The study protocol for a quasi-experimental study on the effectiveness of a mobile health program in enhancing the physical and psychological capabilities of HIV voluntary counseling and testing among the deaf community

Introduction

HIV prevention in the deaf-disabled population is one of the HIV-related health program’s concerns (United Nations, 2016; World Health Organization (WHO), 2021b). Health initiatives relating to the promotion and prevention of sexual and reproductive health, particularly HIV illness, are often more accessible to those without disabilities. This is due to the fact that persons with impairments are seen as sexually inactive and thus get less attention from HIV initiatives (Schenk et al., 2020). At the institutional level, the lack of knowledge and capacity of health workers on sexual and reproductive health issues, the negative attitude and lack of sensitivity of health workers, and the absence of privacy and accessible infrastructure for persons with disabilities are barriers that many people with disabilities encounter when attempting to access these services (Schenk et al., 2020).

Persons with disabilities are 1.1 to 2.05 times more likely to engage in HIV-risk behaviors, such as substance misuse, alcoholism, sexual activity without the use of a condom, and partner switching. Awareness of HIV testing is also 1.1 times lower among people with disabilities compared to the general population (Doyle et al., 2021). Interestingly, earlier research supporting the feasibility study indicate that only 28.9% of deaf individuals had undergone an HIV screening examination (Olakunde & Pharr, 2020).

In addition to the absence of HIV-related information for the deaf, psychological issues are also a common obstacle. Hearing loss at any age is also associated with anxiety, low self-esteem and worth, cognitive decline, and diminished health-related quality of life as well as psychological distress (Mehboob Khan et al., 2019). Adults and teenagers alike are at risk for very negative outcomes when they are experiencing psychological distress. The effect is a breakdown in social and psychological functioning (Alika et al., 2016; Fergusson & Woodward, 2002).

Hearing loss was linked to distress in a major sample of persons under 70 years of age (Bosdriesz et al., 2017; National Insitute on Aging (NIA), 2018). During the COVID-19 epidemic, deaf and hearing loss persons also suffer from psychological issues and post-traumatic stress disorder. The incidence of PTSD and depression among Hearing loss and hearing teens before to and during the COVID-19 epidemic in four Iranian cities (Borujerd, Malayer, Nahavand, ands Tuyskán). In our research, the prevalence of PTSD (46.43%) and depression (41.07%) among teenagers with hearing loss was much greater than predicted (Ariapooran et al., 2021).

Their failure to establish good verbal communication may result in social rejection, a lack of education, and a poor work position, all of which have a significant negative influence on their self-esteem (Gotowiec et al., 2022; Munoz-Baell & Ruiz, 2000; Strong & Shaver, 1991). The study of Jambor and Elliott (2005) on the self-esteem and coping methods of deaf students and deaf children indicated that deaf persons who identify with the deaf culture acquired higher self-esteem than those who identified with the hearing culture and involving physical appearance in hearing impaired ( Indiana et al., 2021; Jambor & Elliott, 2005; Theunissen et al., 2014).

According to WHO estimates, Over 5% of the world’s population, or 430 million individuals, have ‘disabling’ hearing loss and need rehabilitation (432 million adults and 34 million children). It is anticipated that by 2050, approximately 700 million individuals, or one in ten, would suffer from hearing impairment. Less than one percent of deaf, hard of hearing, and deaf and blind children in underdeveloped nations have access to school (World Health Organization (WHO), 2021a). According to World Federation of the Deaf (WFD) data, 80% of deaf people are illiterate or poorly educated (El-Soud & Hassan, 2009). Deaf individuals have difficulty understanding health recommendations (Bahareh & Heidary, 2015). Due to their communication difficulties, limited understanding of deaf persons makes their health treatment more hard (Harmer, 1999). According to research conducted by the England Mental Health Institute, there is a clear correlation between psychological diseases and hearing loss; the incidence of psychological issues among deaf children is almost double that of hearing children (40% against 25%). According to research conducted in several nations, psychiatric illnesses are manifestly more widespread among deaf individuals (National Health Service, 2005). Even in the United States, less than 5% of deaf individuals get mental health treatment, and in the majority of impoverished nations, there is no mental health care for the deaf (Joseph AM, 2009).

There are challenges for the deaf people to get health information (Folkins et al., 2005). Deaf persons and their families need information and education to enhance general understanding of their condition. One of the educational components for deaf and hard of hearing individuals is the use of educational technology, such as computers and distant learning (Kelly & McKenzie, 2018). Multimedia distant information and communication services may serve as the standard electronic platform for continuing deaf education (Drigas et al., 2009).

