Biomedical interventions for HIV prevention in MSM in Amsterdam: a demonstration project

Anno 2014 in the Netherlands, HIV spreads mainly among men who have sex with
men (MSM). The numbers of new HIV infections in this group remain high: of the
1051 new HIV infections, 700 concerned MSM (Source: Stichting HIV Monitoring
report 2013). The trend of a slightly increasing and ongoing HIV transmission
has been visible since 1996 when effective combination antiretroviral therapy
became available. This transforms HIV from a fatal disease into a chronic
disease. New prevention strategies are therefore needed to limit transmission
of HIV.

The effectiveness of a new biomedical intervention for HIV negative risk
groups, pre-exposure prophylaxis (PrEP), was recently described in the
international literature: it provides additional protection against HIV
infection. This iPrEx study (Grant RM et al, N Engl J Med 2010), showed that
Truvada (tenofovir disoproxil fumarate and emtricitabine), if given to
HIV-negative MSM with high-risk behavior, decreased the risk of HIV
seroconversion with 44%, and in those with good compliance, protection
increased to 92%. The open label follow-up study iPrEx OLE reported not only a
risk reduction for HIV infection which was dependent of drug levels in blood.

So PrEP has proven efficacy in research settings to prevent hiv infections in
prioritized populations such as MSM. Centers of Disease Control and Prevention
(CDC) in de US and the World Health Organization state that PrEP is/should be
part of a comprehensive hiv prevention program.

Two important points need attention in PrEP provision: adherence and risk
disinhibition.
Adherence has been inadequate in some studies (VOICE, FEM-PREP), rendering the
effect negligible.
Earlier research showed more risk behaviour after hiv therapy became available.
IPrEx and iPrEx OLE however, did not report this finding. Before PrEP is
implemented in standard care, we have to exclude that an increase in risk
behaviour causes PrEP to be of little effect.

The objective of this project is to investigate uptake, usability and
acceptability of two hiv prevention interventions. These relate to the use of
biomedical interventions, ie the provision of daily and intermittent PrEP to
men who have sex with men with additional risk factors for an HIV infection..

The hypotheses are as follows: to investigate whether Public Health Service
Amsterdam (PHSA) can inform HIV-negative men who have sex with men (MSM) at
high risk for HIV infection about and provide them with pre-exposure
prophylaxis (PrEP) to be taken as part of a comprehensive HIV risk reduction
package.To investigate whether MSM can adequately make own choice between two
different intervention strategies and adhere to the chosen strategy. To
investigate whether this comprehensive HIV prevention program has a good
uptake, acceptability and usability.

Evaluation of a demonstration project of 2 different intervention strategies
for MSM with additional risk factors for HIV infection

1. daily Pre-exposure prophylaxis
2.intermittent pre-exposure prophylaxis

Burden: 4 times per year a 30-minute visit of the STI clinic, for STI and HIV
screening, involving venapunction to draw 25 ml of blood. A computer-based
questionnaire about health including sexual health, burden of project
requirements, number of sex partners, number of comdom-protected and
unprotected sex acts. Keeping a diary on (un)protected sex acts. No risks.

Taking one Truvada pill daily or intermittent. Keep diary of therapy adherence.
Truvada is a safe drug, on the market for HIV treatment since 2004. Moderate
risk of mild side effects, very small risk of more severe side effects such as
kidney problems.


Benefits:: increased frequency of screening for HIV infection and STI: earlier
treatment is possible.
Additional protection for HIV by PrEP (as proven in earliers studies, around
44% up to 92% extra risk reduction)