Introduction

Cervical cancer is one of the most preventable types of cancer, yet too many women die of cervical cancer in low- and middle-income countries (LMICs) because prevention and treatment services are unavailable. Over 300,000 women die of cervical cancer each year; >90% of these deaths occur in LMICs. The World Health Organization is leading a global effort to scale interventions that will eliminate cervical cancer for future generations.

Methods

With support from Unitaid, CHAI has been working since 2019 to expand access to critical tools and services that will enable this expansion in access to screening and treatment for pre-cancer. CHAI operates cervical cancer programs in partnership with 10 countries in Africa and Asia.

Results

With partner governments, the project has successfully reached women with effective secondary prevention services by leveraging and scaling-up existing tools: particularly HPV tests for screening, and portable devices to treat precancerous lesions. The project has brought HPV test prices down by ~40%, cut the cost of thermal ablation devices by 45%, and cut the cost of portable LEEP devices by 20%. The project has screened >725,000 women and treated 82% of screen-positive women. The project has established hundreds of screening and treatment sites offering integrated service delivery: improving access to screening using Visual Inspection with Acetic Acid, expanding HPV testing via existing testing platforms and introduction of self-sampling, increasing awareness on screening and treatment, decentralizing treatment using portable devices, building health worker capacity, tracking patients throughout care, and generating significant learnings to further scale-up these solutions.

Conclusions

By demonstrating effective delivery models for screening, treatment, and linkages to care using existing tools, the project is supporting countries to make significant progress towards WHO’s elimination targets and laying the groundwork for a multi-pronged approach with the scale-up of innovative, affordable, point-of-care screening technologies once available.

Introduction

Cancer incidence and mortality are disproportionally high and on the rise in low-and-middle income countries (LMIC), contributing to wide-ranging social and economic inequalities. There is an urgent need for accessible and affordable screening, diagnostic, and treatment methods that can counteract these trends. Recognizing this crisis, in 2013 the U.S. National Cancer Institute solicited applications for academic-industry partnerships to develop emerging technologies for imaging, detection/diagnosis, prevention, and treatment of cancer in LMIC.

Methods

As part of this initiative, our two teams worked independently on cervical cancer prevention. Each team developed a new technology for treatment of precancerous cervical changes. The technologies that were developed included CryoPop, CryoPen and hand-held thermal ablation. The new products were tested in randomized clinical trials using cure rates of high-grade cervical pre-cancer. Histopathologic diagnosis was assessed both pre and post treatment.

Results

Despite our different approaches, our groups encountered similar technical, administrative, and research challenges through the development process. Both teams noted the difficulty of obtaining biopsy-based cases in low resource settngs where excision therapy is widespread. Here, our goal is to disseminate important lessons learned in order to provide a blueprint for other teams working on the development of innovative cancer technologies for LMIC.

Conclusions

Despite significant advances in screening and early detection technologies, cervical cancer remains the fourth leading cause of cancer death globally with over 90% of incidence and mortality occurring in LMIC. Our teams’ projects focused on the development and validation of three alternative treatment devices for high-grade precancerous changes that can facilitate the implementation of “screen and treat” approaches in low-resource settings.

Introduction

Low-cost ablative treatment is being evaluated and recommended for treatment of cervical precancers among women with a type 1 transformation zone. Recent studies have reported sub-optimal success rate for cryotherapy to treat cervical precancers in women living with HIV (WLHIV). A randomized control trial assessing efficacy of a battery-operated thermal ablator for treatment of precancers is ongoing in Zambia. We describe preliminary results of treatment efficacy stratified by HIV status.

Methods

VIA screen-positive women eligible for ablative treatment were randomized to receive thermal ablation, cryotherapy or LLETZ. Treatment success at 6- and/or 12-month follow-up was negative HPV status among those HPV positive at baseline. and negative VIA test among those HPV negative at baseline.

