Satisfying Clinical Research Guidance and Regulations for mHealth Technologies

Brian Moyer¹, Christopher Whalen¹, Lisa Hoopengardner², Yentram Huyen³, Katie Watkins², Michael Holdsworth¹, Jiwen Sun⁴, Kevin Newell², Susan Vogel⁵, Ruma Das⁶, Alex Rosenthal³, Michael Tartakovsky^3
1Research Data and Communication Technologies, Inc,
USA;  ²Clinical Research Directorate/Clinical Monitoring Research
Program, SAIC-Frederick, Inc., Frederick National Laboratory for
Cancer Research, Maryland, USA; ³Office of Cyber
Infrastructure and Computational Biology, National Institute of
Allergy and Infectious Diseases, National Institutes of Health, USA; ⁴Dell Services, Federal Government, USA; ⁵Regulatory Compliance and Human
Subjects Protection Branch, Division of Clinical Research, National
Allergy and Infectious Disease, National Institute of Health, USA; ⁶Dell-PSGS – Efficiency
System Technology Inc. USA

Journal MTM 1:4S:33, 2012
DOI:10.7309/jmtm.55

Abstract

The Office of Cyber Infrastructure and Computational Biology (OCICB) of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH has been developing a solution that complies with current guidance frameworks and regulatory requirements while leveraging the potentials offered by mHealth technologies for data collection. OCICB has designed an mHealth solution that maps to the paper processes developed over the past century for clinical research. We designed the system for use in regions of low to middle-income countries where the patients often have no other clinical record. For our pilot, we selected a natural history study that does not have the same regulatory requirements as an Investigational New Drug (IND) study. We retained our existing paper-based clinical data capture management system in order to compare quality control reports between paper-based and mobile electronic capture methods. The solution complies with regulatory frameworks and requirements such as Good Clinical Practices and 21 CFR Part 11, which requires full audit trails of the data collection process at the source and the validation stages. It also provides the capacity for workflows that support the data validation process within the field research framework. We expect to show that the accuracy of data collection improves using mobile source data collection. This will reduce the time and cost of validating the collected data before final analysis for clinical research while maintaining the regulatory framework that protects patient interests. The solution will further provide clinical monitors with the ability to remotely access the source data and thus reduce the cost of travel for monitoring as well as reducing the impact on patients due to mistakes made while entering the data.

WelTel Retain: A randomized controlled trial protocol of a text-messaging intervention to improve patient retention in pre-antiretroviral therapy HIV care

Mia Van Der Kop¹, DavidOjakaa²,Lennie Bazira², LehanaThabane³,LilianMbau²,HelenGakuruh² Koki Kinagwi², Edward Mills⁴, Carlo Marra⁵, Richard Lester⁵,

¹University of British Columbia Centre for Disease Control, Vancouver, Canada,  ² African Medical and Research Foundation, Nairobi, Kenya ³McMaster University, Hamilton,Canada⁴University of Ottawa, Ottawa, Canada⁵University of British Columbia, Vancouver,  Canada

Journal MTM 1:4S:1, 2012

DOI:10.7309/jmtm.25

Abstract

High levels of patient retention after first clinical contact contribute to the timely initiation of antiretroviral therapy (ART) and better health outcomes. In Kenya (WelTel Kenya1), a weekly short message service (SMS) text message led to improved ART adherence and viral load suppression.

The objectives of this study are to: 1) determine if the WelTel intervention improves retention in Stage 1 HIV care (patient receives CD4 count results); 2) determine whether the WelTel intervention improves 12-month retention; and 3) evaluate the cost-effectiveness of the WelTel intervention.

A randomized controlled trial will be conducted at the Kibera Community Health Centre in Nairobi, Kenya. Over one year, HIV positive individuals newly enrolling at the clinic will be recruited and randomly allocated to an intervention or control arm (standard care) at a 1:1 ratio. Intervention arm participants will receive a weekly SMS ‘check-in’ to which they will be required to respond within 48 hours. An HIV clinician will follow-up and triage any problems that are identified. Patients will be followed for one year, with a primary endpoint of retention in care at 12 months.

This study is in a pre-enrolment phase; a recruitment target of 686 participants provides 80% power to detect a proportionate difference of 15% in the primary outcome (alpha=0.05). Data will be analyzed according to intention to treat principles. Chi-squared tests will be used for categorical outcomes; and t-tests or Mann-Whitney U tests for continuous outcomes.

The WelTel Retain trial will contribute important information on the effectiveness of an established mHealth intervention to engage patients in care during the first year of HIV care, before initiating ART. Trial results and cost-effectiveness evaluation will inform how WelTel might contribute to the long-term success of PEPFAR-funded programs and towards a sustainable global HIV/AIDS response