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      Evaluating an Innovative HIV Self-Testing Service With Web-Based, Real-Time Counseling Provided by an Artificial Intelligence Chatbot (HIVST-Chatbot) in Increasing HIV Self-Testing Use Among Chinese Men Who Have Sex With Men: Protocol for a Noninferiority Randomized Controlled Trial


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          Counseling support for HIV self-testing (HIVST) users is essential to ensure support and linkage to care among men who have sex with men (MSM). An HIVST service with web-based real-time instruction, pretest, and posttest counseling provided by trained administrators (HIVST-OIC) was developed by previous projects. Although the HIVST-OIC was highly effective in increasing HIVST uptake and the proportion of HIVST users receiving counseling along with testing, it required intensive resources to implement and sustain. The service capacity of HIVST-OIC cannot meet the increasing demands of HIVST.


          This randomized controlled trial primarily aims to establish whether HIVST-chatbot, an innovative HIVST service with web-based real-time instruction and counseling provided by a fully automated chatbot, would produce effects that are similar to HIVST-OIC in increasing HIVST uptake and the proportion of HIVST users receiving counseling alongside testing among MSM within a 6-month follow-up period.


          A parallel-group, noninferiority randomized controlled trial will be conducted with Chinese-speaking MSM aged ≥18 years with access to live-chat applications. A total of 528 participants will be recruited through multiple sources, including outreach in gay venues, web-based advertisement, and peer referral. After completing the baseline telephone survey, participants will be randomized evenly into the intervention or control groups. Intervention group participants will watch a web-based video promoting HIVST-chatbot and receive a free HIVST kit. The chatbot will contact the participant to implement HIVST and provide standard-of-care, real-time pretest and posttest counseling and instructions on how to use the HIVST kit through WhatsApp. Control group participants will watch a web-based video promoting HIVST-OIC and receive a free HIVST kit in the same manner. Upon appointment, a trained testing administrator will implement HIVST and provide standard-of-care, real-time pretest and posttest counseling and instructions on how to use the HIVST kit through live-chat applications. All participants will complete a telephone follow-up survey 6 months after the baseline. The primary outcomes are HIVST uptake and the proportion of HIVST users receiving counseling support along with testing in the past 6 months, measured at month 6. Secondary outcomes include sexual risk behaviors and uptake of HIV testing other than HIVST during the follow-up period. Intention-to-treat analysis will be used.


          Recruitment and enrollment of participants started in April 2023.


          This study will generate important research and policy implications regarding chatbot use in HIVST services. If HIVST-chatbot is proven noninferior to HIVST-OIC, it can be easily integrated into existing HIVST services in Hong Kong, given its relatively low resource requirements for implementation and maintenance. HIVST-chatbot can potentially overcome the barriers to using HIVST. Therefore, the coverage of HIV testing, the level of support, and the linkage to care for MSM HIVST users will be increased.

          Trial Registration

          ClinicalTrial.gov NCT05796622; https://clinicaltrials.gov/ct2/show/NCT05796622

          International Registered Report Identifier (IRRID)


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          Most cited references31

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          The Health Belief Model: a decade later.

          Since the last comprehensive review in 1974, the Health Belief Model (HBM) has continued to be the focus of considerable theoretical and research attention. This article presents a critical review of 29 HBM-related investigations published during the period of 1974-1984, tabulates the findings from 17 studies conducted prior to 1974, and provides a summary of the total 46 HBM studies (18 prospective, 28 retrospective). Twenty-four studies examined preventive-health behaviors (PHB), 19 explored sick-role behaviors (SRB), and three addressed clinic utilization. A "significance ratio" was constructed which divides the number of positive, statistically-significant findings for an HBM dimension by the total number of studies reporting significance levels for that dimension. Summary results provide substantial empirical support for the HBM, with findings from prospective studies at least as favorable as those obtained from retrospective research. "Perceived barriers" proved to be the most powerful of the HBM dimensions across the various study designs and behaviors. While both were important overall, "perceived susceptibility" was a stronger contributor to understanding PHB than SRB, while the reverse was true for "perceived benefits." "Perceived severity" produced the lowest overall significance ratios; however, while only weakly associated with PHB, this dimension was strongly related to SRB. On the basis of the evidence compiled, it is recommended that consideration of HBM dimensions be a part of health education programming. Suggestions are offered for further research.
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            Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis

