HIV Infections
Conditions
Brief summary
Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.
Detailed description
The use of a mobile unit to reach vulnerable HIV-infected people with poor access to the health care system and starting/restarting on the same day ("simplified same day test and treat strategy") is feasible, effective and safe and will allow these people to have a rapid access to ART and long-term follow-up and health care for HIV. At the screening visit the patient will sign the informed consent form, revise the clinical history and ensure compliance with criteria. A history of drug abuse, complete physical examination, pregnancy test, rapid hepatitis C test, questionnaires and social situation will be collected from the patient. At the basal visit the patients enrolled in the study will collect lab test (blood count, biochemistry, coagulation, serology, inmunology and virology), vital signs and directed physical examination, concomitant medication and adverse events. After the basal visit the patient will be followed up on visits week 4, 12, 24, 48 and last visit 50 as follow up safety visit.
Interventions
Patients enrolled in the study and accessing the HIV consultation will start treatment with BIKTARVY on the day of enrollment. Medication will be provided by the sponsor and dispensed through the pharmacy service. The drug will be delivered to the patient with a delegated person outside the hospital environment or it will be the patient himself who picks up the medication.
Sponsors
Fundacion SEIMC-GESIDA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Pilot, prospective, single-centre, single-arm, single-treatment study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Vulnerable person ≥18 years * Understand and sign the informed consent form * Confirmed HIV infection * Not receiving ART or on ART with a PVL \> copies/ml
Exclusion criteria
* Unable to provide contact details * History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine * Taking antiretroviral treatment for less than 1 month * Pregnancy or breastfeeding at the time of screening or gestational desires during the study period. * Suspected or diagnosed of active opportinistic disease * History of severe liver disease (Child- Pugh C) or history of descompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice) * History of kidney disease CKP-EPI\< 30ml/min * Have any condition that, as per investigator criteria, makes the patient not candidate to be included (active disease, social situation, intoxication...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Find Out Whether the Implementation of a Model of Access and Retention in Care for HIV Among Vulnerable People Using a Mobile Screening Unit and a Same-day Diagnosis and Treatment Initiation Strategy is Effective and Safety. | 24-48 weeks | Proportion of subjects making visits at weeks 24 and 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Implementation and Feasibility of the Intervention | Baseline, week 4, week 12, week 24 and week 48 | Proportion of participants with HIV viral load \<50 copies/ml throughout the study |
Countries
Spain
Participant flow
Pre-assignment details
All selected patients were included after taking the first dose of the investigational treatment. The number of participants defined in the study protocol (100) differs from the number of participants who started the study (101) because it was decided to compensate for withdrawals that had occurred (more than anticipated). Only one patient was included because medication was not available to recruit more patients.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 10.7 |
| Baseline HIV Viral Load VL < 50 copies/mL | 13 Participants |
| Baseline HIV Viral Load VL >= 50 copies/mL | 88 Participants |
| Baseline physical examination Normal | 92 Participants |
| Baseline physical examination Pathological | 9 Participants |
| Born in Spain No | 79 Participants |
| Born in Spain Yes | 22 Participants |
| Do you face barriers to accessing the healthcare system? No | 13 Participants |
| Do you face barriers to accessing the healthcare system? Yes | 88 Participants |
| Drug use No | 61 Participants |
| Drug use Yes | 40 Participants |
| Educational level Completed university studies | 14 Participants |
| Educational level Complete primary education | 12 Participants |
| Educational level Complete secondary education | 64 Participants |
| Educational level Incomplete primary education | 5 Participants |
| Educational level Unknown | 6 Participants |
| Have you taken antiretroviral treatment before being included in the study? No | 30 Participants |
| Have you taken antiretroviral treatment before being included in the study? Yes | 71 Participants |
| Having had unprotected anal sex in the last year (outside of a stable relationship) No | 32 Participants |
| Having had unprotected anal sex in the last year (outside of a stable relationship) Unknown | 4 Participants |
| Having had unprotected anal sex in the last year (outside of a stable relationship) Yes | 43 Participants |
| HIV Transmission Injected Drug Use (IDU) | 15 Participants |
| HIV Transmission Nosocomial | 1 Participants |
| HIV Transmission Sexual | 85 Participants |
| Homeless No | 38 Participants |
| Homeless Yes | 63 Participants |
| In the last year, have you been diagnosed with any STIs? No | 81 Participants |
| In the last year, have you been diagnosed with any STIs? Unknown | 1 Participants |
| In the last year, have you been diagnosed with any STIs? Yes | 19 Participants |
| Job No | 86 Participants |
| Job Unknown | 2 Participants |
| Job Yes | 13 Participants |
| Living on the street No | 85 Participants |
| Living on the street Yes | 16 Participants |
| Orientation of desire Bisexual | 5 Participants |
| Orientation of desire Heterosexual | 36 Participants |
| Orientation of desire Homosexual | 57 Participants |
| Orientation of desire Others | 1 Participants |
| Orientation of desire Unknown | 2 Participants |
| Previous failures on ART No | 44 Participants |
| Previous failures on ART Unknown | 21 Participants |
| Previous failures on ART Yes | 6 Participants |
| Previous Opportunistic Infections No | 91 Participants |
| Previous Opportunistic Infections Unknown | 1 Participants |
| Previous Opportunistic Infections Yes | 9 Participants |
| Problematic alcohol use? No | 87 Participants |
| Problematic alcohol use? Yes | 14 Participants |
| Race/Ethnicity, Customized Race categories Caucasian | 26 Participants |
| Race/Ethnicity, Customized Race categories Hispanic | 74 Participants |
| Race/Ethnicity, Customized Race categories Other | 1 Participants |
| Rapid test or serology for hepatitis C Negative | 77 Participants |
| Rapid test or serology for hepatitis C Positive | 24 Participants |
| Region of Enrollment Spain | 101 Participants |
| Resistance study With mutations | 26 Participants |
| Resistance study Without mutations | 53 Participants |
| Resistance study Without resistance study | 22 Participants |
| Right to healthcare No | 82 Participants |
| Right to healthcare Unknown | 1 Participants |
| Right to healthcare Yes | 18 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 87 Participants |
| Sexually active (last year) No | 17 Participants |
| Sexually active (last year) Unknown | 5 Participants |
| Sexually active (last year) Yes | 79 Participants |
| Social support network Family | 16 Participants |
| Social support network Friends | 17 Participants |
| Social support network None | 68 Participants |
| Vital signs Normal | 101 Participants |
| Vital signs Pathological | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 4 / 101 |
Outcome results
None listed