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

Abstract

Introduction: Substantial improvements in viral suppression among people living with HIV (PLHIV) are needed to end the HIV epidemic, requiring extensive scale-up of low-cost HIV monitoring services. Point-of-care (POC) tests for monitoring antiretroviral therapy (ART) adherence and viral load (VL) may be efficient and effective tools for real-time clinical decision making. We aim to evaluate the effects of a combined intervention of POC ART adherence and VL testing compared with standard-of-care on ART adherence, viral suppression and retention at 6 and 18 months post-ART initiation among PLHIV.

Methods and analysis: Simplifying TREAtment and Monitoring for HIV (STREAM HIV) is a two-arm, open-label, randomised controlled superiority trial of POC urine tenofovir (POC TFV) and VL monitoring in PLHIV. We aim to enrol 540 PLHIV initiating a first-line ART regimen at a public HIV clinic in South Africa. Participants will be randomised 1:1 to the intervention or control arm. Intervention arm participants will receive monthly POC TFV testing for the first 5 months and POC VL testing at months 6 and 12. Intervention arm participants will also receive reflex POC TFV testing if viraemic and reflex HIV drug resistance testing for those with viraemia and detectable TFV. Control arm participants will receive standard-of-care, including laboratory-based VL testing at months 6 and 12. Primary outcomes include ART adherence (TFV-diphosphate concentration) at 6 months and viral suppression and retention at 18 months. Secondary outcomes include viral suppression and retention at 6 months, TFV-diphosphate concentration at 18 months, cost and cost-effectiveness of the intervention and acceptability of the intervention among PLHIV and healthcare workers.

Ethics and dissemination: STREAM HIV has received ethical approval from the University of Washington Institutional Review Board (STUDY00007544), University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC/00000833/2019) and Division of AIDS Regulatory Support Center (38509). Findings will be disseminated at international conferences and in peer-reviewed journals.

Trial registration number: NCT04341779.

Keywords: HIV & AIDS; clinical trials; epidemiology; international health services; public health.

Figure 1

CONSORT flow diagram of the STREAM HIV study. ART, antiretroviral therapy; CONSORT, Consolidated Standards of Reporting Trials; POC, point-of-care; STREAM HIV, Simplifying TREAtment and Monitoring for HIV; TDF, tenofovir disoproxil fumarate.

Figure 2

(A) Urine tenofovir adherence assay (Abbott Rapid Diagnostics Division). (B) GeneXpert System and Xpert HIV viral load cartridge (Cepheid).

Figure 3

Participant flow through STREAM HIV study. ART, antiretroviral therapy; POC, point-of-care; SOC, standard-of-care; STREAM, Simplifying TREAtment and Monitoring; TDF, tenofovir disoproxil fumarate; TFV-DP, tenofovir-diphosphate; VL, viral load.

Figure 4

Testing and counselling algorithm for participants in the STREAM HIV study. *Standard-of-care arm procedures for months 1–5 includes standard-of-care adherence counselling and no POC testing procedures. NNRTI, non-nucleoside reverse transcriptase inhibitor; POC, point-of-care; STREAM, Simplifying TREAtment and Monitoring; TFV, tenofovir; TLD, tenofovir/lamivudine/dolutegravir; VL, viral load.