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https://www.readbyqxmd.com/read/28078953/evidence-based-strategies-for-shortening-informed-consent-forms-in-clinical-research
#1
Amy Corneli, Emily Namey, Monique P Mueller, Jenae Tharaldson, Steve Sortijas, Thomas Grey, Jeremy Sugarman
Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once...
January 1, 2017: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/28078644/eight-or-12-week-treatment-of-hepatitis-c-with-ledipasvir-sofosbuvir-real-world-experience-in-a-large-integrated-health-system
#2
Jennifer B Lai, Maxwell A Witt, Mary Patricia Pauly, Joanna Ready, Michael Allerton, Suk Seo, David J Witt
BACKGROUND: Second-generation direct-acting antiviral agents are integral to treatment of hepatitis C (HCV) infection. Eight-week courses of ledipasvir/sofosbuvir (LDV/SOF) have been supported in some studies, but data are limited on efficacy in real-world use. Controversy exists regarding applicability of clinical trials to real-world effectiveness. We report virologic responses of patients with HCV genotype 1 infection receiving LDV/SOF for 8 or 12 weeks in a large integrated healthcare system...
January 11, 2017: Drugs
https://www.readbyqxmd.com/read/28070174/the-hcv-treatment-revolution-continues-resistance-considerations-pangenotypic-efficacy-and-advances-in-challenging-populations
#3
Ira M Jacobson
The US Food and Drug Administration has now approved 10 direct-acting antivirals (DAAs) for the management of hepatitis C virus (HCV). These therapies are combined into 6 regimens that are given for varying durations, with or without ribavirin, depending on the viral genotype, the presence or absence of baseline resistance-associated variants (RAVs), and the patient type. RAVs may be present before exposure to a drug or may become detectable de novo during exposure to a drug. Emerging resistant strains are the most common cause of failure of HCV DAA regimens...
October 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28068935/qualitative-insights-into-implementation-processes-and-outcomes-of-a-randomized-trial-on-peer-support-and-hiv-care-engagement-in-rakai-uganda
#4
April Monroe, Gertrude Nakigozi, William Ddaaki, Jeremiah Mulamba Bazaale, Ronald H Gray, Maria J Wawer, Steven J Reynolds, Caitlin E Kennedy, Larry W Chang
BACKGROUND: People living with human immunodeficiency virus (HIV) who have not yet initiated antiretroviral therapy (ART) can benefit from being engaged in care and utilizing preventive interventions. Community-based peer support may be an effective approach to promote these important HIV services. METHODS: After conducting a randomized trial of the impact of peer support on pre-ART outcomes, we conducted a qualitative evaluation to better understand trial implementation, processes, and results...
January 10, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28063795/effect-of-new-tuberculosis-diagnostic-technologies-on-community-based-intensified-case-finding-a-multicentre-randomised-controlled-trial
#5
Gregory L Calligaro, Lynn S Zijenah, Jonathan G Peter, Grant Theron, Virginia Buser, Ruth McNerney, Wilbert Bara, Tsitsi Bandason, Ureshnie Govender, Michele Tomasicchio, Liezel Smith, Bongani M Mayosi, Keertan Dheda
BACKGROUND: Inadequate case detection results in high levels of undiagnosed tuberculosis in sub-Saharan Africa. Data for the effect of new diagnostic tools when used for community-based intensified case finding are not available, so we investigated whether the use of sputum Xpert-MTB/RIF and the Determine TB LAM urine test in two African communities could be effective. METHODS: In a pragmatic, randomised, parallel-group trial with individual randomisation stratified by country, we compared sputum Xpert-MTB/RIF, and if HIV-infected, the Determine TB LAM urine test (novel diagnostic group), with laboratory-based sputum smear microscopy (routine diagnostic group) for intensified case finding in communities with high tuberculosis and HIV prevalence in Cape Town, South Africa, and Harare, Zimbabwe...
