The objectives of this study are:1) Assessing the user-friendliness of a self-sampling technique.2) Assessing the quality of the self-collected sample (volume and composition).3) To estimate the degree of agreement between viral loads in the self-…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Agreement in viral loads between:
o self-sampled HemoLink and conventional viral load measurement.
Secondary outcome
• Sample quality (volume and clots)
• User friendliness scores
• Laboratory logistics
Background summary
The majority of people living with HIV in the Netherlands who are receiving
treatment for it are in good and stable health. Nevertheless, they are usually
seen at the outpatient clinic twice a year for an appointment with their HIV
treatment team and for monitoring of HIV in their blood. For people with
well-treated HIV and stable health, an appointment with their treatment team
once a year, alternated with a self sampled blood test at home after 6 months,
to determine the amount of viral load could be sufficient. On the one hand,
this would save people living with HIV time and effort, and on the other hand
it would lead to efficient use of the limited resources available for HIV care.
However, it is unclear whether self-sampling of blood at home to determine the
amount of viral load is practically feasible and reliable enough. Proposed
research aims to answer these questions.
Study objective
The objectives of this study are:
1) Assessing the user-friendliness of a self-sampling technique.
2) Assessing the quality of the self-collected sample (volume and composition).
3) To estimate the degree of agreement between viral loads in the
self-collected sample and in the conventional hospital-collected sample.
Study design
Validation study with single routine clinic visit at Amsterdam UMC:
• Regular visit to HIV outpatient clinic & conventional viral load measurement
• Consenting participants are provided with the system for self-sampling of
blood.
• Participants are asked to self-sample at home and send the sample to the
laboratory on the same day.
• Participants are asked to complete a brief questionnaire about convenience of
the self- sampling technique.
Study burden and risks
Risks are minimal. Home-based self-sampling is safe with clear instructions.
Filling in a brief questionnaire about the user-friendliness of self-sampling
is of minimal burden..
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83917.018.23 |