Dataset Information

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

ABSTRACT: 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:The aim of this study will be 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 began 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.

SUBMITTER: Jones J

PROVIDER: S-EPMC7060494 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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

Jones Jeb J Dominguez Karen K Stephenson Rob R Stekler Joanne D JD Castel Amanda D AD Mena Leandro A LA Jenness Samuel M SM Siegler Aaron J AJ Sullivan Patrick S PS

JMIR research protocols 20200221 2

<h4>Background</h4>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.<h4>Objective</h4>The aim of this study will be to assess the efficacy of a mobile app for increasing PrEP uptake among MSM ...[more]

PMID: 32130178

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Project description:BackgroundHIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM.ObjectiveThe aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app.MethodsThis 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY.ResultsApp refinement is underway. Enrollment for the pilot RCT began in October 2018.ConclusionsMyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.International registered report identifier (irrid)PRR1-10.2196/10694.

Project description:BACKGROUND:In the United States, young minority men who have sex with men (MSM) are most likely to become infected with HIV. The use of antiretroviral medications to reduce the risk of acquiring HIV infection (pre-exposure prophylaxis, PrEP) is an efficacious and promising prevention strategy. There have been significant advances regarding PrEP, including the definitive demonstration that PrEP reduces HIV acquisition and the development of clinical prescribing guidelines. Despite these promising events, the practical implementation of PrEP can be challenging. Data show that PrEP's safety and effectiveness could be greatly compromised by suboptimal adherence to treatment, and there is concern about the potential for an increase in HIV risk behavior among PrEP users. Due to these challenges, the prescribing of PrEP should be accompanied by behavioral interventions to promote adherence. OBJECTIVE:This study aimed to develop an immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. METHODS:Game development was guided by social learning theory, taking into consideration the perspectives of young adult MSM who are taking PrEP. A total of 20 young men who have sex with men (YMSM; aged 18-35 years) were recruited from a sexually transmitted infection (STI), HIV testing, and PrEP care clinic in Jackson, Mississippi, between October 2016 and June 2017. They participated in qualitative interviews guided by the information-motivation-behavioral skills (IMB) model of behavior change. The mean age of participants was 26 years, and all the participants identified as male. Acceptability of the game was assessed with the Client Service Questionnaire and session evaluation form. RESULTS:A number of themes emerged that informed game development. YMSM taking PrEP desired informational game content that included new and comprehensive details about the effectiveness of PrEP, details about PrEP as it relates to doctors' visits, and general information about STIs other than HIV. Motivational themes that emerged were the desire for enhancement of future orientation; reinforcement of positive influences from partners, parents, and friends; collaboration with health care providers; decreasing stigma; and a focus on personal relevance of PrEP-related medical care. Behavioral skills themes centered around self-efficacy and strategies for adherence to PrEP and self-care. CONCLUSIONS:We utilized youth feedback, IMB, and agile software development to create a multilevel, immersive, action-oriented iPhone gaming intervention to improve motivation for adherence to PrEP. There is a dearth of gaming interventions for persons on PrEP. This study is a significant step in working toward the development and testing of an iPhone gaming intervention to decrease HIV risk and promote adherence to PrEP for YMSM.

Project description:BackgroundDaily and on-demand pre-exposure prophylaxis (PrEP) has been well demonstrated to effectively prevent HIV acquisition for men who have sex with men (MSM). More than half of the MSM PrEP users in Taiwan prefer on-demand PrEP; however, on-demand PrEP involves a complicated dosing regimen because it requires precoital and postcoital dosing and sex events are hard to anticipate. Although there are a growing number of mobile apps designed to improve access to HIV prevention services and HIV medication adherence, few mobile apps focus on adherence to PrEP or are designed to accommodate a complicated, on-demand PrEP dosing schedule.ObjectiveThe aim of this project is to evaluate the usability of a newly developed mobile app (UPrEPU) to assist MSM PrEP users to self-monitor their adherence to either daily or on-demand PrEP using a user-centered scheme.MethodsThis research will be conducted in 2 phases: app development and usability study. In the app development phase, we will first conduct formative research with end users and stakeholders through in-depth interviews; the results will provide PrEP users' and PrEP navigators' personas as material used in the app conceptualization stage. PrEP navigators are individuals in the health care system that help HIV-negative individuals who need assistance in accessing PrEP care. A low-fidelity prototype of the app feature will be formatted by applying a participatory design approach to engage PrEP users, designers, and app developers in the design process of the app. Then, a high-fidelity prototype of the app will be developed for the usability study and refined iteratively by the multidisciplinary team and new internal testers. Internal testers include the research team consisting of experts in public health, infectious disease, and industrial design and a close network of the research team that is taking PrEP. In the usability study phase, we will enroll 70 MSM PrEP users and follow them up for 4 months. Usability, feasibility, and effectiveness of adherence monitoring will be evaluated.ResultsRefinement of the UPrEPU app is currently ongoing. The usability study commenced in May 2020.ConclusionsThe UPrEPU app is one of the first apps designed to help MSM PrEP users to self-manage their PrEP schedule better regardless of dosing modes. With a design-thinking approach and adapting to the cultural context in Taiwan's MSM population, this novel app will have substantial potential to be acceptable and feasible and contribute to the reduction of new HIV infections.Trial registrationClinicalTrials.gov NCT04248790; https://clinicaltrials.gov/ct2/show/NCT04248790.International registered report identifier (irrid)PRR1-10.2196/20360.

