Trial Outcomes & Findings for Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED) (NCT NCT05405751)
NCT ID: NCT05405751
Last Updated: 2026-06-30
Results Overview
Proportion of subjects making visits at weeks 24 and 48.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
101 participants
Primary outcome timeframe
24-48 weeks
Results posted on
2026-06-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
From Baseline to week 4
STARTED
|
101
|
|
From Baseline to week 4
COMPLETED
|
89
|
|
From Baseline to week 4
NOT COMPLETED
|
12
|
|
From week 4 to week 12
STARTED
|
89
|
|
From week 4 to week 12
COMPLETED
|
80
|
|
From week 4 to week 12
NOT COMPLETED
|
9
|
|
From week 12 to week 24
STARTED
|
80
|
|
From week 12 to week 24
COMPLETED
|
79
|
|
From week 12 to week 24
NOT COMPLETED
|
1
|
|
From week 24 to week 48
STARTED
|
79
|
|
From week 24 to week 48
COMPLETED
|
65
|
|
From week 24 to week 48
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
From Baseline to week 4
Lost to Follow-up
|
4
|
|
From Baseline to week 4
Change of patient's residence
|
4
|
|
From Baseline to week 4
Non-compliance with treatment or study visits
|
2
|
|
From Baseline to week 4
Imprisonment
|
2
|
|
From week 4 to week 12
Lost to Follow-up
|
6
|
|
From week 4 to week 12
Non-compliance with treatment or study visits
|
1
|
|
From week 4 to week 12
Change of patient's residence
|
1
|
|
From week 4 to week 12
Death
|
1
|
|
From week 12 to week 24
Imprisonment
|
1
|
|
From week 24 to week 48
Lost to Follow-up
|
10
|
|
From week 24 to week 48
Non-compliance with treatment or study visits
|
1
|
|
From week 24 to week 48
Imprisonment
|
2
|
|
From week 24 to week 48
Change of patient's residence
|
1
|
Baseline Characteristics
Only participants sexually active (79).
Baseline characteristics by cohort
| Measure |
Patients Received BIKTARVY (BIC/FTC/TAF)
n=101 Participants
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.
|
|---|---|
|
Previous Opportunistic Infections
Yes
|
9 Participants
n=101 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 10.7 • n=101 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=101 Participants
|
|
Race/Ethnicity, Customized
Race categories · Caucasian
|
26 Participants
n=101 Participants
|
|
Race/Ethnicity, Customized
Race categories · Hispanic
|
74 Participants
n=101 Participants
|
|
Race/Ethnicity, Customized
Race categories · Other
|
1 Participants
n=101 Participants
|
|
Region of Enrollment
Spain
|
101 Participants
n=101 Participants
|
|
Born in Spain
Yes
|
22 Participants
n=101 Participants
|
|
Born in Spain
No
|
79 Participants
n=101 Participants
|
|
Educational level
Incomplete primary education
|
5 Participants
n=101 Participants
|
|
Educational level
Complete primary education
|
12 Participants
n=101 Participants
|
|
Educational level
Complete secondary education
|
64 Participants
n=101 Participants
|
|
Educational level
Completed university studies
|
14 Participants
n=101 Participants
|
|
Educational level
Unknown
|
6 Participants
n=101 Participants
|
|
Orientation of desire
Homosexual
|
57 Participants
n=101 Participants
|
|
Orientation of desire
Heterosexual
|
36 Participants
n=101 Participants
|
|
Orientation of desire
Bisexual
|
5 Participants
n=101 Participants
|
|
Orientation of desire
Others
|
1 Participants
n=101 Participants
|
|
Orientation of desire
Unknown
|
2 Participants
n=101 Participants
|
|
Social support network
Family
|
16 Participants
n=101 Participants
|
|
Social support network
Friends
|
17 Participants
n=101 Participants
|
|
Social support network
None
|
68 Participants
n=101 Participants
|
|
Right to healthcare
No
|
82 Participants
n=101 Participants
|
|
Right to healthcare
Yes
|
18 Participants
n=101 Participants
|
|
Right to healthcare
Unknown
|
1 Participants
n=101 Participants
|
|
Do you face barriers to accessing the healthcare system?
No
|
13 Participants
n=101 Participants
|
|
Do you face barriers to accessing the healthcare system?
Yes
|
88 Participants
n=101 Participants
|
|
Homeless
No
|
38 Participants
n=101 Participants
|
|
Homeless
Yes
|
63 Participants
n=101 Participants
|
|
Living on the street
No
|
85 Participants
n=101 Participants
|
|
Living on the street
Yes
|
16 Participants
n=101 Participants
|
|
Problematic alcohol use?
No
|
87 Participants
n=101 Participants
|
|
Problematic alcohol use?
Yes
|
14 Participants
n=101 Participants
|
|
Sexually active (last year)
No
|
17 Participants
n=101 Participants
|
|
Sexually active (last year)
Yes
|
79 Participants
n=101 Participants
|
|
Sexually active (last year)
Unknown
|
5 Participants
n=101 Participants
|
|
Having had unprotected anal sex in the last year (outside of a stable relationship)
No
|
32 Participants
n=79 Participants • Only participants sexually active (79).
|
|
Having had unprotected anal sex in the last year (outside of a stable relationship)
Yes
|
43 Participants
n=79 Participants • Only participants sexually active (79).
|
|
Having had unprotected anal sex in the last year (outside of a stable relationship)
Unknown
|
4 Participants
n=79 Participants • Only participants sexually active (79).
|
|
In the last year, have you been diagnosed with any STIs?
