Evidence map›Paper›PMID 34838115›Full record

Trial reportTrials2021

Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection.

M Masiá, S Padilla, G Estañ, J Portu, A Silva, A Rivero, A González-Cordón, L García-Fraile, O Martínez, E Bernal and 14 more

Erratum issued Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04735445 (IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in Patients With Human Immunodeficiency Virus), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04735445 naunknown statusnot on this map

IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in Patients With Human Immunodeficiency Virus (HIV) Infection

TypeinterventionalSponsorFelix GutierrezRan2019 to 2023Enrolled4,638ConditionsHIV/AIDS, CancerArmsDigital rectal exam and / or anal cytology (day 1 and after 36 months), Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy, Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months), Semestral cervical cytology and cervical sample for HPV detection, Appointment for mammography (day 1 and after 36 months)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Early Detection of Cancer and Precancerous Lesions in Persons With HIV Through a Comprehensive Cancer Screening Protocol.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 17 institutions in 1 country.

M Masiá *Hospital General Universitario de Elche and Universidad Miguel Hernández de Elche, Elche, Spain.
S PadillaHospital General Universitario de Elche and Universidad Miguel Hernández de Elche, Elche, Spain.
G EstañHospital General Universitario de Elche, Elche, Spain.
J PortuHospital Universitario Araba, Vitoria-Gasteiz, Spain.
A SilvaBellvitge University Hospital-IDIBELL, L'Hospitalet de Llobregat, Spain.
A RiveroHospital Universitario Reina Sofía de Córdoba, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC) and Universidad de Córdoba, Córdoba, Spain.
A González-CordónHospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
L García-FraileHospital La Princesa, Madrid, Spain.
O MartínezHospital General Universitario Santa Lucía de Cartagena, Murcia, Spain.
E BernalHospital General Universitario Reina Sofía de Murcia, Murcia, Spain.
C GaleraHospital Virgen de la Arrixaca, Murcia, Spain.
V Boix MartínezHospital General Universitario de Alicante, Alicante, Spain.
J MaciasHospital Universitario de Valme, Seville, Spain.
M MonteroHospital La Fe, Valencia, Spain.
D García-RosadoHospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
M J Vivancos-GallegoHospital Ramon y Cajal and Ramon y Cajal Health Research Institute (IRYCIS), Madrid, Spain.
J Llenas-GarcíaHospital Vega Baja, Alicante, Spain.
M TorralbaHospital Universitario de Guadalajara, Guadalajara, Spain.
J A GarcíaHospital General Universitario de Elche, Elche, Spain.
V AgullóHospital General Universitario de Elche, Elche, Spain.
M Fernández-GonzálezHospital General Universitario de Elche, Elche, Spain.
F Gutiérrez *Hospital General Universitario de Elche and Universidad Miguel Hernández de Elche, Elche, Spain. ueielx@gmail.com.ORCID http://orcid.org/0000-0002-9485-6867
E Martínez *Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
IMPAC-NEO Study Group
Hospital General Universitario de Elche · ESBellvitge University Hospital · ESHospital Clínic de Barcelona · ESHospital Universitario de Canarias · ESHospital Universitario de Valme · ESHospital Universitario Virgen de la Arrixaca · ESUniversitat de Miguel Hernández d'Elx · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Reina Sofía de Murcia · ESHospital Universitario Araba · ESHospital Universitario de Guadalajara · ESHospital Universitario de La Princesa · ESHospital Vega Baja · ESInstituto Cajal · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESLeitat Technological Center · ESSanta Lucía University General Hospital · ES

Funding

Instituto de Salud Carlos III PI18/01861
6 · The paper itself

Abstract

backgroundThe 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.

methodsWe 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 registrationClinicalTrials.gov NCT04735445. Registered on 25 June 2019.

Indexed as

Acquired Immunodeficiency SyndromeHIV InfectionsNeoplasmsEarly Detection of CancerHumansMaleMass ScreeningCancerEarly detection of cancerHIV infectionNeoplasmsNon-AIDS-defining cancersScreening

Identifiers

PMID34838115
PMCPMC8626748
OpenAlexW3214864652

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.