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

National Institute of Allergy and Infectious Diseases (NIAID), Centre for the AIDS Programme of Research 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.

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.

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

We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.

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.

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.

We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.

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.

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.

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

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.

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.