Simplifying Treatment and Monitoring for HIV (STREAM HIV)

Not Applicable

Completed

Interventions: Combination Product: Point-of-care viral load testing and tenofovir adherence testing

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Intervention arm	Point-of-care viral load testing and tenofovir adherence testing	Point-of-care adherence testing and Point-of-care viral load testing

Primary Outcome Measures

Name	Time	Method
Mean tenofovir diphosphate concentration levels in dried blood spots	24 weeks after ART initiation	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Combined measure of virological suppression and retention in care (binary)	72 weeks after ART initiation	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of point-of-care tenofovir and viral load testing	24 and 72 weeks after ART initiation	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	24 and 72 weeks after ART initiation	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.
Tenofovir-diphosphate concentration in dried blood spots (continuous)	72 weeks after ART initiation	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Combined measure of viral suppression and retention in care (binary)	24 weeks after ART initiation	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.

Locations (1): Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa