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

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

Laura Fernàndez-López  1   2   3 , Juliana Reyes-Urueña  4   5 , Laia Egea  4   6 , Andrii Chernyshev  7 , Inga Upmace  8 , Mitja Ćosić  9 , William Mejías  10 , Victoria González  4   5   11 , Karel Blondeel  12   13 , Soe Soe Thwin  12 , Lorenzo Gios  14 , Massimo Mirandola  14   15 , Rosanna Peeling  16 , James Kiarie  12 , Jordi Casabona  4   5   17 , Igor Toskin  12 ; ProSPeRo group
Affiliations

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

Laura Fernàndez-López et al. BMC Infect Dis. .

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.

Keywords: Diagnostic evaluation; HIV; Men who have Sex with Men; Non-Governmental Organizations; Point-of-care; Public health; STI testing; Syphilis.

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Conflict of interest statement

The POCT manufacturers furnished sufficient quantities of the product(s) free of charge in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the publication. WHO shall submit any proposed publication to the manufacturers for review, comments received will be considered in good faith, but the decision to publish rests with WHO.

Figures

Fig. 1
Fig. 1
Conceptual framework for the evaluation of the introduction of a new technology in a CBCVT site
Fig. 2
Fig. 2
Graphic representation of the global users’ feasibility subdomains (N = 844)
Fig. 3
Fig. 3
Users’ Feasibility analysis result
Fig. 4
Fig. 4
Graphic representation of the providers’ feasibility subdomains
Fig. 5
Fig. 5
Providers’ Feasibility analysis result
See this image and copyright information in PMC

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