Share Abstract
Equivalent performance of HIV oral fluid self-testing and rapid testing compared to nucleic acid amplification test in screening adolescents for long-acting injectable cabotegravir in Brazil
Abstract Content:
BACKGROUND: Limited data are available on the risk of developing integrase inhibitor resistance among individuals initiating long-acting injectable cabotegravir (CAB-LA) during acute HIV infection. While nucleic acid amplification test (NAAT) is considered the gold standard in this scenario, its routine implementation during CAB-LA initiation may be impractical due to its high cost and longer processing time. This study aimed to assess the performance of the HIV oral fluid self-test (ST) and the rapid test (RT) in comparison to NAAT for guiding CAB-LA initiation among adolescents in Brazil.
METHODS: The PrEP15-19 Choices study is a real-world implementation project evaluating the use of oral and CAB-LA PrEP among cisgender men who have sex with men, transgender and non-binary individuals aged 15-19 years in three cities in Brazil. Data were collected between April 2024-January 2025. Adolescents enrolled in the CAB-LA arm underwent the HIV Detect® Oral Fluid ST. Peripheral venous blood samples were also collected to perform the fourth-generation RT (Determine'¢ HIV Early Detect) and the NAAT (Xpert® HIV-1 Qual), which served as the reference standard. The ST and RT were evaluated as index tests against NAAT, with sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement coefficients calculated.
RESULTS: Of the 479 adolescents enrolled in the study, 180 (37.6%) opted to initiate CAB-LA and were screened for HIV infection. Two participants were excluded: one due to a missing ST result and another due to an inconclusive ST result recorded by the participant. Among the remaining 178 participants (98.9%) with completed tests, 5 (2.8%; 95%confidence interval [CI]:1.0'6.8) tested positive across all methods, while 173 (97.2%; 95%CI:93.2'99.0) tested negative across all methods. Both the oral fluid ST and the RT demonstrated a sensitivity, specificity, PPV, and NPV exceeding 99.9% (p = 0.006; kappa = 1).
CONCLUSIONS: Despite limitations in the sample size, the findings suggest that both ST and RT produced results that were consistent with the NAAT, indicating that they might be viable for diagnosing adolescents, including those from diverse sexual and gender identities. This could have implications for improving accessibility to testing and treatment for this group.
METHODS: The PrEP15-19 Choices study is a real-world implementation project evaluating the use of oral and CAB-LA PrEP among cisgender men who have sex with men, transgender and non-binary individuals aged 15-19 years in three cities in Brazil. Data were collected between April 2024-January 2025. Adolescents enrolled in the CAB-LA arm underwent the HIV Detect® Oral Fluid ST. Peripheral venous blood samples were also collected to perform the fourth-generation RT (Determine'¢ HIV Early Detect) and the NAAT (Xpert® HIV-1 Qual), which served as the reference standard. The ST and RT were evaluated as index tests against NAAT, with sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement coefficients calculated.
RESULTS: Of the 479 adolescents enrolled in the study, 180 (37.6%) opted to initiate CAB-LA and were screened for HIV infection. Two participants were excluded: one due to a missing ST result and another due to an inconclusive ST result recorded by the participant. Among the remaining 178 participants (98.9%) with completed tests, 5 (2.8%; 95%confidence interval [CI]:1.0'6.8) tested positive across all methods, while 173 (97.2%; 95%CI:93.2'99.0) tested negative across all methods. Both the oral fluid ST and the RT demonstrated a sensitivity, specificity, PPV, and NPV exceeding 99.9% (p = 0.006; kappa = 1).
CONCLUSIONS: Despite limitations in the sample size, the findings suggest that both ST and RT produced results that were consistent with the NAAT, indicating that they might be viable for diagnosing adolescents, including those from diverse sexual and gender identities. This could have implications for improving accessibility to testing and treatment for this group.