Prevalence of High-Risk Human Papilloma Virus in HIV Positive women

Not yet recruiting

Conditions: Human immunodeficiency virus [HIV]disease,

Registration Number: CTRI/2023/05/052348

Lead Sponsor: Molbio Diagnostics Private limited

Brief Summary: As per the GLOBOCAN 2020 data, Cervical cancer is the 3rd most common cancer worldwide . In India, it ranks as the second most common cancer. Cervical cancer differs from any other genital cancer in the sense that it has well defined clinical stages and is caused by persistent infection with carcinogenic types of Human Papillomavirus (HPV) and is a necessary cause for most cervical cancers. The HR-HPV types 16 and 18 are the most common strains, accounting for 70-80% of the total subtypes , while other high risk types accounting for a total of 14 strains are 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 & 68.

Focusing on the Indian territory, the other most prevalent infection is HIV(Human Immunodeficiency Virus) and India ranks 3rd in the world with an absolute number of 2.1 million HIV seropositive people and high-risk types of HPV is an alarming health problem in HIV positive women as immune suppression is the main predisposing factor to HPV infections. It has been observed that Cervical intraepithelial neoplasia (CIN) is more common in HIV-infected females with low CD4 count or AIDS. In order to decrease the overall prevalence of cervical cancer, the most effective strategy is early diagnosis by screening and treatment. Therefore, WHO suggests using HPV DNA detection in a screen, triage and treat approach starting at the age of 25 years with regular screening every 3 to 5 years in HIV seropositive women

Few studies have been published from the Indian subcontinent regarding the prevalence of high-risk HPV and its genotypes in HIV positive women. Therefore, the present study is planned to evaluate HIV seropositive women for high-risk HPV prevalence including its genotypes and detect preinvasive an invasive cervical cancer in this population. The primary objectives of this study is to determine the proportion of HIV positive women with high-risk HPV positivity and the distribution of high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 & 68 among HIV positive women. The samples will be collected over a period of 12 months in Gynaecology OPD of AIIMS Rishikesh and females >/= 25 years attending the ART clinic in AIIMS Rishikesh with HIV seropositivity status will undergo HPV sampling, PAPS and VIA. The reports of the Cobas test will be informed to the patient within 14 days of testing. If the test is positive for high-risk HPV or cytology is >ASCUS, colposcopy will be performed. Cervical biopsy will be taken for high grade lesions (Swede score >5). Cases with low grade lesions (Swede score < 5) will be managed by thermal ablation of the lesion and the transformation zone or managed conservatively with follow up. The primary outcome of this study is to quantify the number of women with high-risk HPV positivity in HIV seropositive women and estimate number of women with various high risk HPV genotypes . Secondary outcome measures are duration of HIV seropositivity(in months since diagnosis) in high-risk HPV positive women, duration of ART in weeks in the above group, CD4 cell count at recruitment, number of women with cytological abnormalities >/= ASCUS and number of cases with CIN and invasive cervical cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 160

Inclusion Criteria

All women > 25 years of age attending ART clinic of AIIMS Rishikesh with HIV seropositive status.

Exclusion Criteria

Pregnant women 2.
Women who have undergone conization or hysterectomy 3.
Not willing to participate in study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify the number of women with high-risk HPV positivity in HIV seropositive women	Once (at recruitment)
To study the distribution of various high risk HPV genotypes in HIV positive women	Once (at recruitment)

Secondary Outcome Measures

Name	Time	Method
Duration of HIV seropositivity (in months since diagnosis) in high-risk HPV positive women.	Duration of ART in weeks in the above group.

Trial Locations

Locations (1): AIIMS Rishikesh
🇮🇳
Dehradun, UTTARANCHAL, India
AIIMS Rishikesh
🇮🇳Dehradun, UTTARANCHAL, India
Dr Riddhi Jadhav
Principal investigator
9518911425
riddhijadhav38@gmail.com