Residual Risk Assessment Of HIV Transmission
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): blood and semen sampling, specific biological exams and biobank and self administered questionnaires
Intervention type(s): Biological
Intervention description(s): blood and semen sampling, specific biological exams and biobank and self administered questionnaires
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: men having sex with men