<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.161505.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>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</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 1 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Rosyad</surname>
                        <given-names>Yafi Sabila</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Funding Acquisition</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-2025-6826</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Aljaberi</surname>
                        <given-names>Musheer Abdulwahid</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a3">3</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Natarajan</surname>
                        <given-names>Satheesh Babu</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a4">4</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Maria</surname>
                        <given-names>Dely</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <xref ref-type="aff" rid="a5">5</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Nursing, Lincoln University College, Petaling Jaya, Selangor, Malaysia</aff>
                <aff id="a2">
                    <label>2</label>STIKes Yogyakarta, Yogyakarta, Indonesia</aff>
                <aff id="a3">
                    <label>3</label>Applied Science, Lincoln University College, Petaling Jaya, Selangor, Malaysia</aff>
                <aff id="a4">
                    <label>4</label>Pharmacy, Lincoln University College, Petaling Jaya, Selangor, Malaysia</aff>
                <aff id="a5">
                    <label>5</label>Fakultas Vokasi, Universitas Kristen Indonesia, East Jakarta, Special Capital Region of Jakarta, Indonesia</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:rosyad2yafi@gmail.com">rosyad2yafi@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>26</day>
                <month>2</month>
                <year>2025</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2025</year>
            </pub-date>
            <volume>14</volume>
            <elocation-id>239</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>11</day>
                    <month>2</month>
                    <year>2025</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Rosyad YS et al.</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/14-239/pdf"/>
            <abstract>
                <sec>
                    <title>Background</title>
                    <p>Deaf person is risk population for health. During the covid-19 epidemic, deaf and hearing loss persons also suffer from psychological issues, post-traumatic stress disorder, and seropositive HIV.</p>
                </sec>
                <sec>
                    <title>Objective</title>
                    <p>This study aims to examine the effectiveness of an mobile health educational program to increase mental health and HIV prevention among deaf community</p>
                </sec>
                <sec>
                    <title>Methods</title>
                    <p>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. pronounced to escalate the sample size to 40 deaf per group, which is 80 total participants.</p>
                </sec>
                <sec>
                    <title>Results</title>
                    <p>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&lt;.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.</p>
                </sec>
                <sec>
                    <title>Conclusion</title>
                    <p>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.</p>
                </sec>
                <sec>
                    <title>Clinical trial</title>
                    <p>SLCTR/2024/039, 25 November 2024, 
                        <uri xlink:href="https://slctr.lk/trials/slctr-2024-039">https://slctr.lk/trials/slctr-2024-039</uri>
                    </p>
                </sec>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>MHealth</kwd>
                <kwd>HIV/AIDS</kwd>
                <kwd>Deaf</kwd>
                <kwd>VCT</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec7" sec-type="intro">
            <title>Introduction</title>
            <p>HIV prevention in the deaf-disabled population is one of the HIV-related health program&#x2019;s concerns (
                <xref ref-type="bibr" rid="ref42">United Nations, 2016</xref>; 
                <xref ref-type="bibr" rid="ref44">World Health Organization (WHO), 2021b</xref>). 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 (
                <xref ref-type="bibr" rid="ref36">Schenk et al., 2020</xref>). 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 (
                <xref ref-type="bibr" rid="ref36">Schenk et al., 2020</xref>).</p>
            <p>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 (
                <xref ref-type="bibr" rid="ref12">Doyle et al., 2021</xref>). Interestingly, earlier research supporting the feasibility study indicate that only 28.9% of deaf individuals had undergone an HIV screening examination (
                <xref ref-type="bibr" rid="ref31">Olakunde &amp; Pharr, 2020</xref>).</p>
            <p>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 (
                <xref ref-type="bibr" rid="ref26">Mehboob Khan et al., 2019</xref>). 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 (
                <xref ref-type="bibr" rid="ref2">Alika et al., 2016</xref>; 
