Montserrat Soler

Long-term outcomes after cervical cancer screening in El Salvador: primary human papillomavirus screen-and-treat compared with cytology

Introduction From 2012 to 2017, the Cervical Cancer Prevention in El Salvador (CAPE) piloted and scaled up a human papillomavirus (HPV) screen-and-treat intervention. Findings resulted in El Salvador’s adoption of the strategy as part of the national programme, but long-term clinical outcomes are unknown. Here, we compare the detection of high-grade cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and HPV infection after recommended screening intervals between two groups: women who participated in CAPE and a comparable group screened via cytology. Methods CAPE participants who had undergone screening at least 5 years previously (screen-and-treat group) and women in the same age range with conventional cytology screening 2 to 3 years previously (cytology group) were recruited for repeat screening with primary HPV testing. Women with positive HPV results were referred for colposcopy and cervical biopsy to determine further management. Women with negative HPV results received recommendations for routine future screening according to national guidelines. Results A total of 6631 women were enrolled (screen-and-treat = 4087; cytology=2544). Significantly less CIN2+ was detected in the screen-and-treat group at 0.7% (29/4087) than in the cytology group at 2.1% (54/2544) (p<0.001) with a risk ratio of 0.41 (95% CI 0.26 to 0.61). HPV positivity was also lower in the screen-and-treat group at 9.5% (388/4077) compared with the cytology group at 11.5% (293/2445) (p=0.008). Conclusion At the first round of repeat screening after the implementation of CAPE, women who underwent HPV testing in a screen-and-treat strategy had significantly less CIN2+ and HPV positivity compared with those who underwent cytology. These outcomes occurred despite a longer screening interval for HPV testing than cytology. Findings provide reassurance for women and health systems that primary HPV screen-and-treat programmes with extended screening intervals, like the one in El Salvador, are achievable and effective in low- and middle-income settings.

Adoption and Implementation of Affordable Cancer Technologies in El Salvador: Identifying Implementation Strategies for Successful Cervical Cancer Prevention in Resource-Limited Settings

As part of the affordable cancer technology program, our team developed and tested a portable thermal ablation (TA) cervical precancer treatment. This research helped support subsequent implementation of the technology in El Salvador. Here, we review successful implementation strategies deployed during the process and point to challenges and implications for other low- and middle-income countries (LMICs). We use the exploration, preparation, implementation, and sustainment framework to guide the discussion and identify associated implementation strategies used during each phase. Significant strategies were the development and maintenance of multi-actor partnerships and accessing new funding to introduce innovations to the country. In this case, planning for implementation began before the decision to adopt TA. The case of El Salvador highlights the need for such pragmatic approaches to shorten the time between scientific research and clinical practice in LMICs. The impact of these efforts has been significant: El Salvador has gone from one of the countries with the lowest cervical cancer screening rates in the region to one that can potentially meet elimination targets in the coming decades. This experience can serve as a blueprint for cervical cancer control efforts in other LMICs.

Safety and Acceptability of Three Ablation Treatments for High-Grade Cervical Precancer: Early Data From a Randomized Noninferiority Clinical Trial

PURPOSE This ongoing trial is comparing the efficacy and safety of three ablation treatments for cervical intraepithelial neoplasia grade 2 or higher. Here, we present early data regarding pain, side effects, and acceptability of CO2 gas-based cryotherapy (CO2), nongas cryotherapy, and thermal ablation (TA). Efficacy results are expected to become available in late 2023. MATERIALS AND METHODS This noninferiority randomized trial is taking place in El Salvador, China, and Colombia. Patients are 1,152 eligible women with biopsy-confirmed cervical intraepithelial neoplasia grade 2 or higher who will receive one of three ablation treatments. Pain is measured before, during, and after treatment with a visual analog scale (1-10). Side effects and acceptability are assessed at 6 weeks. RESULTS To date, 1,024 of 1,152 (89%) women were randomly assigned to treatment. The median pain level was higher during TA (4, IQR = 4) than CO2 (2, IQR = 4) or nongas cryotherapy (2, IQR = 4) ( P < .01, range: 0-10). The most common post-treatment symptom was watery discharge, reported by 97.9% of women, and it lasted longer in the CO2 group than the other two treatments (in days, median [IQR]: CO2 = 20[20], nongas cryotherapy = 15[10], TA = 18[15], P < .01). Bleeding was reported more frequently in women treated with TA (27.6%) than CO2 (17.5) or nongas cryotherapy (18.7%) ( P < .01). The majority of patients reported being very satisfied with the treatment they received at 6 weeks (91%) and again at 12 months post-treatment (97%). CONCLUSION Despite differences in pain and side effects across ablation treatments, all were safe and highly acceptable to patients. In addition to efficacy, considerations such as cost and portability may be more significant in choosing a treatment method.