OBJECTIVE: Our main objective is to study the pre-effects and posteffects of the Personalized Mobile Mental Health Intervention (PMMH-I) for workplace cyberbullying in public and private hospitals in Malaysia.

METHODS: A hospital-based multimethod multi-analytic evidential approach is proposed, involving social and psychological health informatics. The project has been subdivided into 3 stages, starting with Phase 1, a prevalence study, followed by exploratory studies. Phase 2 consists of a quasi-experimental design, whereas the development of a prototype and their testing will be proposed in Phase 3. Each stage includes the use of quantitative and qualitative methods (mixed-method program), using SPSS (version 26.0; IBM Corp) and Stata (version 16.1; StataCorp) as tools for quantitative research, and NVivo (version 1.0; QSR International) and Atlas.ti (version 9.0.16; ATLAS.ti Scientific Software Development GmbH) for qualitative research.

RESULTS: The results of this study will determine the pre- and posteffectiveness of an integrated PMMH-I for health care professionals. The prototype system platform will be developed and implemented in a public and private hospital. Results from Phase 1 will be published in 2021, followed by the implementation of Phase 2 in subsequent years.

CONCLUSIONS: This study will provide evidence and guidance regarding the implementation of a personalized mobile mental health intervention for health care professionals into routine public and private hospitals to enhance communication and resolve conflicts.

OBJECTIVE: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.

METHODS: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)-marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported.

RESULTS: This study protocol was approved by the Tallaght University Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.

CONCLUSIONS: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306.

OBJECTIVE: This study aims to investigate the feasibility of EEG measurements as an objective indicator for the identification of tinnitus-associated neural activities.

METHODS: To reduce heterogeneity, participants served as their own control using residual inhibition (RI) to modulate the tinnitus perception in a within-subject EEG study design with a tinnitus group. In addition, comparison with a nontinnitus control group allowed for a between-subjects comparison. We will apply RI stimulation to generate tinnitus and nontinnitus conditions in the same subject. Furthermore, high-frequency audiometry (up to 13 kHz) and tinnitometry will be performed.

RESULTS: This work was funded by the Infrastructure Grant of the University of Bern, Bern, Switzerland and Bernafon AG, Bern, Switzerland. Enrollment for the study described in this protocol commenced in February 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in 2019.

CONCLUSIONS: This study design helps in comparing the neural activity between conditions in the same individual, thereby addressing a notable limitation of previous EEG tinnitus studies. In addition, the high-frequency assessment will help to analyze and classify tinnitus symptoms beyond the conventional clinical standard.

OBJECTIVE: The aim of this study is to leverage social cohesion to promote healthier behaviors and prevent chronic disease in a low SES community. This protocol outlines the methodology for a pilot study to assess the feasibility of an intervention (Free Time For Wellness [FT4W]) using a social networking platform (Nextdoor) with mothers living in an urban, low-income community to improve social cohesion and promote healthy behaviors.

METHODS: The study will involve three phases: (I) co-designing the intervention with mothers in the neighborhoods of interest, (II) implementing the intervention with community leaders through the social networking platform, and (III) evaluating the intervention's feasibility. Phase I of the study will include qualitative data collection and analysis from in-depth, semistructured interviews and a co-design group session with mothers. Phases II and III of the study include a pre- and postintervention survey of participating mothers. Neighborhood-level data on social cohesion will also be collected to enable comparison of outcomes between neighborhoods with higher and lower baseline social cohesion.

RESULTS: As of March 2021, recruitment and data collection for this study are complete. This protocol outlines our original study plan, although the final enrollment numbers and intervention implementation deviated from our initial planned methodology that is outlined in this protocol. These implementation learnings will be shared in subsequent publications of our study results.

CONCLUSIONS: Ultimately, this study aims to: (1) determine the barriers and facilitators to finding free time for wellness among a population of low-income mothers to inform the co-design process, and (2) implement and study the feasibility of an intervention that leverages social cohesion to promote physical activity in a community of low-income mothers. The results of this study will provide preliminary feasibility evidence to inform a larger effectiveness trial, and will further our understanding of how social cohesion might influence well-being.

OBJECTIVE: This paper presents a study protocol for an online survey (Cyberbullying Among Traditional and Complementary Medicine Practitioner [TCMPs]) that will collect the first nationwide representative data on cyberbullying behavior among traditional and complementary medicine practitioners in Malaysia. The objectives of the survey are to (1) evaluate the cyberbullying behavior among traditional and complementary medicine practitioners in Malaysia, (2) identify sociodemographic and social factors related to cyberbullying, and (3) evaluate the association between cyberbullying behavior, sociodemographic, and social factors.

