Alternative Viral Load Tests During Start of Antiretroviral Therapy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV-1-infection
• Intervention / Treatment: Device: TASSO device

Detailed Description

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:

1. 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.
2. 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.
3. 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Luis Montaner
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Luis Montaner, The Wistar Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TASSO starting ART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No