Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
Mar Masiá, Sergio Padilla, G. Estañ, J. Portu, Alícia Eliege da Silva, Antonio Rivero, Ana Gonzalez‐Cordón, Lucio García‐Fraile, Oswaldo Rahmses Castro Martínez, Enrique Bernal, Carlos Galera, Vicente Boix Martínez, Juan Macı́as, Marta Montero, Dácil García-Rosado, María Jesús Vivancos, Jara Llenas‐García, Miguel Torralba, José Alberto García, Vanesa Agulló, M. Fernández-González, Félix Gutiérrez, Estebán Martínez, IMPAC-NEO Study Group, Antonia Alcaraz-García, Ana L. Caicedo, Alexy Inciarte, Alfredo Espinosa, A. López-Lirola, Concha Amador, Ana Silva, Antonio José Navarro, Ángela Camacho, Aurora Rodríguez Pérez, Carlos Galera, Melissa Carreres, Camila Piatti, David Vinuesa, David Dalmau, Dácil García-Rosado, Marcos Díez-Martínez, Daniel Podzamczer, Ester Saez, Esther Fagúndez-Reloba, Federico García, Juan Flores, Gema García, Javier García‐Abellán, Lucía Guillén, Gema Navarro, Inma González-Cuello, Helena Albendín, Inmaculada Ruiz-Cáceres, Isabel Machuca, Ignacio de los Santos, Itziar Sobron, Juan Emilio Losa, Juan Luís Gómez-Sirvent, José Ramón Blanco, Juan Macı́as, Juan Carlos Gainzarai, Lorena Martinez‐Gamboa, Josep Mallolas, María del Mar Alonso‐Socas, Belén Martínez-López, A Gonzalez Fernandez, María Jehovana Hernández-Rodríguez, Miguel Ángel Morán Rodríguez, Marta Navarro, Reyes Pascual, Francisco Pasquau, Pilar Callau, Joaquín Portilla, Catalina Robledano, Jhon Rojas, Ricardo Pelazas, Sandra Cuéllar, Santos Del Campo, Sònia Calzado, Santiago Moreno, Sofía Scévola, Guillemo Telenti, Zuriñe Ortiz
Abstract
BACKGROUND: The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. It is estimated that the situation will be aggravated by the progressive aging of PLWH. Early diagnosis through intensive cancer screening may improve the ability for therapeutic interventions and could be critical in reducing mortality, but it might also increase expenditure and harms associated with adverse events. The aim of this study is to evaluate an enhanced screening program for early diagnosis of cancer in PLWH compared to standard practice. The specific objectives are (1) to compare the frequency of cancer diagnosed at an early stage, (2) to analyze safety of the enhanced program: adverse events and unnecessary interventions, (3) to analyze the cost-utility of the program, and (4) to estimate the overall and site-specific incidence of NADC in PLWH. METHODS: We will conduct a multicenter, non-blinded, randomized, controlled trial, comparing two parallel arms: conventional vs enhanced screening. Data will be recorded in an electronic data collection notebook. Conventional intervention group will follow the standard of care screening in the participating centers, according to the European AIDS Clinical Society recommendations, and the enhanced intervention group will follow an expanded screening aimed to early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancer. The trial will be conducted within the framework of the Spanish AIDS Research Network Cohort (CoRIS). DISCUSSION: The trial will evaluate the efficacy, safety, and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard of care practice. The information provided will be relevant since there are currently no studies on expanded cancer screening strategies in patients with HIV, and available data estimating cost effectiveness or cost-utility of such as programs are scarce. An enhanced program for NADC screening in patients with HIV could lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions, but it is critical to demonstrate that the benefits clearly outweigh the harms, before the strategy could be implemented. TRIAL REGISTRATION: ClinicalTrials.gov NCT04735445. Registered on 25 June 2019.