No
|
81 Participants
n=101 Participants
|
|
In the last year, have you been diagnosed with any STIs?
Yes
|
19 Participants
n=101 Participants
|
|
In the last year, have you been diagnosed with any STIs?
Unknown
|
1 Participants
n=101 Participants
|
|
HIV Transmission
Sexual
|
85 Participants
n=101 Participants
|
|
HIV Transmission
Injected Drug Use (IDU)
|
15 Participants
n=101 Participants
|
|
HIV Transmission
Nosocomial
|
1 Participants
n=101 Participants
|
|
Previous Opportunistic Infections
No
|
91 Participants
n=101 Participants
|
|
Previous Opportunistic Infections
Unknown
|
1 Participants
n=101 Participants
|
|
Have you taken antiretroviral treatment before being included in the study?
No
|
30 Participants
n=101 Participants
|
|
Have you taken antiretroviral treatment before being included in the study?
Yes
|
71 Participants
n=101 Participants
|
|
Previous failures on ART
No
|
44 Participants
n=71 Participants • Only participants who had taken ART prior to being included in the study were analyzed (71).
|
|
Previous failures on ART
Yes
|
6 Participants
n=71 Participants • Only participants who had taken ART prior to being included in the study were analyzed (71).
|
|
Previous failures on ART
Unknown
|
21 Participants
n=71 Participants • Only participants who had taken ART prior to being included in the study were analyzed (71).
|
|
Drug use
No
|
61 Participants
n=101 Participants
|
|
Drug use
Yes
|
40 Participants
n=101 Participants
|
|
Job
No
|
86 Participants
n=101 Participants
|
|
Job
Yes
|
13 Participants
n=101 Participants
|
|
Job
Unknown
|
2 Participants
n=101 Participants
|
|
Baseline HIV Viral Load
VL >= 50 copies/mL
|
88 Participants
n=101 Participants
|
|
Baseline HIV Viral Load
VL < 50 copies/mL
|
13 Participants
n=101 Participants
|
|
Rapid test or serology for hepatitis C
Negative
|
77 Participants
n=101 Participants
|
|
Rapid test or serology for hepatitis C
Positive
|
24 Participants
n=101 Participants
|
|
Resistance study
Without mutations
|
53 Participants
n=101 Participants
|
|
Resistance study
With mutations
|
26 Participants
n=101 Participants
|
|
Resistance study
Without resistance study
|
22 Participants
n=101 Participants
|
|
Baseline physical examination
Normal
|
92 Participants
n=101 Participants
|
|
Baseline physical examination
Pathological
|
9 Participants
n=101 Participants
|
|
Vital signs
Normal
|
101 Participants
n=101 Participants
|
|
Vital signs
Pathological
|
0 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: 24-48 weeksPopulation: 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.
Proportion of subjects making visits at weeks 24 and 48.
Outcome measures
| Measure |
Patients Received BIKTARVY (BIC/FTC/TAF)
n=101 Participants
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.
|
|---|---|
|
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.
Complete the follow-up at week 48
|
65 Participants
Interval 6.6 to 50.2
|
|
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.
Don´t complete the follow-up at week 48
|
36 Participants
|
|
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.
Complete the follow-up at week 24
|
79 Participants
|
|
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.
Don´t complete the follow-up at week 24
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 12, week 24 and week 48Proportion of participants with HIV viral load \<50 copies/ml throughout the study
Outcome measures
| Measure |
Patients Received BIKTARVY (BIC/FTC/TAF)
n=101 Participants
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.
|
|---|---|
|
To Assess the Implementation and Feasibility of the Intervention
Baseline visit · VL < 50 copies/mL
|
13 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Baseline visit · VL >= 50 copies/mL
|
88 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Baseline visit · Not available
|
0 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Baseline visit · Withdrawal
|
0 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 4 · VL < 50 copies/mL
|
62 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 4 · VL >= 50 copies/mL
|
22 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 4 · Not available
|
5 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 4 · Withdrawal
|
12 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 12 · VL < 50 copies/mL
|
73 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 12 · VL >= 50 copies/mL
|
3 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 12 · Not available
|
4 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 12 · Withdrawal
|
21 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 24 · VL < 50 copies/mL
|
71 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 24 · VL >= 50 copies/mL
|
7 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 24 · Not available
|
1 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 24 · Withdrawal
|
22 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 48 · VL < 50 copies/mL
|
62 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 48 · VL >= 50 copies/mL
|
2 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 48 · Not available
|
1 Participants
|
|
To Assess the Implementation and Feasibility of the Intervention
Week 48 · Withdrawal
|
36 Participants
|
Adverse Events
Patients Received BIKTARVY (BIC/FTC/TAF)
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Patients Received BIKTARVY (BIC/FTC/TAF)
n=101 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis of pancreatic tumor
|
0.99%
1/101 • 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.
No differences
|
|
Musculoskeletal and connective tissue disorders
Submental mass
|
0.99%
1/101 • 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.
No differences
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • 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.
No differences
|
|
Psychiatric disorders
Autolytic attemp
|
0.99%
1/101 • 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.
No differences
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place