A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study

Trials

Study Protocol

Zaynab Essack¹  Xolani Ntinga¹  Alastair van Heerden²  Adam Szpiro³  Connie Celum³  Ruanne Barnabas⁴  Heidi van Rooyen⁵ 

[1] Centre for Community Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa;Centre for Community Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa;MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa;Department of Global Health, University of Washington, Seattle, WA, USA;Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA;Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;MRC/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand, Johannesburg, South Africa;Human Sciences Research Council, Pietermaritzburg, South Africa;

关键词: HIV treatment;    South Africa;    Client-centered;    Differentiated service delivery (DSD);    Sequential multiple assignment randomized trial (SMART);   

DOI  :  10.1186/s13063-022-07025-x

 received in 2022-11-08, accepted in 2022-12-15,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundOf the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. 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. HIV differentiated service delivery (DSD) has simplified ART delivery for clients who achieve viral suppression and engage in care. However, DSD needs adaptation to serve clients who are not engaged in care.MethodsA Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentives, community-based smart lockers, and home delivery. The study plans to enroll up to 900 participants-people living with HIV, eligible for ART, and who are not engaged in care. The study aims to assess the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery and evaluate the cost-effectiveness of adaptive HIV treatment for those who are not engaged in care.DiscussionTo increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with “right-sized” interventions for patients most in need of effective and efficient HIV care delivery strategies.Trial registrationClinicalTrials.gov NCT05090150. Registered on October 22, 2021

【 授权许可】

CC BY   
© The Author(s) 2023

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