Simplifying Treatment and Monitoring for HIV (STREAM HIV)

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS; HIV-1-infection
• Intervention / Treatment: Combination product: Point-of-care viral load testing and tenofovir adherence testing

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 Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zarna Marfatia; Phone Number: +12065203800; Email: zarnam@uw.edu

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4013
      • Recruiting
      • Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
      • Contact: Nigel Garrett, MBBS, PhD; Phone Number: +27312604453; Email: nigel.garrett@caprisa.org
      • Principal Investigator: Nigel Garrett, MBBS, PhD
      • Contact: Pedzisai Munatsi; Phone Number: +27 (0)31 655 0604; Email: pedzisai.manatsi@caprisa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Point-of-care adherence testing and Point-of-care viral load testing	Combination product: 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
No Intervention: Standard-of-care arm; No adherence testing and lab-based viral load testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean tenofovir diphosphate concentration levels in dried blood spots	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.	24 weeks after ART initiation
Combined measure of virological suppression and retention in care (binary)	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. Retention in care will be defined as having collected ART from the study clinic within 8 weeks of study exit.	72 weeks after ART initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined measure of viral suppression and retention in care (binary)	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. Retention in care will be defined as having collected ART from the study clinic within 8 weeks of their 6-month study visit.	24 weeks after ART initiation
Tenofovir-diphosphate concentration in dried blood spots (continuous)	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.	72 weeks after ART initiation
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.	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.	24 and 72 weeks after ART initiation

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Centre for the AIDS Programme of Research in South Africa
• Investigators: Principal Investigator: Nigel Garett, MBBS, PHD, Centre for the AIDS Programme of Research in South Africa (CAPRISA); Principal Investigator: Paul Drain, MD, MPH, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Tenofovir; Point-of-care test; HIV viral load
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: STUDY00007544; R01AI147752 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from the study will be made available
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following publication of primary results.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No