METHODS: A snowball sampling strategy will be applied. Traditional and complementary medicine practitioners who are permanent Malaysian residents will be randomly selected and invited to participate in the survey (N=1023). Cyberbullying behavior will be measured using the Cyberbullying Behavior Questionnaire (CBQ). Data on the following items will be collected: work-related bullying, person-related bullying, aggressively worded messages, distortion of messages, sending offensive photos/videos, hacking computers or sending a virus or rude message, and threatening messages about personal life or family members. We will also collect data on participants' sociodemographic characteristics, social factors, and substance abuse behavior.

RESULTS: This cross-sectional descriptive study was registered with Research Registry (Unique Identifying Number 6216; November 05, 2020). This research work (substudy) is planned under a phase 1 study approved by the Research Management Centre, Xiamen University Malaysia. This substudy has been approved by the Research Ethics Committee of Xiamen University Malaysia (REC-2011.01). The cross-sectional survey will be conducted from July 01, 2021, to June 30, 2022. Data preparation and statistical analyses are planned from January 2022 onward.

CONCLUSIONS: The current research can contribute to identify the prevalence of workplace cyberbullying among Malaysian traditional and complementary medicine practitioners. The results will help government stakeholders, health professionals, and education professionals to understand the psychological well-being of Malaysian traditional and complementary medicine practitioners.

TRIAL REGISTRATION: Research Registry Unique Identifying Number 6216; https://tinyurl.com/3rsmxs7u.

OBJECTIVE: This paper describes a protocol that was used to determine several factors that influence emergency responders' perceptions toward radiological risk practices and visualize the risk radiological framework for emergency preparedness and response.

METHODS: A mixed methods study with a convergent design was performed. A qualitative analysis was performed using a case study approach where 6 key informants were purposely sampled for in-depth interview, and a cross-sectional study involving a self-administered questionnaire was conducted among approximately 260 emergency respondents from national regulatory, research, and services organizations. NVivo (version 12, QSR International) was used to analyze the interview transcripts and emerging themes were identified through abductive coding. Simultaneously, multiple logistic regression analysis was used to determine significant predictors that form the equation model.

RESULTS: The study is still underway. Qualitative findings were based on transcript-coding that informed the relevant thematic analysis, while statistical analyses including multiple logistic regression analysis measured the adjusted odds ratio of significant variables for the equation model. The study is expected to conclude in late 2021.

CONCLUSIONS: Important emerging themes and significant factors that are related to the emergency responders' perceptions regarding radiological governance practices were determined through the convergent design. This potentially facilitated the development of a plausible radiological risk governance framework. Furthermore, our results will provide key insights that can be used in future studies.

OBJECTIVE: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.

METHODS: Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.

RESULTS: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.

CONCLUSIONS: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.

OBJECTIVE: The objective of this study is to evaluate the cost-effectiveness of dental home visits and oral health information, in the form of educational leaflets, in preventing new caries development in young children, compared to those receiving only educational leaflets over a period of two years. Cost-effectiveness analysis will be used to evaluate the cost-effectiveness of dental home visits.

METHODS: This is a collaborative project with the Oral Health Division of the Ministry of Health Malaysia. The Oral Health Division will provide access to a subsample from the National Oral Health of Preschoolers Survey which was carried out in 2015. The population of interest is children aged 5 and 6 years from kindergartens in the Selangor state of Malaysia. The study adopted a societal perspective for cost-effectiveness analysis and all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider or institution, and indirect costs because of loss of productivity.

RESULTS: The trial has been approved by the International Medical University Malaysia's Joint Research and Ethics Committee (Project ID: IMU R157-2014 [File III - 2016]). This trial is currently recruiting participants.

CONCLUSIONS: The number of young children in Malaysia who have been referred to the hospital children's dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia.

OBJECTIVE: The Improving Exposure Assessment Methodologies for Epidemiological Studies on Pesticides (IMPRESS) project aims to assess the reliability and external validity of the surrogate measures used to assign exposure within individuals or groups of individuals, which are frequently based on self-reported data on exposure determinants. IMPRESS will also evaluate the size of recall bias on the misclassification of exposure to pesticides; this in turn will affect epidemiological estimates of the effect of pesticides on human health.

METHODS: The IMPRESS project will recruit existing cohort participants from previous and ongoing research studies primarily of epidemiological origin from Malaysia, Uganda, and the United Kingdom. Consenting participants of each cohort will be reinterviewed using an amended version of the original questionnaire addressing pesticide use characteristics administered to that cohort. The format and relevant questions will be retained but some extraneous questions from the original (eg, relating to health) will be excluded for ethical and practical reasons. The reliability of pesticide exposure recall over different time periods (<2 years, 6-12 years, and >15 years) will then be evaluated. Where the original cohort study is still ongoing, participants will also be asked if they wish to take part in a new exposure biomonitoring survey, which involves them providing urine samples for pesticide metabolite analysis and completing questionnaire information regarding their work activities at the time of sampling. The participant's level of exposure to pesticides will be determined by analyzing the collected urine samples for selected pesticide metabolites. The biomonitoring measurement results will be used to assess the performance of algorithm-based exposure assessment methods used in epidemiological studies to estimate individual exposures during application and re-entry work.

