinaraj Hospital; 🇹🇭 Phitsanulok, Pitsanulok, Thailand

Samutsakorn Hospital; 🇹🇭 Samut Sakhon, Samutsakorn, Thailand

Nong Khai Hospital; 🇹🇭 Nong Khai, Thailand

Mae Chan Hospital; 🇹🇭 Mae Chan, Chiang Rai, Thailand

Hat Yai Hospital; 🇹🇭 Hat Yai, Songkla, Thailand

Lampang Hospital; 🇹🇭 Lampang, Thailand

Rayong Hospital; 🇹🇭 Rayong, Thailand

Phayao Hospital; 🇹🇭 Phayao, Thailand

Ratchaburi Hospital; 🇹🇭 Ratchaburi, Thailand