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Why the FDA Should Say "Yes" on a Rapid Over-The-Counter HIV Test

Posted Apr 26 2012 12:55pm

In order to become the generation which ends AIDS we must progressively move forward using new technology to get people tested for HIV.  We must find new ways to empower people to know their HIV status.

It's important to note that an OTC oral/rapid home test is not replacing the conventional way we currently test.  It is an additional resource an additional option .  I believe people should be able to learn their HIV status the way they want to learn it.   I know from traveling and listening to feedback that many people - (including a population of people who have chosen not to know their status using conventional methods) find it intrusive to communicate sexual  behaviors to complete strangers or to anyone at all- we know that this prevents people from going and learning their status - they simply do not want to share their sexual history with another person in their community.  As important as this service can be - we must acknowledge its true, a certain population don't want to get tested that way.  Stigma continues to prohibit folks from being seen going into a clinic.  An OTC test puts the power in the hands of the person wanting to know their status to decide who they tell, how they tell it and where they want to learn their fate.  No one ever said that learning your HIV status is easy.  It's not.  As an HIV-positive individual for nine years, I know firsthand how difficult it can be.

Everyone acknowledges challenges with this type of test - but should these challenges prohibit a population of people who want to know their status from knowing?  I have been very open with the manufacture as well as the FDA about concerns with counseling and linkage to care and partner notification to name a few.  I know many think everyone should have the counseling in person - but why limit our options if someone wants to know what their status is? There will be 24 hour 7 day a week trained professionals available via phone.  This means that the person never has to be identified if they choose not to be - but they will get the support and the linkage to care they need 24 hours a day 7 days a week (I might add hours in which many clinics are not able to offer).  There will be tools for linkage to care and partner notification.  Now a day we have to consider using new tools and technology to help us end this epidemic.  We have to be willing to be open minded and willing to accept new tools in order to make a bigger impact.  (Remember much of this information will be released at the Blood borne Pathogens Committee (BPAC) meeting of the FDA on May 15th.

I have been following this project for 7 years, I have heard and talked to thousands of folks about this.  I personally feel,  now is the time to move forward with OTC - we can't wait any longer we have new tools and if we want to become the generation which ends AIDS, we can't withhold the tools and technology from a generation crying out to wanting to use them.

Together, I believe we can be the generation which ends AIDS.

Tom Donohue
Founding Director, Who's Positive 


 On May 9th or 10th Who's Positive will release the results of a year long survey which asked  If approved by the FDA - Would you support a mouth swab, rapid, over the counter HIV test which could be purchased at a retail store?

If you would like to see the results of this survey or if you would like to follow our work please provide us with your information below.  Additionally, you can follow us at  or on Facebook at

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