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Abstract Background In low-resource countries, interpretation of the transformation zone (TZ) using the classification of the International Federation for Cervical Pathology and Colposcopy (IFCPC), adopted by the World Health Organization, is critical for determining if visual inspection with acetic acid (VIA) screening and thermal ablation treatment are possible. We aim to assess inter- and intra-observer agreement in TZ interpretation. Methods We performed a prospective multi-observer reliability study. One hundred cervical digital images of Human papillomavirus positive women (30–49 years) were consecutively selected from a Cameroonian cervical cancer screening trial. Images of the native cervix and after VIA were obtained. The images were evaluated for the TZ type at two time points (rounds one and two) by five VIA experts from four countries (Côte d’Ivoire, Cameroon, Peru, and Zambia) according to the IFCPC classification (TZ1 = ectocervical fully visible; TZ2 = endocervical fully visible; TZ3 = not fully visible). Intra- and inter-observer agreement were measured by Fleiss’ kappa. Results Overall, 37.0% of images were interpreted as TZ1, 36.4% as TZ2, and 26.6% as TZ3. Global inter-observer reliability indicated fair agreement in both rounds (kappa 0.313 and 0.288). The inter-observer agreement was moderate for TZ1 interpretation (0.460), slight for TZ2 (0.153), and fair for TZ3 (0.329). Intra-observer analysis showed fair agreement for two observers (0.356 and 0.345), moderate agreement for two other (0.562 and 0.549), and one with substantial agreement (0.728). Conclusion Interpretation of the TZ using the IFCPC classification, adopted by the World Health Organization, is critical for determining if VIA screening and thermal ablation treatment are possible. However, the low inter- and intra-observer agreement suggest that the reliability of the referred classification is limited in the context of VIA. It’s integration in treatment recommendations should be used with caution since TZ3 interpretation could lead to an important referral rate for further evaluation. Trial registration Cantonal Ethics Board of Geneva, Switzerland: N°2017–0110. Cameroonian National Ethics Committee for Human Health Research N°2018/07/1083/CE/CNERSH/SP.

Objectives: Visual inspection with acetic acid (VIA) is a low‐cost approach for cervical cancer screening used in most low‐ and middle‐income countries (LMICs) but, similar to other visual tests, is subjective and requires sustained training and quality assurance. We developed, trained, and validated an artificial‐intelligence‐based "Automated Visual Evaluation" (AVE) tool that can be adapted to run on smartphones to assess smartphone‐captured images of the cervix and identify precancerous lesions, helping augment VIA performance. Design: Prospective study. Setting: Eight public health facilities in Zambia. Participants: A total of 8204 women aged 25–55. Interventions: Cervical images captured on commonly used low‐cost smartphone models were matched with key clinical information including human immunodeficiency virus (HIV) and human papillomavirus (HPV) status, plus histopathology analysis (where applicable), to develop and train an AVE algorithm and evaluate its performance for use as a primary screen and triage test for women who are HPV positive. Main Outcome Measures: Area under the receiver operating curve (AUC); sensitivity; specificity. Results: As a general population screening tool for cervical precancerous lesions, AVE identified cases of cervical precancerous and cancerous (CIN2+) lesions with high performance (AUC = 0.91, 95% confidence interval [CI] = 0.89–0.93), which translates to a sensitivity of 85% (95% CI = 81%–90%) and specificity of 86% (95% CI = 84%–88%) based on maximizing the Youden's index. This represents a considerable improvement over naked eye VIA, which as per a meta‐analysis by the World Health Organization (WHO) has a sensitivity of 66% and specificity of 87%. For women living with HIV, the AUC of AVE was 0.91 (95% CI = 0.88–0.93), and among those testing positive for high‐risk HPV types, the AUC was 0.87 (95% CI = 0.83–0.91). Conclusions: These results demonstrate the feasibility of utilizing AVE on images captured using a commonly available smartphone by nurses in a screening program, and support our ongoing efforts for moving to more broadly evaluate AVE for its clinical sensitivity, specificity, feasibility, and acceptability across a wider range of settings. Limitations of this study include potential inflation of performance estimates due to verification bias (as biopsies were only obtained from participants with visible aceto‐white cervical lesions) and due to this being an internal validation (the test data, while independent from that used to develop the algorithm was drawn from the same study). [ABSTRACT FROM AUTHOR]

