A Sequential Multiple Assignment Randomized Trial of Scalable Interventions for ART Delivery in South Africa: the SMART ART Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
South Africa
Human Sciences Research Council Sweetwaters
RECRUITING
Sweetwaters
Contact Information
Primary
Diane Kanjilal
dkanjilal@mgh.harvard.edu
617-643-9958
Time Frame
Start Date: 2021-11-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 900
Treatments
No_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)
Experimental: 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)
Experimental: Randomized from best clinic practices to smart lockers
Second randomization into community ART through the use of smart lockers
Experimental: Randomized from best clinic practices to home delivery
Second randomization into home ART delivery
Experimental: Randomized from best clinic practices plus lottery incentives to smart lockers
Second randomization into community ART through the use of smart lockers
Experimental: Randomized from best clinic practices plus lottery incentives to home delivery
Second randomization into home ART delivery
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov