scholarly journals The relevance of target product profiles for manufacturers, experiences from the World Health Organization initiative for point-of-care testing for sexually transmitted infections

2021 ◽  
Vol 79 (1) ◽  
Author(s):  
Maurine Murtagh ◽  
Karel Blondeel ◽  
Rosanna W. Peeling ◽  
James Kiarie ◽  
Igor Toskin
Keyword(s):  
Sexually Transmitted Infections ◽  
Development Process ◽  
World Health ◽  
Public Health Issue ◽  
Operational Characteristic ◽  
Target Product ◽  
Low Resource Settings ◽  
Sexually Transmitted ◽  
Low Resource ◽  
Technical Guidance

Abstract Background Sexually transmitted infections (STIs) are a significant global public health issue that cause a high burden of disease, especially in low- and middle-income countries. Screening of key populations and early and accurate diagnosis of infection are critical. Testing for syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, curable STIs, as well as the human papillomavirus (HPV), is frequently unavailable in low-resource settings. Tests for these STIs that can be used at the point of patient care (POCTs) are needed. In recent years, there has been increased attention for STI POCTs, but technical guidance, financial resources and advocacy for additional platforms/tests are required in order to foster the development of STI POCTs. The WHO Department of Sexual and Reproductive Health and Research (SRH) has developed target product profiles (TPPs), a form of technical guidance, for these STI diagnostics. Methods SRH conducted a survey of selected companies that are developing POCTs for one or more of the STIs mentioned above to better understand how these TPPs influence the diagnostic development process – to assess their impact. Results Survey respondents indicated that the STI POCT TPPs provided good guidance with respect to performance expectations and operational characteristics for the tests/platforms. In particular, optimal metrics for sensitivity, specificity, sample types, and time to result were considered to be very useful. Respondents also suggested ways to improve the relevance of the STI POCT TPPs. For example, since it is often not possible for developers to achieve every desired standard, it would be useful to prioritize each performance/operational characteristic of the test and to provide a rationale as to why certain characteristics are considered important. Respondents also emphasized the need to encourage industry participation in the TPP development process and to find creative ways, including via targeted emails, a WHO webpage directed at industry, or a coordinated communications plan to increase awareness of the TPPs. Conclusions Companies value the STI POCT TPPs and want them to continue. In order to maximize impact, WHO should consider the proposals from the manufacturers in the interest of increasing and accelerating access to STI diagnostics and treatment in low-resource settings.

scholarly journals Point-of-care testing for sexually transmitted infections in low-resource settings

2021 ◽  
Author(s):  
Silver Vargas ◽  
Gino Calvo ◽  
Jazmin Qquellon ◽  
Francesca Vasquez ◽  
Karel Blondel ◽  
...  
Keyword(s):  
Sexually Transmitted Infections ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Low Resource Settings ◽  
Sexually Transmitted ◽  
Low Resource

scholarly journals Effect of interventions based on educational technologies on the prevention of sexually transmitted infections in incarcerated women: protocol of a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043373
Author(s):  
Isaiane da Silva Carvalho ◽  
Ryanne Carolynne Marques Gomes Mendes ◽  
Priscila de Oliveira Cabral Melo ◽  
Caroline Ferraz Simões ◽  
Luciana Pedrosa Leal ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Education ◽  
Sexually Transmitted Infections ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Incarcerated Women ◽  
Mean Difference ◽  
World Health ◽  
Educational Technologies ◽  
Sexually Transmitted

IntroductionPrisons are places with high vulnerability and high risk for the development of sexually transmitted infections. World Health Agencies recommend establishing intervention measures, such as information and education, on the prevention of diseases. Thus, technologies as tools for health education have been used to reduce sexually transmitted infections. However, no systematic review has investigated the effectiveness of these interventions. Therefore, this review’s objective is to examine the effect of educational technologies used for preventing sexually transmitted infections in incarcerated women.Methods and analysisPreferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be strictly followed. The following electronic databases will be searched: Scopus; Cumulative Index of Nursing and Allied Health, Education Resources Information Center, Embase, PsycINFO, PubMed/Medline, Web of Science and Google Scholar. Randomised clinical trials of interventions that used educational technologies to prevent sexually transmitted infections in incarcerated women will be searched in the databases from the beginning of 2020 until December by two researchers independently. A narrative synthesis will be constructed for all included studies, and if there are sufficient data, a meta-analysis will be performed using the Review Manager software (V.5.3). Continuous results will be presented as the weighted mean difference or the standardised mean difference with 95% CIs. Under the heterogeneity of the included studies, a random-effects or fixed-effects model will be used. The studies’ heterogeneity will be assessed by the I2 method. The sensitivity analysis will be carried out to examine the magnitude of each study’s influence on the general results. A significance level of p≤0.05 will be adopted.Ethics and disclosureEthical approval is not required because no primary data will be collected. The results will be published in journals reviewed by peers.PROSPERO registration numberCRD42020163820.

