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.

Study Overview

• Status: Unknown
• Conditions: HIV-1-infection
• Intervention / Treatment: Other: Early fast-track care; Other: Standard (deferred fast-track) care

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 Type: Interventional
• Enrollment (Anticipated): 242
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Early fast-track care; 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.
Active Comparator: Standard (Deferred Fast-track) Care; Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (<200 weeks)	Other: Standard (deferred fast-track) care; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
• Collaborators: Brigham and Women's Hospital; Weill Medical College of Cornell University; Florida International University
• Investigators: Principal Investigator: Serena Koenig, MD, Brigham and Women's Hospital/Harvard Medical School; Principal Investigator: Colette Guiteau, MD, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): May 29, 2022

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 15, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HIV; Antiretroviral therapy; Differentiated care; Expedited services
• Other Study ID Numbers: 212336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified data will be shared at the end of the study.
• IPD Sharing Time Frame: Within 48 weeks after study completion
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes