Project to Enhance Patient-Health Engagement in HIV Infection

NCT07571044 | Completed

• 1 other identifier: 6551
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The importance of patient involvement in their care is emerging as a crucial element in the active management of chronic conditions, including HIV infection. For people living with HIV (PLWH), a proactive role in managing their health promotes improved quality of life and greater adherence to treatment. However, data on enhancing patient engagement among PLWH are currently lacking. This project aims to offer, for the first time, training to enhance patient engagement specifically for PLWH, delivered by psychologists at the Infectious Diseases Outpatient Clinic of the Gemelli Hospital in Rome. The program aims to strengthen emotional, cognitive, and behavioral involvement in the treatment process, promoting greater adherence to treatment, improved management of comorbidities, and increased healthy behaviors. Furthermore, the project aims to adapt the training to the specific needs of PLWH and evaluate its actual impact on quality of life and psychological well-being. Scientific Rationale Over 38 million people are living with HIV worldwide, with approximately 1.5 million new infections in 2021. In Italy, 1,770 new HIV diagnoses were recorded in 2021, with a higher incidence in men between the ages of 30 and 39. Thanks to antiretroviral therapy (ART), AIDS mortality has decreased significantly, and the U=U (Undetectable=Untransmittable) principle has confirmed the importance of virological suppression in reducing virus transmission. Despite the success of ART, one of the current challenges is ensuring a good quality of life for PLWH. HIV management is a chronic process that requires continuity of care, treatment adherence, and a multidisciplinary approach to address emerging comorbidities, including cardiovascular, bone, renal, metabolic, oncological, and neuropsychiatric conditions. In this context, active patient involvement becomes essential to improve adherence to therapy and overall health management.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• score of PLWH

  to evaluate whether the score of PLWH obtained in the scale measuring engagement increases significantly after the training

  10 months

Interventions

patient engagement DIAGNOSTIC_TEST

develop targeted training that, in addition to promoting greater therapeutic adherence, supports PLWH in improving their quality of life, reducing psychological symptoms and encouraging proactive health behaviors.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PLWH

You may qualify if:

• Consent to participate in the study
• HIV diagnosis
• Current antiretroviral therapy
• \- Age \>18
• Be able to write, speak, and understand Italian
• Be able to participate in 3 in-person meetings

You may not qualify if:

• Refusal to participate in the study
• No HIV diagnosis
• Not currently receiving antiretroviral therapy
• Not being treated at the Infectious Diseases Outpatient Clinic at the Gemelli Hospital in Rome
• Age \<18 years
• Non-native Italian speaker
• Unable to attend three in-person meetings

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universtiario Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Simona Di Giambenedetto

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: November 8, 2024
• Primary Completion: March 6, 2025
• Study Completion: March 19, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)