grant

A sequential, adaptive model of differentiated service delivery to reach persons living with HIV who are lost-to-follow-up or who have detectable viral load

Organization MASSACHUSETTS GENERAL HOSPITALLocation BOSTON, UNITED STATESPosted 1 Dec 2022Deadline 30 Nov 2026
NIHUS FederalResearch GrantFY2025AIDS VirusAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusActive Follow-upAddressAdherenceAnti-HIV PositivityBackBehaviorCaringCessation of lifeCharacteristicsClientClinicClinic VisitsCommunitiesCost AnalysesCost AnalysisCost SavingsDeathDiseaseDisorderDorsumEnrollmentEvaluationFrequenciesFriendsGoalsHIVHIV InfectionsHIV PositiveHIV PositivityHIV SeroconversionHIV SeronegativitiesHIV SeronegativityHIV SeropositivityHIV antibody positiveHIV negativeHTLV-III InfectionsHTLV-III SeroconversionHTLV-III SeronegativitiesHTLV-III SeronegativityHTLV-III SeropositivityHTLV-III-LAV InfectionsHealth BenefitHomeHuman Immunodeficiency VirusesHuman T-Lymphotropic Virus Type III InfectionsIncentivesInterventionInterviewLAV-HTLV-IIILifeLymphadenopathy-Associated VirusMeasuresModelingMorbidityMorbidity - disease rateParticipantPersonsPopulationProviderRandomization trialRandomizedSalariesSamplingSequential Multiple Assignment Randomized TrialService provisionServicesSouth AfricaSubgroupSystemTestingTransmissionViralViral BurdenViral LoadViral Load resultVirus-HIVWagesWait Timeacceptability and feasibilityactive followupantiretroviral therapyantiretroviral treatmentarmassess costbarrier to carebarrier to health carebarrier to treatmentbudget impactcare deliverycostcost assessmentcost effectivenesscost estimatecost estimationcost evaluationenrollevaluate costexamine costexperiencefollow upfollow-upfollowed upfollowuphomesimprovedincentive strategiesintervention deliverymicrocostingmortalityobstacle to careobstacle to health carepatient barrierspatient-level barrierspeerpreferencepreventpreventingprimary outcomerandomisationrandomizationrandomized trialrandomly assignedrecruitservice deliverysuccesstransmission processtreatment strategytrial design
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Full Description

ABSTRACT
Globally, more than half of the world's 37 million people living with HIV are on antiretroviral therapy (ART)

representing immense and encouraging success with access to HIV care. ART prevents disease, death and HIV

transmission and HIV-positive persons can expect to live as long as their HIV-negative peers when their viral

load is undetectable. However, treatment success still lags behind goals. In South Africa alone, 8 million HIV-

positive persons require ART for life and only 4.5 million are currently on ART. Patient barriers to care, such as

missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable

viral load, the hallmark of struggling to access and take ART. HIV differentiated service delivery (DSD) has

simplified ART delivery: incentives, multi-month scripts, fast-track ART, and community or home ART delivery

motivate clients, reduce the frequency of clinic visits, and decongest clinics. DSD is standard for clients who

achieve viral suppression and engage in care; however, DSD needs adaptation to serve clients who are not

succeeding. Indeed, persons who are not engaged in care arguably need simplified, client-centered

approaches even more than those who can successfully engage.

A suite of adaptive DSD strategies, including community-based ART, have been tested among stable clients

with viral suppression. Lottery incentives effectively change short-term behavior, increasing ART initiation.

Community and home ART delivery increases ART coverage and simplify ART access overcoming clinic

barriers. For stable clients, these DSD activities are as effective as clinic-based care in terms of achieving and

maintaining viral suppression, although among stable clients they have not shown superiority in viral suppression

or cost savings. In contrast, DSD has the potential to improve rates of viral suppression and retention in care

and save costs among more hard-to-reach groups. There is great potential that DSD systems can be client-

responsive and system-efficient for subgroups requiring additional services, matching services with client needs.

A sequential, comprehensive package of DSD approaches, with each step increasing the intensity of service

provision – adaptive DSD – has not been tested to determine the proportion and characteristics of persons who

would achieve viral suppression and retention in care and to estimate the cost-effectiveness and budget impact.

To increase population level viral suppression, persons with detectable viral load need responsive DSD

interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates evaluation of a

stepped, adaptive approach to achieving viral suppression with `right-sized' interventions. We are an experienced

team and propose to build on our strong partnerships to sequentially test adaptive DSD strategies for persons

with detectable viral load: lottery incentives, community-based ART, and home ART delivery. Our aim is to

identify the most effective and efficient HIV care delivery strategies for South Africa.

Grant Number: 5R01MH124465-05
NIH Institute/Center: NIH

Principal Investigator: Ruanne Barnabas

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