HIV-1-infection
Conditions
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.
Interventions
DEVICETASSO device
During this trial, participants will have approximately 15 TASSO collection dates between in clinic and at home.
Sponsors
Luis Montaner
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Tasso viral load test | 12 months | 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. |
| Questionnaire to assess feasibility of implementing a home-based viral load test | 12 months | 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. |
Contacts
PRINCIPAL_INVESTIGATORLuis Montaner
The Wistar Institute
Outcome results
None listed