A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community

Yafi Sabila Rosyad; Musheer Abdulwahid Aljaberi; Satheesh Babu Natarajan; Dely Maria

doi:10.12688/f1000research.161505.2

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Study Protocol

Revised

A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community

[version 2; peer review: 2 approved with reservations]

Previously titled: 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

Yafi Sabila Rosyad ^1-3, Musheer Abdulwahid Aljaberi⁴, Satheesh Babu Natarajan⁵, Dely Maria⁶

PUBLISHED 03 Apr 2025

Author details Author details

¹ STIKes Yogyakarta, Yogyakarta, Indonesia
² Nursing, Lincoln University College, Petaling Jaya, Selangor, Malaysia
³ Department of Nursing, Faculty of Health Science, Universitas Bhakti Husada Indonesia, Kadugede Kuningan, West Java, Indonesia
⁴ Applied Science, Lincoln University College, Petaling Jaya, Selangor, Malaysia
⁵ Pharmacy, Lincoln University College, Petaling Jaya, Selangor, Malaysia
⁶ Fakultas Vokasi, Universitas Kristen Indonesia, East Jakarta, Special Capital Region of Jakarta, Indonesia

Yafi Sabila Rosyad
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Musheer Abdulwahid Aljaberi
Roles: Investigation, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Satheesh Babu Natarajan
Roles: Data Curation, Investigation, Methodology, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Dely Maria
Roles: Conceptualization, Formal Analysis, Methodology, Visualization, Writing – Original Draft Preparation

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Health Services gateway.

Abstract

Background

Deaf individuals are considered a high-risk population for health disparities. During the covid-19 epidemic, deaf and hearing loss persons also suffer from psychological issues, post-traumatic stress disorder, and seropositive HIV.

Objective

This study aims to examine the effectiveness of an mobile health educational program to increase mental health and HIV prevention among deaf community

Methods

This study employs a quasi-experimental design with a non-randomized controlled trial, involving single-blinded participants and a parallel group assignment, purpose for health service research, study phase 2-3. pronounced to escalate the sample size to 40 deaf per group, which is 80 total participants.

Results

The analysis of the data will be conducted utilizing the generalized estimation equation, with a confidence interval set at 95%. Significant differences, both between and within groups, will be identified at a threshold of P<.05. The findings of this study highlight the efficacy of a mobile educational program in enhancing mental health and preventing HIV within the deaf community. Furthermore, the outcomes of this research will augment existing knowledge regarding psychological distress, HIV prevention practices, and coping self-efficacy among individuals who are deaf.

Conclusion

The intervention group is expected to demonstrate significantly lower scores in psychological distress during both the immediate evaluation and the assessment conducted three months post-intervention, compared to the wait-list group. Additionally, the intervention group is anticipated to exhibit enhanced levels of HIV prevention practices and coping self-efficacy, resulting in a greater degree of adjustment.

Clinical trial

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

Keywords

MHealth, HIV/AIDS, Deaf, VCT

Corresponding author: Yafi Sabila Rosyad

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2025 Rosyad YS et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Rosyad YS, Aljaberi MA, Natarajan SB and Maria D. A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community [version 2; peer review: 2 approved with reservations]. F1000Research 2025, 14:239 (https://doi.org/10.12688/f1000research.161505.2) First published: 26 Feb 2025, 14:239 (https://doi.org/10.12688/f1000research.161505.1) Latest published: 04 Jun 2025, 14:239 (https://doi.org/10.12688/f1000research.161505.3)

Revised Amendments from Version 1

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" to "A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community." The abstract now specifies that the study employs a quasi-experimental design with a non-randomized controlled trial, single-blinded participants, and parallel group assignments.
In the Introduction, the term "Deaf person" was replaced with "Deaf individuals," and the statement regarding the limited evidence on mobile health interventions for the Deaf community was updated to emphasize the study’s aim to address this gap.
The methodology section clarifies that the study follows a non-randomized controlled trial, with participants assigned to either the intervention or control group and blinded to the allocation. The KaPi mobile health program consists of 11 structured sessions, each lasting 12 minutes, covering topics such as HIV prevention, coping with psychological distress, and self-efficacy, delivered through Indonesian sign language videos.
Ethical considerations were clarified, with informed consent obtained via video-recorded agreements in Indonesian sign language. Participants can withdraw from the study at any time.
The KaPi program’s content was further clarified, and the conclusion emphasizes the study’s goal to assess the feasibility and effectiveness of a mobile health intervention for Deaf individuals, with potential implications for future public health and digital health strategies.

