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      Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial

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          Abstract

          Background

          Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice in preventive vaccine trials, under the HIV Vaccine Trials Network (HVTN), is to capture related side effects in a hardcopy tool. The reconciliation of this tool, 2 weeks after vaccination at the safety visit, is time consuming, laborious, and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool may improve accuracy and completeness of collected data and prove feasible and acceptable over the hardcopy tool.

          Objective

          The objective of our study is to develop and implement a USSD tool for real-time safety data collection that is feasible and acceptable to participants and staff, allowing for a comparison with the hardcopy tool in terms of completeness and accuracy.

          Methods

          This feasibility study is being conducted at a single study site, the Centre for the AIDS Programme of Research in South Africa eThekwini Clinical Research site, in South Africa. The feasibility study is nested within a parent phase 1/2a preventive HIV vaccine trial (HVTN 108) as an open-label, randomized controlled trial, open to all consenting parent trial participants. Participants are randomly assigned in a 1:1 ratio to the hardcopy or USSD tool, with data collection targeted to the third and fourth injection time points in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the safety visit. We will itemize and compare error rates between the hardcopy tool and the USSD printout and associated source documentation. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool.

          Results

          The study has received regulatory approval. We have designed and developed the USSD tool to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both English and isiZulu have been successfully installed on a tablet. Data collection is complete, but analysis is pending.

          Conclusions

          Several HIV preventive vaccine trials are active in Southern Africa, making tools to improve efficiencies and minimize error necessary. Our results will help to determine whether the USSD tool can be used in future vaccine studies and can eventually be rolled out.

          Trial Registration

          ClincalTrials.gov NCT02915016; https://clinicaltrials.gov/ct2/show/NCT02915016 (Archived by WebCite at http://www.webcitation.org/71h0cztDM)

          Registered Report Identifier

          RR1-10.2196/9396

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          Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection.

          Tara Horvath, Hana Azman, Gail E Kennedy … (2012)
          More than 34 million people are presently living with HIV infection. Antiretroviral therapy (ART) can help these people to live longer, healthier lives, but adherence to ART can be difficult. Mobile phone text-messaging has the potential to help promote adherence in these patients. To determine whether mobile phone text-messaging is efficacious in enhancing adherence to ART in patients with HIV infection. Using the Cochrane Collaboration's validated search strategies for identifying randomised controlled trials and reports of HIV interventions, along with appropriate keywords and MeSH terms, we searched a range of electronic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), MEDLINE (via PubMed), PsycINFO, Web of Science, and the World Health Organization (WHO) Global Index Medicus. The date range was from  01 January 1980 to 01 November 2011. There were no limits to language or publication status. Randomised controlled trials (RCTs) in which patients or their caregivers (in the case of infants and children) of any age, in any setting, and receiving ART were provided with mobile phone text messages as a means of promoting adherence to ART. Two authors independently examined the abstracts of all identified trials. We initially identified 243 references. Seventeen full-text articles were closely reviewed. Both authors abstracted data independently, using a pre-designed, standardised data collection form. When appropriate, data were combined in meta-analysis. Two RCTs from Kenya were included in the review. One trial compared short weekly text messages against standard care. The other trial compared short daily, long daily, short weekly and long weekly messages against standard care. Both trials were with adult patients.In the trial comparing only short weekly messages to standard care, text messaging was associated with a lower risk of non-adherence at 12 months (RR 0.77, 95% CI 0.63 to 0.93) and with the non-occurrence of virologic failure at 12 months (RR 0.83, 95% CI 0.69 to 0.99).In the trial that compared different intervals and lengths for text-messaging to standard care, long weekly text-messaging was not significantly associated with a lower risk of non-adherence compared to standard care (RR 0.79, 95% CI 0.60 to 1.04). Patients receiving weekly text-messages of any length were at lower risk of non-adherence at 48 weeks than were patients receiving daily messages of any length (RR 0.79, 95% CI 0.64 to 0.99). There were no significant differences between weekly text-messaging of any length (RR 1.01, 95% CI 0.75 to 1.37) and between short or long messaging at either interval (RR 0.99, 95% CI 0.78 to 1.27). Compared to standard care, any daily text-messaging, whether short or long, did not reduce the risk for non-adherence (RR 0.99, 95% CI 0.82 to 1.20).In meta-analysis of both trials, any weekly text-messaging (i.e. whether short or long messages) was associated with a lower risk of non-adherence at 48-52 weeks (RR 0.78, 95% CI 0.68 to 0.89). The effect of short weekly text-messaging was also significant (RR 0.77, 95% CI 0.67 to 0.89). There is high-quality evidence from the two RCTs that mobile phone text-messaging at weekly intervals is efficacious in enhancing adherence to ART, compared to standard care. There is high quality evidence from one trial that weekly mobile phone text-messaging is efficacious in improving HIV viral load suppression. Policy-makers should consider funding programs proposing to provide weekly mobile phone text-messaging as a means for promoting adherence to antiretroviral therapy. Clinics and hospitals should consider implementing such programs. There is a need for large RCTs of this intervention in adolescent populations, as well as in high-income countries.
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            mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature

