Optimisation of Care in Vulnerable HIV Infected Individuals

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

Interventions

OTHER

Opticare study

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.

Sponsors & Collaborators

• ViiV Healthcare

  collaborator INDUSTRY

• Institut de Sante Publique, d'Epidemiologie et de Developpement

  collaborator OTHER

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

  lead OTHER

Principal Investigators

• Sophie Seang, MD · Pitie Salpetriere Hospital

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-15

Primary Completion

2022-06-15

Completion

2023-12-15

Countries

• France

Study Locations