Clinical trial NCT01792973: HPV Infection and Cervical Lesions in HIV Infected Women in Thailand: A Prospective Study
Official title: HPV Infection and Cervical Lesions in HIV Infected Women in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: HIV
HPV
Women
Thailand
Antiretrovirals
Cervical cancer
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: National Cancer Institute, France
name: Fondation de France
First posted: 2013-02-15
Enrollment: 829
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected women followed in the PHPT cohort

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.

Eligibility criteria: 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

Primary outcomes:
measure: High risk HPV infection
timeFrame: January 2015
measure: High grade cervical lesions
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chanthaburi
country: Thailand
facility: Prapokklao Hospital
state: Chantaburi
city: Lamphun
country: Thailand
facility: Lamphun Hospital
state: Chiang Mai
city: Mae Rim
country: Thailand
facility: Nakornping Hospital
state: Chiang Mai
city: San Pa Tong
country: Thailand
facility: Sanpatong Hospital
state: Chiang Mai
city: Mae Chan
country: Thailand
facility: Mae Chan Hospital
state: Chiang Rai
city: Mae Sai
country: Thailand
facility: Mae Sai Hospital
state: Chiang Rai
city: Phan
country: Thailand
facility: Phan Hospital
state: Chiang Rai
city: Chiang Rai
country: Thailand
facility: Chiangrai Prachanukroh Hospital
state: Chiangrai
city: Chon Buri
country: Thailand
facility: Chonburi Hospital
state: Chonburi
city: Maha Sarakham
country: Thailand
facility: Mahasarakam Hospital
state: Mahasarakam
city: Nakhon Pathom
country: Thailand
facility: Nakhonpathom Hospital
state: Nakhonpathom
city: Chiang Kham
country: Thailand
facility: Chiang Kham Hospital
state: Phayao
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Hospital
state: Pitsanulok
city: Samut Prakan
country: Thailand
facility: Samutprakarn Hospital
state: Samutprakarn
city: Samut Sakhon
country: Thailand
facility: Samutsakorn Hospital
state: Samutsakorn
city: Hat Yai
country: Thailand
facility: Hat Yai Hospital
state: Songkla
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Chachoengsao
country: Thailand
facility: Bhuddasothorn Hospital
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
city: Nong Khai
country: Thailand
facility: Nong Khai Hospital
city: Phayao
country: Thailand
facility: Phayao Hospital
city: Ratchaburi
country: Thailand
facility: Ratchaburi Hospital
city: Rayong
country: Thailand
facility: Rayong Hospital
Study officials:
affiliation: Institut National d'Etudes Démographiques
name: Sophie Le Coeur, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche pour le Developpement
name: Gonzague Jourdain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche pour le Developpement
name: Nicole Ngo-Giang- Huong, PharmaD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre national de réference des papillomavirus humains, Institut Pasteur
name: Isabelle Heard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nakornping Hospital, Minsitry of Public Health
name: Aram Limtrakul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonburi Hospital, Minsitry of Public Health
name: Nantasak Chotivanich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiang Kham Hospital, Ministry of Public Health
name: Chaiwat Putiyanun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pathology Faculty of Medicine, Chiang Mai University
name: Samreung Rangdaeng, Associate professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dub T, Le Coeur S, Ngo-Giang-Huong N, Matanasarawut W, Suriyachai P, Saisawat K, Putiyanun C, Buranabanjasatean S, Leenasirimakul P, Randaeng S, Delory T. Prevalence of High-Risk Human Papillomavirus Infections before and after Cervical Lesion Treatment, among Women Living with HIV. J Clin Med. 2021 Jul 15;10(14):3133. doi: 10.3390/jcm10143133.
citation: Le Coeur Sophie, Delory Tristan, Ngo-Giang-Huong Nicole, Rangdaeng Samreung, Heard Isabelle, Limtrakul Aram, Chotivanich Nantasak, Putiyanun Chaiwat, Leenasirimakul Prattana, Jourdain Gonzague. 2015. -"HPV Genotypes and factors associated with HR-HPV infection in HIV-infected women on Antiretroviral Therapy (ART) in Thailand: a national cohort". 30th International Papillomavirus Conference (HPV 2015), Lisbon, Portugal. 9-11 sept. 2015.
citation: Delory T, Ngo-Giang-Huong N, Rangdaeng S, Chotivanich N, Limtrakul A, Putiyanun C, Suriyachai P, Matanasarawut W, Jarupanich T, Liampongsabuddhi P, Heard I, Jourdain G, Lallemant M, Le Coeur S; PapilloV study group. Human Papillomavirus infection and cervical lesions in HIV infected women on antiretroviral treatment in Thailand. J Infect. 2017 May;74(5):501-511. doi: 10.1016/j.jinf.2017.02.007. Epub 2017 Feb 28.