A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. There are three planned research viral load evaluations in the trial, which may include but are not limited to the evaluations listed below: CLINICAL CARE VIRAL LOAD - This will take place at the clinic during the regular clinical follow-up to confirm effective viral suppression.. During these visits an HIV viral load sample will be collected using traditional venipuncture methods and analyzed using a qualified commercial test. These plasma values may be used as a comparator with other viral load test results. CLINIC TASSO COLLECTION - Participants will collect one or more Tasso device specimen(s) during in-clinic study visits. The main objective of these measurements is to evaluate HIV viral load monitoring using novel collection approaches with the supervision of trained study staff to minimize user error potential. HOME TASSO COLLECTION - Participants will be provided with Tasso devices to use at home in between regular parent study visits. These devices will be shipped in real-time to Wistar Institute for archiving before HIV viral loads will be measured. The main objective of these measurements is to evaluate the feasibility HIV viral load monitoring using novel collection approaches at home.

Official Title
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A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy in Persons Living With HIV: Reliability and Acceptability of Home Test Measures

Conditions
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HIV-1-infection

Intervention / Treatment
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* Device: TASSO device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL Exclusion Criteria: Persons living with HIV suppressed on ART regimen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TASSO device<br>During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home. | Device: TASSO device<br>* During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and Accuracy | Determine the reliability and accuracy of alternative viral load tests to detect changes in viral load in participants starting ART or working to resuppress a detectable viral load ≥ 5,000 copies/mL at last measurement. | 12 months | 
| Feasibility of implementing a home-based viral load test | 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 ≥10,0005,000 copies/mL at last measurement. | 12 months |