Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 242
- Primary Endpoint
- Viral suppression - 200 copies/mL cut-off
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open label study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Early Fast-Track Care
Participants will be eligible for fast-track care after 8 to 12 weeks, if viral load is suppressed (<200 copies/mL)
Intervention: Early fast-track care (Other)
Standard (Deferred Fast-track) Care
Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (<200 weeks)
Intervention: Standard (deferred fast-track) care (Other)
Outcomes
Primary Outcomes
Viral suppression - 200 copies/mL cut-off
Time Frame: 48 weeks after study enrollment
Proportion of participants with HIV-1 RNA \<200 copies/mL
Secondary Outcomes
- Time in clinic(48 weeks after enrollment)
- Viral suppression - 50 copies/mL cut-off(48 weeks after study enrollment)
- Viral suppression - 1000 copies/mL cut-off(48 weeks after study enrollment)
- Medication tolerability(48 weeks after enrollment)
- Cost(48 weeks after enrollment)
- Adherence of at least 90%(48 weeks after enrollment)