RESUMO
BACKGROUND: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a common enzyme deficiency, prevalent in many malaria-endemic countries. G6PD-deficient individuals are susceptible to hemolysis during oxidative stress, which can occur from exposure to certain medications, including 8-aminoquinolines used to treat Plasmodium vivax malaria. Accordingly, access to point-of-care (POC) G6PD testing in Brazil is critical for safe treatment of P. vivax malaria. METHODOLOGY/PRINCIPAL FINDINGS: This study evaluated the performance of the semi-quantitative, POC STANDARD G6PD Test (SD Biosensor, Republic of Korea). Participants were recruited at clinics and through an enriched sample in Manaus and Porto Velho, Brazil. G6PD and hemoglobin measurements were obtained from capillary samples at the POC using the STANDARD and HemoCue 201+ (HemoCue AB, Sweden) tests. A thick blood slide was prepared for malaria microscopy. At the laboratories, the STANDARD and HemoCue tests were repeated on venous samples and a quantitative spectrophotometric G6PD reference assay was performed (Pointe Scientific, Canton, MI). G6PD was also assessed by fluorescent spot test. In Manaus, a complete blood count was performed. Samples were analyzed from 1,736 participants. In comparison to spectrophotometry, the STANDARD G6PD Test performed equivalently in determining G6PD status in venous and capillary specimens under varied operating temperatures. Using the manufacturer-recommended reference value thresholds, the test's sensitivity at the <30% threshold on both specimen types was 100% (95% confidence interval [CI] venous 93.6%-100.0%; capillary 93.8%-100.0%). Specificity was 98.6% on venous specimens (95% CI 97.9%-99.1%) and 97.8% on capillary (95% CI 97.0%-98.5%). At the 70% threshold, the test's sensitivity was 96.9% on venous specimens (95% CI 83.8%-99.9%) and 94.3% on capillary (95% CI 80.8%-99.3%). Specificity was 96.5% (95% CI 95.0%-97.6%) and 92.3% (95% CI 90.3%-94.0%) on venous and capillary specimens, respectively. CONCLUSION/SIGNIFICANCE: The STANDARD G6PD Test is a promising tool to aid in POC detection of G6PD deficiency in Brazil. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov (identifier: NCT04033640).
Assuntos
Técnicas Biossensoriais , Deficiência de Glucosefosfato Desidrogenase/diagnóstico , Glucosefosfato Desidrogenase/sangue , Testes Imediatos/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aminoquinolinas/uso terapêutico , Antimaláricos/uso terapêutico , Brasil , Criança , Pré-Escolar , Estudos Transversais , Feminino , Deficiência de Glucosefosfato Desidrogenase/sangue , Hemólise , Humanos , Modelos Lineares , Malária Vivax/complicações , Malária Vivax/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Curva ROC , Adulto JovemRESUMO
To evaluate the diagnostic impact of point-of-care breast ultrasound by trained primary care physicians (PCPs) as part of a breast cancer detection program using clinical breast exam in an underserved region of Peru. Medical records and breast ultrasound images of symptomatic women presenting to the Breast Cancer Detection Model (BCDM) in Trujillo, Peru were collected from 2017-2018. Performance was measured against final outcomes derived from regional cancer center medical records, fine needle aspiration results, patient follow-up (sensitivity, specificity, positive, and negative predictive values), and by percent agreement with the retrospective, blinded interpretation of images by a fellowship-trained breast radiologist, and a Peruvian breast surgeon. The diagnostic impact of ultrasound, compared to clinical breast exam (CBE), was calculated for actual practice and for potential impact of two alternative reporting systems. Of the 171 women presenting for breast ultrasound, 23 had breast cancer (13.5%). Breast ultrasound used as a triage test (current practice) detected all cancer cases (including four cancers missed on confirmatory CBE). PCPs showed strong agreement with radiologist and surgeon readings regarding the final management of masses (85.4% and 80.4%, respectively). While the triage system yielded a similar number of biopsies as CBE alone, using the condensed and full BI-RADS systems would have reduced biopsies by 60% while identifying 87% of cancers immediately and deferring 13% to six-month follow-up. Point-of-care ultrasound performed by trained PCPs improves diagnostic accuracy for managing symptomatic women over CBE alone and enhances access. Greater use of BI-RADS to guide management would reduce the diagnostic burden substantially.
Assuntos
Neoplasias da Mama/diagnóstico , Ultrassonografia Mamária , Adulto , Feminino , Humanos , Variações Dependentes do Observador , Peru , Testes Imediatos , Reprodutibilidade dos Testes , Estudos RetrospectivosRESUMO
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.
