The Opposites Attract Study:      Building the evidence for“treatment as prevention” in gay male     serodiscordant relati...
BACKGROUND• Studies in heterosexual serodiscordant couples have  provided critical evidence for the role of HIV  treatment...
HPTN052: A 96% reduction in HIV transmission risk                                        Cohen, MS et al, 2011
BACKGROUND: Unanswered questions• There is a lack of evidence on ‘Treatment As  Prevention’ in homosexual men.• The effect...
BACKGROUND: Unanswered questions• The durability of ‘Treatment As Prevention’   – HTPN052 participants will be followed fo...
CURRENT RESEARCH• The PARTNER Study  – 73 active sites recruiting across Europe in 14 countries.  – Over 650 couples recru...
CURRENT RESEARCH• The PARTNER Study   – 73 active sites recruiting across Europe in 14 countries.   – Over 650 couples rec...
OPPOSITES ATTRACT STUDY PARTNERS•   Coordinated by the Kirby Institute at UNSW.•   14 sexual health and general practice c...
OPPOSITES ATTRACT STUDY AIMS1. Does HIV treatment/undetectable viral load reduce   HIV transmission in anal sex?2. How do ...
OPPOSITES ATTRACT STUDY AIMS•   Data collected will also enable:    – Documenting behavioural risk compensation and its ef...
OPPOSITES ATTRACT STUDY DESIGN• Prospective longitudinal cohort study.• Open enrolment for up to four years.• Unit of recr...
OPPOSITES ATTRACT STUDY DESIGN• A total of approximately 520 serodiscordant male  homosexual pairs in an ongoing sexual re...
OPPOSITES ATTRACT STUDY DESIGN• Defining the term “couple” or “pair”:   – Relationship must be sexual in nature and ongoin...
OPPOSITES ATTRACT STUDY DESIGN• The study revolves around the routine clinical  management schedule of the HIV-positive pa...
OPPOSITES ATTRACT STUDY DESIGN• Phylogenetic testing of viruses if seroconversion  occurs to determine if transmission was...
QUESTIONNAIRESHIV-Positive Partner                  HIV-Negative Partner•   Demographics                      •   Demograp...
SEMEN SUB-STUDY• Semen collection to occur in Sydney.• Aiming for 30% or more of the HIV-positive men• Voluntary participa...
RECRUITMENT• Mixture of clinic- and community-based recruitment.• Aim to have 240 pairs enrolled by the end of 2012.• Over...
CHALLENGES•   There are substantial challenges to conducting longitudinal    ‘Treatment As Prevention’ studies among gay m...
CHALLENGES CHALLENGE 2:  •   High levels of non-monogamy in gay male relationships      and UAI with casual partners is no...
CHALLENGES CHALLENGE 3:  •   Infection most likely in the early stages of      relationships rather than in long-term, est...
CHALLENGES CHALLENGE 4:  •   Legal implications for HIV-positive participants.  •   Legal advice sought and protections pu...
COMMUNITY SUPPORT• Support from community-based organisations is vital  to the success of the Opposites Attract Study.• Ce...
RECRUITING NOW!•   Sydney                             •   Melbourne    –   East Sydney Doctors                –   Centre C...
STUDY CONTACTS• www.OppositesAttract.net.au• OppositesAttract@unsw.edu.au• Opposites Attract Research Assistant:  1800 129...
The Opposites Attract Study: Building the evidence for “treatment as prevention” in gay male serodiscordant relationships
Upcoming SlideShare
Loading in...5
×

The Opposites Attract Study: Building the evidence for “treatment as prevention” in gay male serodiscordant relationships

459

Published on

Ben Bavinton, (The Kirby Institute) discusses how the Opposites Attract' stdy will address the unanswered questions about wther treatment as prevention will work for gay men. This presentation was given at the AFAO/NAPWA Gay Men's HIV Health Promotion Conference in May 2012.

