Gomez Gabriela B, Eakle Robyn, Mbogua Judie, Akpomiemie Godspower, Venter W D Francois, Rees Helen
Wits Reproductive Health and HIV Institute, Johannesburg, South Africa Department of Global Health and Amsterdam, Institute for Global Health and Development, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Wits Reproductive Health and HIV Institute, London School of Hygiene and Tropical Medicine, London, UK.
BMJ Open. 2016 Sep 26;6(9):e011595. doi: 10.1136/bmjopen-2016-011595.
Updated guidelines from the WHO recommend antiretroviral treatment for adults with HIV at any CD4 count and daily oral pre-exposure prophylaxis (PrEP) for people at substantial risk of HIV infection. However, implementation challenges may hinder the ability of programmes to translate these recommendations into successful practice. This demonstration project is the first to integrate PrEP and immediate treatment (ITx) for female sex workers (FSWs) in South Africa to answer operational research questions.
This is a prospective cohort study where the main outcome is retention at 12 months. The study population is recruited into two arms across two urban sites: (1) PrEP for HIV-negative FSWs (n=400) and (2) ITx for HIV-positive FSWs with CD4 greater than national guidelines (n=300). We investigate process and other health indicators, uptake and use of PrEP and ITx through qualitative research, and evaluate cost-effectiveness analysis combined with estimates of impact through epidemiological modelling.
The Treatment And Prevention for female Sex workers in South Africa (TAPS) Project was designed as an implementation study before emtricitabine/tenofovir disoproxil fumarate was licenced as an indication for PrEP in South Africa. Therefore, clinical trial requirements for ethical and South African Medicines Control Council approvals were followed. Results will be disseminated to participants, local health officials and other stakeholders, as well as in peer-reviewed journals and at conferences.
世界卫生组织（WHO）更新后的指南建议，对于任何CD4细胞计数的成年HIV感染者均应进行抗逆转录病毒治疗，对于有较高HIV感染风险的人群应进行每日口服暴露前预防（PrEP）。然而，实施方面的挑战可能会阻碍项目将这些建议转化为成功实践的能力。本示范项目首次在南非将PrEP与即时治疗（ITx）整合用于女性性工作者（FSW），以回答运营研究问题。
这是一项前瞻性队列研究，主要结局是12个月时的留存率。研究人群在两个城市地点分为两组：（1）HIV阴性FSW接受PrEP（n = 400）；（2）CD4细胞计数高于国家指南的HIV阳性FSW接受ITx（n = 300）。我们通过定性研究调查过程和其他健康指标、PrEP和ITx的接受情况及使用情况，并结合流行病学建模的影响估计评估成本效益分析。
在南非，替诺福韦酯富马酸盐/恩曲他滨被批准用于PrEP之前，南非女性性工作者治疗与预防（TAPS）项目被设计为一项实施研究。因此，遵循了伦理和南非药品控制委员会批准的临床试验要求。结果将传播给参与者、当地卫生官员和其他利益相关者，以及发表在同行评审期刊和会议上。
