Clinical trial · Interventional
IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in HIV Patients
IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in Patients With Human Immunodeficiency Virus (HIV) Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Introduction: The incidence of malignancies is higher in the HIV-infected population than in the general population, and it is already one of the leading causes of death in people living with the virus. It is estimated that the situation will be aggravated by the progressive aging of the HIV-infected population. Early diagnosis through enhanced cancer screening can be critical in reducing mortality, but may increase expenditure and harms associated with adverse events. This strategy should then be considered only when the benefits clearly outweigh the harms. There are currently no studies on expanded cancer screening in patients with HIV, and available information from the point of view of costeffectiveness or cost-utility is scarce. Hypothesis: An enhanced program for non-aids cancer screening in patients with HIV can lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions and being cost-effective. Objectives: To evaluate the efficacy, safety and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Specific objectives: 1) To compare the incidence of early diagnosed cancer with enhanced screening versus conventional screening; 2) To assess the incidence of early diagnosed cancer and its overall incidence in the CoRIS cohort; 3) To analyze safety of the program: adverse events and unnecessary interventions; 4) To compare the obtained data stratifying by gender and 5) To analyze the cost-utility of the program. Expected results: 1) To generate scientific evidence to inform decision makers on the advisability of implementing an enhanced screening program of cancer in HIV-infected patients; 2) To broaden knowledge about the programs of early detection of cancer in vulnerable populations and their economic evaluation from the perspective of the National Health Service.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| HIV/AIDS | — | UNRESOLVED | — |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Annual appointment for low dose computed tomography for lung screening | Diagnostic Test | — | UNRESOLVED |
| Annual appointment for mammography | Diagnostic Test | — | UNRESOLVED |
| Annual digital rectal exam and PSA determination | Diagnostic Test | — | UNRESOLVED |
| Annual fecal occult blood test | Diagnostic Test | — | UNRESOLVED |
| Annual general inspection for skin lesions suggestive of malignancy | Diagnostic Test | — | UNRESOLVED |
| Appointment for mammography (day 1 and after 36 months) | Diagnostic Test | — | UNRESOLVED |
| Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months) | Diagnostic Test | — |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional screening
- description
- Standard screening in the participating centers, adjusted to the recommendations of the European AIDS Society (EACS).
- interventionNames
- Diagnostic Test: Digital rectal exam and / or anal cytology (day 1 and after 36 months)
- Diagnostic Test: Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months)
- Diagnostic Test: Appointment for mammography (day 1 and after 36 months)
- Diagnostic Test: Semestral appointment for liver ultrasound
- Diagnostic Test: Fecal occult blood test (day 1 and after 36 months)
- Diagnostic Test: Digital rectal exam and PSA determination (day 1 and after 36 months)
- type
- EXPERIMENTAL
- label
- Enhanced screening
- description
- Expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal and skin cancer.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male ≥40 years or woman ≥18 years * Informed Consent signed Exclusion Criteria: * Active AIDS defining disease * Antecedent of cancer * Terminal disease * Pregnancy or breastfeeding * Patient rejection
References
Publications (19)
- RESULTLopez C, Masia M, Padilla S, Aquilino A, Bas C, Gutierrez F. [Deaths due to non-AIDS diseases among HIV infected patients: A 14-year study (1998-2011)]. Enferm Infecc Microbiol Clin. 2016 Apr;34(4):222-7. doi: 10.1016/j.eimc.2015.04.010. Epub 2015 Jun 18. Spanish. PMID 26093959
- RESULTGarcia-Abellan J, Del Rio L, Garcia JA, Padilla S, Vivancos MJ, Del Romero J, Asensi V, Hernando A, Garcia-Fraile L, Masia M, Gutierrez F; la Cohorte de la Red Nacional de Sida (CoRIS). Risk of cancer in HIV-infected patients in Spain, 2004-2015. The CoRIS cohort study. Enferm Infecc Microbiol Clin (Engl Ed). 2019 Oct;37(8):502-508. doi: 10.1016/j.eimc.2018.11.011. Epub 2019 Jan 22. English, Spanish. PMID 30679001
- RESULTSmith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8. PMID 25042234
- RESULTShiels MS, Cole SR, Kirk GD, Poole C. A meta-analysis of the incidence of non-AIDS cancers in HIV-infected individuals. J Acquir Immune Defic Syndr. 2009 Dec;52(5):611-22. doi: 10.1097/QAI.0b013e3181b327ca. PMID 19770804
- RESULTGrulich AE, van Leeuwen MT, Falster MO, Vajdic CM. Incidence of cancers in people with HIV/AIDS compared with immunosuppressed transplant recipients: a meta-analysis. Lancet. 2007 Jul 7;370(9581):59-67. doi: 10.1016/S0140-6736(07)61050-2. PMID 17617273
- RESULTAlthoff KN, McGinnis KA, Wyatt CM, Freiberg MS, Gilbert C, Oursler KK, Rimland D, Rodriguez-Barradas MC, Dubrow R, Park LS, Skanderson M, Shiels MS, Gange SJ, Gebo KA, Justice AC; Veterans Aging Cohort Study (VACS). Comparison of risk and age at diagnosis of myocardial infarction, end-stage renal disease, and non-AIDS-defining cancer in HIV-infected versus uninfected adults. Clin Infect Dis. 2015 Feb 15;60(4):627-38. doi: 10.1093/cid/ciu869. Epub 2014 Oct 30.