Results

A total of 3065 women with baseline HIV status information have been randomized to treatment, 1797 (59%) of whom were HIV-positive. Almost all HIV-positive women (99%) were on anti-retroviral therapy (ART). Among 1055 (83%) HIV-negative and 1508 (84%) HIV-positive women eligible for follow-up, 743 (70%) HIV-negative and 937 (62%) HIV-positive women had complete follow-up data for assessment of treatment success (TS). Overall, TS was significantly lower among HIV-infected women compared to HIV-negatives (56% [539/937] versus 84% [627/743]; p-value<0.001). Similar TS rates and rate differences were observed regardless of type of treatment received. TS among WLHIV was lower for the HPV positive women. While success rates were around 90% among HPV-negative women regardless of HIV-infection status and type of treatment, that for HPV positive women was substantially lower - 67% and 40% for the HIV-negative and HIV-positive women respectively

Conclusions

With the current WHO initiative for Cervical Cancer Elimination, these findings highlight the challenges in eliminating the disease in women living with HIV through treatment of premalignant lesions. Investigations are underway to determine the underlying causes of the low success rate.

Introduction

Compromised margins after LLETZ could be an indication of treatment failure. The International Federation of Cervical Pathology and Colposcopy (IFCPC) recommends that the type of excision should be chosen to ensure adequate treatment according to the transformation zone (TZ) type. However, additional characteristics related to the presence of compromised margins may help improve excision criteria and therefore post-treatment outcomes. We aimed to identify clinical, and sociodemographic and reproductive health characteristics that may be associated with compromised margins in treated women in ESTAMPA.

Methods

In ESTAMPA, women aged 30-64 years were screened with HPV testing and cytology and referred to colposcopy with biopsy as needed. Women without CIN2+ were recalled at ~18 months for a second HPV test with colposcopy and biopsy as needed. All CIN2+ cases were referred to LLETZ. We explored the TZ type reported on colposcopy with the excision type to understand practitioners’ adherence to IFCPC recommendations. Associations between clinical and sociodemographic and reproductive health characteristics with compromised margins were assessed using odds ratios (OR) estimated with multivariate logistic regressions.

Results

673 treated women were included in the analyses.Among them,124 (18.4%,95%CI 15.7-21.5)had compromised margins.Most excisions (66.5%) were type2 even among women with TZ type3 (67.9%) (Table1). Women with HSIL+ cytology,positive major or suspicion of cancer colposcopic impression,TZtype3, CIN3+before treatment,or not have been screened within 2 years before last cytology were significantly associated with compromised margins while HPV16/18 infection was not associated (Table2).

Table 1. Type of excision according to transformation zone type overall and by compromised margins statusTable 2. Characteristics associated to compromised margins in ESTAMPA participants treated with LLETZ

Conclusions

Reinforcing practitioner’s adherence to established cervical treatment recommendations is needed. Special considerations for choice of treatment are required for women at increased risk of incomplete treatment (HSIL+ cytology, TZ type 3, high-grade colposcopy impression, CIN3+) to improve cervical cancer prevention.

Introduction

Cervical cancer persists as a leading cause of women’s cancer deaths in LMICs, especially among women living with HIV (WLHIV). Aiming to eliminate cervical cancer, WHO recommends countries transition to screening with a high-performance test. SUCCESS (Scale-Up Cervical Cancer Elimination with Secondary Prevention), a project funded by Unitaid and implemented by Expertise France, Jhpiego, and UICC, is supporting LMICs to introduce new technologies for cervical cancer prevention. Early results of this effort are presented here.

Methods

Since 2020, SUCCESS project is harnessing multi-stakeholders’ engagement led by Ministries of Health to drive efforts to introduce and scale-up HPV testing with self-sampling and thermal ablation treatment in Burkina Faso, Côte d'Ivoire, Guatemala, and the Philippines, to reach 175,000 women including 40% WLHIV by 2023. Key interventions include civil society engagement, advocacy and resource mobilization, procurement and management of key products, updating policies and training materials, increasing awareness and demand creation, and strengthening training and health information systems using e-learning and digital health solutions.

