HIV Infections Clinical Trial
Official title:
Self-collected Cervical Cancer Screening Samples for Detection of Human Papillomavirus in HIV-positive Women - a Pilot Study of Self-collected Vaginal and Urine Samples
NCT number | NCT05783167 |
Other study ID # | R351-A20092 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 29, 2023 |
Est. completion date | February 28, 2024 |
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.
Status | Recruiting |
Enrollment | 502 |
Est. completion date | February 28, 2024 |
Est. primary completion date | November 23, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible) - Age between 18 and 65 years Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Centro Tratamento Ambúlatorios na Guinea-Bissau | Bissau |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Bandim Health Project, Randers Regional Hospital, Universiteit Antwerpen |
Guinea-Bissau,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Experiences with self-collected vaginal and urine samples | Among the women accepting the invitation to enroll in the study, the investigators will through a questionnaire obtain data on the participants experiences with the two self-sampling devices. | April 2023 - February 2024 | |
Secondary | HPV-genotype agreement between vaginal- and urine samples | Among HPV-positive women the investigators want to describe the genotype agreement among the two sample types | April 2023 - February 2024 |
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