Eakle Robyn, Gomez Gabriela B, Naicker Niven, Bothma Rutendo, Mbogua Judie, Cabrera Escobar Maria A, Saayman Elaine, Moorhouse Michelle, Venter W D Francois, Rees Helen
Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.
Department of Global Health and Development, London School of Hygiene &Tropical Medicine, London, United Kingdom.
PLoS Med. 2017 Nov 21;14(11):e1002444. doi: 10.1371/journal.pmed.1002444. eCollection 2017 Nov.
Operational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa.
The TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention.
PrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa.
需要开展运筹学研究来设计暴露前预防（PrEP）和早期抗逆转录病毒治疗（ART）的服务提供模式。本文介绍了TAPS示范项目的项目数据、人口统计学、行为学和临床数据的初步分析结果，该项目在南非两个城市的诊所为女性性工作者（FSW）提供了这两种干预措施。
TAPS研究于2015年3月30日至2017年6月30日进行，入组期于2016年7月31日结束。TAPS是一项前瞻性观察性队列研究，有两组在现有服务环境中接受干预措施：（1）为HIV阴性的FSW提供PrEP作为综合预防的一部分；（2）为HIV阳性的FSW提供早期ART。主要结局是随访12个月时的项目留存率。在最初到诊所就诊的947名FSW中，692人接受了HIV检测。HIV患病率为49%。在HIV检测和临床筛查后返回诊所的人中，93%的HIV阴性女性被确认在临床上符合PrEP条件（n = 224/241），41%（n = 110/270）的HIV阳性女性在评估时CD4细胞计数符合国家卫生部ART启动指南。在其余HIV阳性女性中，93%符合早期ART条件（n = 148/160）。在符合条件的人中，分别有98%（n = 219/224）和94%（n = 139/148）接受了PrEP和早期ART。基线时，很大一部分女性有固定伴侣、在妓院工作且出生于津巴布韦。在入组者中，接受PrEP的人中有22%（n = 49/219）和接受早期ART的人中有60%（n = 83/139）在12个月时前来就诊；我们观察到失访率很高：PrEP组和早期ART组分别为71%（n = 156/219）和30%（n = 42/139）。在过去7天内，持续使用避孕套的情况或性伴侣数量随时间变化不大，两个研究组中与客户持续使用避孕套的比例都很高，与固定伴侣使用避孕套的比例较低。在仍参与研究的女性中，接受PrEP者无血清学转换，早期ART有7例病毒学失败。报告的PrEP依从性随时间在70%至85%之间变化，而超过90%的参与者报告在接受早期ART时每天服药。还收集并分析了提供者端成本数据。每人每年PrEP的服务提供总成本约为126美元，早期ART为406美元。本研究的主要局限性包括：由于伦理考虑未设对照组；PrEP未通过监管系统批准时的临床研究要求可能影响了接受率；以及国家性工作者HIV项目实施的时间可能也影响了接受率和留存率。
PrEP和早期ART服务可在高流行率的城市环境中纳入FSW的常规服务。我们观察到PrEP和早期ART的接受率都很高；然而，PrEP的留存率较低。早期ART的留存率与当前标准治疗的留存率相似。虽然干预措施的成本高于此前公布的水平，但大规模实施时有降低成本的潜力。TAPS示范项目的结果为南非首个政府PrEP和早期ART指南以及国家性工作者HIV项目的推广提供了依据。
