The aim of this pilot implementation is first to make a serious start in Chlamydia screening and secondly to determine feasibility, affectivity and cost-effectivity. The results of this pilot implementation will be leading for the decision about the…
ID
Source
Brief title
Condition
- Chlamydial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
· Response rate of 30% (individuals who actually send in their samples to the
laboratory)
· Ct-positivity rate between 3-5%
Secondary outcome
Impact of Chlamydia screening on ct-prevalence (which can be achieved by
chlamydia trend analysis) and the impact on PID-rates.
The results of this implementation will be leading for the decision about the
national roll-out of screening in the Netherlands.
Background summary
Early detection and treatment (screening) of infections with Chlaymydia
trachomatis (CT) is a strategy to reduce complications in infected individuals
and to limit the spread of the infection in the population. In a recent
publication, the National Health Council advises to start a pilot
implementation. The Minister of Health has now issued a directive to perform
such a pilot implementation.
Study objective
The aim of this pilot implementation is first to make a serious start in
Chlamydia screening and secondly to determine feasibility, affectivity and
cost-effectivity. The results of this pilot implementation will be leading for
the decision about the national roll-out of screening in the Netherlands.
Study design
Intervention study by means of a selective systematic home-based screening.
Three hundred fifteen thousand persons will be invited to participate two times
in a 3 year period. They will be invited according to the so called stepped
wedge cluster-randomized designwithin randomized clusters. Stepped wedge design
is a *Sequential roll-out of an intervention to individuals (or clusters) over
a number of time periods. By the end of the study, all participants have
received the intervention, although the order in which they receive the
intervention is determined at random*.
Intervention
Implementation (regional) of selective systematic home-based screening for
chlamydia trachomatis. In Amsterdam and Rotterdam (high population density)
all members of the target population will be invited to participate. In the
eastern part of the lower population density area South Limburg, only part of
the target population will be invited based on a specific risk analysis
Study burden and risks
Screening might have potential side effects. These effects relate to issues
like somatic fixation (feeling dirty; *am I now infertile?*), negative
consequences in the partner relation and a potential negative effect on safer
sex (*I have myself tested and don*t need to do it safe*). However, in our
PILOT CT study we did not find evidence that intention for safer sex decreased,
and among persons tested positive it even increased. Thus, screening can also
have positive side effects and be instrumental to discuss safer sex and give
rise to tailored prevention counselling in primary care. Acceptance of the
screening approach will be studied during the evaluation
The target population are sexually active individuals in the 16 to 29 age
bracket. Minors (16 and 17) are also included because both nationally (Pilot
Ct) as internationally it has been clear that individuals of 25 years and
younger are a very important group to include in screening projects due to
their relatively high background prevalence.
No medical risks for the participants are involved in this implementation
project.
Postbus 93245
2509 AE Den Haag
NL
Postbus 93245
2509 AE Den Haag
NL
Listed location countries
Age
Inclusion criteria
16-29 age bracket
sexual active
registred in standard municipal registers of Amsterdam/Rotterdam/South Limburg
Exclusion criteria
Younger than 16 years
Older than 29 years
not sexual active
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 | NL19809.029.07 |