NCT05418790

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 9, 2022

Last Update Submit

June 9, 2022

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

TASSO device

EXPERIMENTAL

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

Device: TASSO device

Interventions

TASSO deviceDEVICE

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

TASSO device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons living with HIV starting an ART regimen or working to suppress a previously detectable viral load ≥ 5,000 copies/mL

You may not qualify if:

  • Persons living with HIV suppressed on ART regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Luis Montaner

    The Wistar Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Lynn, RN

CONTACT

215-662-8217kelynn@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 14, 2022

Study Start

July 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

June 14, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share