Evaluation of measuring HIV-1 viral load in self-sampled blood.

• Conditions: HIV infection; 10047438

• Registration Number: NL-OMON56653
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• adult (aged >= 18 years) living with HIV
• speak Dutch or English
• provide written informed consent

We will include 2 groups of participants. Additional inclusion criteria in the
2 groups are:

1. Prolonged viral suppression group (n=14):
• stable on ART
• viral load suppressed for more than 2 years
• without comorbidities requiring more than one clinic visit per year

2. Persistent low level viremia group (n=30)
• receiving ART
• known to have low level viremia (200 -400 copies/ mL range).

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Agreement in viral loads between:<br /><br>o self-sampled HemoLink and conventional viral load measurement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Sample quality (volume and clots)<br /><br>• User friendliness scores<br /><br>• Laboratory logistics</p><br>