SAAVI news releases
26 September 2002

Long-term insurance industry HIV testing protocol - changes to accommodate HIV vaccine trials

Life Offices' Association

Medical Research Council

The HIV Testing Protocol of the Life Offices’ Association (LOA) has been adapted to accommodate people who will be participating in clinical trials for an HIV vaccine, says Gerhard Joubert, executive director of the Association.

“This decision has been taken after extensive consultation with the South African AIDS Vaccine Initiative (SAAVI).”

“SAAVI is the national body which was established by the South African government in 1999 to co-ordinate the development of an affordable, effective and locally relevant HIV vaccine for SA,” says Dr Tim Tucker, the Director of SAAVI. “This decision by the LOA should be applauded and seen as a significant step forward within South Africa, ensuring that HIV vaccine trial volunteers are not discriminated against, as a result of their participation, when applying for insurance after HIV vaccination.”

“It was important to implement these changes prior to the first HIV vaccine clinical trial, so as to protect our communities,” says Tucker.

Although HIV vaccine clinical trials have not yet started in South Africa, they will involve a small number of people towards the end of this year and then many more later. As a result, the LOA proactively adopted this protocol to allow for a different methodology of testing for these people.

Discussions with SAAVI indicated that clinical trials with HIV vaccines will expand gradually to involve thousands of people over the next five to seven years, says Joubert. “The LOA therefore decided to take this step to ensure that these people are treated fairly.”

“A proportion of people receiving an HIV vaccine are expected to test positive on the routine HIV ELISA tests that are used by laboratories, although these volunteers are not truly infected by HIV. The routine ELISA tests indicate the presence of antibodies against HIV. If these are present in those who have received an HIV vaccine, this may be one of the positive signs that the HIV vaccine could be effective. However, they do not actually have HIV and therefore have normal mortality, illness profiles and insurance risk as the general population. The only way to distinguish between a natural infection and a positive antibody status due to a vaccine is to do an additional blood test. This test is called a polymerase chain reaction (PCR) test. The PCR tests for the presence of the virus itself and will only test positive in cases of natural infection,” says Tucker.

To accommodate SAAVI trial participants, the LOA HIV Testing Protocol now includes additional information in the pre-test counselling document.

“The document informs prospective clients that SAAVI trial participants would need to be identified, tested differently and accepted for risk cover if natural infection is ruled out,” says Joubert. “Vaccine recipients are identified through an additional question on the HIV consent form where these clients will be asked if they have received an HIV vaccine. A unique SAAVI trial ID-number will be supplied by SAAVI to the client. The insurer can verify this number through the use of a helpline. Insurers are currently paying for HIV testing for insurance purposes and the additional costs related to this test will also be borne by the insurers.”

The LOA HIV Testing Protocol (as amended) is available for download from the LOA website under Code of Conduct at www.loa.co.za.

In addition to the scientific research processes to develop and test an HIV vaccine, SAAVI has an extensive human rights component which aims to ensure the right to equality and non-discrimination of trial participants and their surrounding communities in South Africa, says Thomas Smit of the AIDS Legal Network, which is a consortium partner of the South African HIV Vaccine Action Campaign – the community education wing of SAAVI. “Ensuring that participants are not discriminated against for testing false positive is an important part of minimising the potential social harm associated with participating in HIV vaccine trials. Many other human rights, legal and ethical issues are being researched and addressed by SAAVI in the run up to the commencement of trials in South Africa.”

Contacts
SAAVI: Dr Tim Tucker
Director
SAAVI
+27 (0) 21 938 0262
saavi@mrc.ac.za

Michelle Galloway
Media and Communications
SAAVI/SA HIVAC
+27 (0) 21 938 0205
michelle.galloway@mrc.ac.za

Thomas Smit
ALN/SA HIVAC
+27 (0) 21 419 8882
alncpt@mweb.co.za

LOA: Gerhard Joubert
Executive Director
The Life Offices’ Association (LOA)
+27 (0) 21 423 2233
gerhard@loa.co.za

Dr Denys Schorn
Convenor
LOA Medical and Underwriting Standing Committee
+27 (0) 11 408 2457

Coenie Meyer
Coenie Meyer PR
+27 (0) 21 419 8732
082 448 1796
coenie@cmpr.co.za