Clinical trial NCT05418790: A Pilot Study to Evaluate Alternative Viral Load Tests During Start of Antiretroviral Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV-1-infection
Lead sponsor: The Wistar Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reliability and Accuracy
timeFrame: 12 months
measure: Feasibility of implementing a home-based viral load test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Wistar Institute
name: Luis Montaner
role: PRINCIPAL_INVESTIGATOR
References: