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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]

Introduction: Cancellations of elective surgery in low-and middle-income countries (LMIC) are common and a major hindrance for patients who are in need of surgical therapeutic modalities. This is especially important in the context of scaling up needed surgical interventions for gynaecological cancer care. There is a knowledge gap in the literature related to cancellation of gynaecologic oncology surgeries in LMIC, where there is enormous need for this specific cancer surgical capacity. We report in an observational descriptive fashion, our experience at the UTH/CDH in Lusaka, Zambia, on the causes of surgical cancellations in gynaecologic oncology. Methods: From January 1, 2021 through June 31, 2023, we retrospectively evaluated the surgical registry for gynaecologic oncology at the UTH/CDH in Lusaka, Zambia to assess the number and causes of surgical cancellations. Results: There were a total of 66 (16.96%) surgical cancellations out of 389 scheduled gynaecologic oncology cases. Lack of available blood and/or low haemoglobin was the most frequent cause of surgical cancellations, 27 cases (40.90%). Conclusion: We highlight in our series that the lack of blood, leading to surgical cancellations was the most frequent impediment related to performing scheduled gynaecologic oncology surgical procedures. As gynaecologic oncology services scale up in LMIC, given the radical nature of surgery and its association with blood loss, it is incumbent on the entire clinical ecosystem to address this issue and to develop mitigating strategies, specific to their respective resource setting. [ABSTRACT FROM AUTHOR]

Introduction: The human papillomavirus (HPV) is sexually transmitted and infects approximately 75% of sexually active people early in their sexual life. Persistent infection with oncogenic HPV types can lead to malignant conditions such as cervical cancer. In 2006, the World Health Organisation approved the use of an efficacious HPV vaccine for girls aged 9 to 14 to prevent HPV-related conditions. Despite the HPV vaccine being available for about 15 years, dose completion remains as low as 20% in sub-Saharan African (SSA) countries implementing the vaccination program compared to 77% in Australia and New Zealand. A fraught of barriers to implementation exist which prevent adequate coverage. Achieving success for HPV vaccination in real-world settings requires strategies to overcome implementation bottlenecks. Therefore, a better understanding and mapping of the implementation strategies used in sub-Saharan Africa to increase HPV vaccination uptake is critical. This review aims to identify implementation strategies to increase HPV vaccination uptake for adolescent girls in sub-Saharan Africa and provide a basis for policy and future research, including systematic reviews to evaluate effective strategies as we accelerate the elimination of cervical cancer. Materials and methods: This scoping review will consider studies pertaining to implementation strategies to increase HPV vaccination uptake for adolescent girls in sub-Saharan Africa. Studies targeted at different stakeholders to increase adolescent vaccine uptake will be included. Studies using interventions not fitting the definition of implementation strategies as defined by the refined compilation of implementation strategies from the Expert Recommendations for Implementing Change project will be excluded. MEDLINE (via PubMed), Embase, CINAHL (via EBSCO), Scopus and Google Scholar will be searched. Two independent reviewers will screen titles and abstracts for studies that meet the review's inclusion criteria, and the full text of eligible studies will be reviewed. Data will be extracted from eligible studies using a structured data charting table developed by this team for inclusion by two independent reviewers and presented in a table and graphical form with a narrative summary. [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: 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: In the absence of stand-alone infrastructures for delivering cervical cancer screening services, efforts are underway in sub-Saharan Africa to dovetail screening with ongoing vertical health initiatives like HIV/AIDS care programs. Yet, evidence demonstrating the utilization of cervical cancer prevention services in such integrated programs by women of the general population is lacking. Methods: We analyzed program operations data from the Cervical Cancer Prevention Program in Zambia (CCPPZ), the largest public sector programs of its kind in sub-Saharan Africa. We evaluated patterns of utilization of screening services by HIV serostatus, examined contemporaneous trends in screening outcomes, and used multivariable modeling to identify factors associated with screening test positivity. Results: Between January 2006 and April 2011, CCPPZ services were utilized by 56,247 women who underwent cervical cancer screening with visual inspection with acetic acid (VIA), aided by digital cervicography. The proportion of women accessing these services who were HIV-seropositive declined from 54% to 23% between 2006–2010, which coincided with increasing proportions of HIV-seronegative women (from 22% to 38%) and women whose HIV serostatus was unknown (from 24% to 39%) (all p-for trend<0.001). The rates of VIA screening positivity declined from 47% to 17% during the same period (p-for trend <0.001), and this decline was consistent across all HIV serostatus categories. After adjusting for demographic and sexual/reproductive factors, HIV-seropositive women were more than twice as likely (Odds ratio 2.62, 95% CI 2.49, 2.76) to screen VIA-positive than HIV-seronegative women. Conclusions: This is the first ‘real world’ demonstration in a public sector implementation program in a sub-Saharan African setting that with successful program scale-up efforts, nurse-led cervical cancer screening programs targeting women with HIV can expand and serve all women, regardless of HIV serostatus. Screening program performance can improve with adequate emphasis on training, quality control, and telemedicine-support for nurse-providers in clinical decision making. [ABSTRACT FROM AUTHOR]

