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Evaluation of an HIV Nucleic Acid Testing Program With Automated Internet and Voicemail Systems to Deliver Results

Sheldon R. Morris, MD, MPH; Susan J. Little, MD; Terry Cunningham, MAOM; Richard S. Garfein, PhD, MPH; Douglas D. Richman, MD; and Davey M. Smith, MD, MAS
[+] Article and Author Information

From the University of California, San Diego, San Diego Health and Human Services, and Veterans Affairs San Diego Healthcare System, San Diego, California.


Acknowledgment: The authors thank Dr. Michael Busch and his laboratory for their expert guidance on HIV diagnostic testing and for their support of detuned HIV EIA testing at the Blood Systems Research Institute in San Francisco.

Grant Support: By National Institutes of Health grants MH083552, AI077304, AI69432, MH62512, AI27670, AI38858, AI43638, AI43752, AI047745, NS51132, DA026306, AI29164, AI47745, AI57167, AI074621; UCSD Centers for AIDS Research grant AI36214; and California HIV/AIDS Research Program grant RN07-SD-702.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2510.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available from Dr. Morris (e-mail, shmorris@ucsd.edu).

Requests for Single Reprints: Sheldon Morris, MD, MPH, University of California, San Diego, Antiviral Research Center, 200 Arbor Drive, Mail code 8208, San Diego, CA 92103; e-mail, shmorris@ucsd.edu.

Current Author Addresses: Drs. Morris, Little, Garfein, and Smith: University of California, San Diego, Antiviral Research Center, 200 Arbor Drive, Mail Code 8208, San Diego, CA 92103.

Mr. Cunningham: HIV, STD and Hepatitis Branch, 3851 Rosecrans Street, Suite 207, MS P505, San Diego, CA 92110.

Dr. Richman: 9500 Gilman Drive, Mail Code 0679, La Jolla, CA 92093-0679.

Author Contributions: Conception and design: S.R. Morris, S.J. Little, D.M. Smith.

Analysis and interpretation of the data: S.R. Morris, S.J. Little, R.S. Garfein, D.D. Richman, D.M. Smith.

Drafting of the article: S.R. Morris, S.J. Little, R.S. Garfein, D.M. Smith.

Critical revision of the article for important intellectual content: S.R. Morris, S.J. Little, D.D. Richman, D.M. Smith.

Final approval of the article: S.R. Morris, S.J. Little, T. Cunningham, R.S. Garfein, D.D. Richman, D.M. Smith.

Provision of study materials or patients: S.J. Little, T. Cunningham, D.M. Smith.

Statistical expertise: S.R. Morris.

Obtaining of funding: S.R. Morris, S.J. Little, D.D. Richman, D.M. Smith.

Administrative, technical, or logistic support: S.R. Morris, T. Cunningham, D.D. Richman, D.M. Smith.

Collection and assembly of data: S.R. Morris, S.J. Little, D.M. Smith.


Ann Intern Med. 2010;152(12):778-785. doi:10.7326/0003-4819-152-12-201006150-00005
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Background: Nucleic acid testing (NAT) in routine HIV testing programs can increase the detection of infected individuals, but the most effective implementation of NAT remains unclear.

Objective: To determine how many HIV cases can be identified with NAT and how many persons can be contacted, to identify predictors of acute and early HIV infection cases, and to test reporting of negative results by automated Internet and voicemail systems.

Design: Prospective study.

Setting: San Diego County, California.

Participants: Persons seeking HIV testing.

Measurements: Rates and predictors of HIV infection by stage, notification of positive NAT results, use of automated Internet or voicemail systems to access negative NAT results, and estimated HIV infections prevented.

Results: Of 3151 persons tested, 79 had newly diagnosed cases of HIV: 64 had positive results from rapid HIV test, and 15 had positive results only by NAT (that is, NAT increased the HIV detection yield by 23%). Of all HIV infections, 44% (in 35 persons) were in the acute and early stages. Most participants (56%) and persons with HIV (91%) were men who have sex with men (MSM). All persons with NAT-positive results were notified within 1 week. Of all 3070 uninfected patients, 2105 (69%) retrieved their negative NAT results, with 1358 using the Internet system. After adjustment for covariates, persons reporting MSM behavior, higher incomes, younger ages, no testing at substance abuse rehabilitation centers, no recent syphilis, and no methamphetamine use were more likely to access negative NAT results by either Internet or voicemail systems.

