HIV-1-infection
Conditions
Keywords
HIV, Antiretroviral therapy, Differentiated care, Expedited services
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.
Interventions
OTHEREarly 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.
OTHERStandard (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.
Sponsors
Brigham and Women's Hospital
Weill Medical College of Cornell University
Florida International University
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression - 200 copies/mL cut-off | 48 weeks after study enrollment | Proportion of participants with HIV-1 RNA \<200 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression - 1000 copies/mL cut-off | 48 weeks after study enrollment | Proportion of participants with HIV-1 RNA \<1000 copies/mL |
| Adherence of at least 90% | 48 weeks after enrollment | Adherence to antiretroviral therapy of at least 90% as measured by pharmacy refill records |
| Viral suppression - 50 copies/mL cut-off | 48 weeks after study enrollment | Proportion of participants with HIV-1 RNA \<50 copies/mL |
| Cost | 48 weeks after enrollment | Total cost of early fast-track and standard (deferred fast-track) care from the health center perspective |
| Time in clinic | 48 weeks after enrollment | Median time in clinic |
| Medication tolerability | 48 weeks after enrollment | Proportion of participants discontinuing tenofovir disoproxil/lamivudine/dolutegravir regimen |
Contacts
Primary ContactColette Guiteau, MD
Backup ContactSerena Koenig, MD
Outcome results
None listed