The SMART ART Study

NCT05090150 | Completed

• 2 other identifiers: 2022P001129R01MH124465
• Study Type: interventional
• Target: 874
• Locations: 1 country
• Sites: 1

Brief 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

HIV; ART

Outcome Measures

Primary Outcomes (1)

• Viral suppression at 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

Secondary Outcomes (4)

• Retention in Care

  12 months

• Time to ART initiation

  6 months

• Engagement in care

  18 months

• Comparison to viral suppression and retention outcomes from similar local clinics

  18 months

Study Arms (6)

Best clinic practices

NO INTERVENTION

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)

Best clinic practices plus lottery incentives

EXPERIMENTAL

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)

Other: Best clinic practices + conditional lottery incentives

Randomized from best clinic practices to smart lockers

EXPERIMENTAL

Second randomization into community ART through the use of smart lockers

Other: Smart Lockers (Pele boxes); Other: Best clinic practices

Randomized from best clinic practices to home delivery

EXPERIMENTAL

Second randomization into home ART delivery

Other: Home delivery of ART; Other: Best clinic practices

Randomized from best clinic practices plus lottery incentives to smart lockers

EXPERIMENTAL

Second randomization into community ART through the use of smart lockers

Other: Smart Lockers (Pele boxes); Other: Best clinic practices + conditional lottery incentives

Randomized from best clinic practices plus lottery incentives to home delivery

EXPERIMENTAL

Second randomization into home ART delivery

Other: Home delivery of ART; Other: Best clinic practices + conditional lottery incentives

Interventions

Home delivery of ART OTHER

Home ART refill and monitoring, adherence support

Randomized from best clinic practices plus lottery incentives to home delivery; Randomized from best clinic practices to home delivery

Smart Lockers (Pele boxes) OTHER

Decentralized ART refills and monitoring, adherence support

Randomized from best clinic practices plus lottery incentives to smart lockers; Randomized from best clinic practices to smart lockers

Best clinic practices + conditional lottery incentives OTHER

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

Best clinic practices plus lottery incentives; Randomized from best clinic practices plus lottery incentives to home delivery; Randomized from best clinic practices plus lottery incentives to smart lockers

Best clinic practices OTHER

Continue with best clinic practices

Randomized from best clinic practices to home delivery; Randomized from best clinic practices to smart lockers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Human Sciences Research Council Sweetwaters

Sweetwaters, KwaZulu-Natal, South Africa

Location

Related Publications (1)

• van Heerden A, Szpiro A, Ntinga X, Celum C, van Rooyen H, Essack Z, Barnabas R. A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study. Trials. 2023 Jan 17;24(1):32. doi: 10.1186/s13063-022-07025-x.

  PMID: 36647092 RESULT

Study Officials

• Ruanne V Barnabas, DPhil

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are first randomly assigned to two interventions:either best clinic practices or best clinic practices with a conditional lottery incentive. This stage lasts 6 months. Participants who do not meet the criteria for non-response will continue in the assigned intervention arm. Non-responders will be rerandomized to continue in the clinic intervention arm (standard of care), community ART (smart lockers), or home delivery.

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 22, 2021
• Study Start: November 2, 2021
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

ZA (1)