{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T02:10:43Z","timestamp":1775787043369,"version":"3.50.1"},"reference-count":40,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2020,7,17]],"date-time":"2020-07-17T00:00:00Z","timestamp":1594944000000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Mega-Projects of national science research","award":["2012ZX10001006-001-010"],"award-info":[{"award-number":["2012ZX10001006-001-010"]}]},{"name":"Mega-Projects of national science research","award":["2017ZX10201101-002-007"],"award-info":[{"award-number":["2017ZX10201101-002-007"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["81872674"],"award-info":[{"award-number":["81872674"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100018537","name":"National Science and Technology Major Project","doi-asserted-by":"crossref","award":["2018ZX10101001-001-003"],"award-info":[{"award-number":["2018ZX10101001-001-003"]}],"id":[{"id":"10.13039\/501100018537","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,4,28]]},"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection among men who have sex with men by up to 99%. However, in real-world settings, PrEP users may exhibit risk compensation after uptake of PrEP, including more condomless anal intercourse (CAI) and increased sexually transmitted infection (STI) acquisition. HIV self-testing (HIVST) decreases CAI among men who have sex with men (MSM) by providing awareness of the HIV status of oneself and one\u2019s sexual partners. Here, we describe the rationale and design of a randomised waitlist-controlled trial to examine the impact of HIVST on risk compensation among PrEP users.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The study is a two-arm randomised waitlist-controlled trial with 1000 HIV-negative MSM in four major cities in China who will be taking oral PrEP (involving tenofovir disoproxil fumarate\/emtricitabine) either daily (n=500) or in an event-driven regimen (n=500). The participants will be randomised (1:1) to either the immediate HIVST intervention arm (HIVST plus standard facility-based counselling and testing from 0 to 12 months) or the waitlist arm (standard facility-based counselling and testing from 0 to 6 months, then crossover to receive the HIVST intervention in months 7\u201312). Participants will provide blood samples to assess the incidence of syphilis and herpes simplex virus type 2 (HSV-2) during a follow-up. The primary outcomes will be the occurrence of CAI, number of sexual partners and incidence of syphilis and HSV-2 during a follow-up. The secondary outcomes will be the HIV and STI testing frequency and STI treatment adherence during a follow-up. The planned start and end dates for the study is 26 December 2018 and 31 December 2020.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR1800020374<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-036231","type":"journal-article","created":{"date-parts":[[2020,7,20]],"date-time":"2020-07-20T06:19:09Z","timestamp":1595225949000},"page":"e036231","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["HIV and other STIs self-testing to reduce risk compensation among men who have sex with men who use oral pre-exposure prophylaxis in China: protocol for a randomised waitlist-controlled trial"],"prefix":"10.1136","volume":"10","author":[{"given":"Jing","family":"Zhang","sequence":"first","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaojie","family":"Huang","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China"},{"name":"Beijing Youan Hospital, Capital Medical University, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yaokai","family":"Chen","sequence":"additional","affiliation":[{"name":"Chongqing Public Health Medical Center, Chongqing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Shenzhen Third People\u2019s Hospital, Shenzhen, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yonghui","family":"Zhang","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongyi","family":"Wang","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhu","family":"Mei","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yueru","family":"Jia","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"ZhenXing","family":"Chu","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qing-Hai","family":"Hu","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory 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for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rantong","family":"Bao","sequence":"additional","affiliation":[{"name":"NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, China"},{"name":"Key Laboratory of AIDS Immunology of Liaoning Province, Shenyang, China"},{"name":"Collaborative Innovation Center for Diagnosis and Treatment of Infectious 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CDC recommends pill to protect against HIV. Available: https:\/\/www.cbsnews.com\/news\/cdc-recommends-pill-to-protect-against-hiv\/ [Accessed 3 Sep 2019]."