Dataset Information

Health Outcomes at 1 Year After Thermal Ablation for Cervical Precancer Among Human Papillomavirus- and Visual Inspection With Acetic Acid-Positive Women in Honduras.

ABSTRACT: PURPOSE:This study aims to assess the detection of cervical intraepithelial lesions grades 2 and 3 (CIN2-3) at 1 year after treatment with thermal ablation among human papillomavirus (HPV)-positive and visual inspection with acetic acid (VIA)-positive women. METHODS:All women screened and triaged for cervical cancer at four government health facilities in Honduras who were eligible for ablative treatment were enrolled and treated with thermal ablation. Women with confirmed CIN2-3 and a subset of women with CIN1/normal diagnoses at baseline were evaluated at 12 months. Follow-up procedures included HPV testing (careHPV), VIA, directed biopsy (if VIA-positive), and Papanicolaou test (if HPV positive, VIA negative). Outcomes at 1 year included histologic or cytologic assessment of CIN lesions among those with any abnormal test. RESULTS:Among the 319 women treated with thermal ablation, baseline histologic diagnoses were available for 317. Two (0.6%) had invasive cancer, 36 (11.4%) had CIN3, 40 (12.6%) had CIN2, and 239 (75.4%) had CIN1/normal histology. Among the 127 women eligible for follow-up, 118 (92.9%) completed all study procedures at 1 year. Overall, 98 (83.1%) had no evidence of CIN2-3 or persistent low-grade infection, 13 (11.2%) had CIN1/atypical squamous cells of undetermined significance, six (5.1%) had CIN2/high-grade squamous intraepithelial lesion, and 1 (0.8%) had a persistent CIN3. No adverse events associated with thermal ablation at 1 year were registered. CONCLUSION:A high proportion of women had no evidence of CIN2-3 at 1 year after thermal ablation treatment. Thermal ablation is an alternative to cryotherapy that may facilitate greater treatment coverage and prevent unnecessary deaths from cervical cancer.

SUBMITTER: Slavkovsky RC

PROVIDER: S-EPMC7605374 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Health Outcomes at 1 Year After Thermal Ablation for Cervical Precancer Among Human Papillomavirus- and Visual Inspection With Acetic Acid-Positive Women in Honduras.

Slavkovsky Rose C RC Bansil Pooja P Sandoval Manuel A MA Figueroa Jacqueline J Rodriguez Doris M DM Lobo Jose Saul JS Jeronimo Jose A JA de Sanjosé Silvia S

JCO global oncology 20201001

<h4>Purpose</h4>This study aims to assess the detection of cervical intraepithelial lesions grades 2 and 3 (CIN2-3) at 1 year after treatment with thermal ablation among human papillomavirus (HPV)-positive and visual inspection with acetic acid (VIA)-positive women.<h4>Methods</h4>All women screened and triaged for cervical cancer at four government health facilities in Honduras who were eligible for ablative treatment were enrolled and treated with thermal ablation. Women with confirmed CIN2-3 ...[more]

PMID: 33074738

Similar Datasets

Project description:BackgroundCryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy.MethodsWe report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239.FindingsBetween Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital.InterpretationResults from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results.FundingUS National Institutes of Health.

Project description:BACKGROUND:The human papillomavirus (HPV) is the causative agent of cervical cancer, which is the leading cancer-related cause of death for women in Sub-Saharan Africa. In 2013, the Gabonese Ministry of Health and the Sylvia Bongo Ondimba Foundation implemented cervical cancer screening programs based on the detection of cancerous lesions by visual inspection with acetic acid and/or Lugol's iodine (VIA/VILI). This pilot study was set up to determine the HPV profile and analyze the nucleotide sequence variation of HPV16 circulating in patients with cervical abnormalities detected by VIA/VILI testing. METHODS:The cervical abnormalities observed upon VIA/VILI were confirmed by liquid-based cytology for all tested women. Nested PCR using the MY09/11 and GP5+/6+ primer sets was used to detect HPVs present in the extracted DNA. HPV genotypes were determined after sequencing of amplicons based on a high-throughput sequencing approach. For isolates of the HPV16 genotype, the E6 gene and the long control region (LCR) were directly sequenced using Sanger method. RESULTS:The study included 87 women who showed a positive VIA/VILI result. Cervical abnormalities were found in 40.23 % of women and 40 % were classified as high-grade lesions. The HPV detection rate was 82.9 % among women with abnormal cytology. Among all the identified high-risk HPV genotypes, HPV16, 18 and 33 were the most frequent. Multiple HPV infections were observed in 42.31 % of HPV-infected women. Analysis of the HPV16 sequence variation in the E6 gene and in the LCR showed that 85.3 and 14.7 % belonged to the African and European lineages, respectively. Among the African branch variants, Af2 was the most frequently identified in this study. CONCLUSION:This study offers the first report of the HPV detection rate and molecular epidemiology among Gabonese women with a positive result in a VIA/VILI screening test. Moreover, data on the HPV16 sequence variation confirm the predominance of African variants in high-grade lesions.