                <xref ref-type="bibr" rid="ref16">Fergusson &amp; Woodward, 2002</xref>).</p>
            <p>Hearing loss was linked to distress in a major sample of persons under 70 years of age (
                <xref ref-type="bibr" rid="ref8">Bosdriesz et al., 2017</xref>; 
                <xref ref-type="bibr" rid="ref29">National Insitute on Aging (NIA), 2018</xref>). 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 Tuysk&#x00e1;n). In our research, the prevalence of PTSD (46.43%) and depression (41.07%) among teenagers with hearing loss was much greater than predicted (
                <xref ref-type="bibr" rid="ref4">Ariapooran et al., 2021</xref>).</p>
            <p>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 (
                <xref ref-type="bibr" rid="ref18">Gotowiec et al., 2022</xref>; 
                <xref ref-type="bibr" rid="ref27">Munoz-Baell &amp; Ruiz, 2000</xref>; 
                <xref ref-type="bibr" rid="ref38">Strong &amp; Shaver, 1991</xref>). The study of 
                <xref ref-type="bibr" rid="ref22">Jambor and Elliott (2005)</xref> 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 (
                <xref ref-type="bibr" rid="ref21">
Indiana et al., 2021</xref>; 
                <xref ref-type="bibr" rid="ref22">Jambor &amp; Elliott, 2005</xref>; 
                <xref ref-type="bibr" rid="ref40">Theunissen et al., 2014</xref>).</p>
            <p>According to WHO estimates, Over 5% of the world&#x2019;s population, or 430 million individuals, have &#x2018;disabling&#x2019; 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 (
                <xref ref-type="bibr" rid="ref43">World Health Organization (WHO), 2021a</xref>). According to World Federation of the Deaf (WFD) data, 80% of deaf people are illiterate or poorly educated (
                <xref ref-type="bibr" rid="ref14">El-Soud &amp; Hassan, 2009</xref>). Deaf individuals have difficulty understanding health recommendations (
                <xref ref-type="bibr" rid="ref6">Bahareh &amp; Heidary, 2015</xref>). Due to their communication difficulties, limited understanding of deaf persons makes their health treatment more hard (
                <xref ref-type="bibr" rid="ref19">Harmer, 1999</xref>). 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 (
                <xref ref-type="bibr" rid="ref28">National Health Service, 2005</xref>). 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 (
                <xref ref-type="bibr" rid="ref23">Joseph AM, 2009</xref>).</p>
            <p>There are challenges for the deaf people to get health information (
                <xref ref-type="bibr" rid="ref17">Folkins et al., 2005</xref>). 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 (
                <xref ref-type="bibr" rid="ref24">Kelly &amp; McKenzie, 2018</xref>). Multimedia distant information and communication services may serve as the standard electronic platform for continuing deaf education (
                <xref ref-type="bibr" rid="ref13">Drigas et al., 2009</xref>).</p>
            <p>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&#x2019; ideas and emotions, level of activity, and opinions about technical features of the software, including characteristics of usability and attractiveness (
                <xref ref-type="bibr" rid="ref30">O&#x2019;Brien &amp; Toms, 2013</xref>). User engagement is also intimately tied to a program&#x2019;s usability 
                <xref ref-type="bibr" rid="ref30">O&#x2019;Brien &amp; Toms (2013)</xref>, which includes efficacy, efficiency, and user happiness (
                <xref ref-type="bibr" rid="ref39">The National Standards Authority of Ireland (NSAI), 2018</xref>).</p>
            <p>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 (
                <xref ref-type="bibr" rid="ref5">Arias L&#x00f3;pez et al., 2023</xref>). The need cultural sensitive health communication strategies tailored to the deaf community to enhance engagement and understanding of health information in mental health (
                <xref ref-type="bibr" rid="ref41">Ulutorti, 2024</xref>).</p>
            <p>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.</p>
            <p>

                <bold>Clinical trial: SLCTR/2024/039, 25 November 2024</bold>, 
                <ext-link ext-link-type="uri" xlink:href="https://slctr.lk/trials/slctr-2024-039">https://slctr.lk/trials/slctr-2024-039</ext-link>.</p>
        </sec>
        <sec id="sec8" sec-type="methods">
            <title>Methods</title>
            <p>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 (
                <xref ref-type="bibr" rid="ref9">Chan et al., 2016</xref>), the Consolidated Standards of Reporting Trials (CONSORT) criteria (
                <xref ref-type="bibr" rid="ref37">Schulz et al., 2010</xref>), and the recommendations set forth by the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth (CONSORT-EHEALTH) (
                <xref ref-type="bibr" rid="ref15">Eysenbach et al., 2011</xref>). 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.</p>
            <sec id="sec9">
                <title>Study area</title>
                <p>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.</p>
            </sec>
            <sec id="sec10">
                <title>Study design</title>
                <p>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 (
                    <xref ref-type="bibr" rid="ref45">Polit and Beck, 2017</xref>). 
