PrEP3

執行研究 Implementation study

 

請注意:受新型冠狀病毒疫情影響,此項研究在招募安排上已經作出修改,藉以減少人流和人群聚集。請參加者必須特別注意相關步驟,不便之處,敬請原諒。

Please note: In view of the novel coronavirus outbreak (COVID-19), procedures for enrolment of participants for the study have been revised, so as to reduce the number of attendees for achieving social distancing. Participants are urged to pay special attention to the arrangement.  We apologise for any inconvenience caused.

 

研究目的
Aim and objectives

本研究旨在探討事前預防用藥(英文簡稱PrEP)服務模式及在實際環境的執行性。本研究有三項目標:

  1. 設計適合高風險人士的PrEP服務模式
  2. 探索以PrEP服務結合性病/愛滋病毒感染測試,預防愛滋病毒感染和相關輔導的可行性
  3. 評估PrEP用者自發安排流程的可行性

香港中文大學–新界東醫院聯網臨床研究倫理聯席委員會已批核是項研究(參考編號:2019.345),被授權在有需要時審視參加者個人資料藉以評估研究倫理。

The project aims to develop a service model for PrEP delivery and test its operability in the real world setting.  The objectives are, to:

  1. developing a PrEP service delivery model for sexual health needs of people at high risk of HIV infection;
  2. testing the practicability of integrating STI/HIV testing and HIV prevention and counselling in PrEP service;
  3. testing the incorporation of self-motivated arrangement for accessing PrEP

The Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has approved this study (Ref. No.: 2019.345) and is authorised to access the participants’ records related to the study for ethics review purpose.

執行研究 Implementation study

研究設計 Study design

這是一項為期一年的事前預防用藥(PrEP)觀察研究,間參加者獲免費提供預防藥物Truvada®。參加者需要一共到診五次或以上,並於預約時提交到診前1個月內的愛滋病毒感染陰性報告。期間須完成日記、基線、每月及終期問卷。同時,我們建議參加者每3個月自行進行一次以下測試:愛滋病毒抗體和包括梅毒、衣原體和淋病等性病篩檢。

This is a 1-year study on PrEP usage. During the project period, Truvada® would be offered free to participants. You are required to attend the research clinic for a total of 5 or more visits over a one-year period. Before each appointment, you need to submit a test report confirming your HIV negative status within 1 month before the visit date. Diary, baseline, monthly and exit questionnaires have to completed during the study period. You are also advised to make arrangement for the following tests to be performed every 3-months: HIV antibody, testing for syphilis, gonorrhoea and chlamydia infections.

參加資格 Eligibility criteria

參加者必須:

  1. 十八歲或以上
  2. 經常在港居住
  3. 能使用英文或中文作語言和文字溝通
  4. 過去6個月內多於一次在沒有戴上安全套情況下發生性行為,特別是肛交
  5. 過去三個月內愛滋病毒抗體測試呈陰性
  6. 過去6個月內有以下任何經歷:參與chemsex/chemfun ,同時與兩人或以上進行性行為、有多過一位性伴侶、被診斷患上任何性病、 性伴侶為愛滋病毒感染者
  7. 在未來數月有進行不安全性行為傾向
  8. 沒有感染乙型肝炎
  9. 腎臟功能正常
  10. 沒有懷孕或計劃懷孕(女性)
  11. 非注射吸毒者

To join the study, one must:

  1. be aged 18 or above
  2. be normally resident in Hong Kong
  3. be able to communicate in written and spoken English or Chinese
  4. have more than 1 episode of condomless sex (especially anal sex) in the preceding 6 months
  5. have been tested HIV antibody negative in the past 3 months
  6. have any of the following experiences in the past 6 months: chemsex/chemfun engagement, group sex, having multiple sex partners, STI diagnosis, having HIV+ve sex partner(s)
  7. be inclined to engage in high risk sexual activities in the coming months
  8. not be infected with hepatitis B
  9. have normal kidney function
  10. not be pregnant or planning to get pregnant (for female)
  11. not an injection drug user

 

研究流程 Flow chart of the study

首次到診前,參加者除了需要填答基線網上問卷(需時約15分鐘),記緊自行安排愛滋病毒感染測試。到診日(第0/1次)需要見醫生,抽取血液樣本和取藥。

Before attending the baseline visit 0/1, you are reminded to self-arrange an HIV test apart from completing the baseline questionnaire online. At this clinic visit, you would see the doctor, have blood collected, and receive the prescription.

其後程序 Subsequent Process :

  • 每天服用Truvada®     (醫生特別建議除外)
  • 每週填答日記
  • 每月填答一份簡單網上問卷(需時約5分鐘)
  • 每3個月自行進行一次愛滋病毒感染/性病測試及預約下一次到診時間
  • 在預約日到診,見醫生,抽取血液樣本和取藥
  • 部分參加者研究後期會被邀請參加深層訪談。
  • Take Truvada® every day (unless otherwise advised by doctor)
  • Complete diary every week
  • Complete an update questionnaire every month (takes around 5 mins)
  • Test for HIV/STI and make appointment every 3 months
  • Visit the clinic by appointment for consultation, blood sampling and obtaining Truvada®
  • Some participants would be invited for an in-depth interview towards the latter part of the research.

注意:參加PrEP3研究需經轉介,有興趣者可以
電郵聯絡 info@nonewhiv.hk  查詢詳情。
Attention: Participation in PrEP3 is on a referral basis.
Interested person may contact info@nonewhiv.hk for details.

 

請注意:受新型冠狀病毒疫情影響,此項研究在招募安排上已經作出修改,藉以減少人流和人群聚集。請參加者必須特別注意相關步驟,不便之處,敬請原諒。

Please note: In view of the novel coronavirus outbreak (COVID-19), procedures for enrolment of participants for the study have been revised, so as to reduce the number of attendees for achieving social distancing. Participants are urged to pay special attention to the arrangement.  We apologise for any inconvenience caused.