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

Not Applicable

• Conditions: HIV-1-infection
• Interventions: Device: TASSO device

• Registration Number: NCT05418790
• Lead Sponsor: Luis Montaner

Brief Summary

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

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 Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Start: 2022-07
• Primary Completion: 2023-08
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TASSO device	TASSO device	During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.

Primary Outcome Measures

Name	Time	Method
Reliability and Accuracy	12 months	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.
Feasibility of implementing a home-based viral load test	12 months	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.