See the authors' detailed response to the review by Isiko Isaac

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 individuals 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 individuals 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 individuals 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). The hearing health sector as a dynamic network shaped by innovation and regulation, ensuring quality and risk mitigation. Innovation included both technological and non-technological advancements benefiting consumers. Ethical alignment required consumer involvement in both processes to address stigma and reduce health disparities. (Boisvert et al., 2024).

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). Educational interventions involving sign language interpretation and involvement of personnel involved in hearing loss resulted in significant increases in knowledge(Choi 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).

Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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

This quasi-experimental study follows a non-randomized controlled trial design, in which participants are assigned to either the intervention group, receiving the mobile health KaPi program, and the control group, receiving standard educational materials in the form of e-books. Participants will be blinded to the intervention allocation to minimize bias. Data collection took three months from the first intervention given. 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 area

Yogyakarta district is a city in Indonesia that experiences a significant prevalence of HIV cases among the deaf population. The participants targeted for this study will be individuals associated with the Gerkatin NGO in Yogyakarta, Indonesia.

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.

Inclusion and exclusion criteria participants

Inclusion and exclusion criteria are clearly defined to ensure that the study population is representative of the target demographic. The study consisted of deaf Indonesian nationals 1. Age 18 to 65 years. 2. All gender (Male, Female, and other) 3. Sexually active 4. Has access to a smart phone. This study will exclude those who are deaf and 1. pregnant, 2. already diagnosed with HIV/AIDS, 3. illiterate 4. can’t speak Indonesian sign language. This careful selection process helps to control for confounding variables that could affect the outcomes, such as pre-existing health conditions or communication barriers (Creswell, 2016; Hart et al., 2023). The significance of well-defined inclusion criteria in enhancing the internal validity of health research (Bodicoat et al., 2021; Patino & Ferreira, 2018).

Recruitment

To assess eligibility, the researcher will initiate contact with all regional leaders of Gerkatin NGOs within the district, facilitated through the head of Gerkatin NGOs in the Yogyakarta area. A data collection permit letter, issued by the researcher’s affiliated university, will accompany this communication. This letter will be directed to the regional head of Gerkatin NGOs, who will subsequently disseminate it to all regional leaders. The recruitment strategy will incorporate various approaches known to enhance research participation, such as notifying the Gerkatin head about the study in advance, offering opportunities for involvement, visiting the Gerkatin representative, reaching out to potential participants via telephone and other communication methods, and allowing for inquiries to research staff regarding participation. Dedicated research personnel will oversee the recruitment process.

Following the dispatch of the letter and the acquisition of approval for data collection, the Gerkatin head or designated representative will reach out via telephone to verify eligibility according to the inclusion criteria and gauge interest in participating in the study. Information and consent forms will be provided to selected respondents to secure their agreement to participate. Should any respondents choose to withdraw during the research process, this will be permitted. All aspects related to the research process and the study’s duration will be thoroughly detailed in the Respondent Information and Consent Forms.

Sample size

Sample size was calculated using the software Based on an a priori power analysis (G*Power 3.1) (Faul et al., 2007). The sample size will be an F-test, an a priori type of power analysis (Chow et al., 2002), with power (1- β) of 0.95, α level of 0.05, and an effect size at 0.20, for two groups. This formula provided a sample size of 66, which each group was 33 participants. Finally, the present study calculated a 20% (In et al., 2020; Suresh & Chandrashekara, 2012) dropout rate (33 × 20% = 6.6, rounded up to 7) and pronounced to escalate the sample size to 40 deaf per group, which is 80 total participants.

