Implementing post-trial access plans for HIV prevention research

2018 ◽  
Vol 44 (5) ◽  
pp. 354-358 ◽  
Author(s):  
Amy Paul ◽  
Maria W Merritt ◽  
Jeremy Sugarman
Keyword(s):  
Hiv Prevention ◽  
Large Scale ◽  
Healthcare Systems ◽  
System Level ◽  
Planning Under Uncertainty ◽  
Work Related ◽  
Prevention Trials ◽  
Practical Experiences ◽  
Post Trial ◽  
Local Healthcare

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.

scholarly journals Exploring the Use of Oral Pre-exposure Prophylaxis (PrEP) Among Women from Durban, South Africa as Part of the HIV Prevention Package in a Clinical Trial

2020 ◽  
Author(s):  
Ivana Beesham ◽  
Renee Heffron ◽  
Shannon Evans ◽  
Jared M. Baeten ◽  
Jenni Smit ◽  
...  
Keyword(s):  
South Africa ◽  
Hiv Prevention ◽  
South African ◽  
Medical Research Council ◽  
Trial Site ◽  
Study Staff ◽  
Prevention Trials ◽  
Post Trial ◽  
Exposure Prophylaxis ◽  
First Time

Abstract HIV endpoint-driven clinical trials in Africa enroll women who are at heightened risk of acquiring HIV. In 2017, the South African Medical Research Council recommended the provision of oral pre-exposure prophylaxis (PrEP) in HIV prevention trials, at which time the Evidence for Contraceptive Options and HIV Outcomes trial was ongoing and began to provide PrEP on-site at some trial sites. We interviewed 132 women who initiated PrEP on-site at the Durban, South Africa trial site to explore PrEP use, and conducted phone-based interviews 4–6 months post-trial exit to explore post-trial PrEP access. PrEP uptake was high (42.6%). Among women initiating PrEP on-site, 87.9% felt at risk of acquiring HIV. Most women (> 90%) heard of PrEP for the first time from study staff and three-quarters who initiated PrEP on-site continued at trial-exit. PrEP use declined post-trial exit with more than 50% of women discontinuing PrEP, and barriers relating to access emerged.

Establishing a continuum of care between HIV prevention trials and public healthcare systems: The MIRA Standard of Care program

2010 ◽  
Vol 7 (3) ◽  
pp. 256-264 ◽  
Author(s):  
Kate Clouse ◽  
Elizabeth T Montgomery ◽  
Cecilia Milford ◽  
Connie Watadzaushe ◽  
Busi Nkala ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Care Program ◽  
Standard Of Care ◽  
Continuum Of Care ◽  
Healthcare Systems ◽  
Public Healthcare ◽  
Prevention Trials

Building a Culture of Ethical, Comparable, Authentic Assessment

2019 ◽  
pp. 463-481
Author(s):  
Andrew Reid ◽  
Julie Ballantyne
Keyword(s):  
Teaching And Learning ◽  
Large Scale ◽  
Authentic Assessment ◽  
Subject Area ◽  
Music Educators ◽  
System Level ◽  
Diverse Range ◽  
Effective Learning ◽  
School Based ◽  
The Subject

In an ideal world, assessment should be synonymous with effective learning and reflect the intricacies of the subject area. It should also be aligned with the ideals of education: to provide equitable opportunities for all students to achieve and to allow both appropriate differentiation for varied contexts and students and comparability across various contexts and students. This challenge is made more difficult in circumstances in which the contexts are highly heterogeneous, for example in the state of Queensland, Australia. Assessment in music challenges schooling systems in unique ways because teaching and learning in music are often naturally differentiated and diverse, yet assessment often calls for standardization. While each student and teacher has individual, evolving musical pathways in life, the syllabus and the system require consistency and uniformity. The challenge, then, is to provide diverse, equitable, and quality opportunities for all children to learn and achieve to the best of their abilities. This chapter discusses the designing and implementation of large-scale curriculum as experienced in secondary schools in Queensland, Australia. The experiences detailed explore the possibilities offered through externally moderated school-based assessment. Also discussed is the centrality of system-level clarity of purpose, principles and processes, and the provision of supportive networks and mechanisms to foster autonomy for a diverse range of music educators and contexts. Implications for education systems that desire diversity, equity, and quality are discussed, and the conclusion provokes further conceptualization and action on behalf of students, teachers, and the subject area of music.

scholarly journals Drug Prescription Profiles in Patients with Polypharmacy in Spain: A Large-Scale Pharmacoepidemiologic Study Using Real-World Data

2021 ◽  
Vol 18 (9) ◽  
pp. 4754
Author(s):  
Miguel Ángel Hernández-Rodríguez ◽  
Ermengol Sempere-Verdú ◽  
Caterina Vicens-Caldentey ◽  
Francisca González-Rubio ◽  
Félix Miguel-García ◽  
...  
Keyword(s):  
Psychotropic Drugs ◽  
Large Scale ◽  
Anatomical Therapeutic Chemical ◽  
Drug Prescription ◽  
Age Groups ◽  
System Level ◽  
Real World Data ◽  
Converting Enzyme Inhibitors ◽  
Cross Sectional ◽  
Β Blockers