Project description:PurposeCervical cancer screening has been successful in reducing the rates of cervical cancer in developed countries, but this disease remains the leading cause of cancer deaths among women in sub-Saharan Africa. We sought to understand factors associated with limited uptake of screening services in our cervical cancer-screening program in Western Kenya.Participants and methodsUsing items from a previously validated cancer awareness questionnaire repurposed for use in cervical cancer and culturally adapted for use in Kenya, we interviewed 2,505 women aged 18-55 years receiving care in gynecology clinics or seeking other services in 4 health facilities in Western Kenya between April 2014 and September 2014. We used logistic regression modeling to assess factors associated with uptake (or non-uptake), associated odds ratios (ORs) and the 95% confidence intervals (95% CI).ResultsOnly two hundred and seventy-three women out of 2505 (11%) accepted VIA cervical cancer screening. Knowledge of just how women are screened for cervical cancer was significantly associated with reduced uptake of cervical cancer screening (OR: 0.53; CI 0.38-0.73) as was fear that screening would reveal a cancer (OR 0.70; CI 0.63-0.77), and reliance on prayer with the onset of illness (OR 0.43; CI 0.26-0.71). Participants who thought that one should get cervical cancer screening even if there were no symptoms were more than twice as likely to accept cervical cancer screening (OR 2.21; 95% CI 1.24-3.93). Older patients, patients living with HIV and women who do not know if bleeding immediately after sex might be a sign of cervical cancer were also more likely to accept screening (OR 1.03, CI 1.02-1.04; OR 1.78, CI 1.01-3.14; OR 2.39, CI 1.31-4.39, respectively).ConclusionsIn our population, a high percent of women knew that it is appropriate for all women to get cervical cancer screening, but only a small proportion of women actually got screening. There may be an opportunity to design educational materials for this population that will not only encourage participation in cervical cancer screening but also remediate misconceptions. The discussion illustrates how our findings could be used in such an effort.

Project description:ImportanceLimited evidence supports the performance of human papillomavirus (HPV) DNA testing as a primary screening method, followed by triage with visual inspection with acetic acid, in areas with limited health care resources, as suggested by the 2021 World Health Organization guidelines.ObjectiveTo evaluate the performance of visual inspection with acetic acid and Lugol iodine as a triage method for detecting cervical precancerous lesions among HPV-positive women in 1 visit.Design, setting, and participantsThis cohort study examined the implementation of a government-led cervical cancer screening program conducted from January 1, 2016, to December 31, 2020, in Ordos City, China. Female residents, aged 35 to 64 years, who understood the screening procedures and voluntarily participated were included in the study. Women were excluded if they reported never having had sexual intercourse, were pregnant, had a hysterectomy, or had ever undergone treatment for cervical lesions. Statistical analysis was conducted from December 2022 to December 2023.ExposuresThe program used the careHPV DNA assay as the primary screening method, and immediate triage was performed by visual inspection if HPV screening results were positive, with a 5-year screening interval. A colposcopy was performed for the women who had suspected cancer on visual inspection results or who were HPV positive and had abnormal visual inspection results, all in 1 visit.Main outcomes and measuresThe rate of compliance with colposcopy and the detection rate of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).ResultsThe study included 187 863 women (median age, 46 years [IQR, 40-52 years]) who participated in the program and had valid HPV test results. The overall prevalence of HPV positivity was 12.8% (24 070 of 187 863), and the adherence to triage with visual inspection among HPV-positive women was 93.9% (22 592 of 24 070). Among HPV-positive women, the rate of compliance with colposcopy was 65.6% (2714 of 4137), and the CIN2+ detection rate was 2.8% (643 of 22 592).Conclusions and relevanceThe findings of this cohort study suggest that the implementation of HPV testing, visual inspection, and colposcopy within 1 visit may mitigate losses to follow-up, detect precancerous lesions, and hold significant implications for screening in comparable areas with limited health care resources.

Project description:BackgroundCervical cancer is the second most common cancer in Ethiopia next to breast cancer. Despite the high burden of the disease and availability of free screening services in Ethiopia, uptake is still trivial. This study aims to identify factors associated with cervical cancer screening uptake, VIA (visual inspection with acetic acid) positivity and its predictors among women attending cervical cancer screening service in Addis Ababa, Ethiopia.MethodsConcurrent mixed study approach of qualitative interview (n?=?15) and cross-sectional study among 844 screened women was conducted from February to July 2018. A multistage sampling technique was employed to recruit survey participants from the selected health facilities while the key informants for an in-depth interview were selected purposively. Descriptive statistics were used to summarize the quantitative data and multivariable logistic regression was employed to explore factors associated with VIA positivity of the cervix among screened women. Qualitative data were analyzed using thematic analysis approach.ResultsThe VIA positivity of the cervix was 10.3%. Mean age of study participants was 35.74?±?7.6?years and women in the age group of ?45?years were about >?8 times more likely to have VIA test positive result compared to younger women (?24?years). Being single (AOR?=?3.2, 95%CI: 1.4-7.31), widowed (AOR?=?18.6, 95%CI: 3.8-91.2), initiating sexual intercourse early (<?16?years) (AOR?=?2.72; 95%CI: 1.65-4.49), and having two or more lifetime sexual partners (AOR?=?4.9; 95% CI: 1.31-8.75) were also found to be predictors of being VIA positive. Lack of awareness, inaccessibility of the screening service, cultural beliefs and negative perception towards cancer were found to be the major reasons for low uptake of cervical cancer screening.ConclusionThe VIA positivity among screened women in Addis Ababa was found to be moderately low compared to reports in other parts of Ethiopia. Having multiple sexual partners, being older age and initiation of sexual intercourse at an early age were associated with VIA positivity of the cervix. Thus, concerted efforts must be taken to increase accessibility of screening services and improve awareness regarding cervical cancer screening.

Dataset Information

Health Outcomes at 1 Year After Thermal Ablation for Cervical Precancer Among Human Papillomavirus- and Visual Inspection With Acetic Acid-Positive Women in Honduras.

Publications

Health Outcomes at 1 Year After Thermal Ablation for Cervical Precancer Among Human Papillomavirus- and Visual Inspection With Acetic Acid-Positive Women in Honduras.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets