MedTrace Logo

The SMART ART Study

NCT05090150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 874

Last updated 2026-01-12

No results posted yet for this study

Summary

The investigators propose A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa- the SMART ART study-a randomized study to test adaptive ART delivery for persons with detectable viral load and/or not engaged in care.The types of differentiated service delivery (DSD) that will be examined in this study are incentives, community-based ART, and home delivery. The study plans to enroll up to 900 participants-people living with HIV and who are eligible for ART and living in KwaZulu-Natal, South Africa. The study aims to maximize 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.

Conditions

Interventions

OTHER

Home delivery of ART

Home ART refill and monitoring, adherence support

OTHER

Smart Lockers (Pele boxes)

Decentralized ART refills and monitoring, adherence support

OTHER

Best clinic practices + conditional lottery incentives

Conditional lottery incentives Welcome back service (friendly providers, SMS, adherence support) Fast-track ART

OTHER

Best clinic practices

Continue with best clinic practices

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ruanne V Barnabas, DPhil · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2025-07-03
Completion
2025-07-03

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090150 on ClinicalTrials.gov