Outcome MHealth KaPi Program

Increase in physical and psychological capability of HIV voluntary counseling and testing

Tools for collecting information in research

Ebook Mental Health and HIV/AIDS

The mental health and HIV/AIDS ebook contains general material related to mental health, psychological disorders, coping efficacy, and HIV/AIDS. The material in pdf can be accessed at https://doi.org/10.5281/zenodo.14784036 (Rosyad, 2025a), Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Mobile Health KaPi Program

The KaPi mobile health program consists of 11 structured sessions, each lasting approximately 12 minutes. These sessions cover topics such as HIV prevention strategies, coping mechanisms for psychological distress, and self-efficacy improvement, all delivered through Indonesian sign language videos within the app. The program application can download at playstore with link https://play.google.com/store/apps/details?id=com.project.kapi. for the table this program can acces at https://doi.org/10.5281/zenodo.14784226 (Rosyad, 2025b), Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Questionnaire to be utilized in this study

Researchers use Kessler Psychological Distress Scale (K10) from Kessler et al., (2002), is a 10-item questionnaire assessing anxiety and depressive symptoms over the past four weeks, with scores ranging from 10 to 50. A score under 20 suggests good mental health, while scores from 20 to 50 indicate varying levels of mental disorder severity (Andrew & Slade, 2001; Kessler et al., 2002). Coping self-efficacy questionnaire will be adapting from Chesney et al. (2006), measuring confidence in coping behaviors, such as problem-focused coping and managing emotions. Respondents rate their confidence on an 11-point scale, and higher scores indicate greater coping self-efficacy, with good reliability and predictive validity for decreased psychological distress and increased well-being. and Knowledge, attitude, and practice HIV voluntary and counselling testing (K-A-P VCT) from Addis et al., (2013) is consists of 15 questions assessing participants’ knowledge, attitude, and practice regarding VCT services. Knowledge is measured through correct answers, attitudes are evaluated using a 5-item scale, and practice is determined by a single question about previous use of VCT services.

questionnaire will be adapting from Addis et al. (2013).

Statistical analysis

Allocations of demographic information and predictors variables between groups were analyzed as a proportion (%) and case (n), respectively. Descriptive results like percentage and frequency distribution of all variables were presented using tables and charts. The c² and ANOVA analyzes were used to compare socioeconomic and demographic as well as baseline findings among the four groups, respectively. For the inferential statistic will be using the first, the association between each independent variable with the outcome variable was determined using binary logistic regression. The primary outcomes will be analyzed using generalized estimation equations (GEE) to account for within-group correlations over time. The model will include an interaction term between time and intervention to assess changes in psychological distress, HIV prevention practices, and self-efficacy levels. Adjusted odds ratios with 95% confidence intervals will be reported.

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 study aims to provide evidence on the feasibility and effectiveness of a mobile health intervention tailored for deaf individuals, potentially informing future public health interventions and digital health strategies.

Deaf person is risk population for health ethics and consent

The trial protocol of this study was approved by head of ethics review committe Dwi Nugroho Heri Saputro, S.Kep., Ns., M.Kep., Sp.Kep.MB., PhD.NS on 05 November 2023, 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 on 25 November 2024, https://slctr.lk/trials/slctr-2024-039.

All participants will be provided with a detailed study information sheet in Indonesian sign language, and informed consent will be obtained through video-recorded agreements to ensure accessibility for deaf individuals. There is no coercion to participate in this study, if the respondent agrees then the respondent will sign a written consent form to participate in the study. Should any respondents choose to withdraw during the research process, this will be permitted. All aspects related to the research process and the study’s duration will be thoroughly detailed in the Respondent Information and Consent Forms.

Data availability statement

No data associated with this article.

Reporting guidelines

Articles that report protocols for clinical trials adhere to the SPIRIT reporting guidelines https://doi.org/10.5281/zenodo.14762634 (Rosyad et al., 2025), Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Acknowledgements

None.

