Trial Outcomes & Findings for Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program (NCT NCT04650269)
NCT ID: NCT04650269
Last Updated: 2025-01-08
Results Overview
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
27 participants
Primary outcome timeframe
6 months
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program
Baseline characteristics by cohort
| Measure |
Rapid ART Group
n=27 Participants
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.
|
|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for those participants that were lost to follow-up or death due to COVID pandemic
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Outcome measures
| Measure |
Rapid ART Group
n=16 Participants
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.
|
|---|---|
|
Percentage of Participants With HIV Viral Load Suppression
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Outcome measures
| Measure |
Rapid ART Group
n=16 Participants
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.
|
|---|---|
|
Percentage of Participants With HIV Viral Load Suppression
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data was not collected for those participants that were lost to follow-up or death due to the COVID pandemic
HIV viral load suppression is defined as \<200 copies/ml in participants' blood
Outcome measures
| Measure |
Rapid ART Group
n=19 Participants
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.
|
|---|---|
|
Percentage of Participants With HIV Viral Load Suppression
|
15 Participants
|
Adverse Events
Rapid ART Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Rapid ART Group
n=27 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
death
|
11.1%
3/27 • Number of events 3 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Hansel Tookes
University of Miami Miller School of Medicine
Phone: 3056897030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place