To evaluate interventions aimed at reducing risk behaviour, and ultimately preventing HCV reinfections and onward spread of HCV.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the proportion at risk of HCV reinfection (as determined
by a HCV-MOSAIC risk score >= 2) during the run-in versus intervention periods.
This risk score consists of 6 items related to the risk of HCV and is
calculated by summing up the bèta's of the items when present in the past 6
months:
1. Receptive condomless anal sex (beta 1.1)
2. Sharing of sex toys (beta 1.2)
3. Unprotected fisting (beta 0.9)
4. Injecting drug use (beta 1.4)
5. Sharing of straws during nasally-administered drug use (beta 1.0)
6. Ulcerative sexually transmitted infection (beta 1.4)
Secondary outcome
Secondary outcomes include HCV reinfection incidence, changes in individual
risk behaviour items of the HCV-MOSAIC risk score and changes in sexual
wellbeing.
Background summary
As highly effective therapy against hepatitis C virus (HCV) infection is
available with rapid uptake, there is newfound optimism for HCV elimination.
Nevertheless, HCV reinfections cause great concern in at risk populations,
including men who have sex with men (MSM). In the Netherlands, MSM account for
the majority of new HCV (re-)infections. Although HCV treatment uptake is high
in this group, modelling data indicate HCV elimination would not be feasible
without a reduction in risk behaviour. This finding highlights the urgent need
for effective interventions aimed at reducing risk behaviour and preventing
reinfections in MSM.
Study objective
To evaluate interventions aimed at reducing risk behaviour, and ultimately
preventing HCV reinfections and onward spread of HCV.
Study design
Using a 3-arm randomised trial comparing run-in and intervention periods, we
will evaluate the effect of two interventions, alone and its combination, on
risk behaviour in MSM previously infected with HCV.
Intervention
Intervention I is a targeted, online behavioural intervention developed as part
of the project. Intervention II consists of an additional patient-initiated,
home-based HCV RNA testing service with the use of self-sampled dried blot
spots. Intervention III is a combination of intervention I and II.
Study burden and risks
One site visit will be required for all participants to sign the informed
consent form, which will be a routine visit at the HIV treatement center or
STI/PrEP/sexual health center. All further study procedures will be web-based
or will take place at home. Participants will be exposed to five online
questionnaires, with an interval of 6 months. The interventions might make
participants more aware of their HCV risk. However, we think this study poses
negligible risk to the participants.
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Nieuwe Achtergracht 100
Amsterdam 1018 WT
NL
Listed location countries
Age
Inclusion criteria
- Men who have sex with men >= 18 years
- History of a prior HCV infection (succesfully treated or spontaneously
cleared)
Exclusion criteria
- Acute or chronic HCV infection at time of enrolment (positive HCV RNA).
- Under HCV treatment at time of enrolment.
- Unlikely, in the opinion of the clinician, to comply with the study
procedures.
- Currently participating in an intervention study that offers extra HCV
testing and/or a behavioural intervention.
- Investigators and other dependent persons.
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 | NL68718.018.19 |