Assuntos
Alphapapillomavirus , Infecções por Papillomavirus , Ácido Acético , Feminino , Honduras/epidemiologia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Teste de Papanicolaou , Papillomaviridae , Infecções por Papillomavirus/diagnósticoRESUMO
Scaling up coverage of routine cervical screening in low-resource settings must be accompanied by efforts to retain women throughout the screening cascade and continuum of care, including adequate follow-up of abnormal results. The Scale-Up Project implemented human papillomavirus (HPV) testing for cervical cancer screening within public-sector health facilities in Honduras between 2015 and 2019. Women who were HPV-positive but did not have visually confirmed cervical lesions upon visual inspection with acetic acid (VIA-negative) were instructed to return to the health center after 1 year for repeat HPV testing. The current evaluation assessed the effectiveness of recall strategies to prompt women to return for retesting. Clinic staff placed reminder phone calls and followed up with short message service (SMS) or home visits, if needed. We summarized number of contacts, type of contacts, and time elapsed until return to the clinic, and used log-binomial regression to identify factors associated with return to the clinic. We identified 558 women who were initially HPV-positive VIA-negative from 8 clinics as needing repeat HPV testing 1 year later. Mean age was 43.2 years. Nearly all women (98.6%) were successfully contacted and 75.1% completed repeat HPV testing. The majority of contacts (65.4%) were phone calls, and nearly half of women who returned to the clinic (42.9%) did so after 1 contact. Mean days between contact and presentation at the clinic was 10.7 (standard deviation: 14.7). Women who required 3 or more contacts were 21% less likely to return for repeat HPV testing (prevalence ratio: 0.79; 95% confidence interval=0.69,0.90; P<.001) as compared to women who received only 1 contact. Reminder phone calls were highly successful at recalling women for HPV retesting in Honduras. This low-touch intervention should be included as part of standard follow-up to retain women throughout the continuum of cervical cancer screening and treatment.
Assuntos
Alphapapillomavirus , Colo do Útero/patologia , Comunicação , Continuidade da Assistência ao Paciente , Programas de Rastreamento/métodos , Infecções por Papillomavirus/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Ácido Acético , Adulto , Colo do Útero/virologia , Detecção Precoce de Câncer , Feminino , Honduras , Humanos , Pessoa de Meia-Idade , Infecções por Papillomavirus/patologia , Infecções por Papillomavirus/virologia , Pacientes Desistentes do Tratamento , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/virologiaRESUMO
BACKGROUND: In Nicaragua, cervical cancer is the leading cause of cancer death among women. Human papillomavirus (HPV) testing, primarily using self-sampling, was introduced between 2014 and 2018 in three provinces. We analyzed data from the HPV screening program with the goal of describing key characteristics including reach, HPV prevalence, triage and treatment, and factors associated with follow-up completion. METHODS: We analyzed individual-level data from routinely collected forms for women attending HPV-based cervical cancer screening. HPV-positive women were triaged with Pap or visual inspection with acetic acid (VIA) prior to treatment. Logistic regression was used to identify factors associated with receiving triage and treatment; analyses were adjusted for province, age, and self- vs. provider-collected sampling. RESULTS: Forty-four thousand six hundred thirty-five women were screened with HPV testing; 96.6% of women used self-sampling. Six thousand seven hundred seventy-six women were HPV positive (15.2%), 54.0% of screen-positive women received triage, and 53.1% of triage-positive women were treated, primarily with cryotherapy. If women lost at triage are included, the overall treatment percentage was 27.8%. Province and provider sampling were significantly associated with completing triage. Province and triage type were significantly associated with receiving treatment. The odds of receiving treatment after Pap triage as compared to VIA was significantly lower (aOR: 0.05, 95% CI: 0.04-0.08, p < 0.001), and the relative proportion of women receiving treatment after Pap triage versus VIA was 0.29. CONCLUSIONS: Introduction of HPV testing resulted in a substantial number of women screened, and acceptance of self-sampling was high. Management of screen-positive women remained a challenge, particularly with Pap triage. Our results can inform other developing countries as they work to reach World Health Organization (WHO) elimination targets.
