Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT)

Vallely, Andrew; Saville, Marion; Badman, Steven G; Gabuzzi, Josephine; Bolnga, John; Mola, Glen; Kuk, Joseph; Wai, Malts; Munnull, Gloria; Garland, Suzanne M.; Brotherton, Julia; Kelly‐Hanku, Angela; Morgan, Christopher; Toliman, Pamela J; Kombati, Zure; Kariwiga, Grace; Babona, Delly; Tan, Grace Hwei Ching; Simms, Kate T.; Cornall, Alyssa M.; Tabrizi, Sepehr N.; Wand, Handan; Guy, Rebecca; Canfell, Karen; Kaldor, John

doi:10.1016/s2214-109x(22)00271-6

Cited by 26 publications

(31 citation statements)

References 30 publications

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“…We attempted to understand the experiences from other LMICs on implementing primary HPV-DNA testing in population-based cancer screening. We found studies that tested the feasibility of using HPV-DNA testing for cervical cancer screening in LMICs as standalone projects [8][9][10]. However, none of these studies discussed about the real-time challenges in setting-up of a lab and implementing HPV-DNA testing at community level.…”

Section: Discussionmentioning

confidence: 99%

Challenges in setting up a primary human papillomavirus-DNA testing facility in a lower and middle income country: lessons learned from a pilot programme

Dhanasekaran¹,

Tamang²,

Pradhan³

et al. 2022

ecancer

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Introduction: Detection of high-risk human papillomavirus (hrHPV) is the most sensitive test for the screening of cervical cancer. Although most high-income countries have adopted this strategy in their screening programme, there are a lot of barriers in low and middle-income countries (LMICs) in setting up this facility for screening. The lessons learned based on this experience can be useful for other LMICs in their first steps to integrate HPV testing into a screening programme.Methods: HPV testing using self-sampling was offered to eligible women residing in one district of Sikkim state. To implement the same, a testing laboratory was set up in the district and the challenges faced are listed. Results:The cost of testing equipment, sampler and cold storage was beyond the budget capping. Setting up of the HPV testing lab accessible to study sites and referral centre was a difficult decision to make. Training the health care providers in their proficiency in triaging and treatment was challenging. Coordinating with community health workers and beneficiaries for effective screening and establishing referral linkages was not easy, as we expected. The cost of transportation, consumables and contingencies was higher due to the difficult terrain. Conclusion:The cost of the equipment and consumables for primary HPV screening can be reduced in bulk purchases through negotiations. Adequate knowledge of the terrain and economic implications of the area of interest is crucial during the budgeting of the programme. Collaborating with the state government, integration with the existing health system and repurposing the available resources are key for success. The barriers faced during implementation are stepping stones for improvement.

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Section: Discussionmentioning

confidence: 99%

Challenges in setting up a primary human papillomavirus-DNA testing facility in a lower and middle income country: lessons learned from a pilot programme

Dhanasekaran¹,

Tamang²,

Pradhan³

et al. 2022

ecancer

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“…Successful experiences are emerging with the use of primary HPV testing with self-collection and sameday ablative treatment in LMIC; for example this has been found to be acceptable, effective and costeffective in Papua New Guinea. 25,26 Countries will likely observe high rates of detection of prevalent precancer and invasive cancer in the rst round of screening with HPV (since it is a highly sensitive test). However, in the second and subsequent rounds of screening, the detected disease will be more likely to be incident, and thus the balance of bene ts-to-harms may change and may be less favourable to HPV screen without triaging.…”

Section: Discussionmentioning

confidence: 99%

Benefits, harms and cost-effectiveness of cervical screening and treatment in 78 low-income and lower-middle income countries for women in the general population: modelling to support updated WHO cervical screening and treatment guidelines to prevent cervical cancer

