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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients received BIKTARVY (BIC/FTC/TAF) | Experimental | The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Proportion of subjects making visits at weeks 24 and 48. | 24-48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Implementation and Feasibility of the Intervention | Proportion of participants with HIV viral load <50 copies/ml throughout the study | Baseline, week 4, week 12, week 24 and week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Infanta Leonor | Madrid | Spain |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Received BIKTARVY (BIC/FTC/TAF) | The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| From Baseline to week 4 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2023 |
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Pilot, prospective, single-centre, single-arm, single-treatment study.
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| COMPLETED |
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| NOT COMPLETED |
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| From week 4 to week 12 |
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| From week 12 to week 24 |
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| From week 24 to week 48 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Received BIKTARVY (BIC/FTC/TAF) | The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
| ||||||||||||||||||
| Born in Spain | Count of Participants | Participants |
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| Educational level | Count of Participants | Participants |
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| Orientation of desire | Count of Participants | Participants |
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| Social support network | Count of Participants | Participants |
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| Right to healthcare | Count of Participants | Participants |
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| Do you face barriers to accessing the healthcare system? | Count of Participants | Participants |
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| Homeless | Count of Participants | Participants |
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| Living on the street | Count of Participants | Participants |
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| Problematic alcohol use? | Count of Participants | Participants |
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| Sexually active (last year) | Count of Participants | Participants |
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| Having had unprotected anal sex in the last year (outside of a stable relationship) | Only participants sexually active (79). | Count of Participants | Participants |
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| In the last year, have you been diagnosed with any STIs? | Count of Participants | Participants |
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| HIV Transmission | Count of Participants | Participants |
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| Previous Opportunistic Infections | Count of Participants | Participants |
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| Have you taken antiretroviral treatment before being included in the study? | Count of Participants | Participants |
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| Previous failures on ART | Only participants who had taken ART prior to being included in the study were analyzed (71). | Count of Participants | Participants |
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| Drug use | Count of Participants | Participants |
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| Job | Count of Participants | Participants |
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| Baseline HIV Viral Load | Count of Participants | Participants |
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| Rapid test or serology for hepatitis C | Count of Participants | Participants |
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| Resistance study | Count of Participants | Participants |
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| Baseline physical examination | Count of Participants | Participants |
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| Vital signs | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Proportion of subjects making visits at weeks 24 and 48. | 65 is the number of participant who completed the follow-up and 36 is the number of participants who did not complete the follow-up. | Posted | Count of Participants | Participants | 24-48 weeks |
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| Secondary | To Assess the Implementation and Feasibility of the Intervention | Proportion of participants with HIV viral load <50 copies/ml throughout the study | Posted | Count of Participants | Participants | Baseline, week 4, week 12, week 24 and week 48 |
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Each patient was evaluated from the signing of the informed consent form until the last visit, an average of 48 weeks. The evaluation of all patients was carried out over a period of approximately 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Received BIKTARVY (BIC/FTC/TAF) | The patient enrolled in the study and access HIV consulting will start treatment with BIKTARVY the same day of the inclusion. The medication will provided by the sponsor and it will be dispensed by pharmacy service. The delivery of medication to the patient can be delegated by a member of investigator staff who pick up the mediaction from pharmacy service to be delivered to the patient. The patient can pick up the medication directly from the pharmacy service. It will be recorded the face to face on delegated dispensing. The deliver of medication will be bi-monthly and 2 bottles of tablets will be dispensed. The patients will receive a BIC/FTC/TAF single oral dose per day for 12 months. | 1 | 101 | 4 | 101 | 0 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Autolytic attemp | Psychiatric disorders | Non-systematic Assessment |
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| Metastasis of pancreatic tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Submental mass | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pedro Gil Divasson | FundaciĆ³n SEIMC-GESIDA | 91 556 80 25 | (+34) | pgil@f-sg.org |
| Jun 25, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000620396 | bictegravir |
| D000068679 | Emtricitabine |
| C442442 | tenofovir alafenamide |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Death |
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| Change of patient's residence |
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| Other |
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| Complete secondary education |
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| Completed university studies |
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| Unknown |
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| Bisexual |
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| Others |
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| Unknown |
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| None |
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| Unknown |
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| Unknown |
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| Yes |
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| Unknown |
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| Unknown |
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| Nosocomial |
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| Unknown |
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| Yes |
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| Unknown |
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| Unknown |
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| Without resistance study |
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| Title | Measurements |
|---|---|
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| DonĀ“t complete the follow-up at week 24 |
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