NCT03799276Completed
Optimisation of Care in Vulnerable HIV Infected Individuals
Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals
Source: ClinicalTrials.gov · Last updated 2 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 8 Jan 2019
- Start date
- 15 Jan 2019
- Primary completion date
- 15 Jun 2022
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Diseases
- HIV
- NCT number
- NCT03799276
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 15 Jan 2019 to the primary completion date, 15 Jun 2022
- 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.
Other illness
- Patients with HIV plasma viral load \< 50 cp/ml
- https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts
Other
- Patients unwilling to participate.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yasmine Dudoit Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.