HIV viral load (VL) monitoring is a crucial component of the ongoing scale-up of antiretroviral therapy (ART) in Sub-Saharan Africa. Uganda recently launched a nationwide VL testing system; however, significant implementation gaps have emerged in three critical areas: (1) inadequate VL ordering, (2) slow generation and reporting of VL results, and (3) suboptimal interpretation of VL results for adherence counseling. Additionally, significant disparities exist in sub-populations at high-risk of virologic failure including (1) pregnant women, (2) children and adolescents, (3) persons whose last VL was detectable, and (4) persons missing a VL test. To address the implementation gaps on how best to improve VL ordering, speed up VL turnaround time, and improve VL counseling, we propose a comparative effectiveness, clinic-level cluster randomized trial of a targeted, multi-component intervention package called ?RAPID-VL? among 1,200 high-risk and non-high-risk patients in 20 PEPFAR-supported ART clinics in southwest Uganda. Anchored in the PRECEDE implementation science framework, ?RAPID-VL? consists of (1) a VL ordering flowsheet to increase correct VL ordering, coupled with a performance feedback system to reinforce best practices, (2) a point-of-care VL machine at a hub near the clinics that will speed up the generation and delivery of VL results to clinicians, and (3) a VL counseling package that teaches clinicians an efficient method for counseling patients on VL results.
Aim 1 : Determine the comparative effectiveness of the RAPID-VL intervention on VL ordering and VL turnaround time: We will randomize HIV clinics to RAPID-VL vs. standard VL procedures (n=10 clinics each, 60 patients/clinic, comprised of 20 non-high risk patients plus 10 high risk patients in each of 4 categories), and will compare (1) guideline-indicated VL ordering, (2) VL turnaround time, (3) VL suppression, (4) VL re- suppression after a detectable result, and (5) switching to 2nd line ART.
Aim 2 : Identify facilitators and barriers to implementation, as well as perceived utility of RAPID-VL from both patient and clinician perspectives. We will measure fidelity to each RAPID-VL component via in-clinic observations and training assessments. We will perform qualitative interviews of 20 clinicians and 40 patients to capture facilitators, barriers, acceptability and sustainability of RAPID-VL and examine its perceived utility.
Aim 3 : Determine the costs, cost-effectiveness, and incremental gain costs of RAPID-VL: We will conduct micro-costing analyses of key cost inputs including training, clinician effort, point-of-care VL machinery, and transportation costs. We will compare these to costs of the current standard of care DBS-based system on unit cost and ?cost-per-added success.? We will also estimate cost per disability-adjusted life year (DALY) averted for RAPID-VL. Our overall objective is to rigorously test a novel intervention to improve VL operations in PEPFAR- supported Ugandan HIV clinics. Our long-term goal is to maximize the public health impact of ART by optimizing processes for VL testing. This will improve health, lower mortality, and accelerate ART expansion.

Public Health Relevance

To realize the full benefits of life-saving HIV antiretroviral therapy (ART) in PEPFAR-supported clinics in Sub- Saharan Africa, we must rapidly expand viral load (VL) testing (a crucial component of providing high-quality care to HIV-positive patients) and discover the optimal approaches for its use both in the general patient population, as well as in select patient populations at high risk for virologic failure. This proposed study will evaluate a novel intervention called ?RAPID-VL? designed to (1) increase the successful ordering of VL tests when they are needed, (2) speed up the turnaround time to VL results, and (3) improve clinicians' abilities to interpret VL results and deliver optimal counseling messages to patients. Our findings will give clinic directors, health decision makers, and PEPFAR implementers data they can use to optimize VL operations in ways that meet the needs of their specific patients, clinicians and budgets?information that will enable us to continue expanding the scope and reach of ART throughout Africa.

National Institute of Health (NIH)
Coordinating Office of Global Health (COGH)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZGH1)
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University of California San Francisco
Internal Medicine/Medicine
Schools of Medicine
San Francisco
United States
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