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  Non-Randomized Study Protocols and...

  Apr 8, 2020

  Investigating Health Impacts of Natural Resource Extraction Projects in Burkina Faso, Ghana, Mozambique, and Tanzania: Protocol for a Mixed Methods Study

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  Authors List:

  • Andrea Farnham  
  • Hermínio Cossa  
  • Dominik Dietler  
  • Rebecca Engebretsen  
  • Andrea Leuenberger  
  • Isaac Lyatuu  
  • Belinda Nimako  
  • Hyacinthe R Zabre  
  • Fritz Brugger  
  • Mirko S Winkler  

  Abstract:

  Background: Natural resource extraction projects offer both opportunities and risks for sustainable development and health in host communities. Often, however, the health of the community suffers. Health impact assessment (HIA) can mitigate the risks and promote the benefits of development but is not routinely done in the developing regions that could benefit the most. Objective: Our study aims to investigate health and health determinants in regions affected by extractive industries in Burkina Faso, Ghana, Mozambique, and Tanzania. The evidence generated in our study will inform a policy dialogue on how HIA can be promoted as a regulatory approach as part of the larger research initiative called the HIA4SD (Health impact assessment for sustainable development) project. Methods: The study is a concurrent triangulation, mixed methods, multi-stage, multi-focus project that specifically addresses the topics of governance and policy, social determinants of health, health economics, health systems, maternal and child health, morbidity and mortality, and environmental determinants, as well as the associated health outcomes in natural resource extraction project settings across four countries. To investigate each of these health topics, the project will (1) use existing population-level databases to quantify incidence of disease and other health outcomes and determinants over time using time series analysis; (2) conduct two quantitative surveys on mortality and cost of disease in producer regions; and (3) collect primary qualitative data using focus groups and key informant interviews describing community perceptions of the impacts of extraction projects on health and partnership arrangements between the projects and local and national governance. Differences in health outcomes and health determinants between districts with and without an extraction project will be analyzed using matched geographical analyses in quasi-Poisson regression models and binomial regression models. Costs to the health system and to the households from diseases found to be associated with projects in each country will be estimated retrospectively. Results: Fieldwork for the study began in February 2019 and concluded in February 2020. At the time of submission, qualitative data collection had been completed in all four study countries. In Burkina Faso, 36 focus group discussions and 74 key informant interviews were conducted in three sites. In Ghana, 34 focus group discussions and 64 key informant interviews were conducted in three sites. In Mozambique, 75 focus group discussions and 103 key informant interviews were conducted in four sites. In Tanzania, 36 focus group discussions and 84 key informant interviews were conducted in three sites. Quantitative data extraction and collection is ongoing in all four study countries. Ethical approval for the study was received in all four study countries prior to beginning the fieldwork. Data analyses are underway and results are expected to be published in 2020 and 2021. Conclusions: Disentangling the complex interactions of resource extraction projects with their host communities requires an integrative approach drawing on many methodologies under the HIA umbrella. By using complementary data sources to address the question of population health in project areas from several angles, bias and missing data will be reduced, generating high-quality evidence to aid countries in moving toward sustainable development.

  • JMIR Res Protoc 2020;9(4):e17138

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  RCTs - Protocols/Proposals (non-eHealth)

  Apr 7, 2020

  Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis...

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  Authors List:

  • Peter A Merkel  
  • David R Jayne  
  • Chao Wang  
  • Jan Hillson  
  • Pirow Bekker  

  Abstract:

