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L'étude SMART ART

21 septembre 2026 mis à jour par: Ruanne Barnabas, MBChB, MSc, DPhil., Massachusetts General Hospital

Un essai séquentiel randomisé à assignation multiple d'interventions évolutives pour la prestation de TAR en Afrique du Sud : l'étude SMART ART

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.

Aperçu de l'étude

Description détaillée

Of the 8 million people in South Africa living with HIV, only 56% are on antiretroviral therapy (ART), and 45% are virally suppressed, substantially below the UNAIDS goal of 73%. 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: 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 incentives strategies, community-based ART, and home delivery, have been tested among stable clients with viral suppression. Lottery incentives effectively change short-term behavior, increasing ART initiation.Community-based and home ART delivery increase ART coverage and simplify ART access overcoming clinic barriers11. 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 persons not engaged in care. 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. The investigators are an experienced team and propose to build on the strong partnerships to sequentially test adaptive DSD strategies for persons with detectable viral load and/or not engaged in care: incentives, community-based ART, and home delivery. As the Center for Community Based Research, the investigators maintain strong connections with stakeholders including department of health, traditional leaders and ward counsellors throughout the Greater Edendale Area (GEA) and the Vulindlela sub-district of the uMgungundlovu District Municipality. Due to the size of the recruitment target, this work will centre around the Caluza clinic but will extend into other parts of GEA and sub-district of Vulindlela over the course of recruitment. The aim is to identify the most effective and efficient HIV care delivery strategies.

Type d'étude

Interventionnel

Inscription (Réel)

874

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • KwaZulu-Natal
      • Sweetwaters, KwaZulu-Natal, Afrique du Sud
        • Human Sciences Research Council Sweetwaters

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Must be 18 years or older
  • Able and willing to provide informed consent for study procedures
  • Must self report that they will reside in the study community for the duration of follow-up
  • Living with HIV and eligible for ART by national guidelines, have a detectable viral load greater than the lower limit of detection and/or not engaged in care, and are stable clinically (CD4>100 cells, no moderate/severe screening laboratory abnormalities for kidney function i.e. eGFR >50 mL/min/1.73m2, not receiving treatment for active tuberculosis or other opportunistic infections).

Exclusion Criteria:

  • There are no separate exclusion criteria.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Best clinic practices

Participants start with best clinic practices and continue for 18 months (including participants who are non-responders at month 6 and are randomized to stay in their original arm)

Expérimental: Best clinic practices plus lottery incentives

Participants start with best clinic practices plus lottery incentives and continue for 18 months (including participants who are non-responders at month 6 and are randomized to stay in the original arm)

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

Expérimental: Randomized from best clinic practices to smart lockers

Second randomization into community ART through the use of smart lockers

Decentralized ART refills and monitoring, adherence support

Continue with best clinic practices

Expérimental: Randomized from best clinic practices to home delivery

Second randomization into home ART delivery

Continue with best clinic practices

Home ART refill and monitoring, adherence support

Expérimental: Randomized from best clinic practices plus lottery incentives to smart lockers

Second randomization into community ART through the use of smart lockers

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

Decentralized ART refills and monitoring, adherence support

Expérimental: Randomized from best clinic practices plus lottery incentives to home delivery

Second randomization into home ART delivery

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

Home ART refill and monitoring, adherence support

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Viral suppression at 18 months
Délai: 18 months

The primary outcome is viral suppression at 18 months among the combined group of persons living with HIV who have detectable viral load and persons not engaged in care at enrollment.

18 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Retention in Care
Délai: 12 months

The proportion of clinical visits and medication refills missed over the last 12 months of the intervention

12 months
Time to ART initiation
Délai: 6 months

Time to antiretroviral therapy initiation

6 months
Engagement in care
Délai: 18 months

Proportion of people who are virally suppressed in each intervention arm

18 months
Comparison to viral suppression and retention outcomes from similar local clinics
Délai: 18 months

Proportion of individuals who are virally suppressed who are engaged in care in intervention arms compared to local clinics

18 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Ruanne V Barnabas, DPhil, University of Washington

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 novembre 2021

Achèvement primaire (Réel)

3 juillet 2025

Achèvement de l'étude (Réel)

3 juillet 2025

Dates d'inscription aux études

Première soumission

16 septembre 2021

Première soumission répondant aux critères de contrôle qualité

11 octobre 2021

Première publication (Réel)

22 octobre 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 septembre 2026

Dernière vérification

1 janvier 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 2022P001129
  • R01MH124465 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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