Trial Outcomes & Findings for Simplifying Treatment and Monitoring for HIV (STREAM HIV) (NCT NCT04341779)
NCT ID: NCT04341779
Last Updated: 2026-02-19
Results Overview
We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load \<200 copies/mL. This outcome will also include retention in care.
ACTIVE_NOT_RECRUITING
NA
539 participants
72 weeks after ART initiation
2026-02-19
Participant Flow
The initial enrollment was planned for 540. However, one person was considered ineligible after enrollment. Therefore, this person was not enrolled per-protocol.
Participant milestones
| Measure |
Intervention Arm
Point-of-care urine adherence testing and Point-of-care viral load testing.
Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL \>200 copies/mL and HIV drug resistance testing if TFV test indicated adherence.
Point-of-care test results were provided to participants on the same day as specimen collection, if/when possible.
|
Standard-of-care Arm
Without POC urine adherence testing and POC viral load testing.
Detailed: routine adherence counseling and lab-based viral load testing.
|
|---|---|---|
|
Overall Study
STARTED
|
270
|
269
|
|
Overall Study
COMPLETED
|
270
|
269
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=270 Participants
Point-of-care urine adherence testing and Point-of-care viral load testing.
Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL \>200 copies/mL and HIV drug resistance testing if TFV test indicated adherence.
Point-of-care viral load testing and tenofovir adherence testing: Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants
|
Standard-of-care Arm
n=269 Participants
Without POC urine adherence testing and POC viral load testing.
Detailed: routine adherence counseling and lab-based viral load testing.
|
Total
n=539 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 8.9 • n=270 Participants
|
33.3 years
STANDARD_DEVIATION 8.1 • n=269 Participants
|
33.4 years
STANDARD_DEVIATION 8.5 • n=539 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=270 Participants
|
152 Participants
n=269 Participants
|
317 Participants
n=539 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=270 Participants
|
117 Participants
n=269 Participants
|
222 Participants
n=539 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 72 weeks after ART initiationPopulation: Number of study participants who have data for the comparison of viral load suppression (\<200 copies/ml) and retention in care at 72 weeks after ART initiation.
We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load \<200 copies/mL. This outcome will also include retention in care.
Outcome measures
| Measure |
Intervention Arm
n=270 Participants
Point-of-care urine adherence testing and Point-of-care viral load testing.
Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL \>200 copies/mL and HIV drug resistance testing if TFV test indicated adherence.
Point-of-care test results were provided to participants on the same day as specimen collection, if/when possible.
|
Standard-of-care Arm
n=268 Participants
Without POC urine adherence testing and POC viral load testing.
Detailed: routine adherence counseling and lab-based viral load testing.
|
|---|---|---|
|
Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks
|
186 Participants
|
167 Participants
|
PRIMARY outcome
Timeframe: 72 weeks after ART initiationPopulation: Note: We were not able to collect a dried blood spot (DBS) specimen on people who were not retained in care or refused to provide a sample. Therefore, the denominator reflects testing on those people where were retained in the study and able to provide a fingerprick blood sample.
We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Outcome measures
| Measure |
Intervention Arm
n=223 Participants
Point-of-care urine adherence testing and Point-of-care viral load testing.
Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL \>200 copies/mL and HIV drug resistance testing if TFV test indicated adherence.
Point-of-care test results were provided to participants on the same day as specimen collection, if/when possible.
|
Standard-of-care Arm
n=212 Participants
Without POC urine adherence testing and POC viral load testing.
Detailed: routine adherence counseling and lab-based viral load testing.
|
|---|---|---|
|
Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots
|
148 Participants
0
|
146 Participants
0
|
SECONDARY outcome
Timeframe: 24 and 72 weeks after ART initiationWe will assess acceptability of point-of-care tenofovir and viral load testing by conducting semi-structured in-depth interviews and focus group discussions with study participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 and 72 weeks after ART initiationWe will conduct a micro-costing of the costs associated with point-of-care tenofovir and viral load testing and will estimate the cost-effectiveness of the intervention using an existing individual-based, stochastic HIV model for KwaZulu-Natal for simulating health and economic outcomes.
Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
Standard-of-care Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Morton, Project Manager
University of Washington
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place