Simplifying Treatment and Monitoring for HIV (STREAM HIV)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV/AIDS, HIV-1-infection

Intervention / Treatment
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* Combination Product: Point-of-care viral load testing and tenofovir adherence testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Point-of-care adherence testing and Point-of-care viral load testing | Combination Product: Point-of-care viral load testing and tenofovir adherence testing<br>* Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants<br>|
| No Intervention: Standard-of-care arm<br>No adherence testing and lab-based viral load testing | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point-of-care test, Tenofovir, Adherence, HIV viral load