London School of Hygiene and Tropical Medicine, London, UK.
University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa.
Trials. 2020 Oct 30;21(1):900. doi: 10.1186/s13063-020-04760-x.
BACKGROUND: HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation. METHODS: We propose a mixed-methods study amongst young people aged 13-24 years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13-24 years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2 days, and with the final dose given either 6 or 20 h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue. DISCUSSION: This study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov NCT03986970 . Registered on 14 June 2019.
背景：HIV 仍然是一个主要的公共卫生问题，尤其是在东非和南非。如果坚持使用，暴露前预防（PrEP）非常有效，但由于成本、用户接受度和使用率的限制，其效果有限。非劣效性 III 期试验的成本可能过高，因此，提前选择最佳的药物、剂量和方案至关重要。本研究——联合 HIV 青少年 PrEP 和预防研究（CHAPS）旨在研究预防 HIV 感染所需的 PrEP 药物、剂量和方案，以及撒哈拉以南非洲年轻人对 PrEP 的接受程度，从而为未来的 III 期 PrEP 研究提供干预选择，并改进 PrEP 实施策略。
方法：我们提出了一项在 13-24 岁年轻人中进行的混合方法研究。第一部分是定性研究，旨在确定南非、乌干达和津巴布韦年轻人接受 PrEP 的障碍和动机。第二部分是一项随机临床试验（ClinicalTrials.gov NCT03986970，2019 年 6 月），使用新型体外 HIV 挑战方法来研究最佳 PrEP 治疗（FTC-TDF 与 FTC-TAF）、剂量和方案。我们将从两个地点（南非和乌干达）的自愿男性医疗割礼诊所招募 144 名 HIV 阴性未割包皮的 13-24 岁男性，并将他们随机分为 9 组中的一组。一组在手术前不接受 PrEP；其他组将在 1 天或 2 天内接受 FTC-TDF 或 FTC-TAF，并在手术前 6 小时或 20 小时给予最后一剂。我们将对他们切除的包皮组织进行体外 HIV 挑战。
讨论：本研究将提供定性和定量结果，以帮助确定未来 PrEP 三期试验的最佳药物、剂量和方案。该研究还将提供撒哈拉以南非洲地区为年轻人提供 PrEP 的成功策略的重要信息。
试验注册：ClinicalTrials.gov NCT03986970，于 2019 年 6 月 14 日注册。
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