Groesbeck Parham and colleagues describe their Cervical Cancer Prevention Program in Zambia, which has provided services to over 58,000 women over the past five years, and share lessons learned from the program's implementation and integration with existing HIV/AIDS programs. [ABSTRACT FROM AUTHOR]

Abstract: Objective: We demonstrate the feasibility of implementing a referral and management system for cryotherapy-ineligible women in a “screen-and-treat” cervical cancer prevention program targeting HIV-infected women in Zambia. Methods: We established criteria for patient referral, developed a training program for loop electrosurgical excision procedure (LEEP) providers, and adapted LEEP to a resource-constrained setting. Results: We successfully trained 15 nurses to perform visual inspection with acetic acid (VIA) followed by immediate cryotherapy. Women with positive tests but ineligible for cryotherapy were referred for further evaluation. We trained four Zambian physicians to evaluate referrals, perform punch biopsy, LEEP, and manage intra-operative and post-operative complications. From January 2006 through October 2007, a total of 8823 women (41.5% HIV seropositive) were evaluated by nurses in outlying prevention clinics; of these, 1477 (16.7%) were referred for physician evaluation based on established criteria. Of the 875 (59.2% of 1147 referred) that presented for evaluation, 748 (8.4% of total screened) underwent histologic evaluation in the form of punch biopsy or LEEP. Complications associated with LEEP included anesthesia reaction (n =2) which spontaneously resolved, intra-operative (n =12) and post-operative (n =2) bleeding managed by local measures, and post-operative infection (n =12) managed with antibiotics. Conclusion: With adaptations for a resource-constrained environment, we have demonstrated that performing LEEP is feasible and safe, with low rates of complications that can be managed locally. It is important to establish referral and management systems using LEEP-based excisional evaluation for women with cryotherapy-ineligible lesions in VIA-based “screen-and-treat” protocols nested within HIV-care programs in resource-constrained settings. [Copyright &y& Elsevier]

A letter to the editor is presented in response to the article "HPV Screening for Cervical Cancer in Rural India," by R. Sankaranarayanan et al. in the April 2, 2009 issue.

A letter to the editor is presented in response to the article "A Sexual Health Prevention Priority," by S. Peckham and colleagues that was published in the previous issue.

