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NCT07571044Completed

Project to Enhance Patient-Health Engagement in HIV Infection

Project to Enhance Patient-Health Engagement in HIV Infection: Optimizing Quality of Life and Psychological Well-being Through Involvement (HIV-IN-ACTION)

Source: ClinicalTrials.gov · Last updated 6 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
75 (actual)
First submitted
30 Apr 2026
Start date
8 Nov 2024
Primary completion date
6 Mar 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Diseases
HIV
NCT number
NCT07571044

What you commit to

  • Study type: Observational
  • Participants enrolled: 75
  • From 8 Nov 2024 to the primary completion date, 6 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not currently receiving antiretroviral therapy

Other illness

  • No HIV diagnosis
  • Not being treated at the Infectious Diseases Outpatient Clinic at the Gemelli Hospital in Rome

Age

  • Age \<18 years

Other

  • Refusal to participate in the study
  • Non-native Italian speaker
  • Unable to attend three in-person meetings

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.