Yasmine Dudoit
Paris, 75013, France
NCT Number: NCT03799276
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
The OPTICARE program is an individualized program proposed to vulnerable HIV infected patients according to a baseline evaluation of the clinical, social, psychological and cultural aspects.
Once enrolled in the OPTICARE program, each patient will benefit of:
Regarding the specific needs, each patient may benefit of:
A multidisciplinary team (physician, educational nurse, psychotherapist, social worker and cultural mediator) will proactively assist the patient (home visits, recall) during a one year follow up.
The program is initially proposed to the patient. In case of non-acceptance, the patient can further join the program after 3 months.
Patients who do not accept the OPTICARE program will be followed up in standard of care according to French HIV management guidelines. (https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts/). All administratives and social procedures will be given to the social district.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
AND with HIV plasma viral load > 400 cp/ml (following French HIV guidelines)
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)
Exclusion criteria
https://cns.sante.fr/actualites/prise-en-charge-du-vih-recommandations-du-groupe-dexperts
Each patient will be evaluated by
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.
Time frame: 12 months
Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
Other
Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals
Acronym: OPTICARE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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