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Reaching 90% target of HIV viral suppression: The role of point of care VL monitoring in resources constrained settings

Award Number: U01GH002109
ORGANIZATION: COORDINATING OFFICE OF GLOBAL HEALTH
OPDIV: CDC
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$29 )
2023	2020	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	02	5	12/20/2022	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2023	2020	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	03	5	1/6/2023	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	-$1
2023	2019	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	03	5	1/6/2023	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	-$1
2023	2019	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	02	5	12/20/2022	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2023	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	02	5	12/20/2022	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2023	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	03	5	1/6/2023	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	-$1
2023	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	02	5	12/20/2022	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	-$26
2023	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	03	5	1/6/2023	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2023	2016	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	02	5	12/20/2022	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2023	2016	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS	province			NGA	Global AIDS	03	5	1/6/2023	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
														Subtotal = -$29

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	01	5	3/12/2021	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1 )
2020	2020	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	00	5	7/23/2020	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2019 ( Subtotal = $1 )
2019	2019	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	00	4	7/31/2019	NON-COMPETING CONTINUATION	$1
2019	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	02	3	4/30/2019	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2019	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	01	3	4/26/2019	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2019	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	03	3	7/5/2019	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2019	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	00	4	7/31/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2018 ( Subtotal = $1 )
2018	2018	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	00	3	8/31/2018	NON-COMPETING CONTINUATION	$1
2018	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	001	2	1/2/2018	NON-COMPETING CONTINUATION	$0
2018	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	04	2	3/27/2018	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2018	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	03	2	3/26/2018	ADMINISTRATIVE SUPPLEMENT ( + OR - ) (DISCRETIONARY OR BLOCK AWARDS)	$0
2018	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	000	2	12/7/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $1

Issue Date FY: 2017 ( Subtotal = $498,857 )
2017	2017	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	001	2	9/9/2017	NON-COMPETING CONTINUATION	$498,857
2017	2016	JOS UNIVERSITY TEACHING HOSPITAL	LAMINGO	JOS				NGA	Global AIDS	000	1	1/31/2017	NEW	$0
														Subtotal = $498,857

Issue Date FY: 2016 ( Subtotal = $498,857 )
2016	2016	Jos University Teaching Hospital	Bauchi Road PMB 2076	Jos				NGA	Global AIDS	000	1	9/9/2016	NEW	$498,857
														Subtotal = $498,857

Grand Total All Awards = $997,688

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Reaching 90% target of HIV viral suppression: The role of point of care VL monitoring in resources constrained settings

Award Number: U01GH002109

ORGANIZATION: COORDINATING OFFICE OF GLOBAL HEALTH

OPDIV: CDC

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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