HIV InfectionsOPTICARENCT03799276
Optimisation of Care in Vulnerable HIV Infected Individuals
A study testing Opticare study in people with HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Opticare study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2019to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals
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.
Read more
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.
Read the detailed description
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:
- A comprehensive and complete check up personal interview, through a daily visit, with a physician, an educational nurse, a social worker and a cultural mediator (if needed), in order to identify mains issues
- A specific follow up will be set up with obligatory visits at week 4, week 12, week 24, week 36 and week 48 to assess the evolution of the previously identified issues. If needed, additional visits will be set up.
- Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program.
- Each patient will be accompanied by a tutoring nurse who will be in direct contact with the patient.
Regarding the specific needs, each patient may benefit of:
- a personal assistance to complete administrative procedures (update health insurance, assistance to fill administrative papers, provide a budget for photo ID, transport tickets)
- a personalized medical follow up with regular phone calls, home visits (if the patient agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)
- a close psychological and social support (connection with HIV organizations, participation to monthly support group)
- a specific assistance related to dependence issues (connection with addiction organization, sex therapist consultation)
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.
- Conditions
- HIV Infections
- Being tested
- Opticare study
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opticare studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Opticare study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start15 Jan 2019
- Primary completion15 Jun 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, Institut de Sante Publique, d'Epidemiologie et de Developpement
- Responsible party
- Sponsor
- Investigators
- Sophie Seang, MD, Principal investigator, Pitie Salpetriere Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799276
- Sponsor's protocol ID
- CREPATS 08
- Acronym
- OPTICARE
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Care and Antiretroviral Therapy in Vulnerable HIV Infected Individuals
- ClinicalTrials.gov ID
- NCT03799276
- Acronym / sponsor ID
- OPTICARE / CREPATS 08
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaUniversity, hospital or other
- Collaborators
- ViiV Healthcare, Institut de Sante Publique, d'Epidemiologie et de Developpement
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- A comprehensive and complete check up personal interview, through a daily visit, with a physician, an educational nurse, a social worker and a cultural mediator (if needed), in order to identify mains issues
- A specific follow up will be set up with obligatory visits at week 4, week 12, week 24, week 36 and week 48 to assess the evolution of the previously identified issues. If needed, additional visits will be set up.
- Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program.
- Each patient will be accompanied by a tutoring nurse who will be in direct contact with the patient.
Regarding the specific needs, each patient may benefit of:
- a personal assistance to complete administrative procedures (update health insurance, assistance to fill administrative papers, provide a budget for photo ID, transport tickets)
- a personalized medical follow up with regular phone calls, home visits (if the patient agrees), assistance in taking HIV medication (set up pillbox, therapeutic education)
- a close psychological and social support (connection with HIV organizations, participation to monthly support group)
- a specific assistance related to dependence issues (connection with addiction organization, sex therapist consultation)
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opticare study | Experimental | Other: Opticare studyPhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients Lost to follow-up defined as a patient with no clinical visit:
- 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 :
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opticare studyEach 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. | Other | Opticare study |
Primary outcome
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
Time frame: 12 months
Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Seang, MD principal investigator
Pitie Salpetriere Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opticare study in people with HIV Infections, run by Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.