Self-collected Vaginal and Urine Samples in HIV-positive Women

NCT05783167 | Completed

• 1 other identifier: R351-A20092
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses topics as Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV), and cancer screening methods. The focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in Guinea-Bissau and further to estimate the prevalence of the precancerous virus HPV amongst women living with HIV. In the study the investigators will collect urinary and vaginal self-samples for HPV testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.

Conditions

HIV Infections; HPV-Related Cervical Carcinoma; Cervical Cancer; Coinfection, HIV

Keywords

Cervical cancer screening; Self-sampling; Urine sample; Vaginal sample

Outcome Measures

Primary Outcomes (2)

• Feasibility of implementing HPV self sampling for cervical cancer screening

  Among women meeting the inclusion criteria, the investigators want to estimate the prevalence of how many accepts the offer to collect self-samples, thereby gaining knowledge on the feasibility of implementing self-sampling as a cervical cancer screening method in Guinea-Bissau.

  April 2023 - February 2024

• HPV-prevalence among HIV-infected women in Guinea-Bissau

  The investigators want to estimate the prevalence of high risk HPV infection among HIV-infected women in the Nationwide HIV-cohort in Guinea-Bissau.

  April 2023 - February 2024

Secondary Outcomes (2)

• Experiences with self-collected vaginal and urine samples

  April 2023 - February 2024

• HPV-genotype agreement between vaginal- and urine samples

  April 2023 - February 2024

Study Arms (1)

HIV-positive females in Guinea-Bissau

The study is conducted on female HIV-infected patients in the Nationwide HIV-cohort at the 9 biggest HIV-clinics in Guinea-Bissau. Participants will be invited to enroll in the project when they present to the HIV-clinics for HIV-treatment and consultations.

Diagnostic Test: Self-sampling for HPV infection

Interventions

Self-sampling for HPV infection DIAGNOSTIC_TEST

After informed consent has been provided, the woman will be asked to collect firstly a first-void urine sample using the Collipee device and secondly to collect a vaginal self-sample using the dry Evalyn® Brush device. Socioeconomic, demographic and clinical data will be collected in the Bissau HIV Cohort database and through study questionnaires to collect background information on risk factors for HPV persistence and development of cervical cancer (HIV genotype, immune status, parity). Questionnaires will collect additional information on the acceptance of cervical screening measures to better evaluate the feasibility of implementing self-collected screening among HIV infected women in Guinea-Bissau.

Also known as: Collipee, Evalyn Brush

HIV-positive females in Guinea-Bissau

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is part of an international collaboration between the Department of Infectious Medicine at Aarhus University Hospital, the Bandim Health Project in Guinea-Bissau and Belgian researchers. Bandim Health project is a health and demographic surveillance system site that follows a population of more than 200.000 individuals in Guinea-Bissau. That population has created the base for the Guinea-Bissau Nationwide HIV-cohort with more than 35.000 patients. The patients are provided free HIV-treatment and follow-up in the country. There is currently 9 large HIV-clinics in the country, and women presenting at these clinics will be invited to enroll if they meet the inclusion criteria.

You may qualify if:

• HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible)
• Age between 18 and 65 years

You may not qualify if:

• Current pregnancy
• Pregnancy within the last 3 months
• Prior hysterectomy
• Women using other vaginal products than contraceptives and water based lubricants
• Women who don't understand the extent of the study
• Bleeding due to ongoing period

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Universiteit Antwerpen: collaborator
• Randers Regional Hospital: collaborator
• Bandim Health Project: collaborator

Study Sites (1)

Centro Tratamento Ambúlatorios na Guinea-Bissau

Bissau, Guinea-Bissau

Location

Related Publications (13)

• Chaturvedi AK, Madeleine MM, Biggar RJ, Engels EA. Risk of human papillomavirus-associated cancers among persons with AIDS. J Natl Cancer Inst. 2009 Aug 19;101(16):1120-30. doi: 10.1093/jnci/djp205. Epub 2009 Jul 31.

  PMID: 19648510 BACKGROUND

• Hawes SE, Critchlow CW, Faye Niang MA, Diouf MB, Diop A, Toure P, Aziz Kasse A, Dembele B, Salif Sow P, Coll-Seck AM, Kuypers JM, Kiviat NB. Increased risk of high-grade cervical squamous intraepithelial lesions and invasive cervical cancer among African women with human immunodeficiency virus type 1 and 2 infections. J Infect Dis. 2003 Aug 15;188(4):555-63. doi: 10.1086/376996. Epub 2003 Jul 23.