We aimed to identify and compare medication profiles in populations with polypharmacy between 2005 and 2015. We conducted a cross-sectional study using information from the Computerized Database for Pharmacoepidemiologic Studies in Primary Care (BIFAP, Spain). We estimated the prevalence of therapeutic subgroups in all individuals 15 years of age and older with polypharmacy (≥5 drugs during ≥6 months) using the Anatomical Therapeutic Chemical classification system level 4, by sex and age group, for both calendar years. The most prescribed drugs were proton-pump inhibitors (PPIs), statins, antiplatelet agents, benzodiazepine derivatives, and angiotensin-converting enzyme inhibitors. The greatest increases between 2005 and 2015 were observed in PPIs, statins, other antidepressants, and β-blockers, while the prevalence of antiepileptics was almost tripled. We observed increases in psychotropic drugs in women and cardiovascular medications in men. By patient´s age groups, there were notable increases in antipsychotics, antidepressants, and antiepileptics (15–44 years); antidepressants, PPIs, and selective β-blockers (45–64 years); selective β-blockers, biguanides, PPIs, and statins (65–79 years); and in statins, selective β-blockers, and PPIs (80 years and older). Our results revealed important increases in the use of specific therapeutic subgroups, like PPIs, statins, and psychotropic drugs, highlighting opportunities to design and implement strategies to analyze such prescriptions’ appropriateness.

scholarly journals Integrating syphilis screening in a large-scale HIV prevention program for key populations: the Avahan experience from India

2013 ◽  
Vol 7 (06) ◽  
pp. 484-488 ◽  
Author(s):  
Mugundu Ramien Parthasarathy ◽  
Prakash Narayanan ◽  
Anjana Das ◽  
Anup Gurung ◽  
Parimi Prabhakar ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Prevention Program ◽  
Large Scale ◽  
Point Of Care ◽  
Key Populations ◽  
Immunochromatographic Strip ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Syphilis Screening ◽  
Strip Test

Introduction: Documented experiences from India on the implementation of syphilis screening in large-scale HIV prevention programs for “key populations at higher risk’ (KPs) are limited. Avahan is a large-scale HIV prevention program providing services to more than 300,000 KPs in six high HIV prevalence states of India since 2004. Avahan clinics provide a sexually transmitted infection service package which includes bi-annual syphilis screening. The trends in the coverage of syphilis screening among Avahan clinic attendees were studied retrospectively. Methodology: Screening was performed using either the Rapid Plasma Reagin (RPR) test or point-of-care immunochromatographic strip test (ICST). Clinic records from 2005 to 2009 were collated in an individual tracking database and analyzed with STATA-10. Results: Initially the coverage of syphilis screening (2.6% in 2005) was constrained by the availability and operational complexity of the RPR test. After its introduction in 2007, the use of ICST for screening increased from 7.4% to 77.0% and the proportion of clinic attendees screened increased from 9.0% to 21.6% during 2007-2009. The RPR reactivity rates declined from 6.6% (2006) to 4.4% (2009). Conclusion: The data showed improved rates of screening of clinic attendees and declining trends in sero-reactivity over time. The introduction of point-of-care syphilis tests may have contributed to the improved coverage of syphilis screening. The ICST may be considered for initial syphilis screening at other resource-constrained primary care sites in India such as ante-natal clinics and other KP interventions.

scholarly journals Integration of enzyme constraints in a genome-scale metabolic model of Aspergillus niger improves phenotype predictions

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Jingru Zhou ◽  
Yingping Zhuang ◽  
Jianye Xia
Keyword(s):  
Aspergillus Niger ◽  
Large Scale ◽  
Measurement Techniques ◽  
Metabolic Model ◽  
System Level ◽  
Metabolic Phenotype ◽  
Omics Data ◽  
Prediction Ability ◽  
Phenotype Prediction ◽  
Genome Scale

Abstract Background Genome-scale metabolic model (GSMM) is a powerful tool for the study of cellular metabolic characteristics. With the development of multi-omics measurement techniques in recent years, new methods that integrating multi-omics data into the GSMM show promising effects on the predicted results. It does not only improve the accuracy of phenotype prediction but also enhances the reliability of the model for simulating complex biochemical phenomena, which can promote theoretical breakthroughs for specific gene target identification or better understanding the cell metabolism on the system level. Results Based on the basic GSMM model iHL1210 of Aspergillus niger, we integrated large-scale enzyme kinetics and proteomics data to establish a GSMM based on enzyme constraints, termed a GEM with Enzymatic Constraints using Kinetic and Omics data (GECKO). The results show that enzyme constraints effectively improve the model’s phenotype prediction ability, and extended the model’s potential to guide target gene identification through predicting metabolic phenotype changes of A. niger by simulating gene knockout. In addition, enzyme constraints significantly reduced the solution space of the model, i.e., flux variability over 40.10% metabolic reactions were significantly reduced. The new model showed also versatility in other aspects, like estimating large-scale $$k_{{cat}}$$ k cat values, predicting the differential expression of enzymes under different growth conditions. Conclusions This study shows that incorporating enzymes’ abundance information into GSMM is very effective for improving model performance with A. niger. Enzyme-constrained model can be used as a powerful tool for predicting the metabolic phenotype of A. niger by incorporating proteome data. In the foreseeable future, with the fast development of measurement techniques, and more precise and rich proteomics quantitative data being obtained for A. niger, the enzyme-constrained GSMM model will show greater application space on the system level.

scholarly journals Venue-Based Recruitment of Women at Elevated Risk for HIV: An HIV Prevention Trials Network Study

2014 ◽  
Vol 23 (6) ◽  
pp. 541-551 ◽  
Author(s):  
Danielle F. Haley ◽  
Carol Golin ◽  
Wafaa El-Sadr ◽  
James P. Hughes ◽  
Jing Wang ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Elevated Risk ◽  
Prevention Trials
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