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
459
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

The Opposites Attract Study: Building the evidence for “treatment as prevention” in gay male serodiscordant relationships

  1. 1. The Opposites Attract Study: Building the evidence for“treatment as prevention” in gay male serodiscordant relationships Ben Bavinton The Kirby Institute for infection and immunity in society University of New South Wales, Sydney May 2012
  2. 2. BACKGROUND• Studies in heterosexual serodiscordant couples have provided critical evidence for the role of HIV treatment in preventing HIV transmission.• Observational studies conducted in Africa showed a relationship between HIV treatment/undetectable viral load and transmission.• In 2011, HTPN 052 found a 96% reduction in HIV transmission in serodiscordant couples where the HIV-positive partner had undetectable viral load.
  3. 3. HPTN052: A 96% reduction in HIV transmission risk Cohen, MS et al, 2011
  4. 4. BACKGROUND: Unanswered questions• There is a lack of evidence on ‘Treatment As Prevention’ in homosexual men.• The effectiveness of ‘Treatment As Prevention’ may be different because: – HIV transmission risk is higher for anal sex compared to vaginal sex. – HIV transmission has increased in gay men despite more HIV-positive gay men receiving ART. – Semen viral load does not perfectly correlate with blood viral load: specific ARTs, STIs and adherence to ART can all impact on this correlation.
  5. 5. BACKGROUND: Unanswered questions• The durability of ‘Treatment As Prevention’ – HTPN052 participants will be followed for at least one year• Detailed sociobehavioural information – How do people in serodiscordant couples communicate about viral load? – How do they negotiate protected and unprotected sex in this context? – Do relationship agreements involve viral load? – Knowledge, beliefs and attitudes about HIV, viral load, and risk.
  6. 6. CURRENT RESEARCH• The PARTNER Study – 73 active sites recruiting across Europe in 14 countries. – Over 650 couples recruited (50% of the target). – Gay couples make up one-third of the sample to-date.
  7. 7. CURRENT RESEARCH• The PARTNER Study – 73 active sites recruiting across Europe in 14 countries. – Over 650 couples recruited (50% of the target). – Gay couples make up one-third of the sample to-date.• The Opposites Attract Study
  8. 8. OPPOSITES ATTRACT STUDY PARTNERS• Coordinated by the Kirby Institute at UNSW.• 14 sexual health and general practice clinics in Sydney, Melbourne, Brisbane and Adelaide.• Potential to expand to further clinical sites in Cairns, Canberra, and possibly Bangkok.• Involvement of community partners.
  9. 9. OPPOSITES ATTRACT STUDY AIMS1. Does HIV treatment/undetectable viral load reduce HIV transmission in anal sex?2. How do gay men use viral load to negotiate UAI within serodiscordant relationships?3. Do STIs modify the relationship between viral load and HIV transmission?4. Is semen viral load related to transmission? – What is the correlation between viral load in blood and semen?
  10. 10. OPPOSITES ATTRACT STUDY AIMS• Data collected will also enable: – Documenting behavioural risk compensation and its effect on transmission – Per contact probabilities of transmission – Additional effect of PrEP/PEP (when used)
  11. 11. OPPOSITES ATTRACT STUDY DESIGN• Prospective longitudinal cohort study.• Open enrolment for up to four years.• Unit of recruitment is a pair (couple) comprising two men in an ongoing sexual relationship where one is HIV positive and the other HIV negative at baseline.• Pairs to be replaced if they “break up” or withdraw (>30% per year).
  12. 12. OPPOSITES ATTRACT STUDY DESIGN• A total of approximately 520 serodiscordant male homosexual pairs in an ongoing sexual relationship (involving anal sex).• 240 pairs under follow-up at any given time after the first year.• Over 680 couple-years of follow-up.
  13. 13. OPPOSITES ATTRACT STUDY DESIGN• Defining the term “couple” or “pair”: – Relationship must be sexual in nature and ongoing – Must involve anal intercourse at least monthly (on average) – Does not need to be a “romantic, committed” relationship (e.g. “boyfriends”) – The nature of the relationship can change, providing that it remains ongoing and sexual in nature – No required length of relationship: “Do you think you will still be having sex with each other in 3-6 months?”• Study does not preclude men with multiple regular partners, however participants can enroll with only one partner at a time