RESULTS: The project was funded in September 2017. Enrollment and sample collection was completed for Malaysia in 2019 and is on-going for Uganda and the United Kingdom. Sample and data analysis will proceed in 2020 and the first results are expected to be submitted for publication in 2021.

CONCLUSIONS: The study will evaluate the consistency of questionnaire data and accuracy of current algorithms in assessing pesticide exposures. It will indicate where amendments can be made to better capture exposure data for future epidemiology studies and thus improve the reliability of exposure-disease associations.

OBJECTIVE: This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities.

METHODS: A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed.

OBJECTIVE: The purpose of this study is to identify the changes in the neurobiological signals from EEG, to associate these with functional outcome measures scores, and to compare their associations in different therapy frequency for gait rehabilitation among subacute stroke individuals.

METHODS: A randomized, single-blinded, controlled study among patients with subacute stroke will be conducted with two groups: an intervention group (IG) and a control group (CG). Each participant in the IG and CG will receive therapy sessions three times a week (high frequency) and once a week (low frequency), respectively, for a total of 12 consecutive weeks. Each session will last for an hour with strengthening, balance, and gait training. The main variables to be assessed are the 6-Minute Walk Test (6MWT), Motor Assessment Scale (MAS), Berg Balance Scale (BBS), Modified Barthel Index (MBI), and quantitative EEG indices in the form of delta to alpha ratio (DAR) and delta-plus-theta to alpha-plus-beta ratio (DTABR). These will be measured at preintervention (R0) and postintervention (R1). Key analyses are to determine the changes in the 6MWT, MAS, BBS, MBI, DAR, and DTABR at R0 and R1 for the CG and IG. The changes in the DAR and DTABR will be analyzed for association with the changes in the 6MWT, MAS, BBS, and MBI to measure neuroplasticity changes for both the CG and IG.

RESULTS: We have recruited 18 participants so far. We expect to publish our results in early 2023.

CONCLUSIONS: These associations are expected to be positive in both groups, with a higher correlation in the IG compared to the CG, reflecting enhanced neuroplasticity changes and objective evaluation on the dose-response relationship.

OBJECTIVE: The aim of this study is to determine the impact of a printed educational module on reducing the repetition rate of routine digital chest radiography among radiographers in Makkah Region tertiary hospitals.

METHODS: A quasi-experimental time series with a control group will be conducted in Makkah Region tertiary hospitals for 8 months starting in the second quarter of 2017. Four hospitals out of 5 in the region will be selected; 2 of them will be selected as the control group and the other 2 as the intervention group. Stratification and a simple random sampling technique will be used to sample 56 radiographers in each group. Pre- and postintervention assessments will be conducted to determine the radiographer knowledge, motivation, and skills and repetition rate of chest radiographs. Radiographs of the chest performed by sampled radiographers in the selected hospitals will be collected for 2 weeks before and after the intervention. A piloted questionnaire will be distributed and collected by a researcher in both groups. One-way multivariate analysis of variance and 2-way repeated multivariate analysis of variance will be used to analyze the data.

OBJECTIVE: This study aims to co-design and assess the feasibility of a socially-driven digital health intervention to promote healthy behavior and prevent chronic diseases in a workplace in Malaysia.

METHODS: This study involves two phases: (i) identifying the barriers and facilitators to healthy behaviors at work and co-designing the intervention activities with the employees, (ii) implementing and evaluating the intervention's feasibility. Phase 1 will involve qualitative data collection and analysis through semi-structured, in-depth interviews and co-design workshops with the employees, while Phase 2 will consist of a feasibility study employing quantitative measurements of health behaviors through accelerometers and questionnaires.

RESULTS: This study was funded in June 2021 and ethics approval for Phase 1 was obtained from the Monash University Human Research Ethics Committee in January 2022. As of August 2022, qualitative interviews with 12 employees have been completed and the data has been transcribed and analyzed. These results will be published in a future paper with results from all Phase 1 activities.

CONCLUSIONS: The study will help us to better understand the mechanisms through which digital technologies can promote socially-driven health knowledge and behaviors. This research will also result in a scalable wellness intervention that could be further tailored and expanded to other employers and social groups across the region.

OBJECTIVE: The aim of this study was to study the baseline level of antibiotic-resistant bacteria in the drinking water distribution systems of Malaysia by collecting samples from the pretreatment and posttreatment outlets of water treatment plants in a selected state of Malaysia. We aimed to determine the prevalence of antibiotic-resistant bacteria, the occurrence of antibiotic-resistant genes, and the level of antibiotics present in the drinking water systems.

