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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universtiario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.