Background: WHO has recommended HPV testing for cervical screening where it is practical and affordable. If used, it is important to both clarify and implement the clinical management of positive results. We estimated the performance in Lusaka, Zambia of a novel screening/triage approach combining HPV typing with visual assessment assisted by a deep-learning approach called automated visual evaluation (AVE). Methods: In this well-established cervical cancer screening program nested inside public sector primary care health facilities, experienced nurses examined women with high-quality digital cameras; the magnified illuminated images permit inspection of the surface morphology of the cervix and expert telemedicine quality assurance. Emphasizing sensitive criteria to avoid missing precancer/cancer, ~ 25% of women screen positive, reflecting partly the high HIV prevalence. Visual screen-positive women are treated in the same visit by trained nurses using either ablation (~ 60%) or LLETZ excision, or referred for LLETZ or more extensive surgery as needed. We added research elements (which did not influence clinical care) including collection of HPV specimens for testing and typing with BD Onclarity™ with a five channel output (HPV16, HPV18/45, HPV31/33/52/58, HPV35/39/51/56/59/66/68, human DNA control), and collection of triplicate cervical images with a Samsung Galaxy J8 smartphone camera™ that were analyzed using AVE, an AI-based algorithm pre-trained on a large NCI cervical image archive. The four HPV groups and three AVE classes were crossed to create a 12-level risk scale, ranking participants in order of predicted risk of precancer. We evaluated the risk scale and assessed how well it predicted the observed diagnosis of precancer/cancer. Results: HPV type, AVE classification, and the 12-level risk scale all were strongly associated with degree of histologic outcome. The AVE classification showed good reproducibility between replicates, and added finer predictive accuracy to each HPV type group. Women living with HIV had higher prevalence of precancer/cancer; the HPV-AVE risk categories strongly predicted diagnostic findings in these women as well. Conclusions: These results support the theoretical efficacy of HPV-AVE-based risk estimation for cervical screening. If HPV testing can be made affordable, cost-effective and point of care, this risk-based approach could be one management option for HPV-positive women. [ABSTRACT FROM AUTHOR]

More than 80% of people diagnosed with cancer will require surgery. However, less than 5% have access to safe, affordable and timely surgery in low- and middle-income countries (LMICs) settings mostly due to the lack of trained workforce. Since its creation, virtual reality (VR) has been heralded as a viable adjunct to surgical training, but its adoption in surgical oncology to date is poorly understood. We undertook a systematic review to determine the application of VR across different surgical specialties, modalities and cancer pathway globally between January 2011 and 2021. We reviewed their characteristics and respective methods of validation of 24 articles. The results revealed gaps in application and accessibility of VR with a proclivity for high-income countries and high-risk, complex oncological surgeries. There is a lack of standardisation of clinical evaluation of VR, both in terms of clinical trials and implementation science. While all VR illustrated face and content validity, only around two-third exhibited construct validity and predictive validity was lacking overall. In conclusion, the asynchrony between VR development and actual global cancer surgery demand means the technology is not effectively, efficiently and equitably utilised to realise its surgical capacity-building potential. Future research should prioritise cost-effective VR technologies with predictive validity for high demand, open cancer surgeries required in LMICs. [ABSTRACT FROM AUTHOR]

Objective: To measure key obstetric and neonatal outcomes recorded at a tertiary hospital in Zambia over a 5-year period.Methods: A retrospective analysis was conducted among women who had delivered at the University Teaching Hospital in Lusaka, between January 1, 2008, and December 31, 2012. Data were extracted from electronic medical records. The main outcomes were maternal mortality, cesarean delivery, prenatal or intrapartum hemorrhage, stillbirth, a 5-minute Apgar score of less than 7, and admission to the neonatal intensive care unit.Results: A total of 62 470 deliveries were recorded. Rates of maternal mortality, cesarean delivery, and hemorrhage during pregnancy all declined over time. Decreased admissions to the neonatal intensive care unit were observed; however, the rate spiked temporarily in late 2011 and early 2012 before returning to previous levels. The proportion of stillbirths remained stable over time but reports of a 5-minute Apgar score of less than 7 rose.Conclusion: Routinely collected obstetric and neonatal data could aid ongoing program monitoring and should be used to guide quality improvement activities. [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: 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]

