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Multicenter Study
. 2025 Jul;97(7):e70466.
doi: 10.1002/jmv.70466.

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

Kia Lærke Madsen  1   2 , Mette Tranberg  3   4   5 , Pia Nørgaard  4 , Candida Medina  6   7 , Merete Storgaard  8 , Alex Vorsters  9 , Severien Van Keer  9 , Bo Langhoff Hønge  1   8 , Sanne Jespersen  1   2   8
Affiliations
Multicenter Study

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

Kia Lærke Madsen et al. J Med Virol. 2025 Jul.

Abstract

In Guinea-Bissau, cervical cancer (CC) screening is unimplemented and data on high-risk human papillomavirus (hr-HPV) prevalence among women living with HIV (WLWH) are limited. This study assessed the acceptability of first-void urine (FVU) and vaginal self-sampling for HPV testing and the HPV prevalence and among WLWH in Guinea-Bissau. This multicenter cross-sectional study included a total of 498 WLWH aged 18-64 years. At nine HIV-clinics, women self-collected paired FVU and vaginal samples (VS), using the Colli-Pee and Evalyn Brush device, respectively. The Allplex HPV-HR assay was used for HPV DNA testing. Acceptability and preferences were assessed using questionnaires and hr-HPV genotype concordance was analyzed using Cohen's kappa (κ). Overall, 78% (n = 389/498) tested hr-HPV positive (FVU and/or VS). Good hr-HPV genotype concordance was observed (range 0.64-0.78) between sample types. HPV52 and HPV58 were the most prevalent genotypes (both 21%) followed by HPV66 and HPV16 (both 18%). Both modalities were well-accepted regarding comfort and ease of use, however, the urine device was preferred. Clinic-based FVU and VS self-sampling was feasible and well-accepted by WLWH, with urine sampling as the most preferred modality. The high hr-HPV prevalence underscores the urgency of integrating HPV-based CC screening and treatment into HIV care. Trial Registration: NCT05783167 (clinicaltrials.gov).

Keywords: HPV DNA testing; HPV self‐sampling; cervical cancer screening; early detection of cancer; first‐void urine; women living with HIV.

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Conflict of interest statement

Seegene sponsored the Allplex HR HPV assays for the study. According to the contract between Seegene and the University Research Clinic for Cancer Screening and the Department of Pathology, Randers Regional Hospital, Seegene had no influence on the scientific process and no editorial rights pertaining to this manuscript. The authors retained the right to submit the manuscript. M.T. has participated in other studies with HPV test kits sponsored by Seegene. The University of Antwerp received payment for the participation of S.V.K. in an Advisory Board of Novosanis (subsidiary of OraSure Technologies Inc., Pennsylvania, USA). All funds are handled and managed by the University of Antwerp. A.V. is cofounder and former board member of Novosanis, a spin‐off company of the University of Antwerp, and was a minority shareholder until January 2019. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Inclusion flow diagram. HPV, human papillomavirus; FVU, first‐void urine; VS, vaginal sample.
Figure 2
Figure 2
Prevalence of HPV genotypes according to self‐sampling modality. The HPV prevalence in vaginal (VS; purple bars), first‐void urine (FVU, green bars), and overall (positive in VS and/or FVU, gray bars) are separately displayed on the x‐axis for each genotype (y‐axis). Ranking was performed based on the overall HPV genotype prevalence.
Figure 3
Figure 3
HPV genotype distribution and agreement of paired vaginal (VS) and first‐void urine samples (FVU). The number of paired samples that tested positive in both VS and FVU is indicated by gray bars. Discordant samples for each genotype are separately indicated by purple (VS only) and green (FVU only) bars. The total number of infections was 1025, and the total number of infections covered by the 9‐valent vaccine was 559 (55%). Cohen's kappa (κ) is shown on the right. HPV, human papillomavirus; vaccine type; high‐risk HPV genotype represented in the 9‐valent HPV vaccine Gardasils9.
See this image and copyright information in PMC

References

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