The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV (PAPILLO-VIH)

NCT05968183UNKNOWNOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Centre Hospitalier de Saint-Denis

Enrollment

200

Start Date

2023-07-01

Completion Date

2024-07-01

Study Type

OBSERVATIONAL

Official Title

The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV

Conditions

HIV Seropositivity

Eligibility

Age Range

25 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Women living with HIV
* Age 25-65 years
* Managed in the CHSD maternity ward: consultation or hospitalization
* Having signed a consent form

Exclusion Criteria:

* Age ≤ 24 years, or ≥ 66 years
* Women who are not HIV positive
* Patients under legal protection (guardianship, curatorship)
* Patients deprived of liberty
* Patients not affiliated to a social security system
* Refusal to participate in the research

Outcome Measures

Primary Outcomes

Demographic characteristics

Time frame: Day 1

HIV history

Time frame: Day 1

medical history

Time frame: Day 1

comorbidities

Time frame: Day 1

clinical examination data

Time frame: Day 1

Secondary Outcomes

Results of HPV Cytology

Time frame: Day 1

Results of cell smear

Time frame: Day 1

Results of additional examinations prescribed

Results of any additional examinations prescribed

Time frame: Day 1

Locations

Centre Hospitalier de Saint-Denis, Saint-Denis, France

Linked Papers

2021-09-28

HIV-Infected Women with Low-Grade Squamous Intraepithelial Lesion on Cervical Cytology Have Higher Risk of Underlying High-Grade Cervical Intraepithelial Neoplasia

Objective: To evaluate the risk of histological high-grade cervical lesions defined as cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women with human immunodeficiency virus (HIV) infection who had low-grade squamous intraepithelial lesions (LSIL) on cervical cytological screening compared with HIV-uninfected women who had similar cytology. Methods: 127 HIV-positive women aged 18–65 years with LSIL cytology undergoing colposcopic examination between January 2008 and December 2019 at Chiang Mai University Hospital were reviewed. By matching 1:1 ratio for age (±5 years) and examination time period (±12 months), 127 HIV-negative women with LSIL cytology in the same period were recruited as controlled subjects for comparison. The patients’ characteristics, HIV status, CD4 counts, antiretroviral therapy, and histopathology on cervical biopsy were analyzed. Results: HIV-infected women significantly had early sexual debut (age < 20 years) and more sexual partners (≥2) than HIV-uninfected women. The risk of underlying CIN2+ in HIV-infected women was significantly higher than that in HIV-negative women (20.5% vs. 9.4%, p = 0.021) with an odds ratio (OR) of 2.47 and 95% confidence interval (CI) = 1.18–5.14. After adjustment, the risk of underlying CIN2+ in HIV-infected women remained significantly higher than that in HIV-uninfected women (adjusted OR = 2.55, 95% CI = 1.11–5.82, p = 0.027). Conclusion: Among women with LSIL on cervical cytology, the risk of underlying CIN2+ in HIV-infected women was approximately 2.5 times higher than those without HIV infection. Colposcopy is indicated particularly in the case of women with a long duration of HIV infection.

2021-02-01

Risk of High-Grade Cervical Lesions in Atypical Squamous Cells of Undetermined Significance (ASC-US) Cytology: Comparison between HIV-Infected and HIV-Negative Women

Women with human immunodeficiency virus (HIV) infection have an increased risk of HPV infection, cervical neoplasia. This study was undertaken to compare the risk of having high-grade cervical lesions defined as cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in HIV-infected versus HIV-uninfected women who had atypical squamous cells of undetermined significance (ASC-US) on cervical cytology. Fifty-seven HIV-positive women aged 25-65 years with ASC-US cytology undergoing colposcopic examination between January 2008 and December 2020 at Chiang Mai University Hospital were reviewed. By matching 1:5 ratio, 285 HIV-negative women with ASC-US cytology in the same period were recruited as controlled subjects for comparison. The patient characteristics, HIV status, CD4 cell count within 6 months of colposcopy, antiretroviral therapy, parity, contraception, smoking history, number of sexual partners, and histopathology on cervical biopsy were analyzed. Mean age ± SD of the HIV-positive and HIV-negative groups was 44.28 ± 8.53 years and 44.28 ± 9.68 years, respectively. HIV-positive women were significantly less likely to use contraceptive methods (36.8 % versus 48.8 % in HIV-negative women; P = 0.002). HIV-infected women significantly had more sexual partners than HIV-uninfected women. Both groups had similar risk for CIN 2+ (5.3 % in HIV-positive women compared with 4.9 % in HIV-negative women; odds ratio [OR] = 1.08, 95% confidence interval [CI] = 0.30 -3.87). After adjustment for no contraception use and number of sexual partners, the risk of CIN2+ in HIV-infected women remained unchanged; adjusted OR= 1.15, 95% CI = 0.27-4.92, P= 0.846). The risk of underlying high-grade cervical lesions in women with ASC-US on cervical cytology was approximately 5 %, regardless of HIV status.

Linked Investigators