  14. 14. OPPOSITES ATTRACT STUDY DESIGN• The study revolves around the routine clinical management schedule of the HIV-positive partner – At least two clinic visits per year where viral load is taken – Partners attend clinic visits within 2 weeks of each other• Standard of care testing for viral load, CD4, HIV antibodies and STIs (STIGMA & ASHM guidelines)• Types of clinic visits: – Enrolment visit – Baseline visit – Follow-up visits – Seroconversion visit (if seroconversion occurs)
  15. 15. OPPOSITES ATTRACT STUDY DESIGN• Phylogenetic testing of viruses if seroconversion occurs to determine if transmission was within the pair. – Results of phylogenetic testing will not be provided to participants or clinics.• After each clinic visit (within 48 hours), both partners complete an online questionnaire.
  16. 16. QUESTIONNAIRESHIV-Positive Partner HIV-Negative Partner• Demographics • Demographics• HIV and treatment • HIV testing• Adherence • STI testing and symptoms• STI testing and symptoms • Relationships• Relationships and communication • Agreements and communication• Self-efficacy • Partner viral load• Attitudes • Sexual behaviour with study partner• Study involvement • Sexual behaviour with others • Group sex • PEP and PrEP • Self-efficacy • Attitudes • Study involvement
  17. 17. SEMEN SUB-STUDY• Semen collection to occur in Sydney.• Aiming for 30% or more of the HIV-positive men• Voluntary participation (separate consent form)• Semen collection at the time of every clinic visit• Semen collection on the same day or within 2 days of the clinic visit• Semen viral load and phylogenetic analysis (in cases of partner’s seroconversion) at end of study
  18. 18. RECRUITMENT• Mixture of clinic- and community-based recruitment.• Aim to have 240 pairs enrolled by the end of 2012.• Overall goal: for every HIV-positive gay man in each clinic and each city more broadly to be aware of the study.
  19. 19. CHALLENGES• There are substantial challenges to conducting longitudinal ‘Treatment As Prevention’ studies among gay men. CHALLENGE 1: • High break-up rate (break-up rate of non-committed relationships likely to be even higher than 30%). • The study will need ongoing recruitment until the last six months of the study to replace pairs that break up.
  20. 20. CHALLENGES CHALLENGE 2: • High levels of non-monogamy in gay male relationships and UAI with casual partners is not uncommon. • Phylogenetic analysis to determine transmission within study partnerships is essential. – Blood sample requirements
  21. 21. CHALLENGES CHALLENGE 3: • Infection most likely in the early stages of relationships rather than in long-term, established relationships. • Recruitment will attempt to target men in new relationships and men in non-committed yet ongoing sexual relationships. – Challenging, as the study burden falls primarily on the HIV- negative partner.
  22. 22. CHALLENGES CHALLENGE 4: • Legal implications for HIV-positive participants. • Legal advice sought and protections put in place. 1. Documented that both partners have good knowledge of HIV transmission risks (quiz and education) 2. HIV-negative partner signs a statement that he is aware his partner is HIV-positive. 3. Details about unprotected anal sex collected only from the HIV-negative partner. 4. Phylogenetic test results not provided back to participants or clinics.
  23. 23. COMMUNITY SUPPORT• Support from community-based organisations is vital to the success of the Opposites Attract Study.• Central involvement of community organisations through every stage of study development and implementation.• Especially important for recruitment.
  24. 24. RECRUITING NOW!• Sydney • Melbourne – East Sydney Doctors – Centre Clinic – Holdsworth House – Northside Clinic – Taylor Square Private Clinic – Prahran Market Clinic – Dr Doong’s Surgery – Alfred Hospital – RPA Sexual Health – Melbourne Sexual Health – IBAC – St Vincent’s Centre – Sydney Sexual Health Centre• Brisbane • Adelaide – Gladstone Road Medical – O’Brien Street General Centre Practice
  25. 25. STUDY CONTACTS• www.OppositesAttract.net.au• OppositesAttract@unsw.edu.au• Opposites Attract Research Assistant: 1800 129 073
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.

×