This presentation was given by Andrew Grulich and Iryna Zablotska (NCHECR) at the AFAO HIV Educators Conference 2010.

1. Antiretroviral therapy as HIV prevention in gay men Andrew Grulich and Iryna Zablotska AFAO National Symposium on Prevention May 26 2010

2. In this presentation … Brief review of background Research proposal Study protocol Issues and solutions Where to from here?

3. Background Blood plasma viral load (BPVL) is strongly related to risk of HIV transmission in African heterosexuals Little data on transmission from people on anti-retroviral therapy A RCT that will report in 2013-15 will definitively answer this question in heterosexuals After that, there may be enormous pressure for rolling out therapies as prevention Almost zero completed or ongoing research on ARV therapy and HIV transmission in gay men. Both “test and treat” and the “Swiss statement” assume massive reductions in transmissibility in HIV due to ARV therapy.

4. We propose a study to answer the question: is undetectable viral load associated with a zero – or close to zero - risk of HIV transmission? ie: how effective is ART as a form of HIV prevention in gay men?

5. Review (1): research proposal 240 serodiscordant couples followed for four years (replacement with new couples for any break ups) Sydney, Melbourne, ?Brisbane 3-4 visits/year HIV positive men: viral load, CD4, STI tests Optional semen collection in ~30% HIV negative men: HIV antibody tests, STI tests, risk behaviour This enables calculation of transmission rate by viral load

6. Review (2): recruitment and testing Recruitment: with support from community organisations and clinic-based Testing: At participants usual HIV clinic Usual doctor for HIV negative partner

7. Review (3): data collection (HIV negative men) Sexual behaviour assessments Frequency At enrolment: Interview Follow-up: quarterly, computer-based, self-administered questionnaires Data collected will include: the number of sexual partners by HIV status; Sexual risk practices (both within and outside the relationship) the nature of any negotiated agreements within the relationship, understandings of the HIV-pos partner’s viral load

8. Review (3): data collection (HIV positive men) Assessments of knowledge, awareness, beliefs and attitudes Frequency At enrolment: Interview Follow-up: annual, computer-based, self-administered questionnaires No collection of risk behaviour information In each couple, data collection will be conducted separately to ensure confidentiality

9. Review (4): data collection (seroconversions) Phylogenetic analysis of HIV for seroconversions only Aim: to identify whether the infection has occurred within a relationship. HIV-negative participants: HIV-subtype in blood HIV-positive partners: HIV-subtype in blood and semen

11. including a quiz which must be passed in order to enter the study

12. Acknowledgement by the HIV-negative partner that he is aware of

13. HIV-positive status of his partner, and

14. the means of HIV transmission

15. Consent to provide body fluids (e.g., blood, semen) for future analyses

17. Process of consultations on potential issues Background review of related research and legal history of HIV in Australia (early 2009) issues identified Community consultations (started in Sep 2009) issues formulated several rounds of consultations community representative (Triffitt) joined research team Legal consultations (started in Sep 2009) legal advice obtained from HALC and incorporated in the study proposal

18. Recruitment Clinic based recruitment was unsuccessful in a pilot study Solution: community based recruitment - the better way to go Key role of the community organisations Follow-up support through NCHECR research network clinics in Sydney/Melbourne

19. Recruitment criteria Some positive men may be discouraged from participating by an entry criteria that requires them to say they have been having UAI with their partner Solution: to be eligible, both partners will have to report being in an ongoing sexual relationship involving anal intercourse

20. Data collection Some positive men may be discouraged from participating by a requirement to disclose having UAI with their negative partner Solution: No collection of risk behaviour data from positive partners Not strictly necessary for study outcome Will reduce legal risks within the study

22. Research team Chief Investigators: Grulich, Zablotska, Jin, Prestage (NCHECR) Associate Investigators: Cooper, Kelleher, Koelsch (NCHECR) Fairley (Sexual Health Centre, Melbourne) Triffitt (Positive Life)

23. Time-line (best case scenario) March 2010: grant submitted to NHMRC July 2010: grant commentary, rebuttals November 2010: success announced January 2011: grant commences March 2011: ramp up in publicity, discussion, in depth community-consultations July 2011: start recruiting 240 serodiscordant couples

24. Please give us your feedback! How important do you think the results of this study will be for HIV prevention in your community? How well do you think the study addresses the legal and ethical issues that might affect the willingness of people with HIV to participate? Are you involved in any work with HIV serodiscordant couples? If you answered yes, and you had clients who were eligible for the study, would you recommend that they participate in this study?