Development, Testing and Reporting of Mobile Apps for Psycho-social Interventions: Lessons from the Pharmaceuticals

Naeem, Farooq; Syed, Yumeen

doi:10.4172/2168-9784.1000191

Cited by 10 publications

(5 citation statements)

References 13 publications

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“…Stakeholders will include doctors, nurses, pharmacists, mental health counselors, community outreach workers, and nongovernmental organization (NGO) staff involved in providing HIV-related services to the target population. We will start with 5 FGs (with 6-8 participants per group), each lasting approximately 60 minutes [ 43 ]. We will recruit further if saturation is not achieved.…”

Section: Methodsmentioning

confidence: 99%

“…After adaptation and refinement as described in phase IA (theater testing) and phase IB (alpha testing), beta testing of JomPrEP will be conducted to assess its usability and acceptability with Malaysian MSM. Beta testing of the app (n=50) will also help identify potential bugs and ensure its usability in a real-world setting [ 43 ]. Screening, eligibility criteria, and enrollment will be identical to the procedures used for phase IA (ie, theater testing).…”

Section: Methodsmentioning

confidence: 99%

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Clinic-Integrated Mobile Health Intervention (“JomPrEP” App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial

Shrestha¹,

Wickersham²,

Khati³

et al. 2022

JMIR Res Protoc

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Background Men who have sex with men (MSM) are disproportionately affected by the HIV epidemic in Malaysia and globally. Cross-cutting prevention strategies such as mobile health (mHealth), particularly smartphone apps, hold great promise for HIV prevention efforts among Malaysian MSM, especially when linked to HIV testing and pre-exposure prophylaxis (PrEP). Objective This study aims to adapt an existing app to create and test a clinic-integrated app (JomPrEP), a virtual platform to deliver HIV testing and PrEP services for MSM in Malaysia. Methods The JomPrEP project involves developing and testing an app-based platform for HIV prevention among Malaysian MSM and will be conducted in 2 phases. In phase I (development phase), we will adapt an existing mHealth app (HealthMindr) to create a new clinic-integrated app called “JomPrEP” to deliver holistic HIV prevention services (eg, HIV testing, PrEP, support services for mental health and substance use) among MSM in Malaysia. During phase II (testing phase), we will use a type I hybrid implementation science trial design to test the efficacy of JomPrEP while gathering information on implementation factors to guide future scale-up in real-world settings. Results As of September 2022, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, clinic-integrated JomPrEP app, which provides a virtual platform for MSM in Malaysia to facilitate their engagement in HIV prevention in a fast and convenient manner. Based on participant feedback provided during phase I, we are currently optimizing JomPrEP and the research protocols for a large-scale efficacy trial (phase II), which will commence in January 2023. Conclusions Scant HIV prevention resources coupled with entrenched stigma, discrimination, and criminalization of same-sex sexual behavior and substance use hamper access to HIV prevention services in Malaysia. If found efficacious, JomPrEP can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries. Trial Registration ClinicalTrials.gov NCT05325476; https://clinicaltrials.gov/ct2/show/NCT05325476 International Registered Report Identifier (IRRID) DERR1-10.2196/43318

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Clinic-Integrated Mobile Health Intervention (“JomPrEP” App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial

Shrestha¹,

Wickersham²,

Khati³

et al. 2022

JMIR Res Protoc

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“…Recruitment and screening of participants will be identical to prior phases of the project. A sample size of 10 participants was chosen based on recommendations for initial beta testing of a new technology [30]. Eligible participants will be at least 18 years old, HIV negative or of unknown HIV status, cisgender men, identify as MSM, and have access to have access to a smartphone, computer, or internet-enabled tablet.…”

Section: Participants and Recruitmentmentioning

confidence: 99%

Integrated online-to-offline (O2O) model of care for HIV prevention and treatment among men who have sex with men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial (Preprint)