January 4, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28063075/feasibility-and-acceptability-of-a-task-shifted-intervention-to-enhance-adherence-to-hiv-medication-and-improve-depression-in-people-living-with-hiv-in-zimbabwe-a-low-income-country-in-sub-saharan-africa
#6
Melanie Abas, Primrose Nyamayaro, Tarisai Bere, Emily Saruchera, Nomvuyo Mothobi, Victoria Simms, Walter Mangezi, Kirsty Macpherson, Natasha Croome, Jessica Magidson, Azure Makadzange, Steven Safren, Dixon Chibanda, Conall O'Cleirigh
Using a pilot trial design in an HIV care clinic in Zimbabwe, we randomised 32 adults with poor adherence to antiretroviral therapy and at least mild depression to either six sessions of Problem-Solving Therapy for adherence and depression (PST-AD) delivered by an adherence counsellor, or to Enhanced Usual Care (Control). Acceptability of PST-AD was high, as indicated by frequency of session attendance and through qualitative analyses of exit interviews. Fidelity was >80% for the first two sessions of PST-AD but fidelity to the adherence component of PST-AD dropped by session 4...
January 6, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/28061753/treatment-efficacy-of-azithromycin-1%C3%A2-g-single-dose-versus-doxycycline-100%C3%A2-mg-twice-daily-for-7%C3%A2-days-for-the-treatment-of-rectal-chlamydia-among-men-who-have-sex-with-men-a-double-blind-randomised-controlled-trial-protocol
#7
Andrew Lau, Fabian Kong, Christopher K Fairley, Basil Donovan, Marcus Chen, Catriona Bradshaw, Mark Boyd, Janaki Amin, Peter Timms, Sepehr Tabrizi, David G Regan, David A Lewis, Anna McNulty, Jane S Hocking
BACKGROUND: Rectal infection with Chlamydia trachomatis is one of the most common bacterial sexually transmissible infections among men who have sex with men (MSM) with diagnosis rates continuing to rise. Current treatment guidelines recommend either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. However, there are increasing concerns about treatment failure with azithromycin. We are conducting the first randomised controlled trial (RCT) to compare treatment efficacy of azithromycin versus doxycycline for the treatment of rectal chlamydia in MSM...
January 6, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28061017/feasibility-and-safety-of-extended-release-naltrexone-treatment-of-opioid-and-alcohol-use-disorder-in-hiv-clinics-a-pilot-feasibility-randomized-trial
#8
P Todd Korthuis, Paula J Lum, Pamela Vergara-Rodriguez, Keith Ahamad, Evan Wood, Lynn E Kunkel, Neal L Oden, Robert Lindblad, James L Sorensen, Virgilio Arenas, Doan Ha, Raul N Mandler, Dennis Mccarty
BACKGROUND AND AIMS: HIV-infected persons with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare 1) XR-NTX treatment initiation, 2) retention, and 3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics...
January 6, 2017: Addiction
https://www.readbyqxmd.com/read/28060965/the-clinical-research-landscape-in-rhode-island
#9
George Mao, Bharat Ramratnam
OBJECTIVES: To present an overview of clinical research activity and the state of medical research funding in Rhode Island. METHODS: We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. RESULTS: During 2011-2016, 1651 clinical studies were registered in clinicaltrials...
January 6, 2017: Rhode Island Medical Journal
https://www.readbyqxmd.com/read/28060545/safety-and-immunogenicity-of-adenovirus-35-tb-vaccine-candidate-in-adults-with-active-or-previous-tb-a-randomized-trial
#10
Richard N van Zyl-Smit, Aliasgar Esmail, Mary E Bateman, Rodney Dawson, Jonathan Goldin, Eva van Rikxoort, Macaya Douoguih, Maria Grazia Pau, Jerald C Sadoff, J Bruce McClain, Margaret Ann Snowden, Jacqueline Benko, David A Hokey, Kathryn Tucker Rutkowski, Andrew Graves, Barbara Shepherd, Sadritdin Ishmukhamedov, Benjamin M N Kagina, Brian Abel, Willem A Hanekom, Thomas J Scriba, Eric D Bateman
RATIONALE: Administration of tuberculosis vaccines in participants with previous or current pulmonary tuberculosis may have the potential for causing harmful post-vaccination immunological (Koch-type) reactions. OBJECTIVES: To assess the safety and immunogenicity of three dose levels of the AERAS-402 live, replication-deficient adenovirus 35-vectored tuberculosis candidate vaccine, containing three mycobacterial antigens, in individuals with current or previous pulmonary tuberculosis...
