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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.
A pilot study of alternative viral load testing with samples collected in the clinic and at home compared to traditional viral load monitoring in participants engaged in HIV care. Approximately 15 participants starting ART, or working to suppress a detectable viral load, will monitor viral loads during regular clinic appointments and in intermediate time-points during their participation in this pilot study.
There are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TASSO device | Experimental | During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TASSO device | Device | During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Tasso viral load test | Determine the accuracy of Tasso viral load tests to detect changes in viral load in participants starting ART or reflect resuppression kinetics from a detectable viral load ≥ 5,000 copies/mL at last measurement when compared to standard clinical CLIA certified viral load measures. | 12 months |
| Questionnaire to assess feasibility of implementing a home-based viral load test | Administer questionnaire to determine the feasibility of implementing a home-based viral load test in the context of starting ART or working to resuppress a detectable viral load ≥5,000 copies/mL at last measurement. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Montaner | The Wistar Institute | Principal Investigator |
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