PUBLIC COMMENT

Provided by

James Sykes, The AIDS Institute

Before the

Blood Products Advisory Committee

Food and Drug Administration

Gaithersburg, Maryland

March 10, 2006

 

 

Distinguished Committee Members:

 

My name is James Sykes and I am representing The AIDS Institute, a national public policy organization. Thank you for considering my public comments regarding

over-the counter (OTC) home-use HIV test kits.

 

The AIDS Institute supports efforts by the Centers for Disease Control and Prevention (CDC) to increase access to and availability of HIV testing. The goal of HIV testing is two-fold. First, that an individual become informed of his or her HIV status so that appropriate medical evaluation and treatment can be sought.  Unlike the early domestic HIV epidemic, today improved treatment options are available to people living with HIV.

In many instances HIV has become a chronic disease. Second, people who are aware of their HIV status may be less likely to transmit the virus to others. This is an important public health consideration.

 

The introduction of the HIV rapid test in recent years has expanded HIV testing and increased testing access and availability. One of the advantages of the rapid test is the relative immediacy of receiving the test result. More conventional testing is hampered by relatively poor client return rates, often resulting in clients not receiving test results.

 

The AIDS Institute supports the concept of OTC home-use HIV testing kits. Such an approach will further increase access to and availability of HIV testing. This approach can play a role in the overall HIV domestic testing system. In particular, the approach may be appealing to individuals who resist seeking HIV testing in pubic health settings and private medical practice. For these individuals, use of an OTC home-use HIV test kit may be the only approach by which they become aware of their HIV status.

 

There are a number of issues The AIDS Institute believes must be addressed prior to the implementation of this approach.

 

1. The absence of direct counseling in the OTC home-use HIV test kit setting will require the provision of clear information with the kit including: appropriate use of the kit, HIV prevention, and a statement that HIV infection is a treatable disease.

 

 

PUBLIC COMMENT

Provided by

James Sykes, The AIDS Institute

Before the

Blood Products Advisory Committee

Food and Drug Administration

Gaithersburg, Maryland

March 10, 2006

 

Page 2

 

 

 

 

2. Likewise, the absence of direct counseling with this method will need to be addressed by provision of a toll-free twenty-four hour, seven-day a week telephone number staffed by qualified counselors. The counselors will need to be prepared to answer questions about the test kit and its use; HIV prevention; and local referral options for medical and psychosocial evaluation and assistance.

 

3. The CDC will need to address how this approach may impact HIV case reporting and HIV surveillance data.