                    <xref ref-type="fig" rid="f1">
Figure 1</xref> provides an overview of the study design. The choice of this experimental design is grounded in its robustness and efficacy (
                    <xref ref-type="bibr" rid="ref11">Creswell, 2016</xref>).</p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>
Figure 1. </label>
                    <caption>
                        <title>Summarized the study design.</title>
                    </caption>
                    <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/177544/cfaea39a-15dc-4494-a89d-cbaba20924d7_figure1.gif"/>
                </fig>
            </sec>
            <sec id="sec11">
                <title>Inclusion and exclusion criteria participants</title>
                <p>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&#x2019;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 (
                    <xref ref-type="bibr" rid="ref11">Creswell, 2016</xref>; 
                    <xref ref-type="bibr" rid="ref20">Hart et al., 2023</xref>). The significance of well-defined inclusion criteria in enhancing the internal validity of health research(
                    <xref ref-type="bibr" rid="ref7">Bodicoat et al., 2021</xref>; 
                    <xref ref-type="bibr" rid="ref32">Patino &amp; Ferreira, 2018</xref>).</p>
            </sec>
            <sec id="sec12">
                <title>Recruitment</title>
                <p>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&#x2019;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.</p>
                <p>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&#x2019;s duration will be thoroughly detailed in the Respondent Information and Consent Forms.</p>
            </sec>
            <sec id="sec13">
                <title>Sample size</title>
                <p>Sample size was calculated using the software Based on an a priori power analysis (G*Power) (
                    <xref ref-type="bibr" rid="ref46">Faul et al., 2007</xref>). The sample size will be an 
                    <italic toggle="yes">F</italic>-test, an a priori type of power analysis (
                    <xref ref-type="bibr" rid="ref47">Chow et al., 2002</xref>), with power (1- &#x03b2;) of 0.95, &#x03b1; 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% (
                    <xref ref-type="bibr" rid="ref48">In et al., 2020</xref>; 
                    <xref ref-type="bibr" rid="ref49">Suresh &amp; Chandrashekara, 2012</xref>) dropout rate (33 &#x00d7; 20% = 6.6, rounded up to 7) and pronounced to escalate the sample size to 40 deaf per group, which is 80 total participants.</p>
            </sec>
            <sec id="sec14">
                <title>Outcome MHealth KaPi Program</title>
                <p>Increase in physical and psychological capability of HIV voluntary counseling and testing</p>
            </sec>
            <sec id="sec15">
                <title>Tools for collecting information in research</title>
                <p>

                    <bold>Ebook Mental Health and HIV/AIDS</bold>
                </p>
                <p>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 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.14784036">https://doi.org/10.5281/zenodo.14784036</ext-link> (
                    <xref ref-type="bibr" rid="ref33">Rosyad, 2025a</xref>)
                    <italic toggle="yes">,
</italic> Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero &#x201c;No rights reserved&#x201d; data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
                <p>

                    <bold>Mobile Health KaPi Program</bold>
                </p>
                <p>Mobile health KaPi program is education related about HIV/AIDS and mental. The proposed program will cover a period of 11 sessions and will be conducted over a period of 12.89 minute in each respondent of the intervention group. The program application can download at playstore with link 
                    <ext-link ext-link-type="uri" xlink:href="https://play.google.com/store/apps/details?id=com.project.kapi">https://play.google.com/store/apps/details?id=com.project.kapi</ext-link>. for the table this program can acces at 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.14784226">https://doi.org/10.5281/zenodo.14784226</ext-link> (
                    <xref ref-type="bibr" rid="ref34">Rosyad, 2025b</xref>), Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero &#x201c;No rights reserved&#x201d; data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
            </sec>
            <sec id="sec16">
                <title>Questionnaire to be utilized in this study</title>
                <p>Researchers use Kessler Psychological Distress Scale (K10) from 
