Clinical trial NCT04311944: Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD
Official title: Early Fast-Track Versus Standard Care for Persons With HIV Initiating Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir (TLD) in Haiti: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV-1-infection
Keywords: HIV
Antiretroviral therapy
Differentiated care
Expedited services
Lead sponsor: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Weill Medical College of Cornell University
name: Florida International University
First posted: 2020-03-17
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Viral suppression - 200 copies/mL cut-off
timeFrame: 48 weeks after study enrollment
Secondary outcomes:
measure: Viral suppression - 50 copies/mL cut-off
timeFrame: 48 weeks after study enrollment
measure: Viral suppression - 1000 copies/mL cut-off
timeFrame: 48 weeks after study enrollment
measure: Adherence of at least 90%
timeFrame: 48 weeks after enrollment
measure: Medication tolerability
timeFrame: 48 weeks after enrollment
measure: Cost
timeFrame: 48 weeks after enrollment
measure: Time in clinic
timeFrame: 48 weeks after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
name: Colette Guiteau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Serena Koenig, MD
role: PRINCIPAL_INVESTIGATOR
References: