PrEP2

交叉研究 Crossover study

[The study has ended]

研究目的
Aim and objectives

本研究項目旨在探討具高愛滋感染風險男男性接觸者對於兩種「事前預防投藥」模式的服藥使用情況及相關影響因素。

本研究有四項目標：

  1. 比較需時及每日服藥兩種模式的依從性及性行為的覆蓋程度
  2. 評估使用者對兩種服藥模式的喜惡
  3. 分析服藥後的風險補償行為
  4. 推測不同模式對將來愛滋病毒傳播動力的影響

香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會被授權在有需要時審視個人資料藉以評估研究倫理（參考編號：2016.719）。如果你有更多關於臨床 研究倫理相關問題，請與該委員會聯繫（電郵  crec@cuhk.edu.hk 或 致電 2632 3935）。

The project aims to explore the usage patterns and related determinants of on-demand versus daily mode of PrEP in MSM with substantial risk of HIV infection.

The objectives are, to:

  1. compare the adherence to PrEP and associated protection of sex acts between on-demand and daily mode of delivery
  2. examine the preferred mode of PrEP before and following exposure to periods of two modes of delivery
  3. characterise pattern of risk compensation following PrEP
  4. project transmission dynamics of HIV infection under the influence of different modes of PrEP delivery

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee has approved this study (Ref. No.: 2016.719) and is authorised to access the participants' records related to the study for ethics review purpose. For enquiry regarding clinical research ethics, please contact the Committee at crec@cuhk.edu.hk and phone at 2632 3935.

交叉研究 Crossover study

研究設計 Study design

參加者須接受合共五十星期的觀察。「事前預防用藥」將會免費提供予參加者。經過檢測後，一半參加者在首十六個星期須每天用藥，接著的十六個星期則有需要時服藥。另外一半參加者則先進行有需要時用藥十六星期，然後在餘下的十六星期每天用藥。參加者須定期到訪診所作身體檢查、性病及愛滋病毒感染測試、填寫問卷，以及領取藥物。在第五十個星期，研究人員將會聯絡參加者作跟進問卷調查。

Participants will be followed up for a total of 50 weeks. PrEP will be prescribed to participants free. For half of the participants, a 16-week course of daily PrEP will be provided, followed by another 16 weeks of on-demand treatment. For the other half of the participants, the sequence is reversed. Participants begin with on-demand PrEP for 16 weeks then switch to daily PrEP in the remaining 16 weeks. All participants are asked to visit the clinic regularly for body check-up, HIV and STI tests, complete questionnaire and collect prescription. At week 50, participants will be contacted for follow-up questionnaire.

參加資格 Eligibility criteria

參加者須：

  1. 為十八歲或以上男性、曾與男性肛交，最近一次於過去6個月內
  2. 經常在港居住
  3. 在未來數月有傾向進行不安全性行為
  4. 沒有感染愛滋病毒 (過去3個月內愛滋病毒抗體測試呈陰性反應)
  5. 乙型肝炎表面抗原呈陰性反應
  6. 腎臟功能正常

To join the study, you must:

  1. be male, aged 18 or above, and had anal sex with another man, with the most recent sex act in the last 6 month; and
  2. normally reside in Hong Kong; and
  3. be inclined to have unprotected anal sex in the coming months; and
  4. be HIV negative (HIV antibody test negative within last 3 months); and
  5. be HBsAg negative; and
  6. have normal renal function

研究流程 Flow chart of the study

 

身體檢查及測試包括：

  • 腎功能
  • 乙型肝炎表面抗原
  • 愛滋病毒
  • 梅毒、淋病、衣原體

部份測試須收集尿液及其他樣本；
快速測試將會以拮手指方式進行。

Body check-up & tests:

  • Renal function
  • HBsAg
  • HIV
  • Syphilis, NG/CT

Urine and other samples will be collected.
Fingerprick rapid tests will be performed.

注意： PrEP2研究已經完結。有興趣者可以電郵聯絡 info@nonewhiv.hk ，
查詢其他相關項目招募情況。
Attention: PrEP1 study has ended. Interested person may contact info@nonewhiv.hk for updates on new projects.

香港中文大學何鴻燊防治傳染病研究中心
Stanley Ho Centre for Emerging Infectious Diseases, The Chinese University of Hong Kong