Objective: Thermal ablation (TA) was implemented in public sector cervical cancer prevention services in Zambia in 2012. Initially introduced as a treatment modality in primary healthcare clinics, it was later included in mobile outreach campaigns and clinical research trials. We report the feasibility, acceptability, safety, and provider uptake of TA in diverse clinical contexts. Methods: Screening services based on visual inspection with acetic acid were offered by trained nurses to non-pregnant women aged 25–59 years. Women with a type 1 transformation zone (TZ) were treated with same-visit TA. Those with a type 2 or 3 TZ, or suspicious for cancer, were managed with same-visit electrosurgical excision or punch biopsy, respectively. A provider survey was conducted. Results: Between 2012 and 2020, 2123 women were treated with TA: primary healthcare clinics, n = 746; mobile outreach clinics, n = 1127; research clinics, n = 250. Of the 996 women treated in primary healthcare and research clinics, 359 (48%) were HIV positive. Mild cramping during treatment was the most common adverse effect. No treatment interruptions occurred. No major complications were reported in the early (6 weeks) follow-up period. Providers expressed an overwhelming preference for TA over cryotherapy. Conclusion: TA was feasible, safe, and acceptable in diverse clinical contexts. It was the preferred ablation method of providers when compared with cryotherapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate how the influence of traditional Chiefs can be leveraged to promote access to cervical cancer prevention services in rural Zambia.Methods: A retrospective review of outcome data was conducted for all screening outreach events that occurred in Zambian Chiefdoms between October 4, 2015, and October 3, 2016. Members of the health promotion team of the Cervical Cancer Prevention Program in Zambia visited local Chiefs to inform them of the importance of cervical cancer prevention. The local Chiefs then summoned adults living within their Chiefdoms to assemble for cervical cancer prevention health talks. Screen-and-treat services were implemented within each of the Chiefdoms over a 1-week period.Results: VIA-enhanced digital imaging of the cervix (digital cervicography) was offered to 8399 women in ten Chiefdoms as part of a village-based screening (VBS) program. In all, 419 (4.9%) women had positive screening test results. Of these women, 276 (65.8%) were treated immediately with thermocoagulation and 143 (34.1%) were referred to provincial government hospitals to undergo either the loop electrosurgical excision procedure/large loop excision of the transformation zone (n=109, 26.0%) or punch biopsy (n=34, 8.1%).Conclusion: The influence of traditional Chiefs was leveraged to facilitate access to cervical cancer prevention services in rural Zambia. [ABSTRACT FROM AUTHOR]

Background: HIV infection is associated with a higher incidence of precancerous cervical lesions and their progression to invasive cervical cancer (ICC). Zambia is a global epicenter of HIV and ICC, yet the overall burden of cervical pre-cancer [cervical intraepithelial neoplasia 3 (CIN3)] and ICC among its HIV positive adult female population is unknown. The objective of this study was to determine the burden of cervical disease among HIV positive women in Zambia by estimating the number with CIN3 and ICC. Methods: We conducted a cross-sectional study among 309 HIV positive women attending screening in Lusaka (Zambia’s most populated province) to measure the cervical disease burden by visual inspection with acetic acid enhanced by digital cervicography (DC), cytology, and histology. We then used estimates of the prevalence of CIN3 and ICC from the cross-sectional study and Spectrum model-based estimates for HIV infection among Zambian women to estimate the burden of CIN3 and ICC among HIV positive women nationally. Results: Over half (52 %) of the study participants screened positive by DC, while 45 % had cytologic evidence of high grade squamous intraepithelial lesions (SIL) or worse. Histopathologic evaluation revealed that 20 % of women had evidence of CIN2 or worse, 11 % had CIN3 or worse, and 2 % had ICC. Using the Spectrum model, we therefore estimate that 34,051 HIV positive women in Zambia have CIN3 and 7,297 have ICC. Conclusions: The DC, cytology, and histology results revealed a large cervical disease burden in this previously unscreened HIV positive population. This very large burden indicates that continued scale-up of cervical cancer screening and treatment is urgently needed. [ABSTRACT FROM AUTHOR]

