Dataset Information

Molecular chlamydia and gonorrhoea point of care tests implemented into routine practice: Systematic review and value proposition development

ABSTRACT:

Background

Sexually Transmitted Infections, including Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), continue to be a global health problem. Increased access to point-of-care-tests (POCTs) could help detect infection and lead to appropriate management of cases and contacts, reducing transmission and development of reproductive health sequelae. Yet diagnostics with good clinical effectiveness evidence can fail to be implemented into routine care. Here we assess values beyond clinical effectiveness for molecular CT/NG POCTs implemented across diverse routine practice settings.

Methods

We conducted a systematic review of peer-reviewed primary research and conference abstract publications in Medline and Embase reporting on molecular CT/NG POCT implementation in routine clinical practice until 16th February 2021. Results were extracted into EndNote software and initially screened by title and abstract by one author according to the inclusion and exclusion criteria. Articles that met the criteria, or were unclear, were included for full-text assessment by all authors. Results were synthesised to assess the tests against guidance criteria and develop a CT/NG POCT value proposition for multiple stakeholders and settings.

Findings

The systematic review search returned 440 articles; 28 were included overall. The Cepheid CT/NG GeneXpert was the only molecular CT/NG POCT implemented and evaluated in routine practice. It did not fulfil all test guidance criteria, however, studies of test implementation showed multiple values for test use across various healthcare settings and locations. Our value proposition highlights that the majority of values are setting-specific. Sexual health services and outreach services have the least overlap, with General Practice and other non-sexual health specialist services serving as a “bridge” between the two.

Conclusions

Those wishing to improve CT/NG diagnosis should be supported to identify the values most relevant to their settings and context, and prioritise implementation of tests that are most closely aligned with those values.

SUBMITTER: Fuller S

PROVIDER: S-EPMC8575247 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:OBJECTIVES:Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) increase the risk of HIV transmission among men who have sex with men (MSM). Diagnosis of NG/CT may provide an efficient entry point for prevention of HIV through the delivery of pre-exposure prophylaxis (PrEP); however, the additional population-level impact of targeting PrEP to MSM diagnosed with NG/CT is unknown. DESIGN:An agent-based simulation model of NG/CT and HIV cocirculation among MSM calibrated against census data, disease surveillance reports and the US National HIV Behavioral Surveillance study. SETTING:Baltimore City, Maryland, USA. INTERVENTIONS:PrEP implementation was modelled under three alternative scenarios: (1) PrEP delivery at NG/CT diagnosis (targeted delivery), (2) PrEP evaluation at NG/CT screening/testing and (3) PrEP evaluation in the general community (untargeted). MAIN OUTCOME:The projected incidence of HIV after 20 years of PrEP delivery under two alternatives: when equal numbers of MSM are (1) screened for PrEP or (2) receive PrEP in each year. RESULTS:Assuming 60% uptake and 60% adherence, targeting PrEP to MSM diagnosed with NG/CT could reduce HIV incidence among MSM in Baltimore City by 12.4% (95% uncertainty range (UR) 10.3% to 14.4%) in 20 years, relative to no PrEP. Expanding the coverage of NG/CT screening (such that individuals experience a 50% annual probability of NG/CT screening and evaluation for PrEP on NG/CT diagnosis) can further increase the impact of targeted PrEP to generate a 22.0% (95% UR 20.1% to 23.9%) reduction in HIV incidence within 20 years. When compared with alternative implementation scenarios, PrEP evaluation at NG/CT diagnosis increased impact of PrEP on HIV incidence by 1.5(95% UR 1.1 to 1.9) times relative to a scenario in which PrEP evaluation happened at the time of NG/CT screening/testing and by 1.6 (95% UR 1.2 to 2.2) times relative to evaluating random MSM from the community. CONCLUSIONS:Targeting MSM infected with NG/CT increases the efficiency and effectiveness of PrEP delivery. If high levels of sexually transmitted infection screening can be achieved at the community level, NG/CT diagnosis may be a highly effective entry point for PrEP initialisation.

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