Optimisation of Care in Vulnerable HIV Infected Individuals

NCT03799276 | Completed DMC

• 1 other identifier: CREPATS 08
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Antiretroviral therapy is currently the only way to control HIV disease progression in HIV infected subjects and to prevent transmission. However a sustained virological control through antiretroviral therapy is requested for these objectives. There is currently 8-10% of patients who failed therapy for many reasons other than virological resistance including social unstability, psychiatric disorders, migrant status, drug or alcohol addictions. Because many of these vulnerabilities can be managed and patients helped for following adequately cares and treatments, study team designed the OPTICARE Program to help reduce impact of the patients' vulnerabilities. The OPTICARE study is designed as a prospective implementation interventional study which aims to improve retention in care among vulnerable HIV infected patients over 48 weeks. The OPTICARE program is a support program dedicated to patients either lost to follow up or in highly fraility situation that will offer an individualized care management to fill their gaps towards optimized care and control of viral replication. Our aim is, in patients virally failing in relation with poor adherence to care and treatment to test first part whether tracking proactively lost to follow up patients or detecting frail individuals at risk of lost to care is effective and secondly to evaluate the efficacy, the feasibility and the acceptability of an intervention tailored to each individual to get them to treatment success with viral suppression. In our context, a randomized approach would not be seen as ethical or possible in an environment where investigators need to evaluate such intervention as a pilot approach. Investigators therefore enrolled patients in a cohort population study OPTICARE program aim to actively identify vulnerable HIV+ population and promote optimal access to health care to this population using retention in care program in order to enable long term HIV infection control. The primary objective is to assess the feasability and the effectiveness of the OPTICARE program. The OPTICARE program aims to propose an individualized care to vulnerable HIV infected patients (UNAIDS/Second 90% goal) and to drive them to treatment success (UNAIDS/Third 90% goal) within a one-year period.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Measure of plasma viral load to assess the effectiveness of the OPTICARE Program to attend HIV plasma viral load < 50 cp/ml at week 48

  Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)

  12 months

Study Arms (1)

Opticare study

EXPERIMENTAL

Phase I: Identification and Selection of study population The first step will include an active search by OPTICARE team for vulnerable and lost to follow up patients Phase II: Implementation of the individualized follow-up program The patients who agree to participate to the program will be defined as the OPTICARE population.

Other: Opticare study

Interventions

Opticare study OTHER

Each patient will be evaluated by * An HIV physician * A nurse * A social worker * A psychological therapist * A cultural mediator/member of patients community if needed for migrants Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient. Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence. Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team.

Opticare study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Lost to follow-up defined as a patient with no clinical visit:
• In the 12 months period for patients \> 250/mm3 CD4 cells or
• In the 6 months period for patients \< 250/mm3 CD4 cells or
• In the 3 months period following a new HIV + diagnosis or an AIDS defining illnesses
• AND with HIV plasma viral load \> 400 cp/ml (following French HIV guidelines)
• HIV+ patients with virological failure defined as HIV plasma viral load (pVL) \> 400 cp/ml (2 determinations with at least two weeks apart)
• HIV+ patients presenting with an AIDS defining (\<3 months) event in a context of lost to care prior to the event
• HIV+ patients newly diagnosed with virological failure 6 months after ART initiation (virological failure defined by two HIV plasma viral load \> 50cp/ml following French HIV guidelines \*) and with one of the following vulnerable risk factors :
• Social frailty (lack of health insurance, homeless, accommodation by family/friends, post incarceration)
• Migrants with a first arrival in France in the last 6 months
• Women in postpartum period (3 months after delivery)
• Psychiatric disease
• Intravenous drug users, alcohol consumers (women \> 40g/day or \> 2 standard drinks /day; men \> 60g/day ou \> 3 standard drinks/day)
• A standard glass is defined by a quantity of pure alcohol of 10 grams, corresponding to approximately 10 cl of wine, 25 cl of beer at 5% vol, or 3 cl of alcohol at 40% vol. (https://www.sfalcoologie.asso.fr/download/RBP2014-SFA-Mesusage-AA.pdf)

You may not qualify if:

• Patients unwilling to participate.
• Patients with HIV plasma viral load \< 50 cp/ml
• https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead
• ViiV Healthcare: collaborator
• Institut de Sante Publique, d'Epidemiologie et de Developpement: collaborator

Study Sites (1)

Yasmine Dudoit

Paris, 75013, France

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

• Sophie Seang, MD

  Pitie Salpetriere Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: January 15, 2019
• Primary Completion: June 15, 2022
• Study Completion: December 15, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)