Background: Very few efforts have been undertaken to scale-up low-cost approaches to cervical cancer prevention in low-resource countries. Methods: In a public sector cervical cancer prevention program in Zambia, nurses provided visual-inspection with acetic acid (VIA) and cryotherapy in clinics co-housed with HIV/AIDS programs, and referred women with complex lesions for histopathologic evaluation. Low-cost technological adaptations were deployed for improving VIA detection, facilitating expert physician opinion, and ensuring quality assurance. Key process and outcome indicators were derived by analyzing electronic medical records to evaluate program expansion efforts. Findings: Between 2006-2013, screening services were expanded from 2 to 12 clinics in Lusaka, the most-populous province in Zambia, through which 102,942 women were screened. The majority (71.7%) were in the target age-range of 25–49 years; 28% were HIV-positive. Out of 101,867 with evaluable data, 20,419 (20%) were VIA positive, of whom 11,508 (56.4%) were treated with cryotherapy, and 8,911 (43.6%) were referred for histopathologic evaluation. Most women (87%, 86,301 of 98,961 evaluable) received same-day services (including 5% undergoing same-visit cryotherapy and 82% screening VIA-negative). The proportion of women with cervical intraepithelial neoplasia grade 2 and worse (CIN2+) among those referred for histopathologic evaluation was 44.1% (1,735/3,938 with histopathology results). Detection rates for CIN2+ and invasive cervical cancer were 17 and 7 per 1,000 women screened, respectively. Women with HIV were more likely to screen positive, to be referred for histopathologic evaluation, and to have cervical precancer and cancer than HIV-negative women. Interpretation: We creatively disrupted the 'no screening' status quo prevailing in Zambia and addressed the heavy burden of cervical disease among previously unscreened women by establishing and scaling-up public-sector screening and treatment services at a population level. Key determinants for successful expansion included leveraging HIV/AIDS program investments, and context-specific information technology applications for quality assurance and filling human resource gaps. [ABSTRACT FROM AUTHOR]

Background The most common human papillomavirus (HPV) genotypes isolated from cervical cancer in select African countries are HPV-16, HPV-18, HPV-35, and HPV-45, but the most common genotypes in Zambia are unknown. The overall objective of this study was to assess the potential impact of current HPV vaccines in preventing cervical cancer in Zambia, by determining the combined prevalence of HPV-16 and/or HPV-18 in invasive cervical cancer (ICC) and high-grade pre-cancer [cervical intraepithelial neoplasia 2 or 3 (CIN2/3)] cases. Findings We compared DNA extraction techniques to determine which assay performs well in the Zambian context, where unbuffered formalin is used to fix specimens. We then tested specimens with the Abbott RealTime High-Risk HPV test to estimate the prevalence of HPV-16/18 in formalin-fixed, paraffin-embedded ICC and CIN2/3 specimens. DNA extraction using heat (without xylene) was more successful than xylene-based extraction. Over 80% of specimens tested using heat extraction and the Abbott RealTime HPV test were positive for HPV. HPV-16 and/or HPV-18 were identified in 65/93 (69.9%) ICC specimens positive for HPV and in 43/65 (58.5%) CIN2/3 specimens positive for HPV. Conclusions To our knowledge this is the first report to identify HPV genotypes in cervical cancers in Zambia. A combined HPV-16/18 prevalence of 69.9% in ICC specimens suggests that current vaccines will be highly protective against cervical cancer in Zambia. [ABSTRACT FROM AUTHOR]

Background: In low-resource countries, interpretation of the transformation zone (TZ) using the classification of the International Federation for Cervical Pathology and Colposcopy (IFCPC), adopted by the World Health Organization, is critical for determining if visual inspection with acetic acid (VIA) screening and thermal ablation treatment are possible. We aim to assess inter- and intra-observer agreement in TZ interpretation. Methods: We performed a prospective multi-observer reliability study. One hundred cervical digital images of Human papillomavirus positive women (30–49 years) were consecutively selected from a Cameroonian cervical cancer screening trial. Images of the native cervix and after VIA were obtained. The images were evaluated for the TZ type at two time points (rounds one and two) by five VIA experts from four countries (Côte d'Ivoire, Cameroon, Peru, and Zambia) according to the IFCPC classification (TZ1 = ectocervical fully visible; TZ2 = endocervical fully visible; TZ3 = not fully visible). Intra- and inter-observer agreement were measured by Fleiss' kappa. Results: Overall, 37.0% of images were interpreted as TZ1, 36.4% as TZ2, and 26.6% as TZ3. Global inter-observer reliability indicated fair agreement in both rounds (kappa 0.313 and 0.288). The inter-observer agreement was moderate for TZ1 interpretation (0.460), slight for TZ2 (0.153), and fair for TZ3 (0.329). Intra-observer analysis showed fair agreement for two observers (0.356 and 0.345), moderate agreement for two other (0.562 and 0.549), and one with substantial agreement (0.728). Conclusion: Interpretation of the TZ using the IFCPC classification, adopted by the World Health Organization, is critical for determining if VIA screening and thermal ablation treatment are possible. However, the low inter- and intra-observer agreement suggest that the reliability of the referred classification is limited in the context of VIA. It's integration in treatment recommendations should be used with caution since TZ3 interpretation could lead to an important referral rate for further evaluation. Trial registration Cantonal Ethics Board of Geneva, Switzerland: N°2017–0110. Cameroonian National Ethics Committee for Human Health Research N°2018/07/1083/CE/CNERSH/SP. [ABSTRACT FROM AUTHOR]