A randomized control trial of a battery-operated thermocoagulator for the treatment of precancerous cervical lesions is ongoing in Lusaka, Zambia. We describe preliminary results of treatment efficacy in HIV-positive women. Visual inspection with acetic acid (VIA) screen-positive women eligible for ablative treatment are randomized to receive thermal ablation (TA), cryotherapy or large loop excision of the transformation zone (LLETZ). Demographic information is collected, including human immunodeficiency virus (HIV) status and antiretroviral therapy (ART) use. Human papillomavirus (HPV) DNA sampling for known or suspected oncogenic HPV types is performed at baseline and follow-up. Treatment efficacy is based on VIA and HPV status at 6- and/or 12-month follow-up. Side-effects, pain and client satisfaction are scored and recorded, however, these data are not included in this analysis. Of the 1,683 women who have been randomized to treatment, 994 (59%) are HIV-positive with the vast majority (97%) on anti-retroviral therapy (ART). HIV-positive women were equally distributed between treatment arms (p=0.28). Among the 1328 (79%) eligible for follow-up, follow-up data are available on 722 women (54%), of which 383 are HIV-positive. Based on VIA results alone for cure, HIV positive women had lower overall cure rates than HIV-negative women (77% vs 88%, respectively, p<0.001), regardless of treatment type. HIV-positive women, who were also positive for HPV 16 at baseline, had significantly lower cure rates (HPV 16 clearance and VIA negative) across all study arms, compared to HIV-negative women (73% vs 88%, respectively, p<0.001). When all HPV types are considered, overall cure rates (clearance of baseline type-specific HPV and VIA negative) in HIV positive women decreased to 49% and did not differ based on duration of HIV infection (<2 years, 43%; >2yrs, 55%; p=0.072). [Display omitted] In May 2020, the 173rd World Health Assembly adopted the Global Strategy to Eliminate Cervical Cancer. This sub-analysis of data from a randomized control trial of locally ablative methods for cervical precancer highlights the challenges in eradicating this disease in women living with HIV. Investigations are underway to determine the underlying causes of these findings. (NCI Grant No. 4UH3CA202721-03) [ABSTRACT FROM AUTHOR]

Introduction: Cervical cancer (CC) is the leading cause of cancer-related death among women in sub-Saharan Africa. It occurs most frequently in women living with HIV (WLHIV) and is classified as an AIDS-defining illness. Recent World Health Organisation (WHO) recommendations provide guidance for CC prevention policies, with specifications for WLHIV. We systematically reviewed policies for CC prevention and control in sub-Saharan countries with the highest HIV prevalence.Methods: We included countries with an HIV prevalence ≥ 10% in 2018 and policies published between January 1st 2010 and March 31st 2022. We searched Medline via PubMed, the international cancer control partnership website and national governmental websites of included countries for relevant policy documents. The online document search was supplemented with expert consultation for each included country. We synthesised aspects defined in policies for HPV vaccination, sex education, condom use, tobacco control, male circumcision,cervical screening, diagnosis and treatment of cervical pre-cancerous lesions and cancer, monitoring mechanisms and cost of services to women while highlighting specificities for WLHIV.Results: We reviewed 33 policy documents from nine countries. All included countries had policies on CC prevention and control either as a standalone policy (77.8%), or as part of a cancer or non-communicable diseases policy (22.2%) or both (66.7%). Aspects of HPV vaccination were reported in 7 (77.8%) of the 9 countries. All countries (100%) planned to develop or review Information, Education and Communication (IEC) materials for CC prevention including condom use and tobacco control. Age at screening commencement and screening intervals for WLHIV varied across countries. The most common recommended screening and treatment methods were visual inspection with acetic acid (VIA) (88.9%), Pap smear (77.8%); cryotherapy (100%) and loop electrosurgical procedure (LEEP) (88.9%) respectively. Global indicators disaggregated by HIV status for monitoring CC programs were rarely reported. CC prevention and care policies included service costs at various stages in three countries (33.3%).Conclusion: Considerable progress has been made in policy development for CC prevention and control in sub Saharan Africa. However, in countries with a high HIV burden, there is need to tailor these policies to respond to the specific needs of WLHIV. Countries may consider updating policies using the recent WHO guidelines for CC prevention, while adapting them to context realities. [ABSTRACT FROM AUTHOR]

