Mexican Cervical Cancer Screening Study II: 6-month and 2-year follow-up of HR-HPV women treated with cryotherapy in a low-resource setting.

OBJECTIVE: To determine the efficacy and tolerance of cryotherapy in a visual inspection with acetic acid (VIA) triage protocol after primary human papillomavirus (HPV) screening in a low-resource setting. MATERIALS AND METHODS: This continuous series conducted over 2 years enrolled nonpregnant, high-risk HPV (HR-HPV)-positive women between the ages of 30 and 50 years, who resided in the state of Michoacán, Mexico, and had a history of no Pap smear screening or knowledge of Pap smear results within the last 3 years. These women were initially enrolled in the Mexican Cervical Cancer Screening Study II (MECCS II) trial and were treated with cryotherapy after VIA triage. They subsequently followed up at 6 months and 2 years for repeat VIA, colposcopy, and biopsy. RESULTS: A total of 291 women were treated with cryotherapy, of whom 226 (78%) followed up at 6 months. Of these 226 women, 153 (68%) were HR-HPV-negative; there were no findings of cervical intraepithelial neoplasia grade 2 (CIN2) or worse. The remaining 73 women (32%) were HR-HPV-positive; of these women, 2 had CIN2 and 3 had CIN3. Only 137 women followed up at 2 years. Of these 137 women, 116 were HR-HPV-negative and 21 were HR-HPV-positive. Of the 21 women positive for HR-HPV, 9 had negative biopsy results, 11 had CIN1, and 1 had no biopsy. The clearance rate of HR-HPV was 83% (95% confidence interval: 0.78-0.87). There were no biopsy findings of CIN2 or worse at 2 years. Before cryotherapy, of the 226 women, 15 (6.6%) were positive for endocervical curettage (ECC) and 5 (2.2%) were referred for surgical management. Of these 15 ECC-positive women, 10 (67%) followed up at 6 months and it was shown that no patient was ECC positive at that time point. Moreover, of the 15 ECC-positive women, 11 (73%) followed up at 2 years and it was shown that no patient was ECC positive at that time point. In our study, VIA had a false-positive rate of 5%. CONCLUSIONS: Cryotherapy was an effective, acceptable, and well-tolerated means of treating cervical dysplasia in a low-resource setting.

Primary cervical cancer screening and triage using an mRNA human papillomavirus assay and visual inspection.

OBJECTIVE: Mexican Cervical Cancer Screening Study II (MECCS II) seeks to develop a highly sensitive and highly specific screening program able to be adapted to all socioeconomic levels in Mexico. The objectives of MECCS II are (1) to compare the sensitivity and specificity for cervical intraepithelial neoplasia (CIN) 3 or cancer of self-collected vaginal specimens tested for high-risk types of the human papillomavirus (HR-HPV) by APTIMA with those tested for HR-HPV by Hybrid Capture 2 (HC2); and (2) determine the efficacy of cryotherapy in the treatment of HR-HPV-positive and acetic acid-aided visual inspection (VIA)-positive and -negative women after VIA triage. METHODS: The study was conducted in rural Mexico. Women aged 30 to 50 years, nonpregnant, with no history of hysterectomy or pelvic irradiation and varied histories of screening, participated. A direct endocervical sample was tested for cytology, HC2, and APTIMA assay (AHPV). Subjects positive on any test were recalled for triage VIA, biopsies, and immediate cryotherapy. Tests were compared using McNemar test. RESULTS: Two thousand forty-nine patients have complete results. Mean age of the patients was 39.2 years; 7.7% presented with ≥atypical squamous cells of uncertain significance (ASCUS), 1.8% ≥low-grade squamous intraepithelial neoplasia, and 0.5% ≥high-grade squamous intraepithelial neoplasia. Two percent of patients had ≥CIN2, and 0.78% had ≥CIN3 (including 2 with invasive disease). The sensitivity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 for direct endocervical collection was 87.5%, 100%, and 100%, respectively. The specificity of ThinPrep (>ASCUS), HC2, and AHPV for >CIN3 was 94.1%, 92.2%, and 93.5%, respectively. Specificities of HC2 and AHPV differed significantly. The overall percentage of agreement among HPV assays (HC2 vs APTIMA) is 97%. Four hundred sixty-nine women returned for VIA. Two hundred ninety-one women were treated with cryotherapy. CONCLUSIONS: The specificity of the APTIMA assay along with high sensitivity is an advantage for primary screening. Follow-up evaluation will be important to determine the true impact of potential undertreatment in the screening algorithm. Self-sampling applications are explored.

Mexican Cervical Cancer Screening Study II: acceptability of human papillomavirus self-sampler.

INTRODUCTION: Cervical cancer is the second most common cancer in women worldwide. In countries like Mexico, cervical cancer early detection programs have had a minimal impact on the incidence and death rates from cervical cancer. Self-sampling for the presence of high-risk human papillomavirus is potentially a more effective screening tool to reach women who have limited access to community healthcare resources. The objective of this phase 2 trial was to establish if the fourth generation Preventive Oncology International/National Institutes of Health self-sampler device is well accepted by women of all socioeconomic levels in Michoacán, Mexico. METHODS: This is a prospective phase 2 trial. The patients used the self-sampler, and then the acceptability questionnaire (14 multiple choice questions) was completed with the assistance of nursing staff. RESULTS: Two thousand five hundred seventeen patients completed the questionnaire. The mean age of our patient population was 39 years. Eighty-six percent of patients reported being comfortable when using the self-test, and 76% preferred to do the test at the clinic. Ninety-one percent of patients said that if their only choice was to perform the test at home they would perform it rather than not perform the test. The major barriers for the use of self-sampler identified by the women in the study were fear (75%), woman might not perform the test because she does not feel ill (70%), women felt that husbands may stand in women's way of performing the test (66%), and lack of time (61%). Results differed by location but not by history of Papanicolaou test. CONCLUSIONS: Most patients reported being comfortable when using the Preventive Oncology International/National Institutes of Health fourth generation self-test. Most influential barriers identified by the acceptability questionnaire were fear, lack of signs or symptoms of illness, husbands' influence, cost, lack of time, being unable to read, and lack of trust in the medical community.