Care and Prevention in HIV Vaccine Trials: a site perspective Guy de Bruyn

1. Care and Prevention in HIV Vaccine Trials: a site perspective Guy de Bruyn Perinatal HIV Research UnitUniversity of the WitwatersrandChris Hani Baragwanath HospitalJohannesburg, South Africa

2. Care which is part of the scientific design Care needed to safely complete the trial Care for injuries and adverse events Post trial access Ancillary care Care that some participants will predictably need Access to care (modified from Grady)

3. “a comprehensive care package should be agreed upon through a host/community/sponsor dialogue which reaches consensus prior to initiation of a trial” (UNAIDS 2000, #16)… Dialogue?

4. Avoiding pregnancy during the vaccination period Assessing symptoms of illness Ensuring adequate standard of care to control participants Counselling – pre/post-test, risk reduction, safer sex Providing condoms Protocol mandates

5. Resuscitation equipment Laboratory monitoring of haematologic parameters and other clinical laboratory values of potential interest Anaemia Leukopaenia Alteration of hepatic enzyme tests Care needed to safely complete the trial

6. Some questions What kind of care is needed? For how long? By whom? Whose responsibility? Ancillary care in HIV Vaccine trials

7. Hypertension May be diagnosed incidentally during the conduct of trial procedures Treatment is lifelong Management is multi-modal, i.e. requires attention to weight, nutrition, exercise, in addition to possible pharmacotherapy Facilitating access to services TOP Psychosocial support – rape/trauma/DV Mental illness Dental care Ancillary care – some examples

8. HIV counseling and testing Some protocols may not provide results in ‘real-time’, depending on the complexity of ruling out vaccine-induced seropositivity Impact on testing outside of the trial setting Other VCTs, blood donation, organ donation, testing for insurance purposes What about partners? Should we offer CHCT and who is able to do that? What is “the standard of prevention”?

9. Risk reduction counselling Efforts to standardize that intervention, such as pilot efforts within DAIDS networks Condom promotion vs. provision Male / Female / both What other means should be used to promote condom uptake More “Standard of Prevention”

10. Male circumcision STI treatment Diagnostics Directed versus syndromic therapy Post-exposure prophylaxis Pre-exposure prophylaxis Other investigational agents What about additional HIV prevention technologies?

11. What is the Threshold of Evidence for New Prevention Tools?

12. Cochrane Review of HIV and Circumcision in High Risk Heterosexual Men Siegfried et al. Lancet Infect Dis 2005

13. Phambili timelines 13Oct06. MCC approval 19Oct06. HREC approval 17Mar06. MCC submission. GMO submission 24Jan07. First pt enrolled 7March 2007 First Phambili participant provided MC 12Sep06. IBC submission 8Nov06. IBC approval 21Nov06. GMO approval 8May06. HREC submission December 2006 Kenyan and Ugandan MC trial results 19 Sep 2007 STEP trial interim results July 2005 Orange Farm MC trial results

14. Thirteen studies from nine sub-Saharan African countries Location of Studies of Acceptability Bailey R IAS 2007

15. Public Sector Circumcisions CHB

16. Local Expertise

17. Implementing at the Trial Site / Facilities

18. Circumcision *129/441 were circumcised at baseline