Abstract: Objectives. : HIV-infected women living in resource-constrained nations like Zambia are now accessing antiretroviral therapy and thus may live long enough for HPV-induced cervical cancer to manifest and progress. We evaluated the prevalence and predictors of cervical squamous intraepithelial lesions (SIL) among HIV-infected women in Zambia. Methods. : We screened 150 consecutive, non-pregnant HIV-infected women accessing HIV/AIDS care services in Lusaka, Zambia. We collected cervical specimens for cytological analysis by liquid-based monolayer cytology (ThinPrep Pap Test®) and HPV typing using the Roche Linear Array® PCR assay. Results. : The median age of study participants was 36 years (range 23–49 years) and their median CD4+ count was 165/μL (range 7–942). The prevalence of SIL on cytology was 76% (114/150), of which 23.3% (35/150) women had low-grade SIL, 32.6% (49/150) had high-grade SIL, and 20% (30/150) had lesions suspicious for squamous cell carcinoma (SCC). High-risk HPV types were present in 85.3% (128/150) women. On univariate analyses, age of the participant, CD4+ cell count, and presence of any high-risk HPV type were significantly associated with the presence of severely abnormal cytological lesions (i.e., high-grade SIL and lesions suspicious for SCC). Multivariable logistic regression modeling suggested the presence of any high-risk HPV type as an independent predictor of severely abnormal cytology (adjusted OR: 12.4, 95% CI 2.62–58.1, p =0.02). Conclusions. : The high prevalence of abnormal squamous cytology in our study is one of the highest reported in any population worldwide. Screening of HIV-infected women in resource-constrained settings like Zambia should be implemented to prevent development of HPV-induced SCC. [Copyright &y& Elsevier]

Background: Globally, women living with HIV have a higher risk of vulvar neoplasia than HIV-negative women. Vulvar neoplasia among women living with HIV has not previously been characterised in Zambia. Objective: This study determined the clinical and pathologic features of vulvar neoplasia among women living with HIV at the University Teaching Hospital, Lusaka, Zambia. Methods: We conducted a cross-sectional study of vulvar lesions among 53 women living with HIV who presented with vulvar lesions between July 2017 and February 2018. The study assessed clinical and histological characteristics and prevalence of high-risk human papillomavirus (HRHPV). Results: Twenty-one patients were diagnosed with vulvar squamous cell carcinoma (VSCC), 20 with usual vulvar intraepithelial neoplasm (uVIN), and the rest with either benign lesions or non-neoplastic lesions (NNL). Participants' mean age was 40 years. Patients with VSCC were significantly older than those with NNL (mean (s.d.): 43 (21) vs 33 (10), p = 0.004). The prevalence of HRHPV was 88.9% in VSCC patients and 100.0% in high-grade squamous intraepithelial lesion patients. HPV16 was the most common (52.6%) genotype. The clinical features of neoplasia were similar to those of NNL. Conclusion: VSCC was significantly more common among women aged ≥ 40 years. HRHPV in VSCC and high-grade squamous intraepithelial lesions was high. Women with vulvar lesions, especially those aged > 40 years, should be evaluated for vulvar cancer. Young girls should be vaccinated to prevent vulvar cancer. [ABSTRACT FROM AUTHOR]

Background: Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy.Methods: We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239.Findings: Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital.Interpretation: Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results.Funding: US National Institutes of Health. [ABSTRACT FROM AUTHOR]

PURPOSE: Worldwide, more than 80% of people diagnosed with cancer will require surgery during their disease course, but only 5% to 20% of low- and middle-income countries have access to safe, affordable, and timely surgery. Developing surgical oncology skills requires significant time and mentoring. Virtual reality (VR) simulators can reduce the time required to master surgical procedures but are prohibitively expensive. We sought to determine whether a VR simulator using low-cost computer gaming equipment could train novice surgeons in Africa to perform a virtual radical abdominal (open) hysterectomy (RAH). METHODS: Our RAH VR simulator used the Oculus Rift (Oculus VR, Menlo Park, CA), a VR headset with hand controllers that costs less than $1,500. Surgical novices learned to perform five key steps of a virtual RAH. We measured and identified predictors of movement and time efficiency for the simulation. RESULTS: Ten novice surgeons in Lusaka, Zambia, enrolled in the study. Movement and time efficiency greatly improved over time. Independent predictors of movement efficiency were number of simulations, surgical experience, and time since college graduation. Independent predictors of time efficiency were number of simulations, surgical experience, days between simulation sessions, age, sex, and an interaction between number of simulations and surgical experience. CONCLUSION: Low-cost VR may be an effective tool to help surgical novices learn complex surgical oncology procedures. If learning to perform VR surgical procedures with low-cost hardware leads to faster mastery of surgical procedures in the operating room, low-cost VR may represent one of the solutions to increasing access to surgical cancer care globally. [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]

