# Presentation: 864556

## Over The Counter HIV TestingEstimating The Public Health Benefit – Recommendations for Required Accuracy 

- Freya Spielberg, MD MPH
- Freya@u.washington.edu

## Public Health Risk vs. Benefit 

- Risks
- False negatives – undiagnosed HIV
- False positives – negative emotional reactions.
- Benefits
- Greater knowledge of HIV status – decreased HIV incidence
- Early treatment – Decreased morbidity, mortality, negative economic and psychological consequences.

## Weighing the Risks and Benefits 

- Surveys of Acceptability of OTC Testing1,2
- Experience with Home Specimen Collection3
- Self-Testing Study – Positive Perspective4,5
- Effective Sensitivity6

## Public Health Risk vs. Benefit 

-    If OTC results in more people overall with HIV learning their status then the benefits will likely outweigh the risks.

## Will OTC Reach The Untested?

- Two survey studies among high risk (N=460, N=354), Seattle and San Francisco -OTC preferred by 20 to 24%1,2
- OTC significantly preferred by people who had never tested. 1
- In self-testing study among 240 people with HIV, 61% preferred to learn their results with OTC over clinic testing.3,4
- Home Specimen Collection (HSC) post marketing study - 49% of 1494 HIV positive users had never tested before. 5
- OTC preferred 20 to 24 times more than HSC1,2
- Conclusion:  It is likely that an OTC will reach a substantial number of people with HIV who have never tested before.

## How Accurate Does an OTC Need to be for the Public Health Benefits to Outweigh the Risks?

- Effective Sensitivity –The % of true positives identified in a population when testing is available: Assume performance sensitivity is 99% for staff-testing and 95% for OT C.
- If staff-based rapid testing is accepted by 50% of the people with unidentified HIV,
- and adding an OTC results in an additional 20% of those infected testing
- then the Effective Sensitivity of the staff test would be 49.5% whereas the effective sensitivity in a population where OTC tests were also available would be 66.5%.

## A Case for Lowering the Accuracy Bar for FDA approval of an OTC 

- It is unlikely that people at highest risk will have as high performance accuracy as trained staff.
- In our pilot (N=240) of self testing we found 95% self-testing sensitivity 3
- Requiring equivalent accuracy to lab-based tests (98%) will discourage companies from performing clinical trials.
- Although the test performance sensitivity of an OTC may be somewhat lower than a staff-based test, the overall effective sensitivity of OTC testing will be comparably much higher.

## Recommendations for Accuracy Criteria for OTC Approval

- Standard Clinical Trails – Require performance sensitivity/specificity of _>_ 95%.
- Or require clinical trials that measure effective sensitivity.

## References

**Spielberg F, Branson B, Goldbaum G, Lockhart D, Kurth A, Celum C, Rossini A, Critchlow C, Wood R. Overcoming Barriers to HIV Testing: Preferences for New Strategies Among Clients of a Needle Exchange, an STD Clinic and Sex Venues for MSM. JAIDS *****2003; 32(3):318-327.***
***Skolnik HS, Phillips KA, Binson D, Dilley JW. Deciding where and how to be tested for HIV: what matters most? J Acquir Immune Defic Syndr 2001; 27: 292–300.***
***Spielberg F, Levine RO, Weaver M.  Self-testing for HIV: a new option for HIV prevention? Lancet Infect Dis. 2004 Oct;4(10):640-6. Review.***
***Spielberg F, Camp S, Ramachandra E.  HIV Home Self-Testing: Can It Work?  2003 National HIV Prevention Conference, Atlanta, July 27-30, Abstract #1007. ***
***Branson B. Home sample collection tests for HIV infection. JAMA 1998; 280: 1699–701.***