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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
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.
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.
Viral suppression - 200 copies/mL cut-off
Proportion of participants with HIV-1 RNA \<200 copies/mL
Time frame: 48 weeks after study enrollment
Viral suppression - 50 copies/mL cut-off
Proportion of participants with HIV-1 RNA \<50 copies/mL
Time frame: 48 weeks after study enrollment
Viral suppression - 1000 copies/mL cut-off
Proportion of participants with HIV-1 RNA \<1000 copies/mL
Time frame: 48 weeks after study enrollment
Adherence of at least 90%
Adherence to antiretroviral therapy of at least 90% as measured by pharmacy refill records
Time frame: 48 weeks after enrollment
Medication tolerability
Proportion of participants discontinuing tenofovir disoproxil/lamivudine/dolutegravir regimen
Time frame: 48 weeks after enrollment
Cost
Total cost of early fast-track and standard (deferred fast-track) care from the health center perspective
Time frame: 48 weeks after enrollment
Time in clinic
Median time in clinic
Time frame: 48 weeks after enrollment
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