The objectives of this study are1)To asses the sensitivity, specificity, positive and negative predictive values of HIV, HBV, HCV, syphilis and creatinine screening tests performed on dried blood client-collected samples at home, as compared to…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the sensitivity and specificity of syphilis and
HIV screening tests performed on dried blood self-collected samples at home, as
compared to these respective tests as performed on peripheral blood samples
collected during an STI outpatient consult via vena-puncture.
Secondary outcome
- The sensitivity and specificity of HBV, HCV, and creatinine screening tests
performed on dried blood self-collected samples at home, as compared to these
respective tests as performed on peripheral blood samples collected during an
STI outpatient consult via vena-puncture.
-The acceptability, feasibility and usability of dried blood self-collected
samples at home.
Background summary
STI clinic guidelines recommend regular testing in men who have sex with men
(MSM). However, the reality is that MSM are only partially tested, infrequently
tested or not tested at all. The access time and capacity for clients visiting
the STI outpatient clinic in Amsterdam is a recurring point of concern. With
dried blood spot (DBS) self-sampling, a visit to the STI outpatient clinic may
not be necessary. In addition to the service towards clients, this can also
result in considerable cost savings for the clinic. The funds released can be
used to increase the access time and capacity of clients with complaints, those
who have been warned and those who need extensive counseling.
In this study we will assess the acceptability and feasibility of DBS in MSM
visiting the STI clinic in Amsterdam. We will evaluate the performance of DBS
for screening of HIV, HBV, HCV, syphilis and creatinine and compare these
results to the serum tests collected during the STI consult.
Study objective
The objectives of this study are
1)To asses the sensitivity, specificity, positive and negative predictive
values of HIV, HBV, HCV, syphilis and creatinine screening tests performed on
dried blood client-collected samples at home, as compared to these respective
tests as performed on peripheral blood samples collected during an STI
outpatient consultation via vena-puncture.
2)To assess the acceptability, feasibility and usability of dried blood
self-collected samples at home.
Study design
comparative study design to evaluate the performance of tests performed on
client-collected DBS versus serum tests routinely performed on
provider-collected samples
Study burden and risks
not applicable
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Listed location countries
Age
Inclusion criteria
- 18 years and older
- Being male and report to have had sex with a man in the past 6 months
Exclusion criteria
Having participated previously in this study.
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 | NL68213.018.18 |