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

NCT ID: NCT04311944

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-05-29

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.

Conditions

HIV-1-infection

Keywords

HIV; Antiretroviral therapy; Differentiated care; Expedited services

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Early fast-track care

Intervention Type: OTHER

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.

Standard (Deferred Fast-track) Care

Participants will be eligible for fast-track care after 24 weeks, if viral load is suppressed (\<200 weeks)

Group Type: ACTIVE_COMPARATOR

Standard (deferred fast-track) care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: collaborator

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colette Guiteau, MD

Role: PRINCIPAL_INVESTIGATOR

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Serena Koenig, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital/Harvard Medical School

Central Contacts

Colette Guiteau, MD

Role: CONTACT

Phone: 3449-3596

Email: colette0786@hotmail.com

Serena Koenig, MD

Role: CONTACT

Phone: 617-413-4090

Email: skoenig@bwh.harvard.edu

Other Identifiers

212336

Identifier Type: -

Identifier Source: org_study_id