Simms

Keane

Nguyen

et al. 2022

Preprint

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A strategy for the elimination of cervical cancer as a public health problem, through the scale-up of human papillomavirus (HPV) vaccination, cervical screening and precancer/cancer treatment, was launched by the World Health Organisation (WHO) in November 2020. To support the strategy, WHO published updated cervical screening and treatment guidelines in 2021. A modelled assessment of the benefits, harms and cost-effectiveness of screening approaches for the general population across 78 low-and lower-middle income countries (LMICs) informed the updated guidelines. With the support of the WHO Guidelines Development Group for Screening and Treatment to Prevent Cervical Cancer, we used an established modelling platform, Policy1-Cervix, to evaluate the impact of seven screening algorithms based on primary visual inspection with acetic acid (‘VIA’), primary cytology, and primary HPV DNA (‘primary HPV’) with no triage, or triage using HPV16/18 genotyping, colposcopy, cytology, or VIA. Screening intervals of 3 and 5 years were considered for primary VIA and cytology, and intervals of 5 and 10 years were considered for primary HPV. Screening and triage test performance was informed by updated systematic review evidence. For this normative analysis informing guidelines in screened populations, we assumed 70% of women attended each routine screen, and 90% complied with follow-up or treatment. Outcomes included reduction in cancer incidence and mortality, number of precancer treatments needed to prevent a death (NNT) and preterm delivery events directly due to precancer treatment and cost-effectiveness (US$/Health-Adjusted Life Year Saved [HALYS]). A range of assumptions were considered in sensitivity and supplementary analyses. We found that primary HPV DNA testing approaches, regardless of triaging method, were the most effective and cost-effective screening approaches and they appear on, or near to, the cost-effectiveness frontier. Primary HPV DNA testing without triage every 5 years for ages 30–50 years could result in a 64% reduction in cervical cancer mortality rates, compared to no screening. This strategy was associated with an NNT of 54 to prevent one death and was associated with an incremental cost-effectiveness ratio (ICER) of US$530/HALY saved (69/78[88%] of LMICs have a GDP-per-capita of > = US$518). Strategies involving primary HPV with triage of HPV positive women before treatment were almost as effective, reducing overall cervical cancer mortality rates by 60–63%, had a similar position on the cost-effectiveness frontier, but had an improved benefits-to-harms profile compared to HPV screening without triage, with an NNT of 26–37 to prevent a death. Compared to VIA screening, primary HPV screening, even without triaging, generated at least 60% fewer precancer treatment events and had 47% fewer additional preterm delivery events. In conclusion, primary HPV testing approaches were the most effective, optimised benefits-to-harms, and were cost-effective compared to primary VIA or cytology. If loss-to-follow-up after triage is limited, triaging HPV positive women before treatment reduces precancer treatments and preterm delivery events with minimal loss in effectiveness, and thus further improves the benefits-to-harms. Based on these findings, WHO now recommends primary HPV screening with or without triage for women in the general population. Going forward, country-specific analyses will continue to have an important role because they will be able to consider local factors that influence follow-up options and feasible triage testing approaches.

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“…This qualitative study is part of a large-scale eld trial conducted in Papua New Guinea which aimed to evaluate the clinical performance, cost-effectiveness, acceptability, and health systems requirements of the self-collect HPV screen-and-treat program to inform future national and global program [5,10,11,34,55]. We designed a qualitative study exploring women's, health care workers, and policymakers' experiences of HPV S&T using self-collection at the two trial sites, Modilon General Hospital in Madang Province, and Mount Hagen General Hospital in Western Highlands Province.…”

Section: Methodsmentioning

confidence: 99%

“This is really something: same place, same day result, same day treatment” Women’s experiences of testing positive for HPV and receiving same-day treatment in Papua New Guinea: an interpretative phenomenological analysis

Camara

Nosi

Munnull

et al. 2022

Preprint

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Introduction: Human papillomavirus (HPV) testing is transforming cervical screening globally. The World Health Organization (WHO) now recommends same-day HPV screen-and-treat for primary cervical screening in low- and middle-income countries (LMIC) but there is a lack of evidence on women’s lived experience of testing positive for oncogenic HPV and receiving same-day treatment. This study aimed to address this knowledge gap among women participating in a same-day HPV screen-and-treat (HPV S&T) program in Papua New Guinea. Methods As part of a larger qualitative study, this paper explores the lived experiences of 26 women who tested positive for oncogenic HPV and were treated the same day. We analysed the data using the interpretative phenomenological analysis method. All data were managed using Nvivo 12.5. Results The interpretative phenomenological analysis led to three superordinate themes: 1) alleviating initial worries, (2) transforming the disclosure process, and (3) connecting to their faith. Women’s experiences of the same day HPV screen-and-treat were framed by initial emotional reactions to their positive HPV test result, and having access to treatment on the same day, which helped address their worries and fears, and transformed their experience of disclosing their test result and subsequent treatment to family and friends. Conclusion This study shows that, while women experience similar initial emotional reactions, undergoing same day treatment quickly resolved the women’s worries, making this program highly acceptable. Overall, women’s engagement in the program confirmed its high acceptability and cultural congruence, leaving women feeling empowered and hopeful about their future, and the future of all Papua New Guinea women.

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Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT)

Cited by 26 publications

References 30 publications

Challenges in setting up a primary human papillomavirus-DNA testing facility in a lower and middle income country: lessons learned from a pilot programme

Challenges in setting up a primary human papillomavirus-DNA testing facility in a lower and middle income country: lessons learned from a pilot programme

Benefits, harms and cost-effectiveness of cervical screening and treatment in 78 low-income and lower-middle income countries for women in the general population: modelling to support updated WHO cervical screening and treatment guidelines to prevent cervical cancer

“This is really something: same place, same day result, same day treatment” Women’s experiences of testing positive for HPV and receiving same-day treatment in Papua New Guinea: an interpretative phenomenological analysis

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