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  • A randomised controlled trial to evaluate the impact of sexual health clinic based automated text message reminders on testing of HIV and other sexually transmitted infections in men who have sex with men in China: protocol for the T2T Study

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HIV/AIDS
Protocol
A randomised controlled trial to evaluate the impact of sexual health clinic based automated text message reminders on testing of HIV and other sexually transmitted infections in men who have sex with men in China: protocol for the T2T Study
  1. Huachun Zou1,2,
  2. Xiaojun Meng3,
  3. Andrew Grulich2,
  4. Shujie Huang4,5,
  5. Tianjian Jia3,
  6. Xuan Zhang3,
  7. Zhenzhou Luo6,
  8. Yi Ding6,
  9. Ligang Yang4,5,
  10. Jinmei Han4,5,
  11. Weiying Chen4,5,
  12. Heping Zheng4,5,
  13. Bin Yang4,5
  1. 1 School of Public Health, Sun Yat-sen University, Guangzhou, China
  2. 2 Kirby Institute, University of New South Wales, Sydney, Australia
  3. 3 Department of Infectious Disease Control, Wuxi Municipal Centre for Disease Control and Prevention, Wuxi, China
  4. 4 Dermatology Hospital, Southern Medical University, Guangzhou, China
  5. 5 Guangdong Provincial Dermatology Hospital, Guangzhou, China
  6. 6 Nanshan District Centre for Chronic Disease Control and Prevention, Shenzhen, China
  1. Correspondence to Dr. Huachun Zou; zouhuachun{at}mail.sysu.edu.cn and Dr. Bin Yang; yangbin101{at}hotmail.com

Abstract

Introduction The frequency of screening for HIV and other sexually transmitted infections (STIs) among men who have sex with men (MSM) is still low in China.

Methods and analysis A sexual health clinic based randomised controlled trial will be conducted in Guangzhou, Wuxi and Shenzhen, China, enrolling 600 MSM. Eligibility will be judged by the pre-programed iPad based questionnaire: (1) age ≥18 years and (2) have had two or more male anal sex partners, or condomless anal sex with a casual male sex partner, or an STI history, in the past 6 months, and (3) provides a valid mobile phone number. Eligible men will be randomly allocated 1:1 to the intervention arm (with monthly text messages reminding them to test for HIV/STIs) or to the control arm (with no reminders). Men in both arms will complete a questionnaire onsite at enrolment and after 12 months, and another questionnaire online at 6 months. Men in both arms will be tested for HIV, syphilis, anal gonorrhoea/chlamydia and penile gonorrhoea/chlamydia at enrolment and at 12 months. The primary outcome is the rate and frequency of HIV testing within the 12 months after enrolment. The secondary outcome is the rate of unprotected anal intercourse. An assessment of the cost effectiveness of this intervention is also planned.

Ethics and dissemination The study has been approved by the ethical review committees of the University of New South Wales, Australia (HC16803), the Guangdong Provincial Centre for Skin Disease and STI Control (GDDHLS-20160926) and the Wuxi Centre for Disease Control and Prevention (WXCDC2016009), China. Study findings will be submitted to academic journals and disseminated to local health authorities.

Trial registration number Chinese Clinical Trial Registry at: http://www.chictr.org.cn/showprojen.aspx?proj=15752 and WHO International Clinical Trials Registry Platform at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IOR-16009304.

  • Text message service
  • Reminder
  • HIV
  • STI
  • Men who have sex with men
  • Sexual health clinic

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-015787

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    Footnotes

    • Contributors HZ and XM initiated this research plan and designed this protocol, with BY and AG consulting on ethics and the feasibility of the research. ZL, TJ, XZ, YD and LY provided expertise on recruitment and sample collection and will supervise these aspects at the three study clinics. JH, SH and HZ provided expertise on sample testing and storage. WC helped with the design of the questionnaire and recruitment methods.

    • Funding This work was supported by a grant from the Australian National Health and Medical Research Commission (NHMRC) Early Career Fellowship (APP1092621), and research grants from Guangdong Provincial Centre for Skin Disease and STI Control (YCS201669), Wuxi Municipal Health and Family Planning Commission(MS201613), Wuxi Municipal Science and Technology Bureau (CSZ0N1512) and Nanshan District Centre for Chronic Disease Control and Prevention. The funding bodies other than NHMRC participated in study design, data collection and analysis, preparation of the manuscript and the decision to publish.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The study has been approved by the ethical review committees of the University of New South Wales, Australia (HC16803), the Guangdong Provincial Centre for Skin Disease and STI Control (GDDHLS-20160926) and the Wuxi Centre for Disease Control and Prevention (WXCDC2016009), China.

    • Provenance and peer review Not commissioned; externally peer reviewed.