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
Introduction 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 transmi...
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e036231.full |
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| author | Jing Zhang Weiming Tang Wenqing Geng Zhenxing Chu Junjie Xu Xiaojie Huang Yaokai Chen Yonghui Zhang Hongyi Wang Zhu Mei Yueru Jia Qing-Hai Hu Lukun Zhang Zhili Hu Rantong Bao Shangcao Li Haibo Ding Yongjun Jiang |
| author_facet | Jing Zhang Weiming Tang Wenqing Geng Zhenxing Chu Junjie Xu Xiaojie Huang Yaokai Chen Yonghui Zhang Hongyi Wang Zhu Mei Yueru Jia Qing-Hai Hu Lukun Zhang Zhili Hu Rantong Bao Shangcao Li Haibo Ding Yongjun Jiang |
| author_sort | Jing Zhang |
| collection | DOAJ |
| description | Introduction 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’s 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.Methods and analysis 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 7–12). 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.Ethics and dissemination The Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).Trial registration number ChiCTR1800020374 |
| format | Article |
| id | doaj-art-23af96e5d58c4bbaa9778aa7a2b3b21e |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-23af96e5d58c4bbaa9778aa7a2b3b21e2024-12-05T00:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2019-036231HIV 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 trialJing Zhang0Weiming Tang1Wenqing Geng2Zhenxing Chu3Junjie Xu4Xiaojie Huang5Yaokai Chen6Yonghui Zhang7Hongyi Wang8Zhu Mei9Yueru Jia10Qing-Hai Hu11Lukun Zhang12Zhili Hu13Rantong Bao14Shangcao Li15Haibo Ding16Yongjun Jiang173 School of Public Health, University of New South Wales, Sydney, New South Wales, AustraliaSouthern Medical University Dermatology Hospital, Guangzhou, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaKey Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, ChinaPeking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, ChinaDivision of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing, ChinaCollaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, ChinaDepartment of Cardiology and Hypertension, Peking University People`s Hospital, Beijing, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaDepartment of Infectious Diseases, Shenzhen Third People’s Hospital, Shenzhen, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaCollaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaNHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, ChinaIntroduction 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’s 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.Methods and analysis 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 7–12). 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.Ethics and dissemination The Medical Science Research Ethics Committee of The First Affiliated Hospital of China Medical University has approved the study (IRB(2018)273).Trial registration number ChiCTR1800020374https://bmjopen.bmj.com/content/10/7/e036231.full |
| spellingShingle | Jing Zhang Weiming Tang Wenqing Geng Zhenxing Chu Junjie Xu Xiaojie Huang Yaokai Chen Yonghui Zhang Hongyi Wang Zhu Mei Yueru Jia Qing-Hai Hu Lukun Zhang Zhili Hu Rantong Bao Shangcao Li Haibo Ding Yongjun Jiang 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/7/e036231.full |
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