Funding has been awarded to principal investigator Dr. Paul Drain (Global Health, Medicine – Infectious Diseases) and co-investigators Dr. Ruanne Barnabas (Global Health, Medicine – Infectious Diseases) and Jane Simoni (Psychology – Global Mental Health) by the National Institute of Allergy and Infectious Diseases for “Simplifying HIV Treatment and Monitoring (STREAM2): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa.”
Abstract:
For over 20 million people living with HIV (PLHIV) who are receiving antiretroviral therapy (ART), maintaining adequate ART adherence and receiving routine HIV viral load monitoring are critical to achieving virologic suppression. Management of life-long ART has been challenging for both providers and PLHIV in low- and middle-income countries (LMICs), particularly with respect to poor self-estimation of ART adherence and delays with lab-based testing. Since providers have limited access to drug resistance and ART testing, PLHIV are often switched unnecessarily to more costly second- or third-line ART regimens. In addition, delays in lab-based HIV viral load monitoring can result in prolonged HIV viremia, onward transmission, and poor treatment outcomes. We have completed a pilot study of clinic-based HIV viral load monitoring to demonstrate the initial feasibility, acceptability, and improved clinical outcomes for HIV management in South Africa. We have recently developed a point-of-care (POC) tenofovir adherence assay as a rapid urine dipstick test for improve ART management and adherence in LMICs. As several LMICs, including South Africa, are adopting dolutegravir, tenofovir, and lamivudine (TLD) as a first-line ART regimen, evaluated newer models of HIV care will be critical to maintaining virologic suppression. We propose a study to determine the clinical impact and cost-effectiveness of implementing an integrated model of clinic-based HIV viral load monitoring (time to results in <2 hours) and POC tenofovir adherence testing to improve HIV virological suppression and retention in care among PLHIV in South Africa.
Our long-term goal is to improve clinical HIV diagnosis and management to prevent HIV transmission and reduce AIDS-related mortality in LMICs. Our objective in this application is to test the clinical efficacy and cost of implementing an integrated model for HIV care and ART management that uses clinic-based HIV viral load monitoring and POC tenofovir adherence testing to maintain durable HIV virological suppression among PLHIV in urban and rural South Africa clinics. Our central hypothesis is to prove that clinic-based HIV viral load monitoring and POC tenofovir adherence testing will improve virological suppress and retention in
care, while being preferable and a cost-efficient strategy, for ART management in South Africa. We are well-qualified to answer this question because we have over 10 years of experience conducting clinic-based implementation science research in this HIV-endemic setting, we have a completed a smaller pilot study at the proposed clinical site, and we have established strong partnerships with the South African National Health Laboratory Service (NHLS) and Department of Health.
We will objectively test our central hypothesis with the following specific aims:
Aim #1. To determine if implementing an integrated model for HIV care, using a clinic-based HIV viral load monitoring or a POC tenofovir adherence assay, will improve viral suppression and retention.
Hypothesis: We hypothesize that a model of clinic-based HIV viral load monitoring or POC tenofovir adherence testing will achieve a higher rate of virological suppression and retention, as compared to the standard-of-care (adherence counseling without testing and laboratory-based HIV viral load monitoring).
Approach: At ART initiation, participants will be randomized (1:1:1) into either (1) routine POC adherence testing and counseling; (2) clinic-based HIV viral load monitoring and POC adherence testing and counseling; (3) standard-of-care ART management (adherence counseling without objective testing and laboratory based HIV viral load monitoring). All participants will be followed for 24 months, and we will determine and compare a primary composite outcome of retention and HIV virological suppression on first-line ART.
Aim #2. To determine the feasibility, acceptability, and preferences of using real-time POC adherence testing and HIV viral load monitoring among both patients and providers in South Africa.
Hypothesis: We hypothesize that POC tenofovir adherence testing and HIV viral load monitoring will feasible, acceptable for delivering more efficient HIV care, and will be preferable by both PLHIV and providers.
Approach: We will assess attitudes on POC tenofovir and viral load testing using a mixed-methods approach. We will use semi-structured questionnaires and interview guides to complete serial interviews with participants (weeks 4, 12, 24) and informal small group discussions with PLHIV and providers before and after the study.
Aim #3. To assess the costs, both incurred and averted, of implementing the proposed model in Aim #1, and the cost per HIV-positive person virally suppressed on ART and retained in care.
Hypothesis: We hypothesize that POC adherence testing and HIV viral load monitoring will minimize the costs per PLHIV virally suppressed and retained in care, as compared to the current standard-of-care.
Approach: We will use an activity-based, micro-costing approach to estimate the cost per HIV-positive person virally suppressed and retained in care, as compared to the Standard-of-Care Group.
This innovative work uses a randomized implementation trial of POC testing for both ART adherence and viral load to compare outcomes against the standard of care. At the end of this project we expect to know the clinical effect, acceptability, and cost-effectiveness for implementing an integrated POC testing model for HIV care, which will inform global policy for using POC adherence testing and clinic-based viral load monitoring in LMICs.
Sponsor Award Number: 1R01AI147752