Tuesday, November 10, 2009

Here's a copy of the comments that Christine Harris (in Austin, TX), Rob Hadley (Chicago) and I have submitted to the FDA regarding approval of over-the-counter sale of tests.

We, the undersigned, are submitting these comments to the FDA supporting the approval of over-the-counter rapid HIV-tests. We are people living with HIV/AIDS. We have been active and vocal about HIV/AIDS issues as a whole and have observed the unfolding of the community conversations about the prospect of over-the-counter HIV-testing. What we have noticed is that the driving question has been “Is this a good or a bad thing?” when the question really should be “In what ways can the availability of over-the-counter HIV-tests help us in our collective desire to stop the spread of HIV?” This opens doors to look at the possibilities – many of which are actionable. Here are some thoughts we have:

· The current HIV-testing system is very cost-ineffective (with administrative over-head among other costs). We can also attest to the limitations of the current system – it is often intimidating, humiliating and embarrassing, not always compassionate, and not always free. This includes HIV-testing clinics, health departments and medical providers.

· The current strategy of targeting “high-risk” groups and bringing them into the current testing system only adds to the stigma that we are striving to overcome. All persons sexually active are at risk.

· The concerns about linkage to care can be addressed when people such as ourselves are able to sit with or speak with co-workers, family, and friends to self-administer tests. We know first-hand the importance of care, as well as the limitations of care and the need to assert ourselves. OTC tests can be a means to help us educate others while promoting testing.

· OTC tests are ideal for repeat testers and for people without HIV who are in relationships with people with HIV. The presence of these tests in places where people are highly sexually active and are ignoring the bowl of condoms in the room. The mere presence of these tests may get people to stop and think.

· Women in either healthy or domestically abusive/violent relationships will be more empowered and able to take control of their own health much safer and quicker with the availability and approval of OTC HIV home tests. Placed next to the “at home pregnancy test”, more women would be alerted to the message anyone can become HIV+.

· For many people, the stigma of getting tested can be very intimidating resulting in not testing at all. Many of these people, if they knew they were positive, they would go for treatment and counseling. We know many people who have stated this including ourselves had the option been available.

· There is a concern that people who self-administer HIV-tests and find out they have HIV will harm them selves. Clinically, there is no data to support this. Besides, the FDA routinely approves medications that have harmful, even deadly side effects, and issues warnings about this. Similar warnings can be added to OTC tests including 24-hour hot lines and live peer support lines.

· In the past 2 years, we have seen first-hand many individuals, members of congregations including entire congregations be turned away from testing because they are not in the “high-risk” groups. Many of these people live in communities where asking for an HIV-test from a medical provider carries social and professional consequences as well and is more costly and time consuming for the consumer. Many of these people would be willing to pay $10-12 for an OTC test.

· The ability to test oneself can be extremely empowering.

· The presence and availability of OTC HIV-tests in stores will help market the message that we all can get tested for HIV.

Approval of OTC HIV-tests will not solve the problems we face, but such approval will provide a new option for people. It will provide a new way for those of us who are passionate and committed to stopping the spread of HIV to reach out. To be sure, vigilance about compassion, linkage to care, and factual education is required. We view these tests as a means to accomplishing all of this.

Christine Harris, Woman to Woman Advocate

Austin, TX

RJ Hadley, Community Organizer, Activist

Chicago, IL

Brad Ogilvie, Program Coordinator, HIV-testing advocate

William Penn House, Washington, DC

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