NCT04341779

Simplifying Treatment and Monitoring for HIV (STREAM HIV)

Active, enrolled NA Results posted Last updated 19 February 2026

What this trial tests

NA trial testing Point-of-care viral load testing and tenofovir adherence testing in HIV/AIDS in 539 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 February 2021

Primary endpoint
30 June 2025

31 December 2026

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	539
Start date	4 February 2021
Primary completion	30 June 2025
Estimated completion	31 December 2026
Sites	1 location across South Africa

Drugs / interventions tested

• Point-of-care viral load testing and tenofovir adherence testing

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

University of Washington

Who can join

16 and older, any sex, with HIV/AIDS or HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks Primary · 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.

Group	Value	95% CI
Intervention Arm	186
Standard-of-care Arm	167

Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots Primary · 72 weeks after ART initiation

We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.

Group	Value	95% CI
Intervention Arm	148	± 0
Standard-of-care Arm	146	± 0

Sponsor's own description

This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in improving ART adherence, maintaining durable VL suppression, and improving retention in care among HIV-positive individuals initiating first-line tenofovir disoproxil fumarate (TDF)-based ART in South Africa.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention.
   Drain PK, Bardon AR, Simoni JM, Cressey TR, et al · · 2020 · cited 29× · PMID 32627120 · DOI 10.1007/s11904-020-00512-3
2. Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes.
   Bardon AR, Dorward J, Sookrajh Y, Sayed F, et al · · 2021 · cited 15× · PMID 34610939 · DOI 10.1136/bmjopen-2021-050116
3. Emtricitabine triphosphate in dried blood spots predicts future viremia in persons with HIV and identifies mismatch with self-reported adherence.
   Morrow M, MaWhinney S, Coyle RP, Coleman SS, et al · · 2021 · cited 11× · PMID 34127580 · DOI 10.1097/qad.0000000000002981
4. Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa.
   Wang M, Moodley P, Khanyile M, Bulo E, et al · · 2025 · cited 2× · PMID 40660747 · DOI 10.1002/jia2.70004