January 6, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28060044/early-antiretroviral-therapy-initiation-and-mortality-among-infants-diagnosed-with-hiv-in-the-first-12-weeks-of-life-experiences-from-kinshasa-dr-congo-and-blantyre-malawi
#11
Anna Sheahan, Lydia Feinstein, Queen Dube, Andrew Edmonds, Chawanangwa Mahebere Chirambo, Emily Smith, Frieda Behets, Robert Heyderman, Annelies Van Rie
BACKGROUND: Based on clinical trial results, the WHO recommends infant HIV testing at age 4-6 weeks and immediate antiretroviral therapy (ART) initiation in all HIV-infected infants. Little is known about the outcomes of HIV infected infants diagnosed with HIV in the first weeks of life in resource-limited settings. We assessed ART initiation and mortality in the first year of life among infants diagnosed with HIV by 12 weeks of age. METHODS: Cohort of HIV-infected infants in Kinshasa and Blantyre diagnosed before 12 weeks to estimate 12-month cumulative incidences of ART initiation and mortality, accounting for competing risks...
January 3, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28060013/behavioral-economic-incentives-to-improve-adherence-to-antiretrovirals-early-evidence-from-a-randomized-controlled-trial-in-uganda
#12
Sebastian Linnemayr, Chad Stecher, Barbara Mukasa
OBJECTIVE: Fixed incentives have been largely unsuccessful in improving adherence to antiretroviral (ARV) medication. Therefore we evaluate whether small incentives based on behavioral economic theory can increase adherence to ARV medication among treatment-mature adults in Kampala, Uganda. DESIGN: A randomized control trial design tests whether providing small incentives based on either attending timely clinic visits (intervention group 1) or achieving high medication adherence (intervention group 2) can increase ARV adherence...
January 4, 2017: AIDS
https://www.readbyqxmd.com/read/28059957/the-evolving-role-of-cd4-cell-counts-in-hiv-care
#13
Nathan Ford, Graeme Meintjes, Marco Vitoria, Greg Greene, Tom Chiller
PURPOSE OF REVIEW: The role of the CD4 cell count in the management of people living with HIV is once again changing, most notably with a shift away from using CD4 assays to decide when to start antiretroviral therapy (ART). This article reflects on the past, current and future role of CD4 cell count testing in HIV programmes, and the implications for clinicians, programme managers and diagnostics manufacturers. RECENT FINDINGS: Following the results of recent randomized trials demonstrating the clinical and public health benefits of starting ART as soon as possible after HIV diagnosis is confirmed, CD4 cell count is no longer recommended as a way to decide when to initiate ART...
January 5, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28056752/inhibiting-the-secretion-of-hepatitis-b-surface-antigen-hbsag-to-treat-hepatitis-b-infection-a-review
#14
Simon D Baugh
Chronic Hepatitis B is a major global health issue, and has no known cure. Currently there are over 240 million people infected with the disease, and it leads to the death of over 686,000 people each year. A total of seven treatments which help to control the disease are currently available: interferon-based treatments (pegasys, and interferon alpha), and nucleoside and nucleotide analogs (Viread, Baraclude, Tyzeka, Hepsera, Epivir-HBV), but all require continuing treatment to maintain control of the disease...
January 4, 2017: Infectious Disorders Drug Targets
https://www.readbyqxmd.com/read/28052771/performance-based-financing-for-improving-hiv-aids-service-delivery-a-systematic-review
#15
Amitabh B Suthar, Jason M Nagata, Sabin Nsanzimana, Till Bärnighausen, Eyerusalem K Negussie, Meg C Doherty
BACKGROUND: Although domestic HIV/AIDS financing is increasing, international HIV/AIDS financing has plateaued. Providing incentives for the health system (i.e. performance-based financing [PBF]) may help countries achieve more with available resources. We systematically reviewed effects of PBF on HIV/AIDS service delivery to inform WHO guidelines. METHODS: PubMed, WHO Index Medicus, conference databases, and clinical trial registries were searched in April 2015 for randomised trials, comparative contemporaneous studies, or time-series studies...