  Background: Antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis is a serious, often life-threatening disease. In new-onset disease or a relapse, the standard treatment is immunosuppressive therapy with glucocorticoids; these therapies are associated with substantial short- and long-term toxicity. Complement component 5a (C5a) binding to C5a receptor (C5aR) may play a central role in the pathogenesis of ANCA-associated vasculitis. Avacopan is a novel, orally bioavailable, and highly selective antagonist of human C5aR. Avacopan does not interfere with the production of C5b or the membrane attack complex (ie, terminal complement complex) and does not block C5a binding to a second receptor, C5L2 (also called C5aR2), shown to be protective in antimyeloperoxidase glomerulonephritis. This trial will evaluate if avacopan replaces the need for chronic glucocorticoids in the treatment of ANCA-associated vasculitis. Objective: The aim of this study is to determine the proportions of patients in remission at week 26 and with sustained remission at week 52, defined as Birmingham Vasculitis Activity Score=0, and not taking glucocorticoids within the 4 weeks before week 26 and week 52, respectively. Methods: The Avacopan Development in Vasculitis to Obtain Corticosteroid elimination and Therapeutic Efficacy study is a randomized, double-blind, active-comparator (prednisone), 2-arm study evaluating the safety and efficacy of avacopan versus prednisone, administered in combination with other immunosuppressive therapy. Eligible subjects will have active disease requiring induction of remission. Subjects are stratified based on the type of immunosuppressive therapy, ANCA subtype, and new or relapsing disease. Target sample size is 300 patients, enrolled at over 200 sites globally. All authors and local ethics committees approved the study design. All patients will provide informed consent. Results: Enrollment of patients was completed in Q4 2018. Topline results are anticipated to be published by Q3 2020. Conclusions: Results will be released irrespective of whether the findings are positive or negative. Trial Registration: ClinicalTrials.gov NCT02994927; https://clinicaltrials.gov/ct2/show/NCT02994927

  • JMIR Res Protoc 2020;9(4):e16664

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  RCTs - Protocols/Proposals (eHealth)

  Apr 7, 2020

  Gamified Mobile Computerized Cognitive Behavioral Therapy for Japanese University Students With Depressive Symptoms: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Kengo Yokomitsu  
  • Tomonari Irie  
  • Mayu Sekiguchi  
  • Ayako Shimizu  
  • Hirofumi Matsuoka  
  • Sally Nicola Merry  
  • Karolina Stasiak  

  Abstract:

  Background: Evidence shows that computerized self-help interventions are effective for reducing symptoms of depression. One such intervention, SPARX, is a gamified mobile computerized cognitive behavioral therapy (cCBT) developed for adolescents in New Zealand, which was shown to be as effective as usual care for young people with mild-to-moderate symptoms of depression. However, gamified cCBT has not yet been tested in Japan. Objective: This trial is designed to investigate whether a Japanese-adapted version of SPARX improves depressive symptoms in Japanese university students with mild-to-moderate depressive symptoms. Methods: In this 7-week, multicenter, stratified, parallel-group, superiority randomized trial, participants will be allocated to either a treatment condition (SPARX) or a wait-list control condition. SPARX is a fully automated program, which will be delivered to the mobile phone or tablet device of the participants. SPARX is designed as an interactive fantasy game to guide the user through seven modules that teach key CBT strategies. All participants will be recruited from universities via advertisements on online bulletin boards, the campus newspaper, and posters. Participants in the treatment condition will use the SPARX program weekly. The primary outcome is the reduction of depressive symptoms (using Patient Health Questionnaires-9) measured at baseline and weekly: once after the 7-week intervention and once at a 1-month follow-up. Secondary outcomes include satisfaction with the program and satisfaction with life, measured by the Satisfaction With Life Scale; positive and negative moods, measured by the Profile of Mood States Second Edition; social functioning, measured by the EuroQol Instrument; rumination, measured by the Ruminative Responses Scale; and coping, measured by the Brief Coping Orientation to Problem Experienced Inventory. Results: This study received funding from The Research Institute of Personalized Health Sciences, Health Sciences University of Hokkaido, and obtained institutional review board approval in September 2019. Data collection began in April 2019. Conclusions: Results of this trial may provide further evidence for the efficacy of gamified cCBT for the treatment of depression and, specifically, provide support for using SPARX with Japanese university students. Trial Registration: Japan Primary Registries Network UMIN000034354; https://tinyurl.com/uu7xd77

  • JMIR Res Protoc 2020;9(4):e15164

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  Non-Randomized Study Protocols and...

  Apr 6, 2020

  Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

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  Authors List:

  • Roberto Silingardi  
  • Pasqualino Sirignano  
  • Francesco Andreoli  
  • Wassim Mansour  
  • Mattia Migliari  
  • Francesco Speziale  
  • LIVE Study Collaborators

  Abstract:

  Background: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval.

  • JMIR Res Protoc 2020;9(4):e16959

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  Non-Randomized Study Protocols and...

