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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Florida International University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colette Guiteau, MD | Contact | 3449-3596 | colette0786@hotmail.com | |
| Serena Koenig, MD | Contact | 617-413-4090 | skoenig@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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De-identified data will be shared at the end of the study.
Within 48 weeks after study completion
Open access
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Patients will be randomized in a 1:1 ratio to early fast-track vs. standard care.
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Open label study
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| 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. |
|
| 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 |