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

NCT04311944 | Unknown DMC

• 1 other identifier: 212336
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV-1-infection

Keywords

HIV; Antiretroviral therapy; Differentiated care; Expedited services

Outcome Measures

Primary Outcomes (1)

• Viral suppression - 200 copies/mL cut-off

  Proportion of participants with HIV-1 RNA \<200 copies/mL

  48 weeks after study enrollment

Secondary Outcomes (6)

• Viral suppression - 50 copies/mL cut-off

  48 weeks after study enrollment

• Viral suppression - 1000 copies/mL cut-off

  48 weeks after study enrollment

• Adherence of at least 90%

  48 weeks after enrollment

• Medication tolerability

  48 weeks after enrollment

• Cost

  48 weeks after enrollment

Study Arms (2)

Early Fast-Track Care

EXPERIMENTAL

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

Standard (Deferred Fast-track) Care

ACTIVE COMPARATOR

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

Other: Standard (deferred fast-track) care

Interventions

Early fast-track care 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.

Early Fast-Track Care

Standard (deferred fast-track) care 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.

Standard (Deferred Fast-track) Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: lead
• Brigham and Women's Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• Florida International University: collaborator

Study Officials

• Colette Guiteau, MD

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

  PRINCIPAL INVESTIGATOR

• Serena Koenig, MD

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette Guiteau, MD

CONTACT

3449-3596; colette0786@hotmail.com

Serena Koenig, MD

CONTACT

617-413-4090; skoenig@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 17, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2022
• Study Completion: May 29, 2022
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Within 48 weeks after study completion
• Access Criteria: Open access