  Apr 6, 2020

  Effectiveness of Gastric Bypass Versus Gastric Sleeve for Cardiovascular Disease: Protocol and Baseline Results for a Comparative Effectiveness Study

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  Authors List:

  • Karen J Coleman  
  • Heidi Fischer  
  • David E Arterburn  
  • Douglas Barthold  
  • Lee J Barton  
  • Anirban Basu  
  • Anita Courcoulas  
  • Cecelia L Crawford  
  • Peter Fedorka  
  • Benjamin Kim  
  • Edward Mun  
  • Sameer Murali  
  • Kristi Reynolds  
  • Kangho Suh  
  • Rong Wei  
  • Tae K Yoon  
  • Robert Zane  

  Abstract:

  Background: When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. Objective: The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. Methods: The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. Results: Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m² at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P<.001), more likely to have had an emergency department visit in the year before surgery (P=.006), less likely to have a mental illness before surgery (P<.001), and more likely to have had a CVD event at any time before surgery (P<.001). Conclusions: This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies.

  • JMIR Res Protoc 2020;9(4):e14936

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  Non-randomized Protocols and Methods...

  Apr 3, 2020

  Promoting Wellness Through Mobile Health Technology in a College Student Population: Protocol Development and Pilot Study

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  Authors List:

  • Susanne B Haga  
  • Ryan Shaw  
  • Charles Kneifel  
  • Sarah J Bond  
  • Geoffrey S Ginsburg  

  Abstract:

  Background: The health and well-being of college students has garnered widespread attention and concern in recent years. At the same time, the expansion and evaluation of digital technologies has grown in recent years for different target populations. Objective: This protocol aims to describe a pilot feasibility study on wearables to assess student interest and to gather baseline data from college freshmen, for the academic year 2019 to 2020. Methods: All full-time college freshmen residing in a single residence hall were eligible to participate. Study invitations were sent by post and email 5 weeks prior to move-in. Web-based enrollment and in-person attendance at study orientation sessions were mandatory. We provided the incoming freshmen with a wearable and study app. Wearable data and weekly survey data will be collected through the study app and analyzed. We have collected demographic, enrollment, and attrition data and the number and type of support requests from students. Results: The planning phase of the WearDuke initiative was completed in 2018 to 2019, and the pilot study was launched in July 2019. Of the 175 students invited, 120 enrolled and 114 started the study; 107 students remained active participants till the end of the fall semester. For Apple Watch participants (the majority of study population), weekly survey completion rates ranged from 70% (74/106) to 96% (95/99). Conclusions: Halfway through the pilot, we noticed that the initiative has been received positively by the students with minimal attrition. The short- and long-term benefits may be substantial for students, the campus, the utilization of health services, and long-term health.

  • JMIR Res Protoc 2020;9(4):e16474

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  Non-randomized Protocols and Methods...

  Apr 3, 2020

  User Experience and Potential Health Effects of a Conversational Agent-Based Electronic Health Intervention: Protocol for an Observational Cohort Study

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  Authors List:

  • Marian Z M Hurmuz  
  • Stephanie M Jansen-Kosterink  
  • Harm op den Akker  
  • Hermie J Hermens  

  Abstract:

  Background: While the average human life expectancy has increased remarkably, the length of life with chronic conditions has also increased. To limit the occurrence of chronic conditions and comorbidities, it is important to adopt a healthy lifestyle. Within the European project “Council of Coaches,” a personalized coaching platform was developed that supports developing and maintaining a healthy lifestyle. Objective: The primary aim of this study is to assess the user experience with and the use and potential health effects of a fully working Council of Coaches system implemented in a real-world setting among the target population, specifically older adults or adults with type 2 diabetes mellitus or chronic pain. Methods: An observational cohort study with a pretest-posttest design will be conducted. The study population will be a dynamic cohort consisting of older adults, aged ≥55 years, as well as adults aged ≥18 years with type 2 diabetes mellitus or chronic pain. Each participant will interact in a fully automated manner with Council of Coaches for 5 to 9 weeks. The primary outcomes are user experience, use of the program, and potential effects (health-related factors). Secondary outcomes include demographics, applicability of the virtual coaches, and user interaction with the virtual coaches. Results: Recruitment started in December 2019 and is conducted through mass mailing, snowball sampling, and advertisements in newspapers and social media. This study is expected to conclude in August 2020. Conclusions: The results of this study will either confirm or reject the hypothesis that a group of virtual embodied conversational coaches can keep users engaged over several weeks of interaction and contribute to positive health outcomes. Trial Registration: The Netherlands Trial Register: NL7911; https://www.trialregister.nl/trial/7911

  • JMIR Res Protoc 2020;9(4):e16641

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  RCTs - Protocols/Proposals (non-eHealth)

  Apr 3, 2020

  Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Laura Fiona Gruner  
  • Michael Hoffmeister  
  • Leopold Ludwig  
  • Hermann Brenner  

  Abstract:

  Background: Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low. Objective: The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years. Methods: This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy. Results: A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany—AOK Baden-Wuerttemberg—were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019. Conclusions: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. Trial Registration: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt

  • JMIR Res Protoc 2020;9(4):e16413

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  Non-Randomized Study Protocols and...

