NCT05090150Completed
The SMART ART Study
A Sequential Multiple Assignment Randomized Trial of Scalable Interventions for ART Delivery in South Africa: the SMART ART Study
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 874 (actual)
- First submitted
- 16 Sept 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 3 Jul 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT05090150
What you commit to
- Study type: Interventional
- Participants enrolled: 874
- From 2 Nov 2021 to the primary completion date, 3 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are no separate exclusion criteria.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Human Sciences Research Council Sweetwaters Coordinator of this site? Confirm its status | Sweetwaters | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.