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HIV SeropositivityPAPILLO-VIHNCT05968183

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

An observational study of HIV Seropositivity, run by Centre Hospitalier de Saint-Denis at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 65 years, women only
Conditions the study is for
HIV Seropositivity
How many people
200 participants
Where
1 siteFrance
Study dates
1 Jul 2023to 1 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • Women only
  • Adult, Older adult

Study population: Cohort of patients who have been living with HIV seen in maternity consultations over 1 year at our institution.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

  • Centre Hospitalier de Saint-Denis

    Saint-Denis

    Claire FIEVRE, 01 42 35 68 97, claire.fievre@ch-stdenis.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the detailed 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.

Keywords
HPV test, cervical cancer
Medical subject headings
HIV Seropositivity, Uterine Cervical Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic characteristics

    Measured: Day 1

  2. HIV history

    Measured: Day 1

  3. medical history

    Measured: Day 1

  4. comorbidities

    Measured: Day 1

  5. clinical examination data

    Measured: Day 1

Secondary outcomes (3)

  1. Results of HPV Cytology

    Measured: Day 1

  2. Results of cell smear

    Measured: Day 1

  3. Results of additional examinations prescribed

    Results of any additional examinations prescribed

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Jul 2023
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05968183
Sponsor's protocol ID
CHSD_0026_MATER
Other IDs
2022-A01844-39
Acronym
PAPILLO-VIH
Status last verified
Jul 2023
First submitted
4 Jul 2023
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 2884378

  • 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.

    PubMed 28796882

  • 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.

    PubMed 33639672

  • 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.

    PubMed 24216030

  • 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.

    PubMed 29369827

  • 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.

    PubMed 34639509

  • 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.

    PubMed 16054967

  • 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.

    PubMed 30721904

  • 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.

    PubMed 16418512

  • 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.

    PubMed 22820789

  • 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.

    PubMed 17117020

  • 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.

    PubMed 15784870

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Seropositivity, run by Centre Hospitalier de Saint-Denis at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic characteristics (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968183, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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