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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: Early fast-track care
* Other: Standard (deferred fast-track) care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Fast-Track Care<br>Participants will be eligible for fast-track care after 8 to 12 weeks, if viral load is suppressed (<200 copies/mL) | Other: Early fast-track care<br>* 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.<br>|
| Active Comparator: Standard (Deferred Fast-track) Care<br>Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (<200 weeks) | Other: Standard (deferred fast-track) care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression - 200 copies/mL cut-off | Proportion of participants with HIV-1 RNA <200 copies/mL | 48 weeks after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral suppression - 50 copies/mL cut-off | Proportion of participants with HIV-1 RNA <50 copies/mL | 48 weeks after study enrollment | 
| Viral suppression - 1000 copies/mL cut-off | Proportion of participants with HIV-1 RNA <1000 copies/mL | 48 weeks after study enrollment | 
| Adherence of at least 90% | Adherence to antiretroviral therapy of at least 90% as measured by pharmacy refill records | 48 weeks after enrollment | 
| Medication tolerability | Proportion of participants discontinuing tenofovir disoproxil/lamivudine/dolutegravir regimen | 48 weeks after enrollment | 
| Cost | Total cost of early fast-track and standard (deferred fast-track) care from the health center perspective | 48 weeks after enrollment | 
| Time in clinic | Median time in clinic | 48 weeks after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Antiretroviral therapy, Differentiated care, Expedited services