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Theunissen SCPM, Rieffe C, Netten AP, et al.: Self-esteem in hearing-impaired children: The influence of communication, education, and audiological characteristics. PLoS One. 2014; 9(4): e94521. PubMed Abstract | Publisher Full Text | Free Full Text
Ulutorti AG: Cultural Sensitivity in Psychotherapy for Deaf Individuals in Nigeria. International Journal for Psychotherapy in Africa. 2024; 9(1): 143–153.
United Nations: Disability and HIV/AIDS. Department of Economic and Social Affairs Disability; 2016. Reference Source
World Health Organization (WHO): Deafness and hearing loss.2021a. Reference Source
World Health Organization (WHO): WHO Director-General’s closing remarks at 148th session of the Executive Board. World Health Organization; 2021b. Reference Source

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Version 3

VERSION 3 PUBLISHED 26 Feb 2025

Author details Author details

Musheer Abdulwahid Aljaberi
Roles: Investigation, Project Administration, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Satheesh Babu Natarajan
Roles: Data Curation, Investigation, Methodology, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Dely Maria
Roles: Conceptualization, Formal Analysis, Methodology, Visualization, Writing – Original Draft Preparation

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (3)

version 3

Revised

Published: 04 Jun 2025, 14:239

https://doi.org/10.12688/f1000research.161505.3

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Published: 03 Apr 2025, 14:239

https://doi.org/10.12688/f1000research.161505.2

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Published: 26 Feb 2025, 14:239

https://doi.org/10.12688/f1000research.161505.1

© 2025 Rosyad YS et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Rosyad YS, Aljaberi MA, Natarajan SB and Maria D. A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community [version 2; peer review: 2 approved with reservations]. F1000Research 2025, 14:239 (https://doi.org/10.12688/f1000research.161505.2)

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Version 2

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PUBLISHED 03 Apr 2025

Revised

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Reviewer Report 27 May 2025

Pakorn Akkakanjanasupar, Chulalongkorn University, Bangkok, Thailand

Approved with Reservations

https://doi.org/10.5256/f1000research.179725.r380081

Summary:

Thank you for the opportunity to review this important and much-needed study. The proposed research addresses a significant gap in health equity by focusing on the deaf community—an underserved population often excluded from conventional health interventions. The integration of a mobile health (mHealth) platform using sign language-based video education is both innovative and contextually appropriate. However, to strengthen the scientific rigor, clarity, and ethical robustness of this study protocol, several areas require refinement.

The comments provided below are intended to support the authors in improving the transparency, replicability, and overall quality of the manuscript in line with academic standards and research ethics.

General Assessment & Suggestions

1. Rationale and Objectives (Partly)
The manuscript presents a well-intentioned public health intervention. The introduction offers useful background, including relevant epidemiological data and challenges faced by the deaf population. However, the rationale is not explicitly or succinctly stated. The research problem and the gap in existing literature, particularly regarding the limited evidence on mobile-based HIV prevention in the deaf community, needed clearer articulation.

I recommend adding a concise statement in the introduction that directly links the identified public health challenge to the need for this specific study. A sentence such as, “Despite the proliferation of mobile health interventions in other populations, deaf individuals remain underserved due to linguistic and cultural barriers. This study seeks to address that gap by evaluating a sign language-based mobile health program tailored to this community,” would sharpen the focus and purpose of the research.

2. Study Design and Intervention (Yes)
A quasi-experimental design is appropriate given the practical constraints in randomizing this specific population. The use of a single-blinded structure also aligns with the implementation model. However, the explanation of blinding, control conditions, and assignment procedures is underdeveloped.

It would strengthen the protocol to include a detailed explanation of the blinding process. For example, if outcome assessors are blinded to group allocation, this should be explicitly stated, along with procedures to maintain that blinding. Additionally, since allocation is not randomized, the authors should explain how potential biases will be mitigated—for instance, by using matched groups or adjusting for baseline differences in the analysis.

3. Methodology and Replicability (Partly)
The manuscript includes appropriate tools (K10, CSE, KAP VCT) and a valid analytical approach (GEE). However, the intervention description and sampling calculations are vague.