Results

By June 2022, 42,469 women were screened with HPV test in the four countries, including 8,647 (20.4%) of WLHIV; 87.6% with self-sampling. HPV positivity rate was 11.6% (n=3,918) among HIV negative women and 23.9% (n=2,066) among WLHIV. 1,121 of HPV+ women received ablative or excisional treatment according to algorithm used. Main challenges are related to system strengthening, especially ensuring continuous availability of essential equipment and supplies, timely turnaround of test results and timely treatment, follow-up, quality and integration of services.

Conclusions

SUCCESS’ project experience shows that introducing HPV testing with self-sampling in LMICs is feasible and promising. Government commitment, CSO engagement, health financing, coordination and partnership are key to advance this process. The tools and lessons learned from SUCCESS project implementation will inform efforts to scale-up HPV testing and treatment in other LMICs in the coming years.

Introduction

As part of the WHO-led global effort to eliminate cervical cancer, the government, supported by the SUCCESS project, funded by Unitaid and implemented by Expertise France, Jhpiego, and UICC, is working to screen 40,000 women with HPV testing by 2023, including 46% of WLHIV, and to treat eligible women with thermal ablation or LLETZ in Burkina Faso.

Methods

The Ministry of Health supported by SUCCESS began screening women with HPV testing in June 2021. The WHO-recommended screening-triage-treatment algorithm-1 was adopted to manage HPV-positive women, using VIA as the triage method. In 2022, a decision was made to change to the screening and treatment approach for women in the general population and for WLHIV use the screening and treatment for women positive for HPV 16, 18, and 45, and the screening-triage-treatment for women positive for the other HPV types. This change in algorithm aimed to reduce lost to follow-up as most women live in rural/remote areas with limited access to health services.

Results

In 2021, 4893 women were screened, including 1037 (21%) of WLHIV. 787 (16%) tested HPV positive. 519 (66%) HPV positive women received VIA triage and 148 (28%) resulted VIA positive. Among those VIA positive, 137 (92%) received ablative or excisional treatment according to eligibility.  In the 1st semester 2022, 8805 women were screened, including 1828 (21%) of WLHIV). Of the 667 treatments performed in 2022, 562 (84.25%) were done in the general population where the systematic treatment was 89% on 631 womens recieved visual assessment for treatment (562/631). 105 WLHIV were treated out of 167 who received VAT (62.9%). Systematic treatment was 87% for HPV 16,18,18_45 (29/33). For the other genotypes 76 women were treated, including 45 VAI+ and 31 VIA-. 

Conclusions

Implementing new WHO recommended algorithms for cervical precancer screening and treatment require close monitoring and can lead to services strengthening.

Introduction

Cervical cancer (CC) is the leading cause of mortality by cancer in Sub-Saharan Africa. The human papillomavirus (HPV) infection is recognized as a necessary and sufficient cause for CC. Population-specific estimates of HPV prevalence in the Democratic Republic of Congo (DRC) is unknown. This study aims at estimating the prevalence of HPV and identifying predominant genotypes circulating in Kinshasa, DRC.

Methods

Between July 2015 and July 2018, women were invited to attend a screening program at Mont-Amba Health Centre in Kinshasa. Cervical specimens were collected using the Preservcyt® medium. HPV DNA testing was performed for all the specimen using real-time polymerase chain reaction.

Results

During the 2-years period, a total of 1870 woman aged 25-82 years were screened. The mean age was 46 years (± 11.4). The overall HPV prevalence was 28.2% (95% CI: 26.1-30.3). HrHPV prevalence was 24.8% (95% CI: 22.8-26.8). Women younger than 30 years had the highest overall HPV prevalence (42.2%, 95% CI: 34.7-49.9). A second peak of prevalence was observed in women aged 60 years and older. HPV68 (5.5%, 95% CI: 4.5-6.6) was the most prevalent HPV type.

Conclusions

The distribution of HPV genotypes among women in our population was different compared to other world regions. A key finding was that HPV68 was the most prevalent HrHPV genotype. These findings highlight the need for the determination in our population of the etiologic fraction of different HPV types in invasive cervical cancers. This will guide the development of next-generation vaccines covering the most prevalent HPV types found in our region.

