Ellen Baker

Addressing the cervical cancer burden in the Rio Grande Valley of Texas through a multi-component program to improve screening and diagnostic follow-up: A retrospective cohort study

Cervical cancer is preventable by following guidelines for vaccination, screening, diagnosis and treatment of preinvasive cervical lesions. We implemented a multicomponent intervention to increase rates of colposcopy after abnormal screening results in three clinic systems in the Rio Grande Valley, along the Texas-Mexico border. The goal of this study was to assess the outcomes of this program including participation in colposcopy within 90 days of screening for women with abnormal screening results, and the time between screening and colposcopy appointments during the first year (Year 1/baseline) and subsequent years (Years 2 through 4) of program implementation. We performed a retrospective cohort analysis of medical records of clinics participating in the program. We utilized multiple logistic regression and linear regression to assess the colposcopic outcomes of women with indication for colposcopy. A total of 1556 of the 14,846 (10.5 %) women who had undergone cervical cancer screening had abnormal results and met the criteria to be referred for colposcopy. There was a significant increase in the proportion of women who underwent colposcopy (within 90 days of screening) from Year 1/baseline (82.7 %) to Year 2 (90.6 %), OR= 1.65, p-value< 0.05. Similarly, the mean interval from screening to colposcopy decreased significantly from baseline (79 days) to Year 2 (49 days), to Years 3 and 4 (40 and 41 days, respectively), p < 0.001. Our results suggest that multicomponent interventions can improve and sustain appropriate and timely colposcopy among women in medically underserved regions, improving cervical cancer prevention efforts in resource-limited settings.

A randomized clinical trial to assess the effectiveness of thermal ablation versus loop electrosurgical excision procedure for cervical cancer risk reduction in women living with HIV in Mozambique.

Cervical cancer remains a leading cause of death in low- and middle-income countries. Women living with human immunodeficiency virus (HIV) carry a 6-fold higher risk of cervical cancer than the general population. The effectiveness of thermal ablation versus loop electrosurgical excision procedure (LEEP) in women living with HIV is uncertain, prompting this study. To compare the effectiveness of thermal ablation versus LEEP for the management of abnormal cervical cancer screening results in women living with HIV. Thermal ablation is non-inferior to LEEP for treatment of cervical intra-epithelial neoplasia (CIN) 2/3 and high-risk human papillomavirus (hrHPV) infection in women living with HIV. This is a prospective randomized clinical trial. Participants undergo screening with primary hrHPV testing. Those with positive hrHPV results undergo visual inspection with acetic acid and a review of genotyping results to determine eligibility for treatment. Those who are hrHPV-positive and positive by visual assessment with acetic acid, or human papillomavirus16/18 positive regardless of visual assessment with acetic acid result, are randomized to thermal ablation or LEEP. Participants undergo follow-up at 4 to 8 weeks, 6 months, and 12 months post-procedure. Participants include 25 to 49-year-old women living with HIV in Mozambique. Exclusion criteria include pregnancy, previous total hysterectomy, history of cervical cancer or prior treatment for CIN, or any condition that would preclude adherence to the study protocol. Persistent or recurrent CIN 2/3 (or worse diagnosis) and hrHPV infection at 12 months after initial treatment. To meet our primary objectives and to achieve a power of 0.8 (α = 0.025), we will need to randomize 126 participants with CIN 2/3, 63 to thermal ablation, and 63 to LEEP. We estimate that this will require screening a total of 4844 women living with HIV. We anticipate that study accrual will be completed in 3 years (2027), with an additional 18 months to complete all follow-up visits and data analysis. We anticipate presenting results in 2029. ClinicalTrials.gov #NCT06326294.

Scaling cervical cancer screening in Mozambique: analysis of loop electrosurgical excision procedure (LEEP) specimens

As cervical cancer screening programs are implemented and expanded, an increasing number of women require loop electrosurgical excision procedure (LEEP) for treatment of pre-invasive cervical disease. Our objective was to describe the pathological results of LEEP specimens performed as part of the MULHER study and identify factors associated with positive LEEP margins. The MULHER study enrolled 9014 women who underwent HPV testing followed by visual assessment for treatment (VAT) using visual inspection with acetic acid (VIA) and thermal ablation for those with positive results. Participants with lesions ineligible for ablation underwent LEEP. Pathology reports were reviewed for specimen size/volume, number of fragments, pathological diagnosis and margin status. Multivariable regression analysis was performed to identify variables associated with positive LEEP margins. 169 participants underwent LEEP. The median age was 38 years (range 30-49). 65.1% were women living with HIV. Pathological diagnosis was available for 154 patients and included cancer (n=6, 3.9%); cervical intraepithelial neoplasia (CIN) 2/3 (n=75, 48.7%); CIN 1 (n=67, 43.5%); and normal/benign findings (n=6,3.9%). 31.8% of LEEP specimens were removed in more than one fragment. The mean specimen volume was 2.9 cm Our results showed a high number of LEEP specimens with positive margins. Additional evaluation is needed to better understand the characteristics of precancerous cervical lesions in this high-risk population. As cervical cancer screening programs are scaled in Mozambique and other lower-resource countries, there is a need to train providers to perform high-quality LEEP and for accurate and timely pathological interpretation.