The UNAIDS 90-90-90 goals for 2020 represents an ambitious strategy to end the AIDS epidemic. The third target envisions 90% of all patients receiving antiretroviral therapy to be virally suppressed. In 2013, WHO recommended the transition to viral load (VL) monitoring for all patients on ART for more than 6 months and at least at 12-month intervals thereafter. While VL testing is the gold standard of HIV treatment monitoring, it is not routinely available and employed in low and middle-income countries (LMICs). WHO estimates that only 20% of patients on ART were receiving VL testing in most LMICs. Nigeria, with a population of 180 million, has the second highest burden of HIV in the world. As of 2014, 747.382 Nigerians were on ART, with just under 50% coverage of those considered eligible for treatment. With only 25 VL instruments in the country, it is clear that additional VL capacity is required and we believe that at least some of this need could be rationally filled with the use of point of care (POC) VL technology. . This proposal seeks to optimize VL monitoring in response to objective 6 of this RFA. We propose a randomized control trial of the Simple Amplification-Based Assay (SAMBA) semi-quantitative (SQ) monitoring versus standard of care (SOC) VL monitoring in patients newly initiating ART. We have recently demonstrated excellent performance of the Simple Amplification-Based Assay (SAMBA) semi- quantitative (SQ) HIV-1 VL test, which has the added benefit of providing results in 90 minutes from a finger prick blood sample, in Nigeria. We hypothesize that use of a POC VL will result in increased viral suppression rates as well as improved adherence and retention rates for patients on ART. A tertiary teaching hospital in North-Central Nigeria, Jos University Teaching Hospital, and a secondary district hospital, Comprehensive Health Centre, Zamko, that currently accesses VL monitoring through a networked approach are our proposed trial sites.
The specific aims of the proposed project are to: 1. Compare the 12-month outcomes of patients monitored with POC VL versus SOC VL 2. Compare the retention and adherence rates in patients monitored with POC VL versus SOC VL, with a sub-aim of comparing drug resistant mutation patterns in patients that fail 1L ART by month 12 of treatment. 3. Determine the acceptability and feasibility of implementing POC VL monitoring The proposed trial will provide the first evaluation of a POC VL monitoring program in a relevant ART setting, the results will help inform priorities for the implementation of POC VL in Nigeria and other LMICs.

Public Health Relevance

One of UNAIDS target goals for 2020 is to have 90% of all patients receiving antiretroviral therapy (ART) to have a suppressed viral load (VL) although VL testing is infrequently available to most patients on ART in low and middle-income country settings (LMICs). We propose a trial to compare a point of care (POC) VL assay to the standard of care method for VL monitoring in patients newly initiating ART. The results of the trial and considerations of its feasibility should inform policymakers on the potential utility of POC VL monitoring for national ART programs in LMIC settings.

National Institute of Health (NIH)
Coordinating Office of Global Health (COGH)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZGH1-HMS (03))
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Jos University Teaching Hospital
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