NCT04311944

Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD

Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.

Detailed description

With current approaches to HIV care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. Once they have achieved an undetectable viral load and/or high adherence, patients qualify for expedited services with fewer clinic visits. The problem with this approach is that it's time-intensive early in ART care, when attrition rates are highest. A potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. This strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens. We will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). All participants will receive the same ART regimen, the combination regimen of Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
OTHER	Early fast-track care	Participants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is \<200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA \<200 copies will then be eligible for fast-track care, if they meet other eligibility criteria.
OTHER	Standard (deferred fast-track) care	Participants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is \<200 copies.mL, and they meet other eligibility criteria.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-02-28
• Completion: 2022-05-29
• First posted: 2020-03-17
• Last updated: 2020-07-31