I recommend that the authors include a session-by-session overview of the KaPi program, either in the main text or as an appendix. Each session’s objectives, thematic content, and format (e.g., video, quiz) should be described. Regarding sample size, while G*Power is correctly cited, the effect size and statistical assumptions used in the calculation (e.g., α = 0.05, power = 0.95) should be stated clearly. This transparency is essential for methodological integrity.

4. Statistical Analysis (Partly)
The use of Generalized Estimation Equations (GEE) is methodologically sound for analyzing repeated measures. Nonetheless, the statistical section is overly verbose, with some inconsistencies (e.g., reference to “four groups” instead of two).

It should specify the primary and secondary outcomes, the time points of measurement, and the interaction terms to be tested. Also, clarify how missing data will be handled and ensure that references to group structure are consistent with the described design. I encourage the authors to revise this section for clarity and conciseness.

5. Ethical Considerations and Accessibility (Needs Strengthening)
The manuscript notes that consent will be obtained via sign language video agreements, which is commendable. However, further detail is needed on how informed consent will be verified and how data privacy is protected, especially given the use of a mobile application.

It is better if the authors could describe how participant understanding of the study will be verified (e.g., through comprehension questions or interactive elements). It is also important to discuss how data from the mobile app will be stored and protected, particularly regarding participant anonymity and consent withdrawal. This section should also affirm that no coercion will be used and that participants may exit the study at any point without penalty.

6. Language and Presentation (Requires Revision)
The manuscript is significantly hindered by grammatical errors, awkward syntax, and inconsistent terminology (e.g., “deaf person,” “hearing loss individuals”). This affects the clarity and professionalism of the protocol.

A comprehensive language review is strongly advised. This should address syntax, grammar, and word choice. Terms referring to the study population should be standardized throughout the manuscript; for example, consistently using “deaf individuals” instead of alternating with “deaf persons” or “hearing loss individuals.” This will enhance the manuscript’s coherence and respect for community-preferred terminology.

7. Additional Comments
7.1 Theoretical Framework: Identify a theoretical model guiding the intervention (e.g., Social Cognitive Theory), to support the focus on behavior change and self-efficacy.
I encourage the authors to specify a behavioral or educational theory (e.g., Health Belief Model, Social Cognitive Theory) that informs the intervention’s focus on self-efficacy and behavioral change. This theoretical anchoring would enhance the scientific robustness of the intervention design.

7.2 Recruitment and Retention: Expand on how participants will be retained over three months. Describe follow-up strategies or engagement features within the app.
The authors should expand on how they will ensure sustained participation over the three-month study period. This might include periodic check-ins, app-based reminders, or participant incentives.

7.3Technological Barriers: Address potential challenges in device access, digital literacy, and internet connectivity. Propose solutions or alternatives.
A brief discussion of how the study will address potential technological barriers—such as smartphone access, digital literacy, and internet connectivity—would strengthen the feasibility of the protocol.

7.4 Dissemination Plan: Indicate how results will be communicated to the deaf community (e.g., videos in sign language, community briefings).
The manuscript should include a clear plan for sharing study findings with the deaf community, such as through sign language videos or community feedback sessions.

Conclusion
This is a socially impactful and methodologically promising study addressing a population often excluded from digital health innovations. The intervention is both culturally sensitive and contextually relevant. However, to meet indexing standards, the manuscript requires revisions in methodological clarity, ethical detail, and language quality.

