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

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.

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.

Inclusion Criteria:

• Documentation of positive HIV status (test conducted at GHESKIO)
• Age ≥18 years of age
• Eligible for TLD regimen, according to Haitian Ministry of Health guidelines
• Initiate ART within 3 days prior to enrollment
• Lives in Port-au-Prince metropolitan area
• Ability and willingness to give written informed consent
• Use of reliable contraception (for women of childbearing potential);
• Physician-confirmed WHO Stage 1 or 2 disease

Exclusion Criteria:

• Not ART-naïve (history of ART for any duration in the past)
• World Health Organization Stage 3 or 4 disease;
• Pregnancy or breastfeeding at the screening visit;
• Planning to become pregnant during the study period;
• Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
• Creatinine clearance (CrCl) <50 within 1 month prior to study entry;
• ALT and/or AST> 5X upper limit of normal (ULN) within 1 month prior to study entry;
• Planning to transfer care to another clinic during the study period