HIV Seropositivity Clinical Trial
— PAPILLO-VIHOfficial title:
The Value of HPV Testing for Cervical Cancer Screening in Women Living With HIV
Verified date | July 2023 |
Source | Centre Hospitalier de Saint-Denis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Saint-Denis | Saint-Denis |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Saint-Denis |
France,
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
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 |
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