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  • 1
    Online Resource
    Online Resource
    Cambridge University Press (CUP) ; 2017
    In:  International Journal of Technology Assessment in Health Care Vol. 33, No. S1 ( 2017), p. 129-129
    In: International Journal of Technology Assessment in Health Care, Cambridge University Press (CUP), Vol. 33, No. S1 ( 2017), p. 129-129
    Abstract: The infectious Diseases Institute (IDI) is a research institute at the College of Health Sciences, Makerere University. Over the years, the number of research studies has greatly increased with an average of fifty active studies per year. Because of the voluminous study activities, investigators were faced with inadvertences of ethical approval deadlines (1). In 2015, a centralized electronic Regulatory Affairs Information System (RAIS) was developed and piloted to track the regulatory process of the entire research projects. RAIS is a web-based system, developed using a Net framework and runs on any operating system using a web browser such as “Google Chrome” and “Mozilla Firefox”. METHODS: A signed approval letter from an accredited Research Ethics Committee, National Drug Authority and Uganda National Council of Science and Technology, the reviewed protocol, consent forms and data collection tools are uploaded electronically into the RAIS with study staff contact information, CVs and Good Clinical Practice (GCP) certificates. RAIS sends automatic “no reply” emails to the investigators and research administration notifying for the need of annual renewal 56, 28 and 14 days before the expiry date of the approvals. The investigator or designated person prepares the application package which is then forwarded to the Research Regulatory Officer for review and submission to the regulatory authority. RESULTS: From January 2015 to November 2016, fourty-three ongoing studies were uploaded to the RAIS of which eleven were clinical trials, twenty-one observational studies, seven diagnostic and four implementation studies. Studies that obtained their annual approvals before the expiry date was 90.7 percent, compared to 29 percent that had reported early submission for annual renewal between January 2013 and December 2014. RAIS has enabled continuity of study activities with timely annual renewed approvals, supported the tracking of staff GCP certificates and populated timely notifications to investigators, resulting in submission of annual application packages on time. CONCLUSIONS: RAIS has strengthened ethical regulatory compliance and provided an effective platform for tracking regulatory processes, thus enabled continuity of study activities with timely annual renewal approvals and greatly supported the tracking of staff GCP certificates.
    Type of Medium: Online Resource
    ISSN: 0266-4623 , 1471-6348
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2017
    detail.hit.zdb_id: 2020486-3
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  • 2
    In: JMIR mHealth and uHealth, JMIR Publications Inc., Vol. 9, No. 2 ( 2021-2-11), p. e22229-
    Abstract: Following the successful scale-up of antiretroviral therapy (ART), the focus is now on ensuring good quality of life (QoL) and sustained viral suppression in people living with HIV. The access to mobile technology in the most burdened countries is increasing rapidly, and therefore, mobile health (mHealth) technologies could be leveraged to improve QoL in people living with HIV. However, data on the impact of mHealth tools on the QoL in people living with HIV are limited to the evaluation of SMS text messaging; these are infeasible in high-illiteracy settings. Objective The primary and secondary outcomes were to determine the impact of interactive voice response (IVR) technology on Medical Outcomes Study HIV QoL scores and viral suppression at 12 months, respectively. Methods Within the Call for Life study, ART-experienced and ART-naïve people living with HIV commencing ART were randomized (1:1 ratio) to the control (no IVR support) or intervention arm (daily adherence and pre-appointment reminders, health information tips, and option to report symptoms). The software evaluated was Call for Life Uganda, an IVR technology that is based on the Mobile Technology for Community Health open-source software. Eligibility criteria for participation included access to a phone, fluency in local languages, and provision of consent. The differences in differences (DIDs) were computed, adjusting for baseline HIV RNA and CD4. Results Overall, 600 participants (413 female, 68.8%) were enrolled and followed-up for 12 months. In the intervention arm of 300 participants, 298 (99.3%) opted for IVR and 2 (0.7%) chose SMS text messaging as the mode of receiving reminders and health tips. At 12 months, there was no overall difference in the QoL between the intervention and control arms (DID=0.0; P=.99) or HIV RNA (DID=0.01; P=.94). At 12 months, 124 of the 256 (48.4%) active participants had picked up at least 50% of the calls. In the active intervention participants, high users (received 〉 75% of reminders) had overall higher QoL compared to low users (received 〈 25% of reminders) (92.2 versus 87.8, P=.02). Similarly, high users also had higher QoL scores in the mental health domain (93.1 versus 86.8, P=.008) and better appointment keeping. Similarly, participants with moderate use (51%-75%) had better viral suppression at 12 months (80/94, 85% versus 11/19, 58%, P=.006). Conclusions Overall, there was high uptake and acceptability of the IVR tool. While we found no overall difference in the QoL and viral suppression between study arms, people living with HIV with higher usage of the tool showed greater improvements in QoL, viral suppression, and appointment keeping. With the declining resources available to HIV programs and the increasing number of people living with HIV accessing ART, IVR technology could be used to support patient care. The tool may be helpful in situations where physical consultations are infeasible, including the current COVID epidemic. Trial Registration ClinicalTrials.gov NCT02953080; https://clinicaltrials.gov/ct2/show/NCT02953080
    Type of Medium: Online Resource
    ISSN: 2291-5222
    Language: English
    Publisher: JMIR Publications Inc.
    Publication Date: 2021
    detail.hit.zdb_id: 2719220-9
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  • 3
    In: PLoS ONE, Public Library of Science (PLoS), Vol. 7, No. 12 ( 2012-12-17), p. e51631-
    Type of Medium: Online Resource
    ISSN: 1932-6203
    Language: English
    Publisher: Public Library of Science (PLoS)
    Publication Date: 2012
    detail.hit.zdb_id: 2267670-3
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