Worldwide, more than 80% of people with cancer will require surgery during their disease course, but less than 25% have access to safe, affordable and timely surgery. Among the barriers to increasing surgical capacity are the time and costs required to train novices. Virtual reality (VR) surgical simulations can reduce the time required for novices to reach surgical proficiency, though their costs may exceed USD $100,000. The goal of this study was to determine if a low-cost system, using commercially available technology designed for in-home computer gaming, could be used to create a realistic VR surgical oncology simulation. Standard commercially available VR software and Oculus Rift hardware have been used to provide high-quality visuals and believable surgeon hand interactions. Near identical VR reproduction of an operating room using 1:1 scale matching of real-world elements, including equipment, instruments, supplies and sounds, maintaining frame rate greater than 60 fps to maintain visual fidelity has been created. Internal anatomy was designed as VR replica of human female pelvic anatomy, including organs, veins and other vessels, peritoneum and connective tissue. Internal anatomy was designed to run at 120 fps and to allow for a realistic abdominal radical hysterectomy simulation. Surgical hands were modelled to scale for those with large and small hands. Multiple hand positions were simulated using Oculus touch hardware. Reconstructing the virtual environment to simulate reality as accurately as possible was done to immerse users in the simulator so that they focus on learning and practise without distractions. Training modules were co-designed by experts in learning sciences, human behaviour, VR and gynaecologic oncology. We have successfully created a low-cost VR simulation to help prepare novice surgeons to perform a radical abdominal hysterectomy surgery procedure. The simulation can be used with commercially available computer gaming hardware that currently costs less than USD $1,500. Low-cost VR simulation has the potential to reduce the time and cost to train surgeons to perform surgical oncology procedures, as well as both improve and audit quality. If effective in real-world clinical trials, such simulations have relevance to multiple surgical procedures and applicability in both resource-limited and high-income settings. [ABSTRACT FROM AUTHOR]

Background: Visual inspection with acetic acid and cervicography (VIAC) is a method used to screen for cervical cancer. VIAC can be used as part of a "see and treat" strategy. Nine Harare city council health facilities offer VIAC free of charge with the aim of reducing morbidity and mortality from cervical cancer. Between 2014 and 2016, the number of women utilising VIAC dropped by 35%. We analysed records of clients who utilise VIAC at Harare city health facilities to characterise women accessing VIAC and their outcomes to make recommendations for improving the services.Methods: We conducted a descriptive cross-sectional study using data collected for the Harare city VIAC program. We analysed all records of clients who utilised VIAC services at nine Harare city health facilities from 1 May 2012 to 31 December 2016.Results: We analysed 46,217 records, the median age of the clients was 34 years [Q1 = 27: Q3 = 42]. Of the 46,217 clients screened, 3001 (6.5%) were VIAC positive, and 512 (1.1%) had suspicious of cancer lesions. The prevalence of VIAC positive ranged from 58 to 74 per 1000-screened clients over the 5 years. The prevalence of suspected cancer ranged from 9 to 14 per 1000-screened clients, and there was a general decrease in the prevalence between 2012 and 2016. Of the 3513 clients with VIAC positive or had suspicious of cancer lesions, 2090 (74.1%) did not receive treatment at the site where the screening took place.Conclusion: The majority of women who are accessing VIAC services in Harare are middle-aged, multiparous and married women. There is a treatment gap at most of the VIAC centres such that clients are referred to other centres for management. The objective of "see and treat" is not being realised. [ABSTRACT FROM AUTHOR]