一种在非临床环境中用于筛查男男性行为者 HIV 和梅毒的双 HIV/梅毒即时检测的临床实用性评估。

A clinical utility evaluation of dual HIV/Syphilis point-of-care tests in non-clinical settings for screening for HIV and syphilis in men who have sex with men.

机构信息

Centre of Epidemiological Studies of HIV/AIDS and STI of Catalonia (CEEISCAT), Health Department, Generalitat de Catalunya, Badalona, Spain.

Institute for Health Science Research Germans Trias I Pujol (IGTP), Badalona, Spain.

出版信息

BMC Infect Dis. 2024 Feb 29;24(Suppl 1):264. doi: 10.1186/s12879-024-09017-5.

Abstract

BACKGROUND

Dual point-of-care tests (POCTs) for the simultaneous detection of antibodies to HIV and syphilis have been developed. Since community-based organisations (CBO) are effective providers of HIV and syphilis testing among men who have sex with men (MSM), evaluation of the utility of these dual tests at CBO testing services is a high priority. The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites.

METHODS

This evaluation assessed the utility of two lateral flow immunochromatographic antibody technologies for dual screening for HIV/syphilis among MSM seeking testing in four CBO testing services in Spain, Slovenia, Latvia, and Ukraine. The study's conceptual framework divides the concept of feasibility into two inter-related domains, acceptability, and usability and further breaks it down into six subdomains: learnability, willingness, suitability, satisfaction, efficacy, and effectiveness. The feasibility analysis was performed by calculating the median score in 3 stages (for individual questions, subdomains, and domains), using a summated scores method.

RESULTS

The final sample included 844 participants, 60 of which were found to be HIV test positive (7.1%) and 61 (7.2%) positive on testing for syphilis. There was a small difference (1.1%) when comparing the results of the two dual POCTs under evaluation to the tests routinely used at each site. The inter-rater agreement showed a high concordance between two independent readings. The analysis of the feasibility for the users of the services indicated good satisfaction, suitability, and willingness. In addition, among 18 providers the total mean score showed good acceptability and usability, good willingness, easy learnability, high suitability, and good efficacy, but lower satisfaction and effectiveness. The operational characteristics of both dual study POCTs were well evaluated by providers.

CONCLUSIONS

The introduction of dual HIV and syphilis  POCTs in CBO testing services for screening of MSM is feasible, with a high acceptability and usability both for users and providers. Implementation of dual POCTs for HIV and syphilis in CBO testing services is an opportunity for scaling up integrated HIV/syphilis testing for MSM.

摘要

背景

已经开发出用于同时检测 HIV 和梅毒抗体的双点护理测试(POCT)。由于社区组织(CBO)是男男性行为者(MSM)中 HIV 和梅毒检测的有效提供者,因此评估这些双测试在 CBO 检测服务中的效用是当务之急。本研究的目的是确定在这些非临床场所对这些双 HIV-梅毒 POCT 测试在用户和提供者中进行的可行性。

方法

本评估评估了两种侧向流动免疫层析抗体技术在西班牙、斯洛文尼亚、拉脱维亚和乌克兰的四个 CBO 检测服务中针对寻求检测的 MSM 进行 HIV/梅毒双重筛查的效用。该研究的概念框架将可行性的概念分为两个相互关联的领域,可接受性和可用性,并进一步细分为六个子领域:可学习性、意愿、适用性、满意度、功效和有效性。可行性分析通过使用总和评分法在三个阶段(针对个别问题、子领域和领域)计算中位数得分来进行。

结果

最终样本包括 844 名参与者,其中 60 名 HIV 检测呈阳性(7.1%),61 名梅毒检测呈阳性(7.2%)。与每个站点常规使用的测试相比,评估的两种双 POCT 之间的结果存在很小的差异(1.1%)。两位独立评估者之间的评分一致性显示出高度的一致性。对服务使用者的可行性分析表明满意度、适用性和意愿良好。此外,在 18 名提供者中,总平均分数显示出良好的可接受性和可用性、良好的意愿、易于学习、高适用性和良好的功效,但满意度和有效性较低。提供者对两种双研究 POCT 的操作特性均进行了很好的评估。

结论

在 CBO 检测服务中为 MSM 筛查引入 HIV 和梅毒的双 POCT 是可行的,用户和提供者的接受度和可用性都很高。在 CBO 检测服务中实施 HIV 和梅毒的双 POCT 是为 MSM 扩大综合 HIV/梅毒检测提供了机会。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6096/10902924/423930cb3792/12879_2024_9017_Fig1_HTML.jpg

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