Drug Use, Harm Reduction, HIV Infections
Conditions
Brief summary
The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.
Interventions
Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months
OTHERHIV care
HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.
Sponsors
Gilead Sciences
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (age\>18 years); 2. positive rapid HIV test; 3. ability to provide informed consent; 4. HIV RNA \> 200 copies/ml; 5. creatinine clearance \> 30 mg/dl as measured by serum creatinine; 6. no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies.
Exclusion criteria
1\) Any other comorbidities at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV Viral Load Suppression | 6 months | HIV viral load suppression is defined as \<200 copies/ml in participants' blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV Viral Load Suppression | 1 month | HIV viral load suppression is defined as \<200 copies/ml in participants' blood |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rapid ART Group Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.
Biktarvy 50Mg-200Mg-25Mg Tablet: Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months
HIV care: HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 6 |
Baseline characteristics
| Characteristic | Rapid ART Group |
|---|---|
| Age, Continuous | 41 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 3 / 27 |
Outcome results
Primary
Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Time frame: 6 months
Population: Data was not collected for those participants that were lost to follow-up or death due to COVID pandemic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid ART Group | Percentage of Participants With HIV Viral Load Suppression | 11 Participants |
Secondary
Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Time frame: 1 month
Population: Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid ART Group | Percentage of Participants With HIV Viral Load Suppression | 11 Participants |
Secondary
Percentage of Participants With HIV Viral Load Suppression
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Time frame: 12 months
Population: Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Rapid ART Group | Percentage of Participants With HIV Viral Load Suppression | 15 Participants |