Project description:BackgroundHIV disproportionately affects young men who have sex with men (YMSM) in the United States. Uptake of evidence-based prevention strategies, including routine HIV testing and use of pre-exposure prophylaxis (PrEP), is suboptimal in this population. Novel methods for reaching YMSM are required.ObjectiveThe aim of this study is to describe the development and evaluate the feasibility and acceptability of the MyChoices app, a mobile app designed to increase HIV testing and PrEP use among YMSM in the United States.MethodsInformed by the social cognitive theory, the MyChoices app was developed using an iterative process to increase HIV testing and PrEP uptake among YMSM. In 2017, beta theater testing was conducted in two US cities to garner feedback (n=4 groups; n=28 YMSM). These findings were used to refine MyChoices, which was then tested for initial acceptability and usability in a technical pilot (N=11 YMSM). Baseline and 2-month postbaseline assessments and exit interviews were completed. Transcripts were coded using a deductive approach, and thematic analysis was used to synthesize data; app acceptability and use data were also reported.ResultsThe MyChoices app includes personalized recommendations for HIV testing frequency and PrEP use; information on types of HIV tests and PrEP; ability to search for nearby HIV testing and PrEP care sites; and ability to order free home HIV and sexually transmitted infection test kits, condoms, and lube. In theater testing, YMSM described that MyChoices appears useful and that they would recommend it to peers. Participants liked the look and feel of the app and believed that the ability to search for and be pinged when near an HIV testing site would be beneficial. Some suggested that portions of the app felt repetitive and preferred using casual language rather than formal or medicalized terms. Following theater testing, the MyChoices app was refined, and participants in the technical pilot used the app, on average, 8 (SD 5.0; range 2-18) times over 2 months, with an average duration of 28 (SD 38.9) minutes per session. At the 2-month follow-up, the mean System Usability Scale (0-100) score was 71 (ie, above average; SD 11.8). Over 80% (9/11) of the participants reported that MyChoices was useful and 91% (10/11) said that they would recommend it to a friend. In exit interviews, there was a high level of acceptability for the content, interface, and features.ConclusionsThese data show the initial acceptability and user engagement of the MyChoices app. If future studies demonstrate efficacy in increasing HIV testing and PrEP uptake, the app is scalable to reach YMSM across the United States.Trial registrationClinicaltrials.gov NCT03179319; https://clinicaltrials.gov/ct2/show/NCT03179319.International registered report identifier (irrid)RR2-10.2196/10694.

Project description:BACKGROUND:The uptake of pre-exposure prophylaxis (PrEP) has been slow for young black men who have sex with men (BMSM) living in the southern United States. This is a significant issue because 8 of the 10 states with the highest rates of new HIV infections are in the South. Jackson, Mississippi (MS), the site of this project, has the second highest AIDS diagnosis rate in the nation and the highest rate of HIV infection for young, urban BMSM. This study will develop and test an engaging, interactive, and cost-effective mobile messaging intervention to improve engagement in PrEP care for BMSM aged 18 to 35 years living in Jackson, MS. OBJECTIVE:The goals of this mixed methods study are to (1) conduct qualitative interviews with young BMSM in Jackson, MS, to understand individual, community, and structural barriers affecting engagement in PrEP-related care, (2) assemble a PrEP mobile messaging intervention that includes text messages with publicly available internet content (websites and YouTube videos) that provide factual information, motivational materials, and behavioral skills related to PrEP and HIV prevention, and (3) evaluate the preliminary efficacy of the intervention in a randomized controlled study with PrEP-eligible BMSM receiving care in STI/HIV testing clinics in Jackson, MS. METHODS:This research protocol will be conducted in 2 phases. A development phase will involve in-depth interviews (n=30) with PrEP-eligible BMSM who receive care in STI/HIV testing clinics in MS. These interviews will allow researchers to select the texted material that will be sent out during the intervention. The second phase will consist of an unblinded, small, randomized controlled trial among 66 new participants to examine the preliminary efficacy of the intervention compared with enhanced standard of care (ESC) on attendance at a PrEP services appointment (the first step in initiating PrEP care) and receipt of a PrEP prescription, based on self-report and electronic medical records. The free, publicly available material will be sent to PrEP-eligible BMSM in 8 to 16 interactive text messages over 4 weeks. Study assessments will occur at enrollment and at 4- and 16-weeks postenrollment and can be completed online or in person. All participants will be recruited from a local clinic. RESULTS:Institutional review board approval was received on January 16, 2017, and research activities, subsequently, began in February 2018. Recruitment for the study concluded in November 2019. In total, 65 participants were randomized with 33 being assigned to the intervention and 32 to ESC. Collection of follow-up data is ongoing. CONCLUSIONS:This PrEP mobile messaging intervention aims to increase uptake of PrEP by BMSM in the southern United States. This intervention uses interactive, tailored text messaging and appealing free Web content (publicly accessible educational websites and YouTube videos) to promote linkage to PrEP care and increase HIV preventative behaviors. A cost-effective PrEP mobile messaging intervention has great potential to improve information about PrEP, improve motivation to use PrEP, and decrease stigma and structural barriers that often prevent engagement in PrEP-related medical care. TRIAL REGISTRATION:ClinicalTrials.gov NCT03308097; https://clinicaltrials.gov/ct2/show/NCT03308097. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15781.

Project description:BACKGROUND:Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM. OBJECTIVE:The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT). METHODS:This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups. RESULTS:Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019. CONCLUSIONS:The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population. TRIAL REGISTRATION:ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/10659.

Dataset Information

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

Publications

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

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