Rolling out Determine™, a 4th Gen Rapid HIV Test

thomasBy: Thomas Knoble

“Crap!” I thought to myself. “False positive within our first 20 tests…We’ve put in so much work to get to this point. Did I do something wrong?”

Let me start from the beginning:

We have been doing rapid testing in San Francisco since 2003. Early adopters, that’s how we roll in California. When we heard that the 4th Generation Determine™ test was coming, we started to think about how we could use it in San Francisco. We had great success with our lab-based acute screening for years. Between acute lab screening, increased testing among gay men, other MSM, transwomen, and IDUs (we went from 15,000 to 25,000 tests in 4 years) and treatment as prevention (putting folks on medication as soon as possible), we have seen our HIV rates drop: in 2009, there were 467 new infections compared to 2014, when we had 302 new infections. Now with PrEP rolling out and being a significant part of the National HIV/AIDS Strategy, we are very hopeful that we can get to zero.

Could we do more? Lab-based acute testing is amazing and we are so grateful to be able to run RNA tests after rapid antibody tests, but if we could have a rapid test like Determine™ with a shorter window period, we’d be doing even better: Better linkage to care, better partner services, better health outcomes, and better public health. We thought, of course we should move to Determine™ 4th gen rapid test! Why not change? How hard could it be?



We did all we could to prepare for the roll out: developed trainings, changed quality assurance plans, bought tests, talked with community partners and lab folks, and brainstormed all possible issues. We came up with the following issues to address: the Determine™ test needs a lot more blood; Should we take the window period time from the manufacturer, the lab folks, the clinicians, or the communities impacted? We also had to take into account that change is hard on people. We had our possible pit falls and we made plans to address them.


What we didn’t see coming

When we rolled out rapid in 2003, there was only on test on the market, which meant no competition. The energy from other sales reps this time around has been very noticeable and has at times, surprised me. It makes it hard to look at the data objectively. I hear things like, “Our test is 2nd generation but acts like a 4th generation test,” and I’m not sure what to do with that. Separately, lab folks say you should use the most sensitive test you can find. My background is working with clients, not in a lab, so that’s been something to work out.

Additionally, the issue of false positives has not been any easier. I understand false positives, I have given a number of them. When we started the Determine™ roll out, we had a false positive right off the bat, which was incredibly stressful, but turned into an opportunity.


The Opportunity

I asked, “What are the odds of a false positive in the first 20 tests? Maybe something more happened here. Was it bad luck? User error? Something else entirely?” The folks at the site took a picture of the test, so I explored that and saw a very faint line. I called the manufacturer, and others who were using this test: Tennessee, New Jersey, Michigan, all of whom were so helpful. I decided to take a box of tests and run them using blood known to be HIV negative, to see what these false positive lines looked like.

I started to see patterns that really got me asking, what is a false positive? Is it the user? The test? Perhaps both? And then it hit me: our old way of thinking needed to change. Since 2003, our process had been, “a line is a line is line.” That wasn’t the case anymore and now that required training with a different tone and message. I know this sounds simple but since 2003, we have been looking for any line. With Determine™, we must look for a pink or red line.

The learning process has been very comprehensive. We’ve learned how to get more blood, who to come up with the window period, what we needed to change in our trainings, and working with others from all over the nation as we implemented Determine. This change is hard but very exciting. There’s much more we can talk about, and many lessons we can share from our experience in rolling out Determine™. Join me as I talk more about our experience, lessons learned and next steps on a webinar on August 13, 2015 at 11 am PST.

Check out a recording of Thomas’s webinar on rolling out Determine in San Francisco. The slides can be viewed here (or scroll through them below).

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