Limitation: Findings may not be generalizable to other populations and testing programs.

Conclusion: Nucleic acid testing programs that include automated systems for result reporting can increase case yield, especially in settings that cater to MSM.

Primary Funding Source: California HIV/AIDS Research Program and the National Institutes of Health.

Figures

Grahic Jump Location
Figure.
Study flow diagram.

EIA = enzyme-linked immunoassay; HCV = hepatitis C virus; ID = identification; IFA = immunofluorescent assay; NAT = nucleic acid test; RT = rapid test.

Grahic Jump Location

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Comments

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Two additional implications of HIV nucleic acid testing study
Posted on June 29, 2010
Benjamin Armbruster
Dept of Industrial Engineering and Management Sciences, Northwestern University
Conflict of Interest: None Declared

This study finds that nucleic acid testing (NAT) will identify a significant number of HIV infections not detected with HIV antibody tests. There are two additional implications of this study that are not discussed in the paper. These are a remarkably high incidence rate and a significant tendency for patients to seek testing shortly after a suspected infection.

Of the 3151 patients, 35 had acute or early infections, infections that are less than 133 days old (95% CI, 113 to 160 days). This suggests an incidence rate of r = (35/3151) / 133 * 365 = 3.1% / year (CI, 2.1% to 4.3% / year). For comparison, the CDC estimates that men who have sex with men (MSM) comprise 4% of the US male population aged 13 and older (implying an estimate of 5 million for 2006) [1] and that in 2006 there were 28,700 new HIV infections in the US among MSM [2]. This implies an incidence rate of 0.6% / year among MSM.

The second implication concerns the common assumption that testing is independent of infection; that is, patients do not preferentially seek testing in the period immediately after infection. However, if this were the case then we would have only 3151 * (1-exp(-r*10/365)) = 2.6 (CI, 0 to 7) acute infections (infections that are less than 10 days old; CI, 7 to 14 days) instead of the 15 infections that were found. Thus a significant contributor to the effectiveness of NAT is the tendency of patients to seek testing shortly after a suspected infection.

[1] Hall HI, Song R, Rhodes P, Prejean J, An Q, Lee LM, et al; HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008;300:520-9. [PMID: 18677024]

[2] CDC. HIV and AIDS among Gay and Bisexual Men. 2010. http://www.cdc.gov/nchhstp/newsroom/docs/FastFacts-MSM-FINAL508COMP.pdf

Conflict of Interest:

None declared

Response to comment
Posted on August 20, 2010
Sheldon Morris
University of California, San Diego
Conflict of Interest: None Declared

In this comment on our manuscript it is highlighted that the rate of incidence of HIV at San Diego HIV testing sites in this study are higher than estimates for general population of MSM in the United States and the number of acute infections are disproportionate to the expected number. These numbers would suggest that individuals seeking HIV testing are higher risk and may be responding to recent risk behaviors where they are concerned that they may have been exposed to HIV. During the time of this study we gathered some limited data in 2007 on whether testers reported any symptoms compatible with early HIV infection or thought they had a specific exposure. There were 104/218 (47.71%) of individuals that thought they had a specific exposure and 3/104 (2.88%) had early HIV infection compared to 2/114 (1.75%) that did not report a specific exposure (P=0.671). A smaller group reported symptoms that could be compatible with early HIV infection and 3/40 (7.5%) had early HIV compared to 2/173 (1.16%) of those without symptoms (P=0.047). These limited data would support that individuals seeking HIV testing are likely higher risk and may be testing because they perceived themselves at risk but they were not more likely to have early HIV. However, those testing because of symptoms are more likely to have HIV. It is possible that offering NAT may promote HIV testing among high risk individuals , which is a good thing. High HIV incidence among those seeking the Early Test supports the targeting strategy of NAT screening for the highest yield.

Conflict of Interest:

None

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Summary for Patients

HIV Nucleic Acid Testing Program With Automated Internet and Voicemail Systems

The summary below is from the full report titled “Evaluation of an HIV Nucleic Acid Testing Program With Automated Internet and Voicemail Systems to Deliver Results.” It is in the 15 June 2010 issue of Annals of Internal Medicine (volume 152, pages 778-785). The authors are S.R. Morris, S.J. Little, T. Cunningham, R.S. Garfein, D.D. Richman, and D.M. Smith.

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