Final Recommendation:
With these improvements, the protocol will make a meaningful contribution to health equity, HIV prevention, and inclusive digital health research. I commend the authors for their commitment to addressing disparities in deaf health care and look forward to seeing this work developed further.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: As a reviewer with a background in public health research, digital health intervention design, and applied research methodology, my evaluation of this manuscript focuses on several key domains: the clarity and relevance of the study rationale, the appropriateness and transparency of the study design, the ethical considerations in working with a marginalized population, and the accessibility and cultural sensitivity of the proposed mobile health intervention.In particular, I have assessed:The study’s rationale and objectives, with attention to the public health implications and population-specific context;The quasi-experimental design, including its alignment with the research aims and appropriateness for the study population;The description of the intervention and its accessibility through sign language and mobile platforms;The ethical framework, particularly related to informed consent procedures for deaf participants and data privacy concerns;The community engagement and dissemination plans, given the importance of participatory approaches in underserved populations.While I have reviewed the statistical methods and instruments used for data collection, I defer detailed evaluation of advanced statistical modeling and HIV-specific clinical outcomes to reviewers with specialized expertise in those areas. My feedback is intended to support the authors in enhancing the study’s methodological clarity, cultural competence, and practical implementation for digital health equity.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Version 1

VERSION 1

PUBLISHED 26 Feb 2025

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Reviewer Report 14 Mar 2025

Isiko Isaac, School of Medicine, Makerere University, Kampala, Central Region, Uganda; Department of Community Medicine, Axel Pries Institute of Public Health and Biomedical Sciences, NIMS University, Jaipur, Rajasthan, India

Approved with Reservations

https://doi.org/10.5256/f1000research.177544.r369983

Dear Editor,

Thank you for the opportunity to review this manuscript on the effectiveness of a mobile health program for HIV counseling and testing among the deaf community. Your study addresses a crucial public health issue with significant potential impact.

While the manuscript is well-structured, certain areas need refinement, including clarity in methodology, statistical analysis, and language consistency. I have provided detailed feedback and suggestions to enhance the rigour and readability of your work. I commend your efforts and look forward to your revised submission.

General Comments

The manuscript presents an important study on the effectiveness of a mobile health program aimed at improving the physical and psychological capabilities of HIV voluntary counselling and testing (VCT) among the deaf community. While the topic is highly relevant, the manuscript requires several refinements to enhance clarity, methodology, statistical rigour, and language coherence. The following detailed comments guide areas that need improvement and offer examples of how revisions can be implemented.

Title and Abstract:

The title of the manuscript should be refined to be more precise and informative. For instance, instead of '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,' a more concise version could be 'A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.' This revision ensures clarity and a direct reflection of the study’s scope.
The abstract lacks specificity in the methodology section. Instead of stating, 'Quasi-experimental non-randomized controlled trial with single blinded participants,' it would be clearer to write, 'This study employs a quasi-experimental design with a non-randomized controlled trial, involving single-blinded participants and a parallel group assignment.' This revision provides more structure and readability.

Introduction:

The introduction provides a strong background on the health challenges faced by the deaf community. However, it does not explicitly state the significance of the study. It would be beneficial to clearly articulate the research gap by including a statement like: 'Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population.' This addition will strengthen the rationale for the study.
Additionally, some references cited in the introduction are outdated. Replacing them with more recent studies on digital health interventions will enhance the credibility of the literature review.

Methods:

The study design should be described with greater detail. Instead of simply stating, 'Quasi-experimental non-randomized controlled trial with single blinded participants,' a more comprehensive description could be: 'This quasi-experimental study follows a non-randomized controlled trial design, in which participants are assigned to either the intervention group, receiving the mobile health KaPi program, or the control group, receiving standard educational materials in the form of e-books. Participants will be blinded to the intervention allocation to minimize bias.'
The sample size calculation lacks clarity and should be expanded. The authors mention the use of GPower software, but they do not provide the effect size used in the calculation. A more detailed explanation could be: 'Using GPower 3.1, the sample size was determined based on an expected medium effect size of 0.30, a power of 0.95, and an alpha level of 0.05. These parameters resulted in a required sample size of 80 participants, with 40 in each group.'
The intervention details are somewhat vague. Instead of stating, 'The KaPi mobile health program consists of 11 sessions,' it would be more informative to describe: 'The KaPi mobile health program consists of 11 structured sessions, each lasting approximately 12 minutes. These sessions cover topics such as HIV prevention strategies, coping mechanisms for psychological distress, and self-efficacy improvement, all delivered through Indonesian sign language videos within the app.' Providing this level of detail will help readers understand the intervention’s structure and expected impact.