                    <xref ref-type="bibr" rid="ref25">Kessler et al., (2002)</xref>,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 (
                    <xref ref-type="bibr" rid="ref3">Andrew &amp; Slade, 2001</xref>; 
                    <xref ref-type="bibr" rid="ref25">Kessler et al., 2002</xref>). Coping self-efficacy questionnaire will be adapting from 
                    <xref ref-type="bibr" rid="ref10">Chesney et al. (2006)</xref>, 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 
                    <xref ref-type="bibr" rid="ref1">Addis et al., (2013)</xref> is consists of 15 questions assessing participants&#x2019; 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.</p>
                <p>questionnaire will be adapting from 
                    <xref ref-type="bibr" rid="ref1">Addis et al. (2013)</xref>.</p>
            </sec>
            <sec id="sec17">
                <title>Statistical analysis</title>
                <p>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 c
                    <sup>2</sup> 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 odds ratio, accompanied by the 95% confidence interval, was employed to evaluate the association. Additionally, multiple logistic regression analyses were conducted to account for the effects of confounding variables, utilizing a 95% confidence interval, with adjusted odds ratios serving as indicators of the strength of the association, where P&lt;0.05 denotes statistical significance. Furthermore, generalized estimating equation (GEE) models, adhering to appropriate link function and distribution assumptions, were utilized to assess variations in findings over time and across four distinct groups. In summary, the models were calibrated to account for potential confounding factors.</p>
            </sec>
        </sec>
        <sec id="sec18" sec-type="results">
            <title>Results</title>
            <p>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.</p>
        </sec>
        <sec id="sec19" sec-type="conclusion">
            <title>Conclusion</title>
            <p>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.</p>
            <sec id="sec21">
                <title>Ethics and consent</title>
                <p>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, 
                    <ext-link ext-link-type="uri" xlink:href="https://slctr.lk/trials/slctr-2024-039">https://slctr.lk/trials/slctr-2024-039</ext-link>.</p>
                <p>Information and consent forms will be provided to selected respondents to secure their agreement to participate. 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&#x2019;s duration will be thoroughly detailed in the Respondent Information and Consent Forms.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec24" sec-type="data-availability">
            <title>Data availability statement</title>
            <p>No data associated with this article.</p>
            <sec id="sec20">
                <title>Reporting guidelines</title>
                <p>Articles that report protocols for clinical trials adhere to the SPIRIT reporting guidelines 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.14762634">https://doi.org/10.5281/zenodo.14762634</ext-link> (
                    <xref ref-type="bibr" rid="ref35">Rosyad et al., 2025</xref>), Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">Creative Commons Zero &#x201c;No rights reserved&#x201d; data waiver</ext-link> (CC0 1.0 Public domain dedication).</p>
            </sec>
        </sec>
        <ack>
            <title>Acknowledgements</title>
            <p>None.</p>
        </ack>
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                    <publisher-name>Department of Economic and Social Affairs Disability</publisher-name>;<year>2016</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.un.org/development/desa/disabilities/issues/disability-and-hivaids.html">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref43">
                <mixed-citation publication-type="other">
                    <collab>World Health Organization (WHO)</collab>:
                    <article-title>Deafness and hearing loss.</article-title>
                    <year>2021a</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss">Reference Source</ext-link>
                </mixed-citation>
            </ref>
            <ref id="ref44">
                <mixed-citation publication-type="book">
                    <collab>World Health Organization (WHO)</collab>:
                    <source>

                        <italic toggle="yes">WHO Director-General&#x2019;s closing remarks at 148th session of the Executive Board.</italic>
</source>
                    <publisher-name>World Health Organization</publisher-name>;<year>2021b</year>.
