"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.

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) facing and 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.

Women's acceptability of a self-collect HPV same-day screen-and-treat program in a high burden setting in the Pacific.

BACKGROUND: A field trial to evaluate a self-collect point-of-care HPV screen-and-treat (HPV S&T) program was implemented in two Well Women Clinics in Papua New Guinea (Papua New Guinea). Assessing the acceptability of a health intervention is a core element of evaluation. In this study, we examined women's acceptability of both self-collection and HPV S&T intervention in Papua New Guinea.  METHODS: Sixty-two semi-structured interviews were conducted with women who had undergone cervical screening in the same-day self-collected HPV screen-and-treat program in Madang and Western Highlands Provinces, Papua New Guinea. Data were thematically analysed using the Theoretical Framework of Acceptability (TFA) and managed using NVivo 12.5. RESULTS: Most women agreed that self-collection was transformative: it helped circumvent the culturally embarrassing pelvic examination and increased their self-efficacy, especially due to the provision of health education, instructions, and pictorial aids. The availability of same-day results, and treatment if indicated, was particularly valued by the women because it reduced the financial and temporal burden to return to the clinic for results. It also meant they did not need to wait anxiously for long periods of time for their results. Women also appreciated the support from, and expertise of, health care workers throughout the process and spoke of trust in the HPV-DNA testing technology. Most women were willing to pay for the service to ensure its sustainability and timely scale-up throughout Papua New Guinea to support access for women in harder to reach areas. CONCLUSION: This study reported very high levels of acceptability from a field trial of self-collection and HPV same-day screen-and-treat. The program was deemed culturally congruent and time efficient. This innovative cervical screening modality could be the 'solution' needed to see wider and more immediate impact and improved outcomes for women in Papua New Guinea and other high-burden, low-resource settings.

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).

BACKGROUND: WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. METHODS: HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. FINDINGS: Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. INTERPRETATION: We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. FUNDING: Australian National Health and Medical Research Council.

Towards the elimination of cervical cancer in low-income and lower-middle-income countries: modelled evaluation of the effectiveness and cost-effectiveness of point-of-care HPV self-collected screening and treatment in Papua New Guinea.

INTRODUCTION: WHO has launched updated cervical screening guidelines, including provisions for primary HPV screen-and-treat. Papua New Guinea (PNG) has a high burden of cervical cancer, but no national cervical screening programme. We recently completed the first field trials of a screen-and-treat algorithm using point-of-care self-collected HPV and same-day treatment (hereafter self-collected HPV S&T) and showed this had superior clinical performance and acceptability to visual inspection of the cervix with acetic acid (VIA). We, therefore, evaluated the effectiveness, cost-effectiveness and resource implications of a national cervical screening programme using self-collected HPV S&T compared with VIA in PNG. METHODS: An extensively validated platform ('Policy1-Cervix') was calibrated to PNG. A total of 38 strategies were selected for investigation, and these incorporated variations in age ranges and screening frequencies and allowed for the identification of the optimal strategy across a wide range of possibilities. A selection of strategies that were identified as being the most effective and cost-effective were then selected for further investigation for longer-term outcomes and budget impact estimation. In the base case, we assumed primary HPV testing has a sensitivity to cervical intraepithelial neoplasia 2 (CIN2+) + of 91.8% and primary VIA of 51.5% based on our earlier field evaluation combined with evidence from the literature. We conservatively assumed HPV sampling and testing would cost US$18. Costs were estimated from a service provider perspective based on data from local field trials and local consultation. RESULTS: Self-collected HPV S&T was more effective and more cost-effective than VIA. Either twice or thrice lifetime self-collected HPV S&T would be cost-effective at 0.5× gross domestic product (GDP) per capita (incremental cost-effectiveness ratio: US$460-US$656/life-years saved; 1GDPper-capita: US$2829 or PGK9446 (year 2019)) and could prevent 33 000-42 000 cases and 23 000-29 000 deaths in PNG over the next 50 years, if scale-up reached 70% coverage from 2023. CONCLUSION: Self-collected HPV S&T was effective and cost-effective in the high-burden, low-resource setting of PNG, and, if scaled-up rapidly, could prevent over 20 000 deaths over the next 50 years. VIA screening was not effective or cost-effective. These findings support, at a country level, WHO updated cervical screening guidelines and indicate that similar approaches could be appropriate for other low-resource settings.

A randomised controlled trial of two instruments for vacuum-assisted delivery (Vacca Re-Usable OmniCup and the Bird anterior and posterior cups) to compare failure rates, safety and use effectiveness.

BACKGROUND: Most previous trials of vacuum-assisted delivery have been in settings with high rates of instrumental vaginal delivery (8-12%) and high rates of failure to deliver with the intended instrument (20-30%). Over the past 20 years, vacuum-assisted delivery rates at the Port Moresby General Hospital have been 3-4% with failure rates of <3%. OBJECTIVE: The objective is to compare the failure rates of two vacuum extractor instruments, the Vacca Re-Usable Omnicup and the Bird Vacuum delivery system (anterior and posterior cups). SETTING: Port Moresby General national referral and teaching Hospital (PMGH), Papua New Guinea. POPULATION: Two hundred consecutive women requiring assisted delivery, June-December, 2007. METHODS: When a woman required an assisted delivery, she was randomised into either the Vacca Re-Usable Omnicup (Clinical Innovations Inc.) or Bird anterior or posterior metal cup (depending upon the position of the vertex). One hundred women were randomised to each vacuum device. Statistical analysis was on 'an intention-to-treat' basis. MAIN OUTCOME MEASURES: The main outcome measure was the successful completion of the delivery with the allocated instrument. Secondary outcomes were maternal trauma (episiotomy and trauma to the maternal genital tract), significant scalp trauma (sub-galeal haemorrhage or serious abrasion) and fetal and neonatal outcomes (Apgar score less than seven at 5 minutes, days spent in the Special Care Nursery and neonatal death). RESULTS: Failure rates for both Omnicup (2/100) and Bird metal cups (6/100) were not statistically different (RR 1.05, 95% CI 0.99-1.12; P = 0.17). Rates of maternal trauma and fetal scalp trauma were similar in both groups. CONCLUSION: Both the Vacca re-useable Omnicup and the Bird metal cups are very effective instruments to achieve successful assisted delivery and equally so. Failures and problems were associated with not applying the vacuum cup to the flexion point on the fetal scalp and the mechanical faults with vacuum equipment devices.