Residual Risk Assessment Of HIV Transmission
Residual Risk Assessment Of HIV Transmission
The main objective of this one year multidisciplinary research is to estimate the frequency
 of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an
 undetectable blood viral load (VL) and a detectable VL in semen.

 Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments
 participating to the research project. To warrant feasibility and diversity of participants
 needed, the centers will be located in Paris and nearby suburbs. The study design is based on
 one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be
 taken in the enrolment centers. Biological and virological analyses will be performed by the
 laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological
 analyses are planned in a subsequent study. Socio-behavioral data will be collected through a
 self-administered questionnaire at day 0 and day 30.

 Schedule: Patients' enrolment, collection of biological samples and questionnaires will last
 10 months (end of first quarter 2012). Biological and virological analyses will be performed
 until the end of the first semester 2012. Quantitative and socio-behavioral data will be
 analyzed during the third quarter 2012. Results will be released at the beginning of year
 2013.
The secondary objective is to characterize the biological and behavioral components that
 might influence VL discordance between blood and semen.

 Background: In most cases the semen VL reflects the blood VL. However some seropositive
 people with an undetectable blood VL have a detectable semen VL and thus might be at risk of
 HIV transmission in case of unprotected sexual behaviors. Most of the previously published
 studies were made on rather small numbers of HIV+ heterosexual men, were cross-sectional and
 did not address factors that might be associated with discordant VL between blood and semen.
 Few studies have been performed among seropositive MSM who are one of the most at-risk
 populations for HIV.

 Issue: The working hypothesis is that virus present into reservoirs and risky sexual
 behaviors might influence discordance in VL between blood and semen in MSM. Our hypothesis is
 that this rate might be higher among MSM than among the general population due to the
 existence of biological and specific factors that could lead to HIV local replication. The
 main reasons to address this question in MSM are i) no or very few data available in this
 population; ii) the possibility to measure in this population the impact of life style
 determinants on semen VL (high number of sexual partners; risky sexual behaviors, multi-drugs
 consumption…); and iii) a strong expectation from this community to have new prevention
 strategies and clear information about the HIV transmission risk.

 Outcomes: Quantitative data analysis will allow us to evaluate the proportion of people
 having a detectable semen VL, its variation according to time. Socio-behavioral data analysis
 will allow us to describe the sexual behaviors that might influence discordance of the VL
 between blood and semen in HIV+ MSM. These results will provide information on the HIV
 residual risk of transmission in treated MSM and to better target people who might be at risk
 for HIV transmission in case of unprotected sexual behaviors. Describing the socio-behavioral
 characteristics of these people will help to define adaptated interventions in order to
 improve HIV prevention in MSM
Inclusion Criteria:

 -  Age ≥ 18 and

 -  Able to give written consent

 -  Covered by French Social Security

 -  be a men and have sex with men

 -  be treated with the same ARV treatment for at least 3 months

 -  blood plasma have a CV undetectable (<50 copies / ml) for at least 6 months

 -  accept the constraints imposed by the study, that is to say one or more masturbation
 in hospital

 Exclusion Criteria:

 -  Under protection(saving) of justice