comprehensive prevention strategy (guy de bruyn)

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

1/18

Care and Prevention

in HIV Vaccine Trials:a site perspective

Guy de Bruyn

Perinatal HIV Research Unit

University of the WitwatersrandChris Hani Baragwanath Hospital

Johannesburg, South Africa

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

2/18

Access to care (modified from Grady)

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

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

3/18

Dialogue?

a comprehensive care package should

be agreed upon through ahost/community/sponsor dialogue

which reaches consensus prior to

initiation of a trial (UNAIDS 2000,

#16)

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

4/18

Protocol mandates

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

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

5/18

Care needed to safely complete the trial

Resuscitation equipment

Laboratory monitoring of haematologic

parameters and other clinicallaboratory values of potential interest

Anaemia

Leukopaenia

Alteration of hepatic enzyme tests

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

6/18

Ancillary care in HIV Vaccine trials

Some questions

What kind of care is needed?

For how long? By whom?

Whose responsibility?

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

7/18

Ancillary care some examples

Hypertension May be diagnosed incidentally during the conduct

of trial procedures

Treatment is lifelong

Management is multi-modal, i.e. requires attentionto weight, nutrition, exercise, in addition topossible pharmacotherapy

Facilitating access to services TOP

Psychosocial support rape/trauma/DV

Mental illness

Dental care

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

8/18

What is the standard of prevention?

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?

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

9/18

More Standard of Prevention

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 topromote condom uptake

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

10/18

What about additional HIV prevention

technologies?

Male circumcision

STI treatment

Diagnostics Directed versus syndromic therapy

Post-exposure prophylaxis

Pre-exposure prophylaxis Other investigational agents

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

11/18

What is the Threshold of

Evidence for New PreventionTools?

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

12/18

Cochrane Review of HIV and Circumcision in

High Risk Heterosexual Men

Siegfried et al. Lancet Infect Dis 2005

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

13/18

Phambili timelines

17Mar06. MCC

submission. GMO

submission

8May06. HREC

submission

12Sep06. IBC

submission

13Oct06. MCC approval

19Oct06. HREC approval

24Jan07. First pt

enrolled

19 Sep 2007

STEP trial interim resultsJuly 2005 Orange

Farm MC trial

results

December 2006

Kenyan and Ugandan

MC trial results

7March 2007

First Phambili

participant

provided MC

8Nov06. IBC approval

21Nov06. GMO approval

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

14/18

Location ofStudies ofAcceptability

Thirteen studiesfrom nine sub-Saharan Africancountries

Bailey R IAS 2007

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

15/18

Public Sector Circumcisions CHB

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

16/18

Local Expertise

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

17/18

Implementing at the Trial Site / Facilities

8/7/2019 Comprehensive Prevention Strategy (Guy de Bruyn)

18/18