},{"key":"2025121600001364000_10.7.e036231.2","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2018.00799","article-title":"Efficacy and safety of oral TDF-Based pre-exposure prophylaxis for men who have sex with men: a systematic review and meta-analysis","volume":"9","author":"Huang","year":"2018","journal-title":"Front Pharmacol"},{"key":"2025121600001364000_10.7.e036231.3","unstructured":"AVAC: Global Advocacy for HIV Prevention . Resources. Available: https:\/\/www.avac.org\/resources\/infographics. [Accessed 23 Jul 2019]."},{"key":"2025121600001364000_10.7.e036231.4","unstructured":"NAM . 380,000 people on PreP globally, mostly in the USA and Africa, 2018. Available: http:\/\/www.aidsmap.com\/news\/oct-2018\/380000-people-prep-globally-mostly-usa-and-africa-updated [Accessed 14 Sep 2019]."},{"key":"2025121600001364000_10.7.e036231.5","unstructured":"AVAC: Global Advocacy for HIV Prevention . Pre-exposure prophylaxis for the prevention of HIV in the United States, 2017."},{"key":"2025121600001364000_10.7.e036231.6","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000209"},{"key":"2025121600001364000_10.7.e036231.7","doi-asserted-by":"crossref","first-page":"e104","DOI":"10.1097\/QAI.0000000000002054","article-title":"Predictors of disengagement in care for individuals receiving pre-exposure prophylaxis (PrEP)","volume":"81","author":"Zucker","year":"2019","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2025121600001364000_10.7.e036231.8","doi-asserted-by":"crossref","first-page":"e241","DOI":"10.1016\/S2352-3018(17)30023-1","article-title":"Effect of availability of HIV self-testing on HIV testing frequency in gay and bisexual men at high risk of infection (forth): a waiting-list randomised controlled trial","volume":"4","author":"Jamil","year":"2017","journal-title":"Lancet 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Guidelines on HIV self-testing and partner notification supplement to consolidated guidelines on HIV testing services, 2016. Available: https:\/\/www.who.int\/hiv\/pub\/vct\/hiv-self-testing-guidelines\/en\/. [Accessed 13 Jan 2020]."},{"key":"2025121600001364000_10.7.e036231.35","doi-asserted-by":"crossref","DOI":"10.1038\/s41598-017-18127-x","article-title":"Poppers use and sexual partner concurrency increase the HIV incidence of MSM: a 24-month prospective cohort survey in Shenyang, China","volume":"8","author":"Chu","year":"2018","journal-title":"Sci Rep"},{"key":"2025121600001364000_10.7.e036231.36","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.24490"},{"key":"2025121600001364000_10.7.e036231.37","unstructured":"National AIDS Control Organisation . National guideline for detection of HIV\/AIDS, 2015."},{"key":"2025121600001364000_10.7.e036231.38","doi-asserted-by":"crossref","first-page":"1115","DOI":"10.1177\/0956462416688818","article-title":"Prevalence and the associated risk factors of HIV, STIs and HBV among men who have sex with men in Kunming, China","volume":"28","author":"Zhang","year":"2017","journal-title":"Int J STD AIDS"},{"key":"2025121600001364000_10.7.e036231.39","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0118863","article-title":"The epidemic of HIV, syphilis, Chlamydia and gonorrhea and the correlates of sexual transmitted infections among men who have sex with men in Jiangsu, China, 2009","volume":"10","author":"Fu","year":"2015","journal-title":"PLoS One"},{"key":"2025121600001364000_10.7.e036231.40","doi-asserted-by":"crossref","DOI":"10.1186\/s12879-019-4664-1","article-title":"Anatomical site prevalence and genotypes of Chlamydia trachomatis infections among men who have sex with men: a multi-site study in China","volume":"19","author":"Zhou","year":"2019","journal-title":"BMC Infect Dis"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-036231","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T08:00:39Z","timestamp":1765872039000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-036231"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7]]},"references-count":40,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2020,7,19]]},"published-print":{"date-parts":[[2020,7]]}},"alternative-id":["10.1136\/bmjopen-2019-036231"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-036231","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,7]]}}}