CLINICAL RESEARCH INTEGRATED WITH NARRATIVE-BASED RESEARCH TO UNDERSTAND LIVING AND MANAGING HIV: TMC114FD1HTX4011 - DIAMANTE STUDY - ICAR 2019

CLINICAL RESEARCH INTEGRATED WITH
NARRATIVE-BASED RESEARCH TO
UNDERSTAND LIVING AND MANAGING HIV:
TMC114FD1HTX4011 - DIAMANTE STUDY
 Antinori A,Vergori A, Camici M, Esposito V, Carleo MA, Rosario P, Andreoni M, Malagnino V, Campogiani L, Cascio A,
 Trizzino M, Mazzola G, Ripamonti D,Valenti D, Manzillo E, Pizzella T, Aprea L, Focà E, Celotti A, Cappuccio A, Reale L,
                                           Uglietti A, Mancusi D, Termini R

ALESSANDRA VERGORI
HIV/AIDS UNIT, NATIONAL INSTITUTE FOR INFECTIOUS DISEASES L. SPALLANZANI, IRCCS, ROME, ITALY

MILANO 6 GIUGNO 2019

DISCLOSURES

Dr. Alessandra Vergori received travel grants from Gilead, Janssen and speaker’s fee
from Janssen

BACKGROUND

 Despite the successful reduction in the morbidity and mortality in the
     HAART era, living with HIV (LWH) is still difficult with regards to the
     associated psychological burden.
 Data are scanty as far as the patients’ perception of the persistent
     infection, the risk of transmission to other persons, the fear of disclosure,
     the stigma, the possibility of finding a partner, along with future plans or
     expectations, despite a well controlled HIV infection.
 Narrative-based research is an interdisciplinary method based on the
     collection of patients’ written narratives to gain insight on how a person
     lives his/her illness.

Greenhalgh T. Cultural Contexts of Health: The Use of Narrative Research in the Health Sector. WHO Regional Office for Europe; 2016. (Health
Evidence Network Synthesis Report, No. 49.)

MATERIALS&METHODS

The DIAMANTE study started in
June 2018 in about 20 centers
throughout Italy.

PROs:
1.HIVTSQ
2.Narratives ISTUD Foundation
Researchers analyze the narratives
according to Grounded Theory with
the support of the NVivo10 software.

RESULTS - 1

                 90% had optimal relationships with clinicians
At the end of    Therapy is a doom for the 12%
May 2019, 201
HIV-1+                        Patients’ Emotions
patients were
enrolled in
the study, of
whom 93
already
completed
their
narratives.

RESULTS - 2
 HIV infection doesn’t impact on daily activities of    Just 62% coped with the disease.
   patients and 20% developed new interests after the
                                                         24% of narratives detailed the fear to infect people
   diagnosis.
                                                           around them, while 20% described the worry of not
 86% experienced the stigma associated with HIV           finding a partner or having a family.
             Patients’ Relationships                               Patients’ hopes for the future

CONCLUSIONS

   For the first time, a clinical study
                                                                                      “At the time I thought that HIV was a taboo subject, almost to be avoided.
        includes patients’ narratives as PROs
                                                                                            Despite everything, I always believed I had protected sex, both in
   Narratives point out as HIV impacts on                                           relationship and occasional... unfortunately I was not so lucky. Today, with full
        patients’ lives despite the HAART (i.e.                                      awareness of HIV, something inside me has changed... I feel I have a deeper
        minor symptoms and/or limitations on                                                                        view of the world.”
        daily activities).
   Narratives and clinical data will highlight                                     "How did it feel to be able to tell your experience? Much better,
        new information for HIV management                                            even to be able to speak with such sincerity about everything that went
        and prevention.                                                                               through my head and vent a little 'me".
Acknowledgements
Authors are grateful to all centers (HIV/AIDS Unit, National Institute for Infectious Diseases L. Spallanzani, IRCCS, Rome, Italy, General Infectious Diseases Unit, Department of Infectious Disease
and Infectious Emergencies, Cotugno Hospital, Naples, Italy, Infectious Diseases Clinic, Foundation Policlinico Tor Vergata University Hospital, Rome, Italy, Infectious Diseases Clinic, AOU Policlinico
“P.Giaccone”, Palermo, Italy, Infectious Diseases Clinic, Papa Giovanni XXIII Hospital, Bergamo, Italy, UOS Infectious Disease and Infectious Emergencies, Azienda Ospedaliera dei Colli, Naples, Italy,
Tropical and Infectious Diseases Clinic, ASST Spedali Civili di Brescia, University of Brescia, Brescia – Italy, ISTUD Foundation, Milan, Italy, 9Janssen-Cilag SpA, Cologno Monzese, Italy) and all patients
participating in this study. In particular to all those who shared their experiences and believed in this innovative methodology.

Funding
DIAMANTE study is funded by Janssen‐Cilag SpA, Italy