METHODS: This is a laboratory-based, cross-sectional study in a selected state of Malaysia. Water samples from 6 drinking water treatment plants were collected. Samples were collected at 3 sampling points, that is, the intake sampling station, service reservoir outlet station, and the distribution system sampling station. These were tested against 7 types of antibiotics in triplicates. Samples were screened for antibiotic-resistant bacteria and antibiotic-resistant genes and quantified for the level of antibiotics present in the drinking water treatment plants.

RESULTS: We will show the descriptive statistics of the number of bacterial colonies harvested from water samples grown on Reasoner's 2A agar with or without antibiotics, the occurrence of antibiotic-resistant genes, and the level of antibiotics detected in the water samples. The sampling frame was scheduled to start from November 2021 and continue until December 2022. Data analysis is expected to be completed by early 2023, and the results are expected to be published in mid-2023.

CONCLUSIONS: This study provides baseline information on the status of the antimicrobial-resistant bacteria, the presence of resistance genes as contaminants, and the level of antibiotics present in the drinking water systems of Malaysia, with the aim of demonstrating to policymakers the need to consider antimicrobial resistance as a parameter in drinking water surveillance.

OBJECTIVE: The Malaysian Acute Vascular Events Risk (MAVERIK) study is a retrospective case-control study established to investigate the genomic, lipid-related, and other determinants of acute MI in Malaysia. In this paper, we report the study protocol and early results.

METHODS: By June 2019, we had enrolled approximately 2500 patients with their first MI and 2500 controls without cardiovascular disease, who were frequency-matched by age, sex, and ethnicity, from 17 hospitals in Malaysia. For each participant, serum and whole blood have been collected and stored. Clinical, demographic, and behavioral information has been obtained using a 200-item questionnaire.

RESULTS: Tobacco consumption, a history of diabetes, hypertension, markers of visceral adiposity, indicators of lower socioeconomic status, and a family history of coronary disease were more prevalent in cases than in controls. Adjusted (age and sex) logistic regression models for traditional risk factors indicated that current smoking (odds ratio [OR] 4.11, 95% CI 3.56-4.75; P30 kg/m2; OR 1.19, 95% CI 1.05-1.34; P=.009) were associated with MI in age- and sex-adjusted models.

CONCLUSIONS: The MAVERIK study can serve as a useful platform to investigate genetic and other risk factors for MI in an understudied Southeast Asian population. It should help to hasten the discovery of disease-causing pathways and inform regionally appropriate strategies that optimize public health action.

OBJECTIVE: This study aims to assess the effectiveness of the Malaysian Geriatric Patients' Hospital Foodservice Protocol (MYGERYFS).

METHODS: The protocol comprises 3 phases. Phase One is a cross-sectional study that took place at public hospitals with geriatric wards in the Klang Valley. Univariate data from Phase One were analyzed descriptively. Pearson correlation and chi-square were conducted to find factors associated with foodservice satisfaction. Phase Two involves the collaboration of health care professionals in the geriatric field. In Phase Three, a feasibility study will be conducted to determine the feasibility of the MYGERYFS protocol in a hospital among 60 geriatric patients. These patients will be randomized into control and intervention groups, respectively. Intervention care will be done to ensure the safety of the protocol.

RESULTS: Data collection for Phase One of the study has been completed. A total of 233 geriatric respondents with the mean age of 71.39 (SD 7.99) years were gathered. Approximately 51.5% (n=120) of the respondents were female, while 48.5% (n=113) were male, with a mean BMI of 24.84 (SD 6.05) kg/m2. Their mean energy and protein intakes were 1006.20 kcal (SD 462.03 kcal) and 42.60 (SD 22.20) grams, respectively. Based on the Mini Nutritional Assessment, older patients who scored 12-14 (normal) were 27.9% (n=65), those who scored 8-11 (at risk) were 54.9% (n=128), and those who scored 0-7, which is the lowest (malnutrition), were 17.2% (n=40) of the study population. Hence, most patients were at risk of malnutrition. Although a majority of the patients claimed to have good foodservice satisfaction 26.2% (n=61), they also experienced at least 3 barriers during mealtimes. It was found that dietary intake and mealtime barriers were significantly associated with the respondent's foodservice satisfaction. Data for Phase Two and Phase Three are yet to be collected and analyzed.

CONCLUSIONS: This study protocol could potentially benefit the hospital foodservice system and aid in improving geriatric nutritional status.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04858165; https://clinicaltrials.gov/ct2/show/NCT04858165.

OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation.

METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212).

RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022.

CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706.

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.

OBJECTIVE: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components.

METHODS: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders.

RESULTS: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024.

CONCLUSIONS: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention.

TRIAL REGISTRATION: OSF Registries; https://osf.io/f32ky.