Ethical Considerations:

While ethical approval is mentioned, the manuscript should elaborate on the informed consent process. Instead of stating, 'Participants provided consent,' it would be clearer to describe: 'All participants will be provided with a detailed study information sheet in Indonesian sign language, and informed consent will be obtained through video-recorded agreements to ensure accessibility for deaf individuals.' This revision ensures that the ethical considerations specific to the deaf community are well addressed.

Results Section (Planned Analysis):

The statistical analysis section should provide more depth on how changes over time will be measured. Instead of simply stating, 'The data will be analyzed using generalized estimation equations (GEE) with a confidence interval of 95%,' a more precise description would be: 'The primary outcomes will be analyzed using generalized estimation equations (GEE) to account for within-group correlations over time. The model will include an interaction term between time and intervention to assess changes in psychological distress, HIV prevention practices, and self-efficacy levels. Adjusted odds ratios with 95% confidence intervals will be reported.' This level of detail ensures clarity in the planned statistical approach.

Discussion (Expected Implications):

The discussion should emphasize the study’s contributions to HIV prevention strategies for the deaf community. Instead of a general statement like, 'This study will help improve health outcomes among the deaf population,' a more detailed perspective could be: 'By demonstrating the effectiveness of a culturally tailored mobile health intervention, this study has the potential to inform future digital health policies aimed at increasing HIV awareness and mental health support among deaf individuals.'
Potential limitations should also be discussed more explicitly. Instead of stating, 'This study may face some limitations,' the authors could write, 'One limitation of this study is the reliance on self-reported measures, which may introduce reporting bias. Future studies should consider incorporating objective measures, such as biomarker data, to validate self-reported behavioral changes.' This approach strengthens the critical evaluation of the study design.

Language and Formatting:

The manuscript contains numerous grammatical errors and unclear sentences, which affect readability. For example, the sentence 'Deaf person is risk population for health' should be revised to 'Deaf individuals are considered a high-risk population for health disparities.' Careful proofreading and language editing will significantly improve the overall clarity and professionalism of the manuscript.

Additionally, consistency in terminology is essential. Terms like 'deaf persons' and 'hearing loss individuals' should be standardized. Using 'deaf individuals' throughout the text would improve coherence.

Conclusion:

The conclusion should emphasize the expected contributions of the study rather than presenting definitive results. Instead of 'The intervention group is expected to show significant improvements in psychological distress and HIV prevention,' a more appropriate statement would be: 'This study aims to provide evidence on the feasibility and effectiveness of a mobile health intervention tailored for deaf individuals, potentially informing future public health interventions and digital health strategies.'

Final Recommendation

The manuscript presents a valuable study but requires significant revisions for clarity, methodological rigor, and readability. Addressing the points outlined above will enhance the quality and impact of the research, ensuring that it effectively communicates its contributions to the field.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Public health, disease modelling, maternal and child health, HIV, Malaria, Neglected tropical diseases, Machine learning, communicable diseases, Global Health, mental health

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Author Response 03 Apr 2025

Yafi Sabila Rosyad, Nursing, Lincoln University College, Petaling Jaya, Malaysia

03 Apr 2025

Author Response

1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled The study protocol for a quasi-experimental study on the effectiveness of a ... Continue reading 1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled 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 to A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.
2 abstract has little revision in methodology
3 statement at introduce "Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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.
4 correction Grammarly.
1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled 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 to A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.
2 abstract has little revision in methodology
3 statement at introduce "Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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.
4 correction Grammarly.
Competing Interests: none Close
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COMMENTS ON THIS REPORT

Author Response 03 Apr 2025

Yafi Sabila Rosyad, Nursing, Lincoln University College, Petaling Jaya, Malaysia

03 Apr 2025

Author Response

1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled The study protocol for a quasi-experimental study on the effectiveness of a ... Continue reading 1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled 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 to A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.
2 abstract has little revision in methodology
3 statement at introduce "Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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.
4 correction Grammarly.
1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled 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 to A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.
2 abstract has little revision in methodology
3 statement at introduce "Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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.
4 correction Grammarly.
Competing Interests: none Close
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Version 3

