scholarly journals A Theory-based mHealth Intervention for Methamphetamine-using MSM: Study Protocol for a Randomized Controlled Trial (Getting Off) (Preprint)

2020 ◽  
Author(s):  
Cathy J Reback ◽  
Jesse B Fletcher ◽  
Raymond P Mata
Keyword(s):  
Public Health ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Repeated Measures Design ◽  
Historical Comparison ◽  
Randomized Controlled ◽  
Cross Platform ◽  
The Impact

BACKGROUND Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased rates of HIV prevalence and transmission, as well as substandard advancement along the HIV Prevention and Care Continua. Meth use among MSM is deeply integrated into socio-sexual networks including the use of smartphone applications (“app”) and websites to find sexual partners. Given the growth of mobile health (mHealth) technology, it is no longer necessary or reasonable to limit meth treatment options to physical sites, clustered in urban areas, and administered using generic, non-tailored content. OBJECTIVE In a two-arm randomized controlled trial (N=300), Getting Off will assess the impact and non-inferiority of a cross-platform app (developed from an established manualized Getting Off meth treatment intervention) to help MSM (18 to 65 years) reduce or eliminate meth use and HIV sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum including uptake of HIV testing, pre-, and post-exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those who are HIV negative; ART uptake and adherence for those who are HIV positive. METHODS Participants will be randomized into one of two arms: Arm A: Immediate access to the Getting Off app (Immediate Delivery [ID]: n=150); or Arm B: Participants will have access to the Getting Off app after a delayed 30-day period (Delayed Delivery [DD]: n=150). Participants in both arms will receive the same Getting Off app and participants in both arms will be given 30-days to complete the 24 sessions. The randomized two-arm repeated measures design will assess participants at 1-, 2- (DD arm only), 3-, 6-, and 9-months post-randomization to determine longitudinal intervention effects, overserved treatment effects, and a historical comparison with a matched sample of participants (n=600) who have attended the brick-and-mortar group-based Getting Off intervention. RESULTS Recruitment began in January 2019 for Phase 1, the formative phase. In January and February 2019, four separate focus groups (N=36) were conducted to provide input on the adaptation of the Getting Off group-based manual to a cross-platform computerized mobile app. The data collection for Phase 2, the randomized controlled trial, is expected to be completed in January 2023. Final results are anticipated for April 2023. CONCLUSIONS By creating a culturally responsive, cross-platform computerized mobile app, Getting Off aims to reduce methamphetamine use and improve sexual health outcomes among meth-using MSM. Given the severe personal and public health consequences of meth use, the Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent and highly scalable meth treatment for MSM and other high-risk populations. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03884946 https://clinicaltrials.gov/ct2/show/NCT03884946

scholarly journals A Theory-Based mHealth Intervention (Getting Off) for Methamphetamine-Using Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/22572 ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. e22572
Author(s):  
Cathy J Reback ◽  
Jesse B Fletcher ◽  
Raymond P Mata
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Care Continuum ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Brick And Mortar ◽  
Sex With Men ◽  
The Impact

Background Methamphetamine (meth) use among men who have sex with men (MSM) is associated with increased HIV prevalence and transmission and substandard advancement along the HIV prevention and care continuum. Given the growth of mobile health (mHealth) technologies, it is no longer necessary to limit meth treatment options to physical, brick-and-mortar sites, and administration using generic, nontailored content. Objective In a 2-arm randomized controlled trial (RCT; N=300), we aim to evaluate the use of an mHealth intervention (Getting Off) to assess the impact and noninferiority of a cross-platform app (developed from a manualized meth treatment intervention) to help MSM reduce meth use and HIV sexual risk behaviors and improve their advancement along the HIV prevention and care continuum (HIV testing, pre-exposure prophylaxis uptake and persistence, and antiretroviral therapy uptake and adherence). Methods Participants will be randomized into 2 arms: arm A, with immediate access to the app (immediate delivery: n=150), or arm B, with delayed access to the app after a 30-day period (delayed delivery: n=150). Participants in both arms will use the same Getting Off app and will have 30 days to complete the 24 sessions. Participants will be assessed at the 1-, 2- (delayed delivery arm only), 3-, 6-, and 9-month timepoints to determine observed treatment effects and will be compared with a historical matched sample of participants (n=~600) who received the brick-and-mortar group-based Getting Off intervention. Results Recruitment began in January 2019 for phase 1, the formative phase. In January and February 2019, 4 focus groups (N=36) were formed to provide input on the adaptation of the group-based manual intervention to a mobile app. Data collection for phase 2, the RCT, is expected to be completed in January 2023. The final results are anticipated in April 2023. Conclusions By creating a culturally responsive mobile app, Getting Off aims to reduce meth use and improve sexual health outcomes among meth-using MSM. The Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent, and highly scalable meth treatment for MSM. Trial Registration Clinicaltrials.gov NCT03884946; https://clinicaltrials.gov/ct2/show/NCT03884946 International Registered Report Identifier (IRRID) DERR1-10.2196/22572

scholarly journals The impact of teleconsultation on type 2 diabetic patients in the Brazilian public Health System: Randomized Controlled Trial (TELEconsulta Diabetes trial) (Preprint)