Global cancer centres operate across different sizes, scales, and ecosystems. Understanding the essential aspects of the creation, organisation, accreditation, and activities within these settings is crucial for developing an affordable, equitable, and quality cancer care, research, and education system. Robust guidelines are scarce for cancer units, cancer centres, and comprehensive cancer centres in low-income and middle-income countries. However, some robust examples of the delivery of complex cancer care in centres in emerging economies are available. Although it is impossible to create an optimal system to fit the unique needs of all countries for the delivery of cancer care, we summarise what has been published about the development and management of cancer centres in low-income and middle-income countries so far and highlight the need for clinical and political leadership. [ABSTRACT FROM AUTHOR]

Purpose In 2005, the Cervical Cancer Prevention Program in Zambia (CCPPZ) was implemented and has since provided cervical cancer screen-and-treat services to more than 500,000 women. By leveraging the successes and experiences of the CCPPZ, we intended to build capacity for the early detection and surgical treatment of breast cancer. Methods Our initiative sought to build capacity for breast cancer care through the (1) formation of a breast cancer advocacy alliance to raise awareness, (2) creation of resource-appropriate breast cancer care training curricula for mid- and high-level providers, and (3) implementation of early detection and treatment capacity within two major health care facilities. Results Six months after the completion of the initiative, the following outcomes were documented: Breast health education and clinical breast examination (CBE) services were successfully integrated into the service platforms of four CCPPZ clinics. Two new breast diagnostic centers were opened, which provided access to breast ultrasound, ultrasound-guided core needle biopsy, and needle aspiration. Breast health education and CBE were provided to 1,955 clients, 167 of whom were evaluated at the two diagnostic centers; 55 of those evaluated underwent core-needle biopsy, of which 17 were diagnosed with invasive cancer. Newly trained surgeons performed six sentinel lymph node mappings, eight sentinel lymph node dissections, and 10 breast conservation surgeries (lumpectomies). Conclusion This initiative successfully established clinical services in Zambia that are critical for the early detection and surgical management of breast cancer. [ABSTRACT FROM AUTHOR]

Purpose: In 2005, the Cervical Cancer Prevention Program in Zambia (CCPPZ) was implemented and has since provided cervical cancer screen-and-treat services to more than 500,000 women. By leveraging the successes and experiences of the CCPPZ, we intended to build capacity for the early detection and surgical treatment of breast cancer. Methods: Our initiative sought to build capacity for breast cancer care through the (1) formation of a breast cancer advocacy alliance to raise awareness, (2) creation of resource-appropriate breast cancer care training curricula for mid- and high-level providers, and (3) implementation of early detection and treatment capacity within two major health care facilities. Results: Six months after the completion of the initiative, the following outcomes were documented: Breast health education and clinical breast examination (CBE) services were successfully integrated into the service platforms of four CCPPZ clinics. Two new breast diagnostic centers were opened, which provided access to breast ultrasound, ultrasound-guided core needle biopsy, and needle aspiration. Breast health education and CBE were provided to 1,955 clients, 167 of whom were evaluated at the two diagnostic centers; 55 of those evaluated underwent core-needle biopsy, of which 17 were diagnosed with invasive cancer. Newly trained surgeons performed six sentinel lymph node mappings, eight sentinel lymph node dissections, and 10 breast conservation surgeries (lumpectomies). Conclusion: This initiative successfully established clinical services in Zambia that are critical for the early detection and surgical management of breast cancer. [ABSTRACT FROM AUTHOR]

Objective: To determine factors associated with low birth weight (LBW) in an urban Zambian cohort and investigate risk of adverse outcomes for LBW neonates.Methods: The present retrospective cohort analysis used data recorded between February 2006 and December 2012 for singletons and first-born twins delivered in the public health system of Lusaka, Zambia. Routine clinical data and generalized estimating equations were used to examine covariates associated with LBW (<2500 g) and describe outcomes of LBW.Results: In total, 200 557 neonates were included, 21 125 (10.5%) of whom were LBW. Placental abruption, delivery before 37 weeks, and twin pregnancy were associated with LBW in multivariable analysis (P<0.01 for all). Compared with neonates weighing more than 2500 g, LBW neonates were at higher risk of stillbirth (adjusted odds ratio [AOR] 8.6, 95% confidence interval [CI] 6.5-11.5), low Apgar score (AOR 5.7, 95% CI 4.6-7.2), admission to the neonatal intensive care unit (AOR 5.4, 95% CI 3.5-8.3), and very early neonatal death (AOR 6.2, 95% CI 3.7-10.3).Conclusion: LBW neonates are at increased risk of adverse outcomes, including stillbirth and neonatal death, independent of pregnancy duration at delivery and multiple pregnancy. These findings underscore the need for early, comprehensive, and high-quality prenatal care. [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 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]

