Adaptive ART delivery for HIV in South Africa
A Sequential Multiple Assignment Randomized Trial of Scalable Interventions for ART Delivery in South Africa: the SMART ART Study
NA · Massachusetts General Hospital · NCT05090150
This study is testing different ways to deliver HIV treatment to people in South Africa to see which methods help them better manage their health and achieve viral suppression.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Sweetwaters, Kwa-zulu Natal) |
| Trial ID | NCT05090150 on ClinicalTrials.gov |
What this trial studies
The SMART ART study is a randomized trial designed to test various adaptive interventions for antiretroviral therapy (ART) delivery among individuals living with HIV in South Africa. It focuses on individuals with detectable viral loads or those not engaged in care, examining strategies such as community-based ART, home delivery, and incentive programs. The study aims to enroll up to 900 participants in KwaZulu-Natal and seeks to maximize the proportion of ART-eligible individuals achieving viral suppression within 18 months. Additionally, it will assess client and provider preferences for these differentiated service delivery models and evaluate their cost-effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older living with HIV, eligible for ART, and either having a detectable viral load or not engaged in care.
Not a fit: Patients who are not living with HIV or those who are already virally suppressed and engaged in care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve ART adherence and viral suppression rates among individuals living with HIV in South Africa.
How similar studies have performed: Previous studies have shown success with similar differentiated service delivery approaches, indicating potential for positive outcomes in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sweetwaters, Kwa-zulu Natal
- Human Sciences Research Council Sweetwaters — Sweetwaters, Kwa-zulu Natal, South Africa (RECRUITING)
Study contacts
- Principal investigator: Ruanne V Barnabas, DPhil — University of Washington
- Study coordinator: Diane Kanjilal
- Email: dkanjilal@mgh.harvard.edu
- Phone: 617-643-9958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.