                    <ext-link ext-link-type="uri" xlink:href="https://www.who.int/director-general/speeches/detail/who-director-general-s-closing-remarks-at-148th-session-of-the-executive-board">Reference Source</ext-link>
                </mixed-citation>
            </ref>
        </ref-list>
    </back>
    <sub-article article-type="reviewer-report" id="report369983">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.177544.r369983</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Isaac</surname>
                        <given-names>Isiko</given-names>
                    </name>
                    <xref ref-type="aff" rid="r369983a1">1</xref>
                    <xref ref-type="aff" rid="r369983a2">2</xref>
                    <role>Referee</role>
                    <uri content-type="orcid">https://orcid.org/0000-0002-3612-5054</uri>
                </contrib>
                <aff id="r369983a1">
                    <label>1</label>Department of Community Medicine, Axel Pries Institute of Public Health and Biomedical Sciences, NIMS University, Jaipur, Rajasthan, India</aff>
                <aff id="r369983a2">
                    <label>2</label>School of Medicine, Makerere University, Kampala, Central Region, Uganda</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>14</day>
                <month>3</month>
                <year>2025</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2025 Isaac I</copyright-statement>
                <copyright-year>2025</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport369983" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.161505.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>
                <bold>Dear Editor,</bold>
            </p>
            <p> </p>
            <p> 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.</p>
            <p> </p>
            <p> 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.</p>
            <p> </p>
            <p> 
                <bold>General Comments</bold>
            </p>
            <p> </p>
            <p> &#x00a0;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.</p>
            <p> </p>
            <p> 
                <bold>Title and Abstract:</bold>
            </p>
            <p> </p>
            <p> &#x00a0;The title of the manuscript should be refined to be more precise and informative. For instance, instead of 
                <italic>'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,'</italic> a more concise version could be 
                <italic>'A Quasi-Experimental Study Protocol on the Impact of a Mobile Health Program for HIV Counseling and Testing in the Deaf Community.'</italic> This revision ensures clarity and a direct reflection of the study&#x2019;s scope.</p>
            <p> The abstract lacks specificity in the methodology section. Instead of stating, 
                <italic>'Quasi-experimental non-randomized controlled trial with single blinded participants,'</italic> it would be clearer to write, 
                <italic>'This study employs a quasi-experimental design with a non-randomized controlled trial, involving single-blinded participants and a parallel group assignment.'</italic> This revision provides more structure and readability.</p>
            <p> </p>
            <p> 
                <bold>&#x00a0;Introduction:</bold>
            </p>
            <p> </p>
            <p> 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: 
                <italic>'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.'</italic> This addition will strengthen the rationale for the study.</p>
            <p> 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.</p>
            <p> </p>
            <p> 
                <bold>&#x00a0;Methods:</bold>
            </p>
            <p> </p>
            <p> &#x00a0;The study design should be described with greater detail. Instead of simply stating, 
                <italic>'Quasi-experimental non-randomized controlled trial with single blinded participants,'</italic> a more comprehensive description could be: 
                <italic>'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.'</italic>
            </p>
            <p> The sample size calculation lacks clarity and should be expanded. The authors mention the use of G
                <italic>Power 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.'</italic>
            </p>
            <p> The intervention details are somewhat vague. Instead of stating, 
                <italic>'The KaPi mobile health program consists of 11 sessions,'</italic> it would be more informative to describe: 
                <italic>'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.'</italic> Providing this level of detail will help readers understand the intervention&#x2019;s structure and expected impact.</p>
            <p> </p>
            <p> 
                <bold>Ethical Considerations:</bold>
            </p>
            <p> </p>
            <p> &#x00a0;While ethical approval is mentioned, the manuscript should elaborate on the informed consent process. Instead of stating, 
                <italic>'Participants provided consent,'</italic> it would be clearer to describe: 
