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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
539
Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants
Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa
Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks
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. This outcome will also include retention in care.
Time frame: 72 weeks after ART initiation
Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots
We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Time frame: 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.
Time frame: 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.
Time frame: 24 and 72 weeks after ART initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.