Application of a Telecolposcopy Program in Rural Settings.

BACKGROUND: Individuals in rural areas are often restricted by the amount of physicians' availability, thus limiting access to healthcare in those settings. INTRODUCTION: While Pap smear screening has increased across the United States, the rural South still reports high rates of cervical cancer and mortality. One solution to improve patient outcomes related to cervical cancer in rural settings is telecolposcopy. MATERIALS AND METHODS: Women with abnormal Pap results or an abnormal visual examination needing an evaluation by colposcopy were referred to a hospital-based telecolposcopy program. Descriptive data are provided that include patients' access to care based on travel time and transportation costs. RESULTS: Over a 15-month time period, 940 unique patients were seen using telecolposcopy. Telecolposcopy was done at eight spoke sites across Arkansas representing patients from 72 of the 75 counties. Data for risk factors that include smoking, first sexual experience, and number of sexual partners in past 12 months and in a lifetime are discussed. Pap results and impression are provided. In addition, avoided transportation costs and travel time have been calculated and included. DISCUSSION: Cervical cancer is important public health concern especially for women residing in rural areas. We were able to demonstrate that our telecolposcopy program has provided sustainability statewide since its inception and that patients are willing to participate. In addition to providing increased access to care, the program also reduced travel time and costs associated with a face-to-face visit. CONCLUSION: Telecolposcopy should be further explored and utilized in rural settings as a way to reduce patient costs and improve cervical cancer outcomes.

A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with Candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3.

PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 µg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 µg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.