The objectives of this study are: 1) To assess the user friendliness of the DBS self-sampling technique.2) To assess the quality of ssDBS.3) To estimate the agreement between viral loads in ssDBS and laboratory spotted DBS (labDBS).
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
* User friendliness
* Self-sampled DBS quality
* Viral loads
Secondary outcome
Not applicable
Background summary
As part of a larger project to stop the transmission of hepatitis C virus
(HCV) among HIV positive men who have sex with men (MSM), we intend to develop
a home-based HCV-RNA testing service, where dried blood spot (DBS) samples are
collected at home and sent to our laboratory by regular post.
A home-collection test can only be implemented when people are capable of
self-sampling a DBS at home of good enough quality. Therefore, in this study we
aim to evaluate the self-sampling DBS technique for the detection of HCV RNA.
The evaluation will include the assessment of user friendliness of the
self-sampling technique and the quality of the self-sampled DBS (ssDBS).
Furthermore, we will estimate the level of agreement between viral loads
measured in ssDBS and in DBS spotted in the laboratory (labDBS).
To evaluate whether ssDBS performance depends on the target (viral pathogen),
as in the future the testing service will be expanded to other viruses, we will
also assess ssDBS for measuring human immunodeficiency virus (HIV) and
hepatitis B virus (HBV) in this study.
Study objective
The objectives of this study are:
1) To assess the user friendliness of the DBS self-sampling technique.
2) To assess the quality of ssDBS.
3) To estimate the agreement between viral loads in ssDBS and laboratory
spotted DBS (labDBS).
Study design
This study is a qualitative and quantitative study to to test the feasibility
and evaluate the performance of DBS self-sampling for measuring viral loads.
Study burden and risks
Although drawing blood is a safe procedure, it can be uncomfortable and it may
cause localised bruising. The participant may also feel some pain during the
self-sampling of the DBS sample at home. The time investment from the
participant is kept to a minimum by adding the recruitment visit onto a regular
hospital visit so that no additional visits are required. Participants are not
burdened by receiving a new diagnosis as they are already aware of their
positive HCV, HIV or HBV status. The overall risks associated with
participation are considered negligible and the burden minimal. All
participants will be fully informed about the procedures and time investment
requested.
For patients with an HCV infection, the development of a home testing service
can be of benefit to screen for possible re-infections in the future if risk
behaviour is not reduced.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* at least 18 years of age;
* speak Dutch;
* HCV, HIV or HBV viremic
* mentally competent;
* capable of understanding the study information, and
* provide written informed consent.
Exclusion criteria
* does not have a home address
Design
Recruitment
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 | NL62275.018.17 |