  Apr 2, 2020

  Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol...

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  Authors List:

  • Charlotte Ward  
  • Kevin Baker  
  • Sarah Marks  
  • Dawit Getachew  
  • Tedila Habte  
  • Cindy McWhorter  
  • Paul Labarre  
  • Jonathan Howard-Brand  
  • Nathan P Miller  
  • Hayalnesh Tarekegn  
  • Solomie Jebessa Deribessa  
  • Max Petzold  
  • Karin Kallander  

  Abstract:

  Background: Acute respiratory infections (ARIs), primarily pneumonia, are the leading infectious cause of under-5 mortality worldwide. Manually counting respiratory rate (RR) for 60 seconds using an ARI timer is commonly practiced by community health workers to detect fast breathing, an important sign of pneumonia. However, correctly counting breaths manually and classifying the RR is challenging, often leading to inappropriate treatment. A potential solution is to introduce RR counters, which count and classify RR automatically. Objective: This study aims to determine how the RR count of an Automated Respiratory Infection Diagnostic Aid (ARIDA) agrees with the count of an expert panel of pediatricians counting RR by reviewing a video of the child’s chest for 60 seconds (reference standard), for children aged younger than 5 years with cough and/or difficult breathing. Methods: A cross-sectional study aiming to enroll 290 children aged 0 to 59 months presenting to pediatric in- and outpatient departments at a teaching hospital in Addis Ababa, Ethiopia, was conducted. Enrollment occurred between April and May 2017. Once enrolled, children participated in at least one of three types of RR evaluations: (1) agreement—measure the RR count of an ARIDA in comparison with the reference standard, (2) consistency—measure the agreement between two ARIDA devices strapped to one child, and (3) RR fluctuation—measure RR count variability over time after ARIDA attachment as measured by a manual count. The agreement and consistency of expert clinicians (ECs) counting RR for the same child with the Mark 2 ARI timer for 60 seconds was also measured in comparison with the reference standard. Results: Primary outcomes were (1) mean difference between the ARIDA and reference standard RR count (agreement) and (2) mean difference between RR counts obtained by two ARIDA devices started simultaneously (consistency). Conclusions: Study strengths included the design allowing for comparison between both ARIDA and the EC with the reference standard RR count. A limitation is that exactly the same set of breaths were not compared between ARIDA and the reference standard since ARIDA can take longer than 60 seconds to count RR. Also, manual RR counting, even when aided by a video of the child’s chest movements, is subject to human error and can result in low interrater reliability. Further work is needed to reach global consensus on the most appropriate reference standard and an acceptable level of agreement to provide ministries of health with evidence to make an informed decision on whether to scale up new automated RR counters. Trial Registration: ClinicalTrials.gov NCT03067558; https://clinicaltrials.gov/ct2/show/NCT03067558

  • JMIR Res Protoc 2020;9(4):e16531

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  RCTs - Pilots/Feasibility Studies...

  Apr 2, 2020

  A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility...

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  Authors List:

  • Ping Zou  
  • Jennifer Stinson  
  • Monica Parry  
  • Cindy-Lee Dennis  
  • Yeqin Yang  
  • Zhongqiu Lu  

  Abstract:

  Background: This proposed study aims to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC), a classroom-based, antihypertensive, dietary educational intervention, to an innovative smartphone app (mDASHNa-CC). This study will enable Chinese Canadian seniors to access antihypertensive dietary interventions anytime, regardless of where they are. It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. Objective: The goal of this study is to design and test the usability and feasibility of a smartphone-based dietary educational app to support a healthy diet and hypertension control for Chinese Canadian seniors. Methods: A mixed-method two-phase design will be used. The study will be conducted in a Chinese immigrant community in Toronto, Ontario, Canada. Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited. In Phase I, we will design and test the usability of the app using a user-centered approach. In Phase II, we will test the feasibility of the app, including implementation (primary outcomes of accrual and attrition rates, technical issues, acceptability of the app, and adherence to the intervention) and preliminary effectiveness (secondary outcomes of systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization), using a pilot, two-group, randomized controlled trial with a sample size of 60 participants in a Chinese Canadian community. Results: The study is supported by the Startup Research Grant from Nipissing University, Canada. The research ethics application is under review by a university research ethics review board. Conclusions: The study results will make several contributions to the existing literature, including illustrating the rigorous design and testing of smartphone app technology for hypertension self-management in the community, exploring an approach to incorporating traditional medicine into chronic illness management in minority communities and promoting equal access to current technology among minority immigrant senior groups. Trial Registration: Clinicaltrials.gov NCT03988894; https://clinicaltrials.gov/ct2/show/NCT03988894

