HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial.
HPTN 071 (PopART): rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment - a study protocol for a cluster randomised trial.
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DOI：
10.1186/1745-6215-15-57
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发表时间：
2014-02-13
期刊：
影响因子：
2.5
通讯作者：
HPTN 071 (PopART) Study Team
中科院分区：
文献类型：
--
作者：
Hayes R;Ayles H;Beyers N;Sabapathy K;Floyd S;Shanaube K;Bock P;Griffith S;Moore A;Watson-Jones D;Fraser C;Vermund SH;Fidler S;HPTN 071 (PopART) Study Team
迫切需要采取有效的干预措施，减少撒哈拉以南非洲的艾滋病毒发病率。数学建模和艾滋病毒预防试验网络（HPTN）052试验结果表明，普遍的艾滋病毒检测与立即抗逆转录病毒治疗（ART）相结合，应大大降低发病率，并可能消除艾滋病毒作为一个公共卫生问题。我们描述的理由和设计的试验来评估这一假设。需要对普遍检测和治疗（UTT）干预措施进行严格设计的试验，因为：i）尚不清楚这些干预措施是否可以大规模提供并得到充分吸收; ii）模型中存在许多不确定性，因此这些干预措施的人口影响尚不清楚;和ii）存在潜在的不利影响，包括性风险解除抑制、HIV相关的耻辱、卫生系统负担过重、依从性差、毒性和耐药性。在HPTN 071（PopART）试验中，赞比亚和南非的21个社区（总人口120万）将被随机分配到三组。A组将接受完整的PopART联合HIV预防包，包括每年一次的家庭HIV检测，促进HIV阴性男性的医学男性包皮环切术，并为HIV检测阳性者提供立即ART; B组将接受完整的包，但ART启动将遵循当前的国家指南; C组将接受标准治疗。将在每个社区随机选择2，500名成年人的人群队列，并随访3年，以衡量艾滋病毒发病率的主要结局。根据模型预测，该试验将有很好的把握度来检测对HIV发病率和次要结局的预测影响。试验结果，结合建模和成本数据，将提供短期和长期的UTT干预措施的成本效益估计。重要的是，三臂设计将能够评估通过优化当前政策的交付可以实现多少目标，以及将其扩展到UTT的成本和收益。ClinicalTrials.gov NCT01900977。
Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed. Mathematical modelling and the HIV Prevention Trials Network (HPTN) 052 trial results suggest that universal HIV testing combined with immediate antiretroviral treatment (ART) should substantially reduce incidence and may eliminate HIV as a public health problem. We describe the rationale and design of a trial to evaluate this hypothesis. A rigorously-designed trial of universal testing and treatment (UTT) interventions is needed because: i) it is unknown whether these interventions can be delivered to scale with adequate uptake; ii) there are many uncertainties in the models such that the population-level impact of these interventions is unknown; and ii) there are potential adverse effects including sexual risk disinhibition, HIV-related stigma, over-burdening of health systems, poor adherence, toxicity, and drug resistance. In the HPTN 071 (PopART) trial, 21 communities in Zambia and South Africa (total population 1.2 m) will be randomly allocated to three arms. Arm A will receive the full PopART combination HIV prevention package including annual home-based HIV testing, promotion of medical male circumcision for HIV-negative men, and offer of immediate ART for those testing HIV-positive; Arm B will receive the full package except that ART initiation will follow current national guidelines; Arm C will receive standard of care. A Population Cohort of 2,500 adults will be randomly selected in each community and followed for 3 years to measure the primary outcome of HIV incidence. Based on model projections, the trial will be well-powered to detect predicted effects on HIV incidence and secondary outcomes. Trial results, combined with modelling and cost data, will provide short-term and long-term estimates of cost-effectiveness of UTT interventions. Importantly, the three-arm design will enable assessment of how much could be achieved by optimal delivery of current policies and the costs and benefits of extending this to UTT. ClinicalTrials.gov NCT01900977.
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DOI：
10.1056/nejmoa0911486
发表时间：
2010-06-17
期刊：
The New England journal of medicine
影响因子：
--
作者：
Chasela CS;Hudgens MG;Jamieson DJ;Kayira D;Hosseinipour MC;Kourtis AP;Martinson F;Tegha G;Knight RJ;Ahmed YI;Kamwendo DD;Hoffman IF;Ellington SR;Kacheche Z;Soko A;Wiener JB;Fiscus SA;Kazembe P;Mofolo IA;Chigwenembe M;Sichali DS;van der Horst CM;BAN Study Group
通讯作者：
BAN Study Group
影响因子：
3.8
作者：
Cu-Uvin, Susan;DeLong, Allison K.;Caliendo, Angela M.
通讯作者：
Caliendo, Angela M.
影响因子：
4.4
作者：
Cremin, Ide;Nyamukapa, Constance;Sherr, Lorraine;Hallett, Timothy B.;Chawira, Godwin;Cauchemez, Simon;Lopman, Ben;Garnett, Geoffrey P.;Gregson, Simon
通讯作者：
Gregson, Simon
DOI：
10.1097/qad.0b013e32833433fe
发表时间：
2010-03-13
期刊：
AIDS (London, England)
影响因子：
--
作者：
Dodd PJ;Garnett GP;Hallett TB
通讯作者：
Hallett TB
影响因子：
15.8
作者：
Auvert B;Taljaard D;Lagarde E;Sobngwi-Tambekou J;Sitta R;Puren A
通讯作者：
Puren A