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

HIV Seropositivity Clinical Trial

— PAPILLO-VIH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968183
• Other study ID #: CHSD_0026_MATER
• Secondary ID: 2022-A01844-39
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier de Saint-Denis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to evaluate the interest of a screening strategy based on the HPV test in patients living with HIV, compared to the cell smear alone in the same population. The Secondary objective of this study is to verify if the use of HPV testing could allow for a longer follow-up of these patients in case of negativity, and thus allow for a standardization of clinicians' practices.

Description:

Since 2019, a new screening strategy has been implemented and is based on high-risk, HPV tests, which, when negative, allow for spaced monitoring in the general population after age 30 (every 5 years instead of every 3 years.) These tests therefore allow for earlier detection of patients at risk but also for longer follow-up when they are negative. To our knowledge, there is currently no evaluation of HPV testing as part of routine screening in patients living with HIV. The recommendations for this population are based on the use of the cervico-vaginal smear with cytological analysis. The smear should be taken every year and surveillance may be repeated every 3 years. If there are 3 consecutive smears without abnormalities and a controlled viral load with CD4 counts > 500 mm3. In practice, many patients do not meet these criteria and must, therefore, undergo annual screening; the increase in the number of smears also leads to an increase in the number of second-line examinations such as colposcopy. Since there is no recommendation for HPV testing in this population, the use of dual detection (cytology and HPV testing) is left to the discretion of the clinician. By mutual agreement with the clinicians of the maternity department of the Saint-Denis Hospital (CHSD), this double detection was introduced in 2021, using the same sample (single swab for both analyses: cytology and HPV test). Therefore, it seems interesting to verify the possibility of a screening strategy based on HPV testing in patients living with HIV, by correlating the results of HPV testing and cell smears in the population of patients living with HIV.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Seropositivity
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Denis	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Denis

Country where clinical trial is conducted

France, 

References & Publications (12)

Clifford GM, Goncalves MA, Franceschi S; HPV and HIV Study Group. Human papillomavirus types among women infected with HIV: a meta-analysis. AIDS. 2006 Nov 28;20(18):2337-44. doi: 10.1097/01.aids.0000253361.63578.14. — View Citation

Denslow SA, Rositch AF, Firnhaber C, Ting J, Smith JS. Incidence and progression of cervical lesions in women with HIV: a systematic global review. Int J STD AIDS. 2014 Mar;25(3):163-77. doi: 10.1177/0956462413491735. Epub 2013 Aug 29. — View Citation

Gupta K, Philipose CS, Rai S, Ramapuram J, Kaur G, Kini H, Gv C, Adiga D. A Study of Pap Smears in HIV-Positive and HIV-Negative Women from a Tertiary Care Center in South India. Acta Cytol. 2019;63(1):50-55. doi: 10.1159/000496211. Epub 2019 Feb 5. — View Citation

Harris TG, Burk RD, Palefsky JM, Massad LS, Bang JY, Anastos K, Minkoff H, Hall CB, Bacon MC, Levine AM, Watts DH, Silverberg MJ, Xue X, Melnick SL, Strickler HD. Incidence of cervical squamous intraepithelial lesions associated with HIV serostatus, CD4 cell counts, and human papillomavirus test results. JAMA. 2005 Mar 23;293(12):1471-6. doi: 10.1001/jama.293.12.1471. — View Citation

Hawes SE, Critchlow CW, Sow PS, Toure P, N'Doye I, Diop A, Kuypers JM, Kasse AA, Kiviat NB. Incident high-grade squamous intraepithelial lesions in Senegalese women with and without human immunodeficiency virus type 1 (HIV-1) and HIV-2. J Natl Cancer Inst. 2006 Jan 18;98(2):100-9. doi: 10.1093/jnci/djj010. — View Citation

Keller MJ, Burk RD, Xie X, Anastos K, Massad LS, Minkoff H, Xue X, D'Souza G, Watts DH, Levine AM, Castle PE, Colie C, Palefsky JM, Strickler HD. Risk of cervical precancer and cancer among HIV-infected women with normal cervical cytology and no evidence of oncogenic HPV infection. JAMA. 2012 Jul 25;308(4):362-9. doi: 10.1001/jama.2012.5664. — View Citation

Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, Schunemann H, Paraskevaidis E, Arbyn M. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev. 2017 Aug 10;8(8):CD008587. doi: 10.1002/14651858.CD008587.pub2. — View Citation

Laara E, Day NE, Hakama M. Trends in mortality from cervical cancer in the Nordic countries: association with organised screening programmes. Lancet. 1987 May 30;1(8544):1247-9. doi: 10.1016/s0140-6736(87)92695-x. — View Citation

Liu G, Sharma M, Tan N, Barnabas RV. HIV-positive women have higher risk of human papilloma virus infection, precancerous lesions, and cervical cancer. AIDS. 2018 Mar 27;32(6):795-808. doi: 10.1097/QAD.0000000000001765. — View Citation

Nappi L, Carriero C, Bettocchi S, Herrero J, Vimercati A, Putignano G. Cervical squamous intraepithelial lesions of low-grade in HIV-infected women: recurrence, persistence, and progression, in treated and untreated women. Eur J Obstet Gynecol Reprod Biol. 2005 Aug 1;121(2):226-32. doi: 10.1016/j.ejogrb.2004.12.003. Epub 2005 Jan 18. — View Citation

Sakdadech N, Muangmool T, Srisomboon J. HIV-Infected Women with Low-Grade Squamous Intraepithelial Lesion on Cervical Cytology Have Higher Risk of Underlying High-Grade Cervical Intraepithelial Neoplasia. Int J Environ Res Public Health. 2021 Sep 28;18(19):10211. doi: 10.3390/ijerph181910211. — View Citation

Srisomboon S, Tantipalakorn C, Muangmool T, Srisomboon J. Risk of High-Grade Cervical Lesions in Atypical Squamous Cells of Undetermined Significance (ASC-US) Cytology: Comparison between HIV-Infected and HIV-Negative Women. Asian Pac J Cancer Prev. 2021 Feb 1;22(2):547-551. doi: 10.31557/APJCP.2021.22.2.547. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristics		Day 1
Primary	HIV history		Day 1
Primary	medical history		Day 1
Primary	comorbidities		Day 1
Primary	clinical examination data		Day 1
Secondary	Results of HPV Cytology		Day 1
Secondary	Results of cell smear		Day 1
Secondary	Results of additional examinations prescribed	Results of any additional examinations prescribed	Day 1