  • JMIR Res Protoc 2020;9(4):e15545

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  RCTs - Pilots/Feasibility Studies...

  Apr 2, 2020

  Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot...

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  Authors List:

  • Paul Drain  
  • Kenneth Ngure  
  • Nelly Mugo  
  • Matthew Spinelli  
  • Purba Chatterjee  
  • Peter Bacchetti  
  • David Glidden  
  • Jared Baeten  
  • Monica Gandhi  

  Abstract:

  Background: The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. Objective: The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. Methods: The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. Results: This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. Conclusions: A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. Trial Registration: ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464

  • JMIR Res Protoc 2020;9(4):e15029

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  RCTs - Protocols/Proposals (funded,...

  Apr 1, 2020

  Efficacy and Safety of Rituximab in Refractory CIDP With or Without IgG4 Autoantibodies (RECIPE): Protocol for a Double-Blind, Randomized, Placebo-Controlled...

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  Authors List:

  • Shinobu Shimizu  
  • Masahiro Iijima  
  • Yuki Fukami  
  • Natsuko Tamura  
  • Masahiro Nakatochi  
  • Masahiko Ando  
  • Ryoji Nishi  
  • Haruki Koike  
  • Kenichi Kaida  
  • Michiaki Koga  
  • Takashi Kanda  
  • Hidenori Ogata  
  • Jun-Ichi Kira  
  • Masahiro Mori  
  • Satoshi Kuwabara  
  • Masahisa Katsuno  

  Abstract:

  Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated peripheral neuropathy that is currently classified into several clinical subtypes, which are presumed to have different pathogenic mechanisms. Recently, studies identified a subgroup of patients with CIDP who were positive for IgG4 autoantibodies against paranodal proteins, such as neurofascin-155 and contactin-1, who respond poorly to first-line therapies for typical CIDP, including intravenous immunoglobulin therapy. Objective: This study aims to evaluate the efficacy and safety of intravenous rituximab according to IgG4 autoantibody status in patients with refractory CIDP. Methods: The Evaluation of the Efficacy and Safety of Rituximab in Refractory CIDP Patients with IgG4 Autoantibodies in the Exploratory Clinical (RECIPE) trial consists of 2 cohorts: a multicenter, placebo-controlled, randomized study cohort of 15 patients with IgG4 autoantibody-positive CIDP (rituximab:placebo = 2:1) and an open-label trial cohort of 10 patients with antibody-negative CIDP. The primary endpoint is improvement in functional outcome assessed using the adjusted Inflammatory Neuropathy Cause and Treatment Disability Scale score at 26, 38, or 52 weeks after the start of treatment with rituximab in patients with CIDP and anti-paranodal protein antibodies. Secondary outcome measures include grip strength, manual muscle testing sum scores, results of nerve conduction studies, and other functional scales. Results: We plan to enroll 25 cases for the full analysis set. Recruitment is ongoing, with 14 patients enrolled as of January 2020. Enrollment will close in September 2020, and the study is planned to end in December 2021. Conclusions: This randomized controlled trial will determine if rituximab is safe and effective in patients with anti-paranodal antibodies. An open-label study will provide additional data on the effects of rituximab in patients with antibody-negative CIDP. The results of the RECIPE trial are expected to provide evidence for the positioning of rituximab as a pathogenesis-based therapeutic for refractory CIDP. Trial Registration: ClinicalTrials.gov NCT03864185, https://clinicaltrials.gov/ct2/show/NCT03864185 ; The Japan Registry of Clinical Trials jRCT2041180037, https://jrct.niph.go.jp/en-latest-detail/jRCT2041180037

  • JMIR Res Protoc 2020;9(4):e17117

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