scholarly journals Derivation of the first clinical diagnostic models for dehydration severity in patients over five years with acute diarrhea

2021 ◽  
Vol 15 (3) ◽  
pp. e0009266
Author(s):  
Adam C. Levine ◽  
Meagan A. Barry ◽  
Monique Gainey ◽  
Sabiha Nasrin ◽  
Kexin Qu ◽  
...  
Keyword(s):  
Acute Diarrhea ◽  
Diarrheal Disease ◽  
Characteristic Curve ◽  
World Health ◽  
Simplified Model ◽  
Full Model ◽  
Low Resource Settings ◽  
Low Resource ◽  
Clinical Diagnostic ◽  
Diagnostic Models

Diarrheal diseases lead to an estimated 1.3 million deaths each year, with the majority of those deaths occurring in patients over five years of age. As the severity of diarrheal disease can vary widely, accurately assessing dehydration status remains the most critical step in acute diarrhea management. The objective of this study is to empirically derive clinical diagnostic models for assessing dehydration severity in patients over five years with acute diarrhea in low resource settings. We enrolled a random sample of patients over five years with acute diarrhea presenting to the icddr,b Dhaka Hospital. Two blinded nurses independently assessed patients for symptoms/signs of dehydration on arrival. Afterward, consecutive weights were obtained to determine the percent weight change with rehydration, our criterion standard for dehydration severity. Full and simplified ordinal logistic regression models were derived to predict the outcome of none (<3%), some (3–9%), or severe (>9%) dehydration. The reliability and accuracy of each model were assessed. Bootstrapping was used to correct for over-optimism and compare each model’s performance to the current World Health Organization (WHO) algorithm. 2,172 patients were enrolled, of which 2,139 (98.5%) had complete data for analysis. The Inter-Class Correlation Coefficient (reliability) was 0.90 (95% CI = 0.87, 0.91) for the full model and 0.82 (95% CI = 0.77, 0.86) for the simplified model. The area under the Receiver-Operator Characteristic curve (accuracy) for severe dehydration was 0.79 (95% CI: 0.76–0.82) for the full model and 0.73 (95% CI: 0.70, 0.76) for the simplified model. The accuracy for both the full and simplified models were significantly better than the WHO algorithm (p<0.001). This is the first study to empirically derive clinical diagnostic models for dehydration severity in patients over five years. Once prospectively validated, the models may improve management of patients with acute diarrhea in low resource settings.

scholarly journals Prevalence and Social Correlates of Sexual Intercourse among School-Going Adolescents in Thailand

2011 ◽  
Vol 11 ◽  
pp. 1812-1820 ◽  
Author(s):  
Karl Peltzer ◽  
Supa Pengpid
Keyword(s):  
Sexually Transmitted Infections ◽  
Sexual Intercourse ◽  
Multivariable Analysis ◽  
Psychosocial Distress ◽  
Public Health Issue ◽  
Current Smoking ◽  
Sexually Transmitted ◽  
School Based ◽  
Using Data ◽  
Current Alcohol

Adolescent sexuality is a relevant public health issue, as it affects risk to contract HIV and other sexually transmitted infections. The assessment of prevalence of sexual intercourse among adolescents may guide policies and programmes aimed at reducing the transmission of sexually transmitted infections among this age group. Using data from the Thailand Global School-Based Student Health Survey (GSHS) 2008, we assessed the prevalence of sexual intercourse in the last 12 months and its associated factors among adolescents (). Overall the prevalence of sexual intercourse in the past 12 months was 11.0% (14.6% males and 7.6% females). Variables positively associated with the outcome in multivariable analysis were male gender (; 95% CI 1.14–242), older age, ≥15 years (, 1.80–3.74), current alcohol use (, 1.46–3.36), psychosocial distress (, 1.44–3.09) and among females current smoking (, 1.62–18.48), lifetime drug use (, 1.04–18.3) and lack of parental or guardian bonding (, 0.27–0.97). Efforts to control unhealthy lifestyles (substance use) and psychosocial distress may impact on adolescents' sexual activity.

