A novel cervical cancer screen-triage-treat demonstration project with HPV self-testing and thermal ablation for women in Malawi: Protocol for a single-arm prospective trial

Chinula, Lameck; McGue, Shannon; Smith, Jennifer S.; Saidi, Friday; Mkochi, Tawonga; Msowoya, Lizzie; Varela, Amanda; Lee, Fan; Gopal, Satish; Chagomerana, Maganizo; Tomoka, Tamiwe; Mwapasa, Victor; Tang, Jennifer H.

doi:10.1016/j.conctc.2022.100903

Cited by 8 publications

(10 citation statements)

References 44 publications

(57 reference statements)

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“…We utilized stored self- and provider-collected samples from 315 WLWH in Malawi who participated in a single-arm prospective trial evaluating the feasibility and performance of a same-day HPV-based “screen-triage-treat” algorithm. 41 The parent study (R21 CA236770) took place between July 2020 and February 2022 at the University of North Carolina (UNC)-Project in Lilongwe, Malawi and enrolled 625 WLWH and 625 HIV-negative women aged 25-50 years. Participant sociodemographic and clinical characteristics were collected at baseline, including HIV status verification, using a rapid (UniGold) and confirmatory (Bio-Rad Geenius) assay.…”

Section: Methodsmentioning

confidence: 99%

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Mungo,

Guliam,

Chinula

et al. 2024

Preprint

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BackgroundThe World Health Organization (WHO) recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries (LMICs) account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi.MethodsWe utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis - cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to <CIN2.Results315 matched self- and provider-collected specimens had valid results from both Xpert and ScreenFire testing and were included in analyses. Of these, 245 (78%) had normal pathology, 21 CIN1 (7%), 14 CIN2 (4%), and 35 CIN3 (11%). Among provider-collected specimens, the assays had 80% agreement on overall HPV positivity (unweighted kappa 0.59, 95% 0.50-0.69). ScreenFire was HPV-positive in 90% of self-collected specimens that were HPV-positive on Xpert. Channel agreement between the assays was high for both self- and provider-collected specimens, but slightly lower for HPV18/45. In hierarchical analysis, ScreenFire demonstrated high concordance with Xpert testing for detecting CIN2+ cases in all channels, missing no HPV 16 or HPV 18/45 positive CIN2+ case that was positive on Xpert, in both self- and provider-collected specimens.ConclusionIn this study of stored specimens, the ScreenFire HPV assay performed well in the detection of HPV and CIN2+ among WLWH compared to the Xpert HPV assay. If supported by larger validation studies, ScreenFire could be an affordable alternative point-of-care HPV assay for use in LMICs.

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Section: Methodsmentioning

confidence: 99%

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Mungo,

Guliam,

Chinula

et al. 2024

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…We utilized stored self-and provider-collected samples from 315 WLWH in Malawi who participated in a single-arm prospective trial evaluating the feasibility and performance of a same-day HPV-based "screen-triagetreat" algorithm [41]. The parent study (R21 CA236770) took place between July 2020 and February 2022 at the University of North Carolina (UNC)-Project in Lilongwe, Malawi and enrolled 625 WLWH and 625 HIV-negative women aged 25-50 years.…”

Section: Study Design Population and Sample Collectionmentioning

confidence: 99%

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Mungo,

Guliam,

Chinula

et al. 2024

Infect Agents Cancer

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Background The World Health Organization recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi. Methods We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis—cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to <CIN2. Results 315 matched self- and provider-collected specimens had valid results from both Xpert and ScreenFire testing and were included in analyses, of which 279 and 36 were HPV positive and HPV negative, respectively, on Xpert self-collection. Of the 315, 245 (78%) had normal pathology, 21 CIN1 (7%), 14 CIN2 (4%), and 35 CIN3 (11%). Of the 245 with normal pathology, 213 (87%) and 188 (77%) were HPV-positive on Xpert and ScreenFire self-collected specimens, respectively. Among provider-collected specimens, the assays had 80% agreement on overall HPV positivity (unweighted kappa 0.59, 95% 0.50–0.69). ScreenFire was HPV-positive in 90% of self-collected specimens that were HPV-positive on Xpert. Channel agreement between the assays was high for both self- and provider-collected specimens, but slightly lower for HPV18/45. In hierarchical analysis, ScreenFire demonstrated high concordance with Xpert testing for detecting CIN2+ cases in all channels, missing no HPV 16 or HPV 18/45 positive CIN2+ case that was positive on Xpert, in both self- and provider-collected specimens. Conclusion In this study of stored specimens, the ScreenFire HPV assay performed well in the detection of HPV and CIN2+ among WLWH compared to the Xpert HPV assay. If supported by larger validation studies, ScreenFire could be an affordable alternative point-of-care HPV assay for use in LMICs.

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“…The increase in recent and ongoing research activities around urine self-sampling for HPV testing [64,65,[80][81][82][83] indicates that there is a lot of interest in its potential as an alternative method of cervical screening. To further inform screening programmes, further research is needed to optimise urine collection, the volume of urine collected, transport media, and compatibility of new or existing HPV assays.…”

Section: Future Researchmentioning

confidence: 99%

An economic evaluation of two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling

Huntington

Sudhir

Schneider

et al. 2022

Preprint

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Objective: To compare the cost and effects of three sampling strategies for human papillomavirus (HPV) primary screening. Design: Cost-consequence analysis using a decision tree in Excel. Setting: England. Participants: A cohort of 10,000 women age 25 to 65 eligible for the NHS Cervical Screening Programme (NHSCSP) (Box 1). Methods: The model was informed by the NHSCSP HPV primary screening pathway and adapted for self-sampling. It used a 3-year recall cycle with routine screening in year 1 and recall screening in years 2/3. Parameters were obtained from published studies, manufacturers, NHSCSP reports, and input from experts. Interventions: Three sampling strategies were: 1) routine clinician-collected cervical sample, 2) self-collected first-void (FV) urine; 3) self-collected vaginal swab. The hypothetical self-sampling strategies involved women being mailed a sampling kit at home. Main outcome measures: Primary outcomes: overall costs (for all screening steps to colposcopy), number of complete screens, and cost per complete screen. Secondary outcomes: number of women screened, number of women lost to follow-up, cost per colposcopy, and total screening costs for a plausible range of uptake scenarios. Results: In the base case, the average cost per complete screen was GBP 56.81 for clinician-collected cervical sampling, GBP 38.57 for FV urine self-sampling, and GBP 40.37 for vaginal self-sampling. In deterministic sensitivity analysis (DSA), the variables most affecting the average cost per screen were the cost of sample collection for clinician-collected sampling and the cost of laboratory HPV testing for the self-sampling strategies. Scaled to consider routine screening in England, if uptake in non-attenders increased by 15% and 50% of current screeners converted to self-sampling, the NHSCSP would save GBP 19.2 million (FV urine) or GBP 16.5 million (vaginal) per year. Conclusion: Self-sampling could provide a less costly alternative to clinician-collected sampling for routine HPV primary screening and offers opportunities to expand the reach of cervical screening to under-screened women.

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A novel cervical cancer screen-triage-treat demonstration project with HPV self-testing and thermal ablation for women in Malawi: Protocol for a single-arm prospective trial

Cited by 8 publications

References 44 publications

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi

An economic evaluation of two self-sampling strategies for HPV primary cervical cancer screening compared with clinician-collected sampling

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