January 4, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28043754/a-longitudinal-analysis-of-antiretroviral-adherence-among-young-black-men-who-have-sex-with-men
#16
Dexter R Voisin, Katherine Quinn, Dong Ha Kim, John Schneider
PURPOSE: Young black men who have sex with men (YBMSM) experience poorer antiretroviral therapy (ART) medication adherence relative to their white counterparts. However, few studies have longitudinally examined factors that may correlate with various classifications of ART adherence among this population, which was the primary aim of this study. METHODS: Project nGage was a randomized controlled trial conducted across five Chicago clinics from 2012 to 2015. Survey and medical records data were collected at baseline and 3- and 12-month periods to assess whether psychological distress, HIV stigma, substance use, family acceptance, social support, and self-efficacy predicted ART medication adherence among 92 YBMSM ages 16-29 years...
December 30, 2016: Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine
https://www.readbyqxmd.com/read/28043488/development-of-the-food-supplement-nyaditum-resae-as-a-new-tool-to-reduce-the-risk-of-tuberculosis-development
#17
Nestani Tukvadze, Paula Cardona, Sergo Vashakidze, Natalia Shubladze, Zaza Avaliani, Cris Vilaplana, Pere-Joan Cardona
Nyaditum resae (NR) is a galenic preparation of heat-killed Mycobacterium manresensis (hkMn). This is a new species that belongs to the Mycobacterium fortuitum complex, and it is present in drinking water-thus, regulatorily speaking, it is considered a food supplement. Preclinical studies in the murine model of active tuberculosis (TB) in the C3HeB/FeJ strain have demonstrated that daily administration of NR containing 10(3)-10(6)hkMn for 14days was able to stop the progression toward active TB [1]. The mechanism of action was linked to the induction of low dose tolerance and was related to the increase of Tuberculin Purified Protein Derivative (PPD) memory-specific Tregs (CD4(+)CD25(+)CD39(+) cells) after ex vivo incubation of splenocytes for 7days...
December 2016: International Journal of Mycobacteriology
https://www.readbyqxmd.com/read/28043170/impact-of-disease-drug-and-patient-adherence-on-the-effectiveness-of-antiviral-therapy-in-pediatric-hiv
#18
Chiara Piana, Meindert Danhof, Oscar Della Pasqua
Maintaining effective antiretroviral treatment for life is a major problem, in both resource-limited and resource-rich countries. Despite the progress observed in paediatric antiretroviral therapy, approximately 12% of children still experience treatment failure due to drug resistance, inadequate dosing and poor adherence. We explore the current status of antiretroviral therapy in children with focus on the interaction between disease, drug pharmacokinetics and patient behavior, all of which are strongly interconnected and determine treatment outcome...
January 3, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28042354/simplification-of-haart-therapy-on-ambulatory-hiv-patients-in-malaysia-a-randomized-controlled-trial
#19
Tineshwaran Velvanathan, Farida Islahudin, Benedict L Sim, Nur A Taha
OBJECTIVE: Evaluate the impact of fixed-dose combination (FDC) containing emtricitabine (FTC), tenofovir (TDF), and efavirenz (EFV) versus a free-dose combination (FRC) of the same three drugs on clinical outcomes, adherence and quality of life in Malaysian outpatients with HIV. METHODS: HIV patients (n=120) on highly active antiretroviral therapy (HAART) in the infectious disease clinic of Hospital Sungai Buloh were randomized to either FDC (n=60) or FRC (n=60)...
October 2016: Pharmacy Practice
https://www.readbyqxmd.com/read/28042165/coupled-gel-spreading-and-diffusive-transport-models-describing-microbicidal-drug-delivery
#20
Claire Funke, Kelsey MacMillan, Anthony Ham, Andrew J Szeri, David F Katz
Gels are a drug delivery platform that is being evaluated for application of active pharmaceutical ingredients, termed microbicides, that act topically against vaginal and rectal mucosal infection by sexually transmitted HIV. Despite success in one Phase IIb trial of a vaginal gel delivering tenofovir, problems of user adherence to designed gel application scheduling have compromised results in two other trials. The microbicides field is responding to this dilemma by expanding behavioral analysis of the determinants of adherence while simultaneously improving the pharmacological, biochemical, and biophysical analyses of the determinants of microbicide drug delivery...
October 2, 2016: Chemical Engineering Science
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