Khati,

Wickersham,

Gautam

et al. 2024

Preprint

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BACKGROUND HIV continues to have a disproportionate impact on specific populations in Malaysia, particularly men who have sex with men (MSM). HIV self-testing (HIVST) is a strategy that has been shown to scale-up HIV testing rates. However, it faces shortcomings due to concerns about self-efficacy, result interpretation, and lack of counseling and linkage to care. This underscores the need for an innovative approach that integrates HIVST with timely counseling, expert guidance, and referrals to enhance engagement in relevant HIV prevention or treatment. OBJECTIVE This study aims to describe the protocol used in developing and testing a web-based platform (i.e., CINTAI) providing an HIVST kit and real-time e-counseling to support online-to-offline linkage to HIV care services for MSM in Malaysia. METHODS The methods are reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines. The CINTAI project will be conducted in two phases. In phase I (development phase), we will adapt existing HIVST web-based platforms (Jom-Test and Adam's Love) to create a new online-to-offline HIVST and counseling platform called “CINTAI” for Malaysian MSM. In phase II (testing phase), we will use a type 1 hybrid implementation trial design to determine the feasibility, acceptability, and preliminary efficacy of “CINTAI” compared to treatment as usual among Malaysian MSM, with assessments conducted over 6 months. Multilevel implementation factors will also be collected using the Consolidated Framework for Implementation Research (CFIR) to guide future adoption and scale-up. RESULTS As of April 2024, we have completed phase I of the proposed study. Based on a series of formative work completed during phase I, we developed a fully functional, web-based platform, called CINTAI, which provides a virtual platform for MSM in Malaysia to order HIVST kits for free and to receive HIV counseling, followed by offline linkage to HIV prevention services (if HIV-negative) or HIV treatment services (if HIV-positive). Based on participant feedback during Phase I, we are currently optimizing CINTAI and the research protocols for a pilot trial (phase II), which will commence in May 2024. CONCLUSIONS Despite being at high risk for HIV transmission, MSM in Malaysia have alarmingly low testing and linkage to HIV care services, prompting the need for innovative approaches to support HIV prevention efforts. If found to be feasible and acceptable, CINTAI can be easily adapted for a range of health outcomes and health care delivery services for MSM, including adaptation to other low- and middle-income countries.

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“…A complementary desktop application is also being developed for the PCP and nurse to use in the clinic. This prototype is currently undergoing the alpha (utility) testing by medical experts [51,52] and beta (usability) testing by patients with MetS [53]. Data which are entered by the PCP and patients into the app will be stored in a secure server.…”

Section: Development Of the Empower-sustain Self-management Mobile Apmentioning

confidence: 99%

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

Daud

Ramli

Abdul-Razak

et al. 2020

Preprint

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Background: Epidemiological studies from various parts of the world have clearly demonstrated that Metabolic Syndrome (MetS) is an increasing global health problem, not only in the western societies but also in the Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour in patients with MetS components i.e. diabetes or hypertension. However, evidence is lacking in terms of its effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN © Self-Management e-Health Intervention in improving patient activation and self-management behaviours among patients with MetS. This paper presents the study protocol. Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18-60 years old with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN © intervention for 6 months and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN © intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurse and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app © , strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure ® short form Malay version (PAM ® -13-M) questionnaire. The secondary outcomes include the change in waist circumference, body mass index, blood pressure, patients’ physical activity level, eating behavior, patients’ perception on chronic illness care, satisfaction in patient-physician interaction and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. These include acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and its potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.

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Development, Testing and Reporting of Mobile Apps for Psycho-social Interventions: Lessons from the Pharmaceuticals

Cited by 10 publications

References 13 publications

Clinic-Integrated Mobile Health Intervention (“JomPrEP” App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial

Clinic-Integrated Mobile Health Intervention (“JomPrEP” App) to Improve Uptake of HIV Testing and Pre-exposure Prophylaxis Among Men Who Have Sex With Men in Malaysia: Protocol for an Intervention Development and Multiphase Trial

Integrated online-to-offline (O2O) model of care for HIV prevention and treatment among men who have sex with men in Malaysia: Protocol for an Intervention Development and a Multiphase Trial (Preprint)

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

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