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. 2025 Sep;29(9):2841-2854.
doi: 10.1007/s10461-025-04741-8. Epub 2025 May 6.

Performance of Adherence Measures for Oral, Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Systematic Review

Diana Zeballos  1 , Nathalia Sernizon Guimarães  2 , Marcos Pereira  3 , Laio Magno  3   4 , Inês Dourado  3
Affiliations

Performance of Adherence Measures for Oral, Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Systematic Review

Diana Zeballos et al. AIDS Behav. 2025 Sep.

Abstract
in English, Spanish

Accurate adherence measures to HIV pre-exposure prophylaxis (PrEP) are essential for identifying individuals with low adherence and providing tailored support. This systematic review summarizes evidence on the performance of PrEP indirect adherence measures and explores their potential use in clinical practice. Following a registered protocol (PROSPERO: CRD42020144733) we searched PubMed, Embase, LILACS and Web of Science until December 2024. We included studies that assessed PrEP adherence among individuals using daily oral PrEP with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC). The reference standard involved quantifying PrEP in dried blood spots or plasma, and index tests included self-reported adherence, pill counts, pharmacy records, electronic monitoring, or composite measures. We used QUADAS-2 to assess the risk of bias and applicability concerns. Twenty-three studies, which included 6649 individuals, fulfilled the inclusion criteria. Most were observational studies (n = 17, 73.9%), and the most common measure was self-report (n = 18, 78.3%). The performance of indirect measures was reported through accuracy statistics in 12 studies (52.2%), concordance in two (8.7%), correlation in eight (34.8%), and proportions in one (4.3%). The risk of bias and applicability concerns were generally low or unclear due to unclear reporting. This review underscores the wide heterogeneity of indirect measures used to assess PrEP adherence, with self-reports being the most frequently utilized. Despite some correlation with direct measures, these methods showed mixed evidence of accuracy, with studies reporting moderate discriminatory capacity for identifying high protective levels of TFV-DP. This finding limits the broader applicability of the measures and underscores the need for further research.

Medidas precisas de adherencia a la profilaxis previa a la exposición al VIH (PrEP) son esenciales para identificar a las personas con baja adherencia y ofrecerles un apoyo personalizado. Esta revisión sistemática resume la evidencia sobre el desempeño de medidas indirectas de adherencia a la PrEP y explora su posible uso en la práctica clínica. Siguiendo un protocolo registrado (PROSPERO: CRD42020144733), realizamos la búsqueda en PubMed, Embase, LILACS y Web of Science hasta diciembre de 2024. Incluimos estudios que evaluaron la adherencia a la PrEP entre personas usuarias de PrEP oral diaria con tenofovir disoproxil fumarato más emtricitabina (TDF/FTC),. La prueba de referencia fue la cuantificación de PrEP en sangre seca o plasma, y las pruebas en estudio incluyeron la autodeclaración de adherencia, el recuento de comprimidos, los registros de farmacia, el monitoreo electrónico o medidas compuestas. Utilizamos la herramienta QUADAS-2 para evaluar la calidad de los estudios. Veintitrés estudios, que incluyeron a 6.649 personas, cumplieron con los criterios de inclusión. La mayoría fueron estudios observacionales (n = 17, 73,9%) y la medida más común fue la autodeclaración (n = 18, 78,3%). El desempeño de las medidas indirectas fue reportado mediante estadísticas de precisión en 12 estudios (52,2%), concordancia en dos (8,7%), correlación en ocho (34,8%) y proporciones en uno (4,3%). El riesgo de sesgo y las preocupaciones sobre la aplicabilidad fueron en general bajos o poco claros debido a una descripción poco detallada. Esta revisión destaca la heterogeneidad de las medidas indirectas utilizadas para evaluar la adherencia a la PrEP, siendo la autodeclaración la más utilizada. A pesar de cierta correlación con medidas directas, estos métodos mostraron evidencia mixta en cuanto a su precisión, con estudios que reportaron una capacidad discriminatoria moderada para identificar niveles protectores altos de TFV-DP. Este hallazgo limita la aplicabilidad de las medidas e indica la necesidad de más investigaciones.

Keywords: Adherence measures; HIV; PrEP; Systematic review.

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Conflict of interest statement

Declarations. Competing Interests: The authors declare that they have no competing interests.

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