VERSION 3 PUBLISHED 26 Feb 2025

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Version 3 (revision) 04 Jun 25		read
Version 2 (revision) 03 Apr 25		read
Version 1 26 Feb 25	read

Isiko Isaac, Makerere University, Kampala, Uganda; NIMS University, Jaipur, India
Pakorn Akkakanjanasupar, Chulalongkorn University, Bangkok, Thailand

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Reviewer Report

7 Views

16 Jun 2025 | for Version 3

Pakorn Akkakanjanasupar, Chulalongkorn University, Bangkok, Thailand

7 Views Cite this report Responses(0)

Approved

Assessment of the Revisions
It's clear the author has truly taken to the feedback and put significant effort into refining this manuscript.

The proposed revisions effectively enhance both the clarity and scientific rigor of the protocol. From sharpening the title and abstract to providing crucial details in the methodology and ethical considerations, every change seems well-considered. Their commitment to a thorough language review is also a vital step that will ensure the document is polished and professional.

Overall, these are excellent adjustments. They promise to transform this protocol into a much stronger and more impactful contribution to the field.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

My review, based on my public health and digital health research background, focused on the manuscript's rationale, design, ethics (for marginalized groups), and intervention accessibility/cultural sensitivity. The authors' revisions have successfully improved the study's methodological clarity, cultural competence, and practical implementation for digital health equity.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

12 Views

27 May 2025 | for Version 2

Pakorn Akkakanjanasupar, Chulalongkorn University, Bangkok, Thailand

12 Views Cite this report Responses(0)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

As a reviewer with a background in public health research, digital health intervention design, and applied research methodology, my evaluation of this manuscript focuses on several key domains: the clarity and relevance of the study rationale, the appropriateness and transparency of the study design, the ethical considerations in working with a marginalized population, and the accessibility and cultural sensitivity of the proposed mobile health intervention.In particular, I have assessed:The study’s rationale and objectives, with attention to the public health implications and population-specific context;The quasi-experimental design, including its alignment with the research aims and appropriateness for the study population;The description of the intervention and its accessibility through sign language and mobile platforms;The ethical framework, particularly related to informed consent procedures for deaf participants and data privacy concerns;The community engagement and dissemination plans, given the importance of participatory approaches in underserved populations.While I have reviewed the statistical methods and instruments used for data collection, I defer detailed evaluation of advanced statistical modeling and HIV-specific clinical outcomes to reviewers with specialized expertise in those areas. My feedback is intended to support the authors in enhancing the study’s methodological clarity, cultural competence, and practical implementation for digital health equity.

Respond to this report

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Reviewer Report

26 Views

14 Mar 2025 | for Version 1

26 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Public health, disease modelling, maternal and child health, HIV, Malaria, Neglected tropical diseases, Machine learning, communicable diseases, Global Health, mental health

Respond to this report

Responses (1)

Author Response

03 Apr 2025

Yafi Sabila Rosyad, Nursing, Lincoln University College, Petaling Jaya, Malaysia

1 I have revised the title of the article according to the reviewer's suggestion, which was originally titled 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 to A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.
2 abstract has little revision in methodology
3 statement at introduce "Despite the increasing use of mobile health interventions in marginalized communities, there is limited evidence on their effectiveness in improving HIV-related health outcomes among deaf individuals. This study aims to bridge this gap by assessing a mobile health educational program specifically designed for this population. 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.
4 correction Grammarly.

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Competing Interests

none

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community

Abstract

Background

Objective

Methods

Results

Conclusion

Clinical trial

Keywords

Revised Amendments from Version 1

Introduction

Methods

Study area

Study design

Figure 1. Summarized the study design.

Inclusion and exclusion criteria participants

Recruitment

Sample size

Outcome MHealth KaPi Program

Tools for collecting information in research

Questionnaire to be utilized in this study

Statistical analysis

Results

Conclusion

Deaf person is risk population for health ethics and consent

Data availability statement

Reporting guidelines

Acknowledgements

References

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