Trial Outcomes & Findings for Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC) (NCT NCT04793750)
NCT ID: NCT04793750
Last Updated: 2026-04-23
Results Overview
The primary outcome of the study was linkage to care rate, defined as having at least one in-person or telehealth interaction with a clinical team about HIV ART or PrEP within the study follow-up period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
224 participants
Primary outcome timeframe
12 Weeks
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
POC HIV VL Testing
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
Participants will receive routine standard of care HIV testing.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
111
|
|
Overall Study
COMPLETED
|
113
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)
Baseline characteristics by cohort
| Measure |
POC HIV VL Testing
n=113 Participants
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
n=111 Participants
Participants will receive routine standard of care HIV testing.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group · Less than 25
|
10 Participants
n=60 Participants
|
8 Participants
n=56 Participants
|
18 Participants
n=116 Participants
|
|
Age, Customized
Age group · 25 - 40
|
55 Participants
n=60 Participants
|
42 Participants
n=56 Participants
|
97 Participants
n=116 Participants
|
|
Age, Customized
Age group · More than 40
|
48 Participants
n=60 Participants
|
61 Participants
n=56 Participants
|
109 Participants
n=116 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=60 Participants
|
38 Participants
n=56 Participants
|
88 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=60 Participants
|
73 Participants
n=56 Participants
|
136 Participants
n=116 Participants
|
|
Linked to care
Linked to care
|
51 Participants
n=60 Participants
|
50 Participants
n=56 Participants
|
101 Participants
n=116 Participants
|
|
Linked to care
Not linked to care
|
62 Participants
n=60 Participants
|
61 Participants
n=56 Participants
|
123 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American or Another Race
|
77 Participants
n=60 Participants
|
74 Participants
n=56 Participants
|
151 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
36 Participants
n=60 Participants
|
37 Participants
n=56 Participants
|
73 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksThe primary outcome of the study was linkage to care rate, defined as having at least one in-person or telehealth interaction with a clinical team about HIV ART or PrEP within the study follow-up period.
Outcome measures
| Measure |
POC HIV VL Testing
n=113 Participants
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
n=111 Participants
Participants will receive routine standard of care HIV testing.
|
|---|---|---|
|
Participants Linked Either to Care (PrEP or ART)
|
51 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
POC HIV VL Testing
n=51 Participants
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
n=50 Participants
Participants will receive routine standard of care HIV testing.
|
|---|---|---|
|
HIV: Time to Linkage to Either PrEP or ART
|
49 days
Interval 5.0 to 91.0
|
74 days
Interval 7.0 to 93.0
|
SECONDARY outcome
Timeframe: Day 0 and Week 12Population: Enrolled at baseline: n=224. Completed the week 12 follow-up visit: n=136
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
Outcome measures
| Measure |
POC HIV VL Testing
n=113 Participants
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
n=111 Participants
Participants will receive routine standard of care HIV testing.
|
|---|---|---|
|
Participants Reporting Condom-less Sex
Participants reporting condom-less sex at baseline
|
63 participants
|
70 participants
|
|
Participants Reporting Condom-less Sex
Participants reporting condom-less sex at week-12
|
28 participants
|
34 participants
|
Adverse Events
POC HIV VL Testing
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SOC HIV Testing
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
POC HIV VL Testing
n=113 participants at risk
Participants will receive the standard of care HIV tests plus the HIV POC VL test.
|
SOC HIV Testing
n=111 participants at risk
Participants will receive routine standard of care HIV testing.
|
|---|---|---|
|
General disorders
Adverse events noted per protocol
|
14.2%
16/113 • From enrollment unitl end of follow-up, up to 12 weeks
|
22.5%
25/111 • From enrollment unitl end of follow-up, up to 12 weeks
|
Additional Information
Matthew M. Hamill, MBChB, PhD
Johns Hopkins School of Medicine
Phone: 4105509080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place