            Caricia Catalani, William Philbrick, Hamish Fraser … (2013)
            This systematic review assesses the published literature to describe the landscape of mobile health technology (mHealth) for HIV/AIDS and the evidence supporting the use of these tools to address the HIV prevention, care, and treatment cascade. The speed of innovation, broad range of initiatives and tools, and heterogeneity in reporting have made it difficult to uncover and synthesize knowledge on how mHealth tools might be effective in addressing the HIV pandemic. To do address this gap, a team of reviewers collected literature on the use of mobile technology for HIV/AIDS among health, engineering, and social science literature databases and analyzed a final set of 62 articles. Articles were systematically coded, assessed for scientific rigor, and sorted for HIV programmatic relevance. The review revealed evidence that mHealth tools support HIV programmatic priorities, including: linkage to care, retention in care, and adherence to antiretroviral treatment. In terms of technical features, mHealth tools facilitate alerts and reminders, data collection, direct voice communication, educational messaging, information on demand, and more. Studies were mostly descriptive with a growing number of quasi-experimental and experimental designs. There was a lack of evidence around the use of mHealth tools to address the needs of key populations, including pregnant mothers, sex workers, users of injection drugs, and men who have sex with men. The science and practice of mHealth for HIV are evolving rapidly, but still in their early stages. Small-scale efforts, pilot projects, and preliminary descriptive studies are advancing and there is a promising trend toward implementing mHealth innovation that is feasible and acceptable within low-resource settings, positive program outcomes, operational improvements, and rigorous study design
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              H_pe for mHealth: more "y" or "o" on the horizon?

              Garrett Mehl, Sulie L. Chang, Alain Labrique … (2013)
              Efforts in the domain of mobile health, or mHealth, have been criticized for the unfettered proliferation of pilots and a lack of a rigorous evidence base to support these strategies. In this letter, we present the response of a group of researchers in the mHealth community to the recent calls for evidence issued by global health and funding agencies. We support our conclusions through a summary of the numerous ongoing mHealth studies listed in the US federal clinical trial registry. We conducted a search on the US federal clinicaltrials.gov database using the keywords "mHealth", "mobile" or "cell AND phone" to obtain 1678 results of studies. We manually inspected each result to check if it fit the purview of an mHealth study. Studies that were terminated or withdrawn prior to submission were excluded. We identified 215 unique mHealth studies that were registered in the clinicaltrials.gov database, of which 8.4% (n=18) were observational in nature while the remaining 91.6% (n=197) were interventional. Of the 215 studies, 81.8% (n=176) studies used a classical randomized trial design and 40 new studies were added to the database between May and November 2012 alone. Based on these results, we posit that the field is entering a new 'era' where a body of rigorous evaluation of mHealth strategies is rapidly accumulating. The transition into an era of evidence-based mHealth supports our position that innovation in this domain can be evaluated with the same rigor as other public health strategies, attenuating some of the hype previously associated with mHealth. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.
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                Author and article information

                Contributors
                Kathryn Therese Mngadi:
                Clinical Research DepartmentThe Aurum InstituteThe Ridge, Aurum House29 Queens Road, ParktownJohannesburg, 1693South Africa27 0825744541kmngadi@auruminstitute.org
                ORCID: http://orcid.org/0000-0002-7847-3671
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: October 2018
                Publication date (Electronic): 03 October 2018
                Volume: 7
                Issue: 10
                Electronic Location Identifier: e175
                Affiliations
                [1 ] Centre for the AIDS Programme of Research in South Africa Durban South Africa
                [2 ] Clinical Research Department The Aurum Institute Johannesburg South Africa
                [3 ] Fred Hutchinson Cancer Research Center Seattle, WA United States
                Author notes
                Corresponding Author: Kathryn Therese Mngadi kmngadi@ 123456auruminstitute.org
                Author information
                http://orcid.org/0000-0002-7847-3671
                http://orcid.org/0000-0003-1935-4637
                http://orcid.org/0000-0003-4252-5297
                http://orcid.org/0000-0001-9940-7676
                http://orcid.org/0000-0002-2016-8500
                Article
                Publisher ID: v7i10e175
                DOI: 10.2196/resprot.9396
                PMC ID: 6231778
                PubMed ID: 30282622
                SO-VID: df835087-3675-4d0c-b07c-ddae7c0aba09
                Copyright © ©Kathryn Therese Mngadi, Bhavna Maharaj, Yajna Duki, Douglas Grove, Jessica Andriesen. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.10.2018.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                History
                Date received : 12 November 2017
                Date revision requested : 18 January 2018
                Date revision received : 13 June 2018
                Date accepted : 29 June 2018
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: research protocol,mobile health application,hiv preventive vaccines,telemedicine,mobile applications,aids vaccines
                Data availability:
                Keywords: research protocol, mobile health application, hiv preventive vaccines, telemedicine, mobile applications, aids vaccines

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