Increasingly prevalent digital health technologies are employed for the prevention, diagnosis, and treatment of mental health issues. There is minimal research on mental health and HIV prevention in online initiatives for the deaf community. Engagement involves individual users’ ideas and emotions, level of activity, and opinions about technical features of the software, including characteristics of usability and attractiveness (O’Brien & Toms, 2013). User engagement is also intimately tied to a program’s usability O’Brien & Toms (2013), which includes efficacy, efficiency, and user happiness (The National Standards Authority of Ireland (NSAI), 2018).

Recent studies have begun to explore innovative approve to address these gaps. For instance, a 2023 study highlighted the effectiveness of digital health interventions in improving health literacy and self-efficacy among deaf individuals, demonstrating a positive impact on their overall well-being (Arias López et al., 2023). The need cultural sensitive health communication strategies tailored to the deaf community to enhance engagement and understanding of health information in mental health (Ulutorti, 2024).

This study aims to evaluate the effectiveness of mobile health educational program designed to enhance both mental health and HIV prevention among deaf individuals. By focusing on this underserved population, the research seeks to contribute valuable insights into the psychological distress, HIV prevention practice, and coping self-efficacy of deaf individuals, ultimately fostering a more inclusive approach to health care.

Clinical trial: SLCTR/2024/039, 25 November 2024, https://slctr.lk/trials/slctr-2024-039.

Methods

The study used a quantitative method with a quasi-experimental non-randomized controlled trial approach. Data collection took three months from the first intervention given. The intervention group will be given education through the KaPi Program mobile health application using Indonesian sign language and the control group will be given education through e-books. To ensure that the intervention carried out is in accordance with the standards, the researcher using the Standard Protocol Items as a guide. The study will adhere to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Chan et al., 2016), the Consolidated Standards of Reporting Trials (CONSORT) criteria (Schulz et al., 2010), and the recommendations set forth by the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth (CONSORT-EHEALTH) (Eysenbach et al., 2011). Participation in the study was voluntary, and no financial compensation was offered. To ensure the accuracy and validity of this study, we will take strategic steps to minimize bias. The study will start with clear, testable objectives and hypotheses, and random sampling will be used to ensure representativeness. Data will be collected using valid, reliable instruments and standardized procedures. A blind or double-blind design will be implemented to reduce bias from both researchers and participants. Data analysis will follow appropriate statistical methods to avoid misinterpretation. The research process will be transparently reported, with methods and results available for replication. Peer review and potential replication by other researchers will further confirm the findings, ensuring the study produces valid, unbiased results.

Study design

Research design in this research will be use quasi-experimental non-randomized controlled trial with single blinded participants, control standard therapy, assignment use parallel, purpose for health service research, study phase 2-3. One or two (experimental group) receives the Mobile health KaPi Program intervention under test and the other (comparison group or control) receives the standard e book/leaflet. Then follow up on the two or more groups to see if there are any differences in the results. The results of the study and subsequent analysis are used to assess the effectiveness of the intervention mobile health application. Quasi-experimental are the most rigorous way to determine if there is a causal link between interventions and outcomes (Polit and Beck, 2017). Figure 1 provides an overview of the study design. The choice of this experimental design is grounded in its robustness and efficacy (Creswell, 2016).

Figure 1. Summarized the study design.

Results

The trial protocol of this study was approved by Health Research Ethics Committee Stikes Bethesda Yakkum, Indonesia have granted ethical approval No.036/KEPK.02.01/V/2023 and Trial registration: Sri Lanka Clinical Trials Registry (SLCTR) with number SLCTR/2024/039. Approval for participation in the study was secured from the governing bodies of the selected NGOs, Gerkatin. The findings of the study will be disseminated at both the cluster and individual levels, encompassing data on Psychological Distress, Coping Self-Efficacy, Knowledge, Attitudes, and Practices regarding HIV voluntary counseling and testing, intentions to withdraw from the study, the effectiveness of the intervention, estimated effect sizes along with their precision, and the primary outcomes. Preliminary results are anticipated to be submitted for publication by the conclusion of the 2024/2025 academic semester, and the research will be presented at both national and international conferences or published in a Scopus-indexed journal.

Conclusion

This trial aims to offer significant insights into the implementation and effectiveness of the Mobile health KaPi program, an Android mobile application designed to enhance the physical and psychological capabilities of HIV voluntary counseling and testing within the deaf community, in comparison to the standard e-book. The outcomes of the process evaluation will deliver contextual information regarding the implementation decisions made for deaf individuals, the foundations of the deaf community, health workers, and health services.