NCT04341779

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-04
• Primary completion: 2025-06-30
• Completion: 2026-12-31
• First posted: 2020-04-10
• Last updated: 2026-02-19
• Results posted: 2026-02-19

Locations

1 site across 1 country: South Africa