scholarly journals Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial

2015 ◽  
Vol 4 (1) ◽  
pp. e11 ◽  
Author(s):  
Kelly L L'Engle ◽  
Kimberly Green ◽  
Stacey M Succop ◽  
Amos Laar ◽  
Samuel Wambugu
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Hiv Care ◽  
Randomized Controlled ◽  
Care And Treatment

scholarly journals Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial

2018 ◽  
Vol 6 (7) ◽  
pp. e155 ◽  
Author(s):  
Willem Venter ◽  
Jesse Coleman ◽  
Vincent Lau Chan ◽  
Zara Shubber ◽  
Mothepane Phatsoane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Hiv Care ◽  
Randomized Controlled ◽  
Linkage To Hiv Care

scholarly journals Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Willem Venter ◽  
Jesse Coleman ◽  
Vincent Lau Chan ◽  
Zara Shubber ◽  
Mothepane Phatsoane ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Laboratory Test ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Hiv Care ◽  
Hiv Patients ◽  
Randomized Controlled ◽  
Laboratory Results ◽  
Linkage To Hiv Care

BACKGROUND In HIV treatment program, gaps in the “cascade of care” where patients are lost between diagnosis, laboratory evaluation, treatment initiation, and retention in HIV care, is a well-described challenge. Growing access to internet-enabled mobile phones has led to an interest in using the technology to improve patient engagement with health care. OBJECTIVE The objectives of this trial were: (1) to assess whether a mobile phone–enabled app could provide HIV patients with laboratory test results, (2) to better understand the implementation of such an intervention, and (3) to determine app effectiveness in improving linkage to HIV care after diagnosis. METHODS We developed and tested an app through a randomized controlled trial carried out in several primary health care facilities in Johannesburg. Newly diagnosed HIV-positive patients were screened, recruited, and randomized into the trial as they were giving a blood sample for initial CD4 staging. Trial eligibility included ownership of a phone compatible with the app and access to the internet. Trial participants were followed for a minimum of eight months to determine linkage to HIV care indicated by an HIV-related laboratory test result. RESULTS The trial outcome results are being prepared for publication, but here we describe the significant operational and technological lessons provided by the implementation. Android was identified as the most suitable operating system for the app, due to Android functionality and communication characteristics. Android also had the most significant market share of all smartphone operating systems in South Africa. The app was successfully developed with laboratory results sent to personal smartphones. However, given the trial requirements and the app itself, only 10% of screened HIV patients successfully enrolled. We report on issues such as patient eligibility, app testing in a dynamic phone market, software installation and compatibility, safe identification of patients, linkage of laboratory results to patients lacking unique identifiers, and present lessons and potential solutions. CONCLUSIONS The implementation challenges and lessons of this trial may assist future similar mHealth interventions to avoid some of the pitfalls. Ensuring sufficient expertise and understanding of the programmatic needs by the software developer, as well as in the implementation team, with adequate and rapid piloting within the target groups, could have led to better trial recruitment. However, the majority of screened patients were interested in the study, and the app was installed successfully in patients with suitable smartphones, suggesting that this may be a way to engage patients with their health care data in future. CLINICALTRIAL ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW)

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

scholarly journals Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Martha G Welch ◽  
◽  
Myron A Hofer ◽  
Susan A Brunelli ◽  
Raymond I Stark ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Randomized Controlled

scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

BACKGROUND Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. OBJECTIVE The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. METHODS We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. RESULTS Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; <i>P</i>&lt;.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; <i>P</i>&lt;.001) and a higher recommendation rate for future use (95% vs 64%; <i>P</i>&lt;.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. CONCLUSIONS MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

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