  PMID: 12898443 BACKGROUND

• Mezei AK, Armstrong HL, Pedersen HN, Campos NG, Mitchell SM, Sekikubo M, Byamugisha JK, Kim JJ, Bryan S, Ogilvie GS. Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review. Int J Cancer. 2017 Aug 1;141(3):437-446. doi: 10.1002/ijc.30695. Epub 2017 Apr 3.

  PMID: 28297074 BACKGROUND

• Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015 Feb;136(2):189-97. doi: 10.1016/j.ygyno.2014.11.076. Epub 2015 Jan 8.

  PMID: 25579108 BACKGROUND

• Gilham C, Sargent A, Kitchener HC, Peto J. HPV testing compared with routine cytology in cervical screening: long-term follow-up of ARTISTIC RCT. Health Technol Assess. 2019 Jun;23(28):1-44. doi: 10.3310/hta23280.

  PMID: 31219027 BACKGROUND

• Coorevits L, Traen A, Binge L, Van Dorpe J, Praet M, Boelens J, Padalko E. Are vaginal swabs comparable to cervical smears for human papillomavirus DNA testing? J Gynecol Oncol. 2018 Jan;29(1):e8. doi: 10.3802/jgo.2018.29.e8.

  PMID: 29185266 BACKGROUND

• Boggan JC, Walmer DK, Henderson G, Chakhtoura N, McCarthy SH, Beauvais HJ, Smith JS. Vaginal Self-Sampling for Human Papillomavirus Infection as a Primary Cervical Cancer Screening Tool in a Haitian Population. Sex Transm Dis. 2015 Nov;42(11):655-9. doi: 10.1097/OLQ.0000000000000345.

  PMID: 26462192 BACKGROUND

• Jun JK, Lim MC, Hwang SH, Shin HY, Hwang NR, Kim YJ, Yoo CW, Lee DO, Joo J, Park SY, Lee DH. Comparison of DRY and WET vaginal swabs with cervical specimens in Roche Cobas 4800 HPV and Abbott RealTime High Risk HPV tests. J Clin Virol. 2016 Jun;79:80-84. doi: 10.1016/j.jcv.2016.04.012. Epub 2016 Apr 23.

  PMID: 27111579 BACKGROUND

• Van Keer S, Latsuzbaia A, Vanden Broeck D, De Sutter P, Donders G, Doyen J, Tjalma WAA, Weyers S, Arbyn M, Vorsters A. Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. J Clin Virol. 2022 Oct;155:105271. doi: 10.1016/j.jcv.2022.105271. Epub 2022 Aug 24.

  PMID: 36049283 BACKGROUND

• Tranberg M, Jensen JS, Bech BH, Andersen B. Urine collection in cervical cancer screening - analytical comparison of two HPV DNA assays. BMC Infect Dis. 2020 Dec 4;20(1):926. doi: 10.1186/s12879-020-05663-7.

  PMID: 33276740 BACKGROUND

• Tranberg M, Bech BH, Blaakaer J, Jensen JS, Svanholm H, Andersen B. Preventing cervical cancer using HPV self-sampling: direct mailing of test-kits increases screening participation more than timely opt-in procedures - a randomized controlled trial. BMC Cancer. 2018 Mar 9;18(1):273. doi: 10.1186/s12885-018-4165-4.

  PMID: 29523108 BACKGROUND

• Tranberg M, Jensen JS, Bech BH, Blaakaer J, Svanholm H, Andersen B. Good concordance of HPV detection between cervico-vaginal self-samples and general practitioner-collected samples using the Cobas 4800 HPV DNA test. BMC Infect Dis. 2018 Jul 27;18(1):348. doi: 10.1186/s12879-018-3254-y.

  PMID: 30053836 BACKGROUND

• Madsen KL, Tranberg M, Norgaard P, Medina C, Storgaard M, Vorsters A, Van Keer S, Honge BL, Jespersen S. Feasibility of First-Void Urinary and Vaginal Self-Sampling for High-Risk Human Papillomavirus Testing Among Women Living With Human Immunodeficiency Virus in Guinea-Bissau-A Multicenter Cross-Sectional Study. J Med Virol. 2025 Jul;97(7):e70466. doi: 10.1002/jmv.70466.

  PMID: 40590686 DERIVED

Related Links

• WHO Cervical Cancer elimination Strategy

MeSH Terms

Conditions

HIV Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Sanne Jespersen, MD, PhD

  Department of infectious diseases, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: May 29, 2023
• Primary Completion: November 23, 2023
• Study Completion: February 28, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-03

Locations

GU (1)