Introduction

Women living with HIV (WLWH) have a 6-fold increased risk to develop cervical cancer (CC), which mostly arises from persistent infection with high-risk (HR-) human papillomavirus (HPV). Tanzania has the highest HPV prevalence in East Africa, with a HR-HPV positivity rate of 46.7% among WLWH. From 07/2021-09/2022, WLWH attending a care-and-treatment-center in Ifakara, southern-central Tanzania, were screened for HPV.

Methods

Inclusion criteria were: age 18-65 years, enrollment in Kilombero and Ulanga Antiretroviral Cohort, at least 3-months on antiretroviral therapy, non-pregnant and consent provision. Women with known invasive CC or conditions interfering with cervix visualization were excluded. After cervical self-sampling (Evalyn®Brush); with Seegene Anyplex^TM II 28 HPV Detection Test, 19 HR-HPV and 9 low-risk (LR-)HPV were genotyped. The project, ethically approved (TMDA-WEB0021/CTR/002/03), is registered (ClinicalTrials.gov NCT03633643).

Results

1494 WLWH with a median age of 45 years (18-65 ), median number of pregnancies of 4 (0-14) and median number of births of 4 (0-12) were enrolled. 1066 (71.5%) did not use any contraceptive methods. Median time of HIV diagnosis was 9 years ago (recent–25 years) and 38.7% (n=575) were stage-1, 22% (n=327) stage-2, 26.9% (n=400) stage-3 and 12.4% (n=184) stage-4. At baseline, HPV was undetectable in 1099 (73.8%) and detected in 462 (30.9%), specifically 35 (15.8%), 16 (15.2%), 18 (15%), 58 (13%), 53 (11.9%), 33 (10.6%), 52 (10.2%), 59 (7.81%), 68 (7.59%), 45 (6.94%), 39 (6.72%), 73 (6.51%), 51 (6.29%), 82 (5.42%), 66 (4.99%), 69 (4.34%), 56 (3.90%), 31 (3.47%) and 26 (0.65%). Infections with multiple HR-HPV types were found in 12.31% (n=184). The most prevalent LR-HPV type was 42 (27.6%).

Conclusions

This study provides valuable information about HPV prevalence in a WLWH cohort prior to the implementation of the national HPV immunization program. Furthermore, WLWH with HR-HPV have access to monitoring and treatment (VIA, thermal ablation, LEEP); which will be also evaluated.

Introduction

Cervical cancer is the leading cause of cancer deaths in Kenya. The World Health Organization recommends linkage to treatment after screening as a key intervention to achieve elimination. A ‘screen-and-treat’ approach is the most feasible approach in low and middle-income countries, where loss to follow-up is high. While cryotherapy has been previously used in Kenya for treatment of cervical pre-cancerous lesions (PCL), adoption has been limited by cost of refilling treatment gases and bulkiness. As part of the national cervical cancer screening and treatment scale-up, NCCP has adopted thermal ablation (TA) for PCL treatment. We present the findings and lessons of the roll-out of TA in primary care in Kenya.

Methods

Implementation was done through collaboration between NCCP (Ministry of Health), CHAI and the respective county departments of health between 2020-2021 in 25 counties. The implementation package consisted of training and mentorship – provided by a team of master-trainers as well as county level trainers. In addition, procurement of high quality-assured, portable TA equipment i.e., Liger© (Liger Medical LLC) and Wisap© (Wisap Medical Technologies GmbH) be used to provide treatment of PCL.

Results

Currently, 820 TA devices have been distributed and 6000 healthcare workers trained on cervical cancer screening and treatment using TA. Contribution of TA in treatment of PCL in the 25 counties increased from 0% (0/787) in January-June 2019 to 18.8% (369/1959) in January-June 2022 (p<0.001). Cervical PCL treatment is now possible at lower-level primary care facilities (dispensaries and health centers) even in areas with power interruptions.

Conclusions

Adoption of TA can improve cervical cancer screening and treatment at primary care. However, continuous mentorship is necessary to sustain such interventions, while maintaining quality of the screening program.