Trial Outcomes & Findings for One-step HCV RNA Testing Among SSP Participants (HOT Study) (NCT NCT06634342)
NCT ID: NCT06634342
Last Updated: 2026-06-24
Results Overview
Percentage of individuals who complete a HCV RNA test and who also receive their test results.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
6 months
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
Participants of a Syringe Services Program
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
HCV RNA point-of-care testing: Participants will receive point-of-care hepatitis C RNA testing using the GeneXpert IV Xpress System technology.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One-step HCV RNA Testing Among SSP Participants (HOT Study)
Baseline characteristics by cohort
| Measure |
Participants of a Syringe Services Program
n=200 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Age, Customized
22-29 years
|
24 Participants
n=20 Participants
|
|
Age, Customized
30-39 years
|
73 Participants
n=20 Participants
|
|
Age, Customized
40-49 years
|
51 Participants
n=20 Participants
|
|
Age, Customized
50-59 years
|
37 Participants
n=20 Participants
|
|
Age, Customized
60+ years
|
15 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Male
|
129 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Female
|
64 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Trans female
|
1 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Trans male
|
0 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Non-binary
|
2 Participants
n=20 Participants
|
|
Sex/Gender, Customized
Other/no response
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
159 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=20 Participants
|
|
History of injection drug use, ever
No
|
51 Participants
n=20 Participants
|
|
History of injection drug use, ever
Yes
|
149 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of individuals who complete a HCV RNA test and who also receive their test results.
Outcome measures
| Measure |
Participants of a Syringe Services Program
n=200 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Receipt of HCV RNA Test Results
|
193 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of individuals who test positive for HCV who are connected with HCV treatment services
Outcome measures
| Measure |
Participants of a Syringe Services Program
n=31 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Linkage to HCV Care
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of individuals who test positive for HCV who are cured of HCV.
Outcome measures
| Measure |
Participants of a Syringe Services Program
n=31 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Cure Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of participants who receive an HCV RNA test who test positive for HCV
Outcome measures
| Measure |
Participants of a Syringe Services Program
n=200 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Testing Results
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of participants offered the HCV RNA test who agree to be tested
Outcome measures
| Measure |
Participants of a Syringe Services Program
n=200 Participants
Participants of the syringe services program who will be offered point-of-care hepatitis C RNA testing will be adults 22 or older who do not already know they have HCV infection.
|
|---|---|
|
Testing Willingness
|
200 Participants
|
Adverse Events
Participants of a Syringe Services Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place