Although there is a growing literature on the clinical performance of visual inspection with acetic acid in HIV-infected women, to the best of our knowledge, none have studied visual inspection with acetic acid enhanced by digital cervicography. We estimated clinical performance of cervicography and cytology to detect cervical intraepithelial neoplasia grade 2 or worse. Sensitivity and specificity of cervicography were 84% [95% confidence interval (CI): 72 to 91) and 58% (95% CI: 52 to 64). At the high-grade squamous intraepithelial lesion or worse cutoff for cytology, sensitivity and specificity were 61% (95% CI: 48 to 72) and 58% (95% CI: 52 to 64). In our study, cervicography seems to be as good as cytology in HIV-infected women. [ABSTRACT FROM AUTHOR]

Background: In Zambia, a country with a generalized HIV epidemic, age-adjusted cervical cancer incidence is among the highest worldwide. In 2006, the University of Alabama at Birmingham-Center for Infectious Disease Research in Zambia and the Zambian Ministry of Health launched a visual inspection with acetic acid (VIA) -based "see and treat" cervical cancer prevention program in Lusaka. All services were integrated within existing government-operated primary health care facilities.Objective: Study aims were to (i) identify women's motivations for cervical screening, (ii) document women's experiences with screening and (iii) describe the potentially reciprocal influences between women undergoing cervical screening and their social networks.Design and Methods: Focus group discussions (FGD) and in-depth interviews (IDI) were conducted with women who accepted screening and with care providers. Low-level content analysis was performed to identify themes evoked by participants. Between September 2009 and July 2010, 60 women and 21 care providers participated in 8 FGD and 10 IDI.Results: Women presented for screening with varying needs and expectations. A majority discussed their screening decisions and experiences with members of their social networks. Key reinforcing factors and obstacles to VIA screening were identified.Conclusions: Interventions are needed to gain support for the screening process from influential family members and peers. [ABSTRACT FROM AUTHOR]

Background: In Zambia, a country with a generalized HIV epidemic, age-adjusted cervical cancer incidence is among the highest worldwide. In 2006, the University of Alabama at Birmingham-Center for Infectious Disease Research in Zambia and the Zambian Ministry of Health launched a visual inspection with acetic acid (VIA) -based 'see and treat' cervical cancer prevention program in Lusaka. All services were integrated within existing government-operated primary health care facilities. Objective: Study aims were to (i) identify women's motivations for cervical screening, (ii) document women's experiences with screening and (iii) describe the potentially reciprocal influences between women undergoing cervical screening and their social networks. Design and methods: Focus group discussions (FGD) and in-depth interviews (IDI) were conducted with women who accepted screening and with care providers. Low-level content analysis was performed to identify themes evoked by participants. Between September 2009 and July 2010, 60 women and 21 care providers participated in 8 FGD and 10 IDI. Results: Women presented for screening with varying needs and expectations. A majority discussed their screening decisions and experiences with members of their social networks. Key reinforcing factors and obstacles to VIA screening were identified. Conclusions: Interventions are needed to gain support for the screening process from influential family members and peers. [ABSTRACT FROM AUTHOR]