                <italic>'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.'</italic> This revision ensures that the ethical considerations specific to the deaf community are well addressed.</p>
            <p> </p>
            <p> 
                <bold>&#x00a0;Results Section (Planned Analysis):</bold>
            </p>
            <p> </p>
            <p> &#x00a0;The statistical analysis section should provide more depth on how changes over time will be measured. Instead of simply stating, 
                <italic>'The data will be analyzed using generalized estimation equations (GEE) with a confidence interval of 95%,'</italic> a more precise description would be: 
                <italic>'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.'</italic> This level of detail ensures clarity in the planned statistical approach.</p>
            <p> </p>
            <p> 
                <bold>Discussion (Expected Implications):</bold>
            </p>
            <p> </p>
            <p> The discussion should emphasize the study&#x2019;s contributions to HIV prevention strategies for the deaf community. Instead of a general statement like, 
                <italic>'This study will help improve health outcomes among the deaf population,'</italic> a more detailed perspective could be: 
                <italic>'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.'</italic>
            </p>
            <p> Potential limitations should also be discussed more explicitly. Instead of stating, 
                <italic>'This study may face some limitations,'</italic> the authors could write, 
                <italic>'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.'</italic> This approach strengthens the critical evaluation of the study design.</p>
            <p> </p>
            <p> 
                <bold>&#x00a0;Language and Formatting:</bold>
            </p>
            <p> </p>
            <p> The manuscript contains numerous grammatical errors and unclear sentences, which affect readability. For example, the sentence 
                <italic>'Deaf person is risk population for health'</italic> should be revised to 
                <italic>'Deaf individuals are considered a high-risk population for health disparities.'</italic> Careful proofreading and language editing will significantly improve the overall clarity and professionalism of the manuscript.</p>
            <p> </p>
            <p> Additionally, consistency in terminology is essential. Terms like 
                <italic>'deaf persons'</italic> and 
                <italic>'hearing loss individuals'</italic> should be standardized. Using 
                <italic>'deaf individuals'</italic> throughout the text would improve coherence.</p>
            <p> </p>
            <p> 
                <bold>Conclusion:</bold>
            </p>
            <p> </p>
            <p> The conclusion should emphasize the expected contributions of the study rather than presenting definitive results. Instead of 
                <italic>'The intervention group is expected to show significant improvements in psychological distress and HIV prevention,'</italic> a more appropriate statement would be: 
                <italic>'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.'</italic>
            </p>
            <p> </p>
            <p> 
                <bold>Final Recommendation</bold>
            </p>
            <p> </p>
            <p> 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.</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Partly</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>Not applicable</p>
            <p>Reviewer Expertise:</p>
            <p>Public health, disease modelling, maternal and child health, HIV, Malaria, Neglected tropical diseases, Machine learning, communicable diseases, Global Health, mental health</p>
            <p>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.</p>
        </body>
        <sub-article article-type="response" id="comment13596-369983">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Rosyad</surname>
                            <given-names>Yafi Sabila</given-names>
                        </name>
                        <aff>Nursing, Lincoln University College, Petaling Jaya, Selangor, Malaysia</aff>
                    </contrib>
                </contrib-group>
                <author-notes>
                    <fn fn-type="conflict">
                        <p>
                            <bold>Competing interests: </bold>none</p>
                    </fn>
                </author-notes>
                <pub-date pub-type="epub">
                    <day>20</day>
                    <month>3</month>
                    <year>2025</year>
                </pub-date>
            </front-stub>
            <body>
                <p>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.</p>
                <p> 2 abstract has little revision in methodology&#x00a0;</p>
                <p> 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.</p>
                <p> 4 correction Grammarly.</p>
            </body>
        </sub-article>
    </sub-article>
</article>
