Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design.
Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design.
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艾滋病毒阳性男性（ESSAHM）中增强的梅毒筛查：使用梯级楔形设计的诊所随机试验的研究方案。
DOI：
10.1186/s13012-016-0371-0
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发表时间：
2016-01-16
期刊：
影响因子：
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通讯作者：
Tan DH
中科院分区：
文献类型：
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作者：
Burchell AN;Allen VG;Grewal R;MacPherson PA;Rachlis A;Walmsley S;Mishra S;Gardner SL;Raboud J;Cooper C;Gough K;Rourke SB;Rousseau R;Salit I;Tan DH
目前梅毒在城市男男性行为者（MSM）中的流行对那些合并感染人类免疫缺陷病毒（HIV）的人有严重的影响。常规和频繁的梅毒筛查有可能确保早期发现和治疗，尽量减少疾病负担，并有助于控制梅毒和艾滋病毒的持续传播。我们的目标是通过开展一项基于临床的干预，将选择退出梅毒检测纳入该人群的常规艾滋病毒实验室评估，从而加强艾滋病毒阳性男性的梅毒筛查。试验目的是确定干预措施(1)提高未治疗梅毒检出率的程度，(2)增加筛查覆盖率，(3)增加筛查频率，(4)根据性行为达到高危男性的程度。该试验是一项实用的、阶梯式楔形集群随机对照试验，在加拿大安大略省的四个城市艾滋病诊所逐步引入干预措施。干预措施包括，每当艾滋病毒护理的男性接受艾滋病毒载量检测时，都要进行梅毒血清学检测，这种检测通常每3-6个月进行一次。控制条件是维持目前由提供者发起的梅毒检测做法。将对大约3100名艾滋病毒阳性男子进行为期30个月的随访。测试结果将从安大略省的省级集中实验室获得，并将由标准化临床工作表和诊所的医疗图表审查加以补充。详细的临床，社会心理和行为数据可用于接受艾滋病毒治疗的男性子集，他们也是全省范围的安大略省艾滋病毒治疗网络队列研究的参与者。流程评估计划包括审核和反馈参与中心的合规性，以确定将此类实践引入常规护理的潜在障碍。卫生经济部分包括对干预措施的影响和成本效益的评价。该试验将是加拿大首个此类试验，并将提供有关临床干预的可行性、临床有效性和成本效益的证据，以改善艾滋病毒阳性男性的梅毒筛查。如果干预有效，知识使用者参与试验设计、实施和分析的所有阶段将有助于扩大规模。ClinicalTrials.gov NCT02019043
The current syphilis epidemic among urban men who have sex with men (MSM) has serious implications for those co-infected with human immunodeficiency virus (HIV). Routine and frequent syphilis screening has the potential to ensure early detection and treatment, minimize disease burden, and help control the ongoing spread of syphilis and HIV. We aim to enhance syphilis screening among HIV-positive men by conducting a clinic-based intervention that incorporates opt-out syphilis testing into routine HIV laboratory evaluation for this population. Trial objectives are to determine the degree to which the intervention (1) increases the detection rate of untreated syphilis, (2) increases screening coverage, (3) increases screening frequency, and (4) reaches men at highest risk according to sexual behaviors. The trial is a pragmatic, stepped wedge cluster-randomized controlled trial that introduces the intervention stepwise across four urban HIV clinics in Ontario, Canada. The intervention includes standing orders for syphilis serological testing whenever a male in HIV care undergoes HIV viral load testing, which typically occurs every 3–6 months. The control condition is the maintenance of current, provider-initiated syphilis testing practice. Approximately 3100 HIV-positive men will be followed over 30 months. Test results will be obtained from the centralized provincial laboratory in Ontario and will be supplemented by a standardized clinical worksheet and medical chart review at the clinics. Detailed clinical, psychosocial, and behavioral data is available for a subset of men receiving HIV care who are also participants of the province-wide Ontario HIV Treatment Network Cohort Study. Process evaluation plans include audit and feedback of compliance of the participating centers to identify potential barriers to the introduction of this type of practice into routine care. Health economic components include evaluation of the impact and cost-effectiveness of the intervention. This trial will be the first of its kind in Canada and will provide evidence regarding the feasibility, clinical effectiveness, and cost-effectiveness of a clinic-based intervention to improve syphilis screening among HIV-positive men. Involvement of knowledge users in all stages of trial design, conduct, and analysis will facilitate scale-up should the intervention be effective. ClinicalTrials.gov NCT02019043