Simplifying Treatment and Monitoring for HIV (STREAM HIV)

NCT04341779 | Active Not Recruiting Results DMC

• 2 other identifiers: STUDY00007544R01AI147752
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

Brief 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 care among HIV-positive individuals initiating first-line tenofovir disoproxil fumarate (TDF)-based ART in South Africa.

Conditions

HIV/AIDS; HIV-1-infection

Keywords

Point-of-care test; Tenofovir; Adherence; HIV viral load

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  72 weeks after ART initiation

Secondary Outcomes (2)

• Acceptability of Point-of-care Tenofovir and Viral Load Testing

  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

  24 and 72 weeks after ART initiation

Study Arms (2)

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.

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.

Interventions

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

Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants

Intervention arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Washington: lead
• Centre for the AIDS Programme of Research in South Africa: collaborator

Study Sites (1)

Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal

Durban, KwaZulu-Natal, 4013, South Africa

Location

Related Publications (2)

• 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.

  PMID: 40660747 DERIVED

• Bardon 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.

  PMID: 34610939 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

There was a high rate of loss-to-follow-up in this study, which limited the number of participants who provided blood specimens for HIV viral load and tenofovir drug concentration testing at the end of the study.

Results Point of Contact

• Title: Jennifer Morton, Project Manager
• Organization: University of Washington

jfmorton@uw.edu

206-520-3820

Study Officials

• Paul Drain, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Nigel Garett, MBBS, PHD

  Centre for the AIDS Programme of Research in South Africa (CAPRISA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: February 4, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following publication of primary results.
• Access Criteria: De-identified data generated under this project will be administered in accordance with University of Washington, CAPRISA, and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

Locations

ZA (1)