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

Not Applicable

• Conditions: HIV-1-infection
• Interventions: Other: Early fast-track care; Other: Standard (deferred fast-track) care

• Registration Number: NCT04311944
• Lead Sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

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 Timeline

• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-15
• Study First Posted: 2020-03-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31
• Study Start: 2020-09-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Fast-Track Care	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)
Standard (Deferred Fast-track) Care	Standard (deferred fast-track) care	Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (\<200 weeks)

Primary Outcome Measures

Name	Time	Method
Viral suppression - 200 copies/mL cut-off	48 weeks after study enrollment	Proportion of participants with HIV-1 RNA \<200 copies/mL

Secondary Outcome Measures

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