HIV/AIDSNCT04341779
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
A study testing Point-of-care viral load testing and tenofovir adherence testing in people with HIV/AIDS and HIV-1-infection, run by University of Washington at 1 site in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV/AIDS, HIV-1-infection
- What is being tested?
- Point-of-care viral load testing and tenofovir adherence testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 539 participants
- Where
- 1 siteSouth Africa
- Study dates
- 4 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HIV-positive
- ≥16 years old
- Initiating a TDF-based, first-line ART regimen
- Do not self-report being on an ART regimen in the prior month
- Willing/able to provide written informed consent
Who cannot join
- Does not plan to continue receiving HIV care at the CDC Clinic
- Per the decision or opinion of the PI (for example, a clinically significant acute or chronic medical condition or circumstances that would make the patient unsuitable for participation or jeopardize the safety or rights of the participant
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
Durban, KwaZulu-Natal, 4013
About this study
Official title: Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
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.
Read the detailed description
This study will be a two-arm, open-label, randomized controlled superiority trial at an HIV clinic in Durban. HIV-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line ART will be randomized to receive POC VL testing and POC TFV adherence testing, versus standard-of-care (SoC) viral load testing. The schedule for VL testing and management of VL test results will follow South African guidelines for HIV VL testing after ART initiation. 540 participants will be randomized (1:1) at ART initiation into the intervention arm (routine POC TFV adherence testing with POC VL monitoring) or the standard-of-care (SoC) arm (no objective TFV adherence testing and SoC VL monitoring).
Participants will be followed to compare concentrations between study arms at 24 weeks after ART initiation and a composite outcome of VL suppression and retention in care between the study arms at 72 weeks after ART initiation. The study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the POC assays. Micro-costing will be conducted to estimate intervention costs.
- Conditions
- HIV/AIDS, HIV-1-infection
- Being tested
- Point-of-care viral load testing and tenofovir adherence testing
- Keywords
- Point-of-care test, Tenofovir, Adherence, HIV viral load
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care viral load testing and tenofovir adherence testingCombination product
Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Combination Product: Point-of-care viral load testing and tenofovir adherence testing |
| Standard-of-care arm | No intervention | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks
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.
Measured: 72 weeks after ART initiation
Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots
We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Measured: 72 weeks after ART initiation
Secondary outcomes (2)
Acceptability of Point-of-care Tenofovir and Viral Load Testing
We 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.
Measured: 24 and 72 weeks after ART initiation
Cost-effectiveness of Providing Routine Point-of-care Tenofovir and Viral Load Testing as Compared to Standard-of-care Viral Load Monitoring
We 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.
Measured: 24 and 72 weeks after ART initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start4 Feb 2021
- Primary completion30 Jun 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centre for the AIDS Programme of Research in South Africa
- Responsible party
- Principal investigator, Paul Drain, University of Washington
- Investigators
- Paul Drain, MD, MPH, Principal investigator, University of WashingtonNigel Garett, MBBS, PHD, Principal investigator, Centre for the AIDS Programme of Research in South Africa (CAPRISA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341779
- Sponsor's protocol ID
- STUDY00007544
- Other IDs
- R01AI147752
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2020
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from the study will be made available
Publications
Wang M, Moodley P, Khanyile M, Bulo E, Zondi M, Naidoo K, Sookrajh Y, Dorward J, Gandhi M, Garrett N, Drain PK, Sharma M. Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa. J Int AIDS Soc. 2025 Jul;28(7):e70004. doi: 10.1002/jia2.70004.
PubMed 40660747Bardon AR, Dorward J, Sookrajh Y, Sayed F, Quame-Amaglo J, Pillay C, Feutz E, Ngobese H, Simoni JM, Sharma M, Cressey TR, Gandhi M, Lessells R, Moodley P, Naicker N, Naidoo K, Thomas K, Celum C, Abdool Karim S, Garrett N, Drain PK. 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. BMJ Open. 2021 Oct 5;11(10):e050116. doi: 10.1136/bmjopen-2021-050116.
PubMed 34610939
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa
- ClinicalTrials.gov ID
- NCT04341779
- Acronym / sponsor ID
- STUDY00007544
- Conditions
- HIV/AIDS, HIV-1-infection
- Keywords
- Point-of-care test, Tenofovir, Adherence, HIV viral load
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 539 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Centre for the AIDS Programme of Research in South Africa
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a two-arm, open-label, randomized controlled superiority trial at an HIV clinic in Durban. HIV-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line ART will be randomized to receive POC VL testing and POC TFV adherence testing, versus standard-of-care (SoC) viral load testing. The schedule for VL testing and management of VL test results will follow South African guidelines for HIV VL testing after ART initiation. 540 participants will be randomized (1:1) at ART initiation into the intervention arm (routine POC TFV adherence testing with POC VL monitoring) or the standard-of-care (SoC) arm (no objective TFV adherence testing and SoC VL monitoring).
Participants will be followed to compare concentrations between study arms at 24 weeks after ART initiation and a composite outcome of VL suppression and retention in care between the study arms at 72 weeks after ART initiation. The study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the POC assays. Micro-costing will be conducted to estimate intervention costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Combination Product: Point-of-care viral load testing and tenofovir adherence testingPoint-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. |
| Standard-of-care arm | No intervention | –Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-positive
- ≥16 years old
- Initiating a TDF-based, first-line ART regimen
- Do not self-report being on an ART regimen in the prior month
- Willing/able to provide written informed consent
Key exclusion criteria (2 listed)
- Does not plan to continue receiving HIV care at the CDC Clinic
- Per the decision or opinion of the PI (for example, a clinically significant acute or chronic medical condition or circumstances that would make the patient unsuitable for participation or jeopardize the safety or rights of the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care viral load testing and tenofovir adherence testingPoint-of-care testing of HIV viral load and tenofovir, and providing same day results to participants | Combination product | Intervention arm |
Primary outcome
Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks
Time frame: 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.
Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots
Time frame: 72 weeks after ART initiation
We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
2 secondary outcomes
Acceptability of Point-of-care Tenofovir and Viral Load Testing
Time frame: 24 and 72 weeks after ART initiation
Cost-effectiveness of Providing Routine Point-of-care Tenofovir and Viral Load Testing as Compared to Standard-of-care Viral Load Monitoring
Time frame: 24 and 72 weeks after ART initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40660747Wang M, Moodley P, Khanyile M, Bulo E, Zondi M, Naidoo K, Sookrajh Y, Dorward J, Gandhi M, Garrett N, Drain PK, Sharma M. Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa. J Int AIDS Soc. 2025 Jul;28(7):e70004. doi: 10.1002/jia2.70004.
- Derived from this study: PubMed 34610939Bardon AR, Dorward J, Sookrajh Y, Sayed F, Quame-Amaglo J, Pillay C, Feutz E, Ngobese H, Simoni JM, Sharma M, Cressey TR, Gandhi M, Lessells R, Moodley P, Naicker N, Naidoo K, Thomas K, Celum C, Abdool Karim S, Garrett N, Drain PK. 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. BMJ Open. 2021 Oct 5;11(10):e050116. doi: 10.1136/bmjopen-2021-050116.
- Individual participant dataSharing planned: Yes. De-identified data from the study will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Drain, MD, MPH principal investigator
University of Washington
Nigel Garett, MBBS, PHD principal investigator
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care viral load testing and tenofovir adherence testing in people with HIV/AIDS and HIV-1-infection, run by University of Washington at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks (time frame: 72 weeks after ART initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04341779, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.