Assuntos
Detecção Precoce de Câncer/métodos , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/terapia , Adulto , Detecção Precoce de Câncer/estatística & dados numéricos , Feminino , Humanos , Pessoa de Meia-Idade , Nicarágua/epidemiologia , Infecções por Papillomavirus/epidemiologiaRESUMO
OBJECTIVE: To evaluate the acceptability and safety of thermal ablation (TA) for the treatment of precancerous cervical lesions in women in Honduras. METHODS: Human papillomavirus (HPV) and visual inspection with acetic acid (VIA) screen-positive eligible women received TA. After treatment, women rated the level of pain experienced during treatment using the Wong-Baker FACES® pain-rating scale from 0 to 10. Short-term safety outcomes that could require medical attention were assessed one month after treatment. RESULTS: A total of 319 women received TA treatment. The average pain rating was 2.5 (95% CI: 2.3-2.8), and 85% rated their pain levels as less than 6. No significant differences in low (below 6) or high (6 and above) pain were found by age or number of biopsies performed, but there was a significant difference by the number of TA applications (P < 0.01). When asked if they would recommend this treatment, all women said they would. At the one-month follow-up visit, the most common reported discomforts were bleeding (10%) and cramping (8.4%); 11 women reported severe lower abdominal pain, and none required medical attention. CONCLUSIONS: TA is safe and acceptable to patients as a treatment option for precancerous cervical lesions in low-resource settings.
OBJECTIF: Evaluer l'acceptabilité et la sécurité de l'ablation thermique (AT) pour le traitement des lésions cervicales précancéreuses chez les femmes au Honduras. MÉTHODES: Les femmes éligibles, portant le virus du papillome humain (VPH) et avec une inspection visuelle positive au test de dépistage à l'acide acétique (IVA) ont reçu une AT. Après le traitement, les femmes ont estimé le niveau de douleur ressenti au cours du traitement à l'aide de l'échelle d'évaluation de la douleur Wong-Baker FACES® de 0 à 10. Les résultats de sécurité à court terme pouvant nécessiter une attention médicale ont été évalués un mois après le traitement. RÉSULTATS: 319 femmes ont reçu un traitement d'AT. L'estimation moyenne de la douleur était de 2,5 (IC95%: 2,3-2,8) et 85% estimaient que leur niveau de douleur était inférieur à 6. Aucune différence significative dans la douleur faible (moins de 6) ou élevée (6 et plus) n'a été constatée en fonction de l'âge ou du nombre de biopsies réalisées, mais il y avait une différence significative selon le nombre d'applications d'AT (P < 0,01). Lorsqu'on leur a demandé si elles recommanderaient ce traitement, toutes les femmes ont répondu qu'elles le feraient. Lors de la visite de suivi à un mois, les malaises les plus fréquents signalés étaient les saignements (10%) et les crampes (8,4%). Onze femmes ont rapporté des douleurs sévères dans le bas de l'abdomen et aucune n'a nécessité de soins médicaux. CONCLUSIONS: L'AT est sûre et acceptable pour les patientes comme option de traitement pour les lésions cervicales précancéreuses dans les régions à faibles ressources.
Assuntos
Infecções por Papillomavirus/cirurgia , Satisfação do Paciente , Neoplasias do Colo do Útero/cirurgia , Adolescente , Adulto , Ablação por Cateter , Feminino , Honduras , Humanos , Pessoa de Meia-Idade , Medição da Dor , Papillomaviridae , Lesões Pré-Cancerosas , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: Vaginal self-sampling with HPV-DNA tests is a promising primary screening method for cervical cancer. However, women's experiences, concerns and the acceptability of such tests in low-resource settings remain unknown. METHODS: In India, Nicaragua, and Uganda, a mixed-method design was used to collect data from surveys (N = 3,863), qualitative interviews (N = 72; 20 providers and 52 women) and focus groups (N = 30 women) on women's and providers' experiences with self-sampling, women's opinions of sampling at home, and their future needs. RESULTS: Among surveyed women, 90% provided a self- collected sample. Of these, 75% reported it was easy, although 52% were initially concerned about hurting themselves and 24% were worried about not getting a good sample. Most surveyed women preferred self-sampling (78%). However it was not clear if they responded to the privacy of self-sampling or the convenience of avoiding a pelvic examination, or both. In follow-up interviews, most women reported that they didn't mind self-sampling, but many preferred to have a provider collect the vaginal sample. Most women also preferred clinic-based screening (as opposed to home-based self-sampling), because the sample could be collected by a provider, women could receive treatment if needed, and the clinic was sanitary and provided privacy. Self-sampling acceptability was higher when providers prepared women through education, allowed women to examine the collection brush, and were present during the self-collection process. Among survey respondents, aids that would facilitate self-sampling in the future were: staff help (53%), additional images in the illustrated instructions (31%), and a chance to practice beforehand with a doll/model (26%). CONCLUSION: Self-and vaginal-sampling are widely acceptable among women in low-resource settings. Providers have a unique opportunity to educate and prepare women for self-sampling and be flexible in accommodating women's preference for self-sampling.