            Abstract Introduction: HIV self-testing (HIVST) is a discreet and convenient way to reach people with HIV who do not know their status, including many who may not otherwise test. To inform World Health Organization (WHO) guidance, we assessed the effect of HIVST on uptake and frequency of testing, as well as identification of HIV-positive persons, linkage to care, social harm, and risk behaviour. Methods: We systematically searched for studies comparing HIVST to standard HIV testing until 1 June 2016. Meta-analyses of studies reporting comparable outcomes were conducted using a random-effects model for relative risks (RR) and 95% confidence intervals. The quality of evidence was evaluated using GRADE. Results: After screening 638 citations, we identified five randomized controlled trials (RCTs) comparing HIVST to standard HIV testing services among 4,145 total participants from four countries. All offered free oral-fluid rapid tests for HIVST and were among men. Meta-analysis of three RCTs showed HIVST doubled uptake of testing among men (RR = 2.12; 95% CI: 1.51, 2.98). Meta-analysis of two RCTs among men who have sex with men showed frequency of testing nearly doubled (Rate ratio = 1.88; 95% CI: 1.17; 3.01), resulting in two more tests in a 12–15-month period (Mean difference = 2.13; 95% CI: 1.59, 2.66). Meta-analysis of two RCTs showed HIVST also doubled the likelihood of an HIV-positive diagnosis (RR = 2.02; 95% CI: 0.37, 10.76, 5.32). Across all RCTs, there was no indication of harm attributable to HIVST and potential increases in risk-taking behaviour appeared to be minimal. Conclusions: HIVST is associated with increased uptake and frequency of testing in RCTs. Such increases, particularly among those at risk who may not otherwise test, will likely identify more HIV-positive individuals as compared to standard testing services alone. However, further research on how to support linkage to confirmatory testing, prevention, treatment and care services is needed. WHO now recommends HIVST as an additional HIV testing approach.
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              The prevalence of HIV among MSM in China: a large-scale systematic analysis

              Background The prevalence of HIV among men who have sex with men (MSM) has become a significant public health challenge. The aim was to comprehensively estimate the national prevalence of HIV among MSM and its time trends through a large-scale systematic analysis. Methods Systematic search of Cochrane Library, PubMed, EMBASE, CNKI, VIP, and Wanfang Data databases without language restriction for studies on the prevalence of HIV among MSM published before Dec.31, 2018. Studies were eligible for inclusion if they were published in the peer-reviewed literature and used validated assessment methods to assess the prevalence of HIV among MSM. Estimates were pooled using random-effects analysis. Results Data were extracted from 355 cross-sectional studies (571,328 individuals) covered 59 cities from 30 provinces and municipalities of China. The overall national prevalence of HIV among MSM from 2001 to 2018 was estimated to be 5.7% (95% CI: 5.4–6.1%), with high between-study heterogeneity (I 2 = 98.0%, P <  0.001). Our study showed an increased tendency in the HIV prevalence as time progressed by meta-regression analysis (I 2 = 95.9%, P <  0.0001). HIV prevalence was the highest in those aged 50 years and older with HIV prevalence of 19.3% (95%CI: 13.1-27.4%, N = 13). HIV was more prevalent in the illiterate population (16.8%), than in those who had received an education. Although the internet was a major venue for Chinese MSM seeking male sex partners (35.6, 95%CI: 32.3-39.9%, N = 101), seeking MSM in bathhouses/saunas had the highest associated prevalence of HIV (13.4, 95%CI: 10.3-17.1%, N = 22). The HIV prevalence among MSM varied by location: compared with other regions in China, HIV was highly prevalent among MSM in the southwest (10.7, 95%CI: 9.3-12.2%, N = 91). Compared to participants who sometimes or always used condoms, participants who had never used a condom in the past 6 months had a higher risk of HIV infection, with odds ratios of 0.1 (95%CI: 0.08-0.14). Conclusions Our analysis provided reliable estimates of China’s HIV burden among MSM, which appears to present an increasing national public health challenge. Effective government responses are needed to address this challenge and include the implementation of HIV prevention.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                30 June 2023
                : 12
                : e48447
                [1 ] Centre for Health Behaviours Research, Jockey Club School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong Hong Kong Hong Kong
                [2 ] School of Data Science, The City University of Hong Kong Hong Kong Hong Kong
                [3 ] AIDS Concern Hong Kong Hong Kong
                [4 ] Department of Health and Physical Education, The Education University of Hong Kong Hong Kong Hong Kong
                Author notes
                Corresponding Author: Zixin Wang wangzx@ 123456cuhk.edu.hk
                Author information
                ©Siyu Chen, Qingpeng Zhang, Chee-kit Chan, Fuk-yuen Yu, Andrew Chidgey, Yuan Fang, Phoenix K H Mo, Zixin Wang. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.06.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 24 April 2023
                : 19 May 2023
                : 22 May 2023
                : 25 May 2023
                Custom metadata
                The proposal for this study was peer-reviewed by: Council for the AIDS Trust Fund, Centre for Health Protection Department of Health (Hong Kong). See the Multimedia Appendix for the peer-review report;

                chatbot,counseling,hiv self-testing,men who have sex with men,non-inferiority randomized controlled trial


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