IMPACt of an Enhanced Screening Program on the Detection of Non-AIDS NEOplasms in HIV Patients

Summary

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

• HIV/AIDS
• Cancer

Interventions

DIAGNOSTIC_TEST

Digital rectal exam and / or anal cytology (day 1 and after 36 months)

For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (day 1 and after 36 months)

DIAGNOSTIC_TEST

Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy

For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (semestral)

DIAGNOSTIC_TEST

Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months)

For Cervix Screening in sexually active woman (day 1 and after 36 months)

DIAGNOSTIC_TEST

Semestral cervical cytology and cervical sample for HPV detection

For Cervix Screening in sexually active woman (semestral)

DIAGNOSTIC_TEST

Appointment for mammography (day 1 and after 36 months)

For Breast Screening in woman between 50-70 years old (day 1 and after 36 months)

DIAGNOSTIC_TEST

Annual appointment for mammography

For Breast Screening in woman between 45-70 years old (annual)

DIAGNOSTIC_TEST

Semestral appointment for liver ultrasound

For Hepatic Screening: Cirrhosis or Chronic HBV, and meet any of the following risk factors: * Asian male\> 40 years old * Asian woman\> 50 years old * African man or woman * HCC family history

DIAGNOSTIC_TEST

Semestral appointment for liver ultrasound

Having chronic liver disease with fibrosis ≥ F3 or Presents chronic HBV

DIAGNOSTIC_TEST

Semestral blood collection for alpha-fetoprotein and others hepatic biomarkers determination

Having chronic liver disease with fibrosis ≥ F3 or Presents chronic HBV

DIAGNOSTIC_TEST

Fecal occult blood test (day 1 and after 36 months)

For Colon Screening: Age between 50-70 years old

DIAGNOSTIC_TEST

Annual fecal occult blood test

For Colon Screening: Age older than 40 years

DIAGNOSTIC_TEST

Digital rectal exam and PSA determination (day 1 and after 36 months)

For Prostate Screening: Man older than 50 years

DIAGNOSTIC_TEST

Annual digital rectal exam and PSA determination

For Prostate Screening: Man older than 50 years

DIAGNOSTIC_TEST

Annual appointment for low dose computed tomography for lung screening

For Lung Screening: should accomplish ALL the following criteria: * Age \> 40 years * Active smoker or former smoker\<3 years, with IPY ≥20. IPY: index of packages-year: nº packages that smoke per day x nº years smoking * No contraindications for thoracic surgery * No lung infection in the last 2 months

DIAGNOSTIC_TEST

Annual general inspection for skin lesions suggestive of malignancy

For Skin Screening: Woman ≥18 years Man ≥40 years

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Hospital General Universitario Reina Sofía de Murcia

  collaborator OTHER

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Hospital General Universitario de Alicante

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital General Universitario Santa Lucia

  collaborator OTHER

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  collaborator OTHER

• Hospital Universitario de Guadalajara

  collaborator UNKNOWN

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Complejo Hospitalario Universitario de Albacete

  collaborator OTHER

• Hospital Universitario Fundación Alcorcón

  collaborator OTHER

• Hospital General Universitario Elche

  collaborator OTHER

• Felix Gutierrez

  lead OTHER

Principal Investigators

• Félix Gutiérrez-Rodero, PhD · Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-11

Primary Completion

2022-12-31

Completion

2023-06-30

Countries

• Spain

Study Locations