Abstract: Invasive cervical cancer is the second most common cancer among women worldwide, with approximately 85% of the disease burden occurring in developing countries. To date, there have been few systematic efforts to document African women''s conceptualization of cervical cancer after participation in a visual inspection with acetic acid (VIA)-based “see and treat” cervical cancer prevention program. In this study, conducted between September, 2009–July, 2010, focus groups and in-depth interviews were conducted with 60 women who had recently undergone cervical cancer screening at a government-operated primary health care clinic in Lusaka, Zambia. Interviewers elicited participants'' causal representations of cervical cancer, associated physical signs and symptoms, perceived physical and psychological effects, and social norms regarding the disease. The lay model of illness causation portrayed by participants after recent exposure to program promotion messages departed in several ways from causal models described in other parts of the world. However, causal conceptualizations included both lay and biomedical elements, suggesting a possible shift from a purely traditional causal model to one that incorporates both traditional concepts and recently promoted biomedical concepts. Most, but not all, women still equated cervical cancer with death, and perceived it to be a highly stigmatized disease in Zambia because of its anatomic location, dire natural course, connections to socially-condemned behaviors, and association with HIV/AIDS. No substantive differences of disease conceptualization existed according to HIV serostatus, though HIV positive women acknowledged that their immune status makes them more aware of their health and more likely to seek medical attention. Further attention should be dedicated to the processes by which women incorporate new knowledge into their representations of cervical cancer. [ABSTRACT FROM AUTHOR]

Abstract: Invasive cervical cancer is the second most common cancer among women worldwide, with approximately 85% of the disease burden occurring in developing countries. To date, there have been few systematic efforts to document African women''s conceptualization of cervical cancer after participation in a visual inspection with acetic acid (VIA)-based “see and treat” cervical cancer prevention program. In this study, conducted between September, 2009–July, 2010, focus groups and in-depth interviews were conducted with 60 women who had recently undergone cervical cancer screening at a government-operated primary health care clinic in Lusaka, Zambia. Interviewers elicited participants'' causal representations of cervical cancer, associated physical signs and symptoms, perceived physical and psychological effects, and social norms regarding the disease. The lay model of illness causation portrayed by participants after recent exposure to program promotion messages departed in several ways from causal models described in other parts of the world. However, causal conceptualizations included both lay and biomedical elements, suggesting a possible shift from a purely traditional causal model to one that incorporates both traditional concepts and recently promoted biomedical concepts. Most, but not all, women still equated cervical cancer with death, and perceived it to be a highly stigmatized disease in Zambia because of its anatomic location, dire natural course, connections to socially-condemned behaviors, and association with HIV/AIDS. No substantive differences of disease conceptualization existed according to HIV serostatus, though HIV positive women acknowledged that their immune status makes them more aware of their health and more likely to seek medical attention. Further attention should be dedicated to the processes by which women incorporate new knowledge into their representations of cervical cancer. [Copyright &y& Elsevier]

Background: Since the mid-1990s, there have been growing efforts to prevent cervical cancer in less-developed countries through the development of innovative screening approaches such as visual inspection of the cervix associated with same day management of cervical lesions with cryotherapy or loop electrosurgical excision procedure (LEEP). In the past, promising cancer screening interventions have been widely promoted despite incomplete evidence, only to become the subject of intense controversies about ensuing net health benefit. Because the efficacy and effectiveness of the new protocols for global cervical cancer screening have not been well characterized yet, and as a contribution to the evaluation of the balance between the benefits and risks of these protocols, we reviewed the literature on the safety of cryotherapy and LEEP for cervical intraepithelial neoplasia (CIN) in low- and middle-income countries. Methods: We searched 12 databases (Medline, Google Scholar, Scopus, Cochrane Library, Web of Science, OCLC, PAIS International Database, WHO Global Health Library, CINAHL, Science.gov, NYAM Grey Literature Report, and POPLINE) for original research published between January 1995 and April 2009. Both peer-reviewed publications and items of "grey" literature were retrieved; no language restriction was applied. We calculated the median (minimum, maximum) reported rate for each harm considered. Because of limitations and heterogeneity in the data, no formal meta-analysis was performed. Results: The search identified 32 articles that reported safety data from 24 cryotherapy and LEEP studies. The combined sample consisted of 6,902 women treated by cryotherapy and 4,524 women treated by LEEP. Most studies were conducted in reference or research settings in Asia and Africa. Short-term harms of cryotherapy and LEEP appeared to be similar to those described in the literature from high-income countries. Information was sparse on HIV-related harms and long-term reproductive outcomes of treatment. Conclusions: When performed in resource-limited settings by qualified providers, cryotherapy and LEEP are not associated with excess harm. However, available data are insufficient to propose fully evidence-based protocols for routine screening of HIV-infected women and women of reproductive age. [ABSTRACT FROM AUTHOR]