A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Jared Floersch ◽  
Elsa Hauschildt ◽  
Adam Keester ◽  
Samuel Poganski ◽  
Kiet Tran ◽  
...  
Keyword(s):  
Continuous Positive Airway Pressure ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Low Cost ◽  
World Health ◽  
Pure Oxygen ◽  
Hypodermic Needle ◽  
Low Resource Settings ◽  
Low Resource ◽  
Tract Infections

Abstract Continuous positive airway pressure (CPAP) is a method of respiratory support used around the world to treat children with lower respiratory tract infections (LRTI) (WHO, 2016, Oxygen Therapy for Children, World Health Organization, Geneva, Switzerland, Report). Bubble continuous positive airway pressure (bCPAP) is an effective form of CPAP that is currently used in both high- and low-resource countries. Low-cost, modified bCPAP devices have been designed as an ideal form of CPAP in low-resource areas (Bjorklund, A. R., Mpora, B. O., Steiner, M. E., Fischer, G., Davey, C. S., and Slusher, T. M., 2018, “Use of a Modified Bubble Continuous Positive Airway Pressure (bCPAP) Device for Children in Respiratory Distress in Low- and Middle-Income Countries: A Safety Study,” Paediatr. Int. Child Health, 39(3), pp. 1–8). However, patients in low-resource settings undergoing bCPAP treatment are often given pure oxygen, which has been linked to retinopathy of prematurity, cardiovascular complications, and patient mortality (Rodgers, J. L., Iyer, D., Rodgers, L. E., Vanthenapalli, S., and Panguluri, S. K., 2019, “Impact of Hyperoxia on Cardiac Pathophysiology,” J. Cell. Physiol., 234(8), pp. 1–9; Ramgopal, S., Dezfulian, C., Hickey, R. W., Au, A. K., Venkataraman, S., Clark, R. S. B., and Horvat, C. M., 2019, “Association of Severe Hyperoxemia Events and Mortality Among Patients Admitted to a Pediatric Intensive Care Unit,” JAMA Network Open, 2(8), p. e199812). This problem is typically avoided by using commercial oxygen blenders, which can titrate down the concentration of oxygen delivered to the minimum needed; however, these blenders can cost nearly 1000 USD and are almost always unavailable in low-resource settings. The lack of available low-cost oxygen blenders compatible with modified bCPAP circuits creates a barrier for low-resource hospitals to be able to provide blended oxygen to patients. There is a need for a low-cost oxygen blender for use in low-resource settings. We propose a passive oxygen blender that operates via entrainment of atmospheric air. The device can easily be assembled in low-resource areas using a 22 gauge hypodermic needle, two 3 cc syringes, tape or super glue, and the materials required for bCPAP—for approximately 1.40 USD per device. The blender has not been clinically tested yet, but can achieve oxygen concentrations as low as 60% with bCPAP levels of 5 cm H2O (490 Pa) when used in a standard bCPAP circuit without a patient.

scholarly journals Detecting tuberculosis: rapid tools but slow progress

2019 ◽  
Vol 9 (3) ◽  
pp. 80-83
Author(s):  
K. England ◽  
T. Masini ◽  
E. Fajardo
Keyword(s):  
Point Of Care ◽  
Scale Up ◽  
Critical Issue ◽  
World Health ◽  
High Turnover ◽  
Low Resource Settings ◽  
Laboratory Staff ◽  
Low Resource ◽  
Point Of Care Test ◽  
Health Organization

The World Health Organization (WHO) currently recommends Xpert® MTB/RIF as the initial test for all people with presumptive tuberculosis (TB). A number of challenges have been reported, however, in using this technology, particularly in low-resource settings. Here we examine these challenges, and provide our perspective of the barriers to Xpert scale-up as assessed through a survey in 16 TB burden countries in which the Médecins Sans Frontières is present. We observed that the key barriers to scale-up include a lack of policy adoption and implementation of WHO recommendations for the use of Xpert, resulting from high costs, poor sensitisation of clinical staff and a high turnover of trained laboratory staff; insufficient service and maintenance provision provided by the manufacturer; and inadequate resources for sustainability and expansion. Funding is a critical issue as countries begin to transition out of support from the Global Fund. While it is clear that there is still an urgent need for research into and development of a rapid, affordable point-of-care test for TB that is truly adapted for use in low-resource settings, countries in the meantime need to develop functional and sustainable Xpert networks in order to close the existing diagnostic gap.

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