10.2196/23679 ◽  
2020 ◽  
Author(s):  
Daniela Laranja Gomes Rodrigues ◽  
Gisele Silvestre Belber ◽  
Frederica Valle De Queiroz Padilha ◽  
Frederico Rafael Moreira ◽  
Marcos Aurélio Maeyama ◽  
...  
Keyword(s):  
Public Health ◽  
Randomized Controlled Trial ◽  
Public Health System ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Randomized Controlled ◽  
The Impact ◽  
Type 2 Diabetic

scholarly journals Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Payal Agarwal ◽  
Geetha Mukerji ◽  
Laura Desveaux ◽  
Noah M Ivers ◽  
Onil Bhattacharyya ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mobile App ◽  
Self Management ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Intervention Impact ◽  
The Impact ◽  
Hba1c Levels

BACKGROUND As the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear. OBJECTIVE The primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls. METHODS The study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app. RESULTS The results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG−WLC] −0.42, 95% CI −1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants’ 3-month HbA1c levels (95% CI −0.03 to −0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51). CONCLUSIONS The results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed. CLINICALTRIAL Clinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343)

scholarly journals A Theoretically-Based Mobile App to Increase Pre-exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

10.2196/16231 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e16231 ◽  
Author(s):  
Jeb Jones ◽  
Karen Dominguez ◽  
Rob Stephenson ◽  
Joanne D Stekler ◽  
Amanda D Castel ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
Mobile App ◽  
Southern United States ◽  
Randomized Controlled ◽  
Southern Us ◽  
Sex With Men ◽  
Exposure Prophylaxis

Background HealthMindr is a mobile phone HIV prevention app for men who have sex with men (MSM). In a previous pilot study, HealthMindr was found to be acceptable among users and to demonstrate preliminary effectiveness for increasing pre-exposure prophylaxis (PrEP) uptake among MSM. PrEP is a highly effective HIV prevention intervention; however, uptake remains low. Objective To assess the efficacy of a mobile app for increasing PrEP uptake among MSM in the southern United States. Methods In this randomized controlled trial, we will assess the efficacy of HealthMindr for increasing PrEP uptake among MSM in the following three southern US cities: Atlanta, Georgia; Jackson, Mississippi; and Washington, DC. In total, 657 men will be recruited and randomized to intervention and control arms in a 2:1 ratio. Participants in the intervention arm will receive access to the full HealthMindr app, with information and resources about PrEP (eg, frequently asked questions, risk assessment tool, and PrEP provider locator), other HIV prevention information, ability to order free HIV/sexually transmitted infection test kits, and additional resources related to substance use and mental health. Participants in the control arm will use the HealthMindr app but will only have access to the study timeline and a message center to communicate with study staff. Participants will complete quarterly surveys to assess self-reported PrEP uptake over 12 months of follow-up. Self-reported PrEP uptake will be verified by dried blood spot testing and/or uploading a photograph of a PrEP prescription. Results Participant recruitment is expected to begin in January 2020. Conclusions This trial will determine whether the HealthMindr app can increase PrEP uptake among MSM in the southern United States. Trial Registration ClinicalTrials.gov NCT03763942; https://clinicaltrials.gov/ct2/show/NCT03763942 International Registered Report Identifier (IRRID) PRR1-10.2196/16231

scholarly journals The effectiveness of a mobile phone education-based on self-efficacy and DASH diet among patient with high blood pressure: a randomized controlled trial

2020 ◽  
Author(s):  
Zahra Darabi ◽  
Marzieh Araban ◽  
Amir Abbas Azizi ◽  
Kambiz Ahmadi Angali ◽  
Fatemeh Borazjani
Keyword(s):  
Public Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Mobile App ◽  
Public Health Care ◽  
Dash Diet ◽  
Randomized Controlled ◽  
Health Care Centers

Abstract Background: Hypertension HTN is a global public health problem with an increasing incidence worldwide. On one hand the imperative role of self-efficacy in controlling of chronic disease has been reported; on the other hand, dietary approach to stop hypertension (DASH) diet reported as one of most appropriate dietary approaches for controlling HTN. Here in present study we aimed to investigate the efficiency of mobile app for improving self-efficacy on adherence of DASH diet in HTN patients. Methods: the present randomized controlled trial conducted on 88 patients with hypertension who referring to public health care centers between Novomber2019 to March 2020. The subjects were randomly assigned to receive mobile app for DASH-related recommendation +usual care; or control group to follow their habitual diets and given usual health care in public health care centers for twelve weeks. Self-efficacy, SBP and DBP, body mass index, physical activity and dietary intakes were assessed at the baseline and the end of trial. The ANCOVA was used to show the differences between the two groups and adjusting for baseline and covariates. Results: Results showed that whilst there were no significant differences in DBP and SBP at the baseline, but intervention lead to significant decrease in both SBP and DBP. Results from self-efficacy showed that baseline values were not significantly different between two groups; however, all five components improved significantly at the end of trial. Conclusion: Here we showed that using mobile apps for educating DASH diet and improving self-efficacy lead to better control of BP among patients whilst their self-efficacy improved simultaneously.Trial registration: Iran Clinical Trials Registry: IRCT20190930044933N1.Date of registration:31.10.2019URL of trial registry record: https://www.irct.ir/trial/42612

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