Free HIV self-tests boost diagnoses in CDC study

By Emily Hayes, LabPulse.com editor in chief

November 18, 2019 -- Providing free HIV self-tests to men who have sex with men (MSM) doubled the number of reports of the infection in a yearlong study by the U.S. Centers for Disease Control and Prevention (CDC). Results were published online November 18 in JAMA Internal Medicine.

Scanning electron microscopic image of HIV-1 virions budding from cultured lymphocyte
Scanning electron microscopic image of HIV-1 virions budding from cultured lymphocyte. Image courtesy of the CDC: C. Goldsmith, P. Feorino, E.L. Palmer, W.R. McManus.

The Evaluation of Rapid HIV Self-testing Among MSM Project (eSTAMP) was designed to evaluate the effect of internet intervention and mailed HIV self-tests for men at risk. Two tests were used: OraQuick of oral fluids (OraSure Technologies) and the Sure Check HIV 1/2 finger-stick blood test (Chembio Diagnostics Systems).

Using dating websites and other online channels, the researchers recruited 2,665 participants who reported having had anal sex within the past year and who were either HIV-negative or did not know their status; 16.6% had never been tested.

There were twice as many new diagnoses in men who were mailed free test kits than in those who did not get free kits, concluded lead author Capt. Robin MacGowan, a research officer in the CDC's Division of HIV/AIDS Prevention, and colleagues in JAMA Internal Medicine. Furthermore, the men who received the tests were not instructed to share them; however, they often did pass them on in their social circles, which led to 34 newly identified infections outside of the study population, according to the researchers.

"To our knowledge, this study is the first nationwide, large, internet-based, randomized clinical trial of HIV self-testing in the United States, and participants were not required to interact with healthcare providers, counselors, or peers," they wrote. "By mailing HIV self-tests, this design aimed to increase distribution efficiency and reduce some of the barriers associated with clinical and peer-based HIV testing programs, such as patient and physician time, testing costs, stigma, and face-to-face interactions."

Test cost is a barrier

Although much progress has been made regarding HIV, with the number of new cases dropping in the U.S., fewer than half of adults have ever been tested and approximately 15% with HIV are unaware of their infection, research shows.

Self-testing, in theory, could expand the number of diagnoses. The OraQuick test for HIV-1 and HIV-2 was approved by the U.S. Food and Drug Administration in 2012 for use in preliminary testing; self-tests do need to be followed up with a confirmatory test. Globally, about 20 different self-tests are commercially available, according to market research firm Kalorama Information, a sister company of LabPulse.com.

"Despite high hopes and the considerable consequences of HIV infections, self-tests have not been largely successful -- actual revenues are limited," said Bruce Carlson, publisher of Kalorama Information. "Consumer resistance to testing without a doctor's encouragement has been an obstacle, and also the need to do additional testing if there is a positive result."

MacGowan and colleagues wrote that the use of self-testing in the U.S. is low and that cost is "frequently reported as a barrier."

For the CDC study, participants were offered up to $90 each. All participants were given web-based resources for testing and counseling, and half also received the mailed self-tests. Participants who got the self-tests were given information on test use in online videos; four tests were given at the start of the study and could be replenished after each quarterly survey.

Those who had a positive result during the study were asked to complete a dried blood spot card and submit it for analysis by the CDC. The other participants were asked to submit a dried blood spot card at the end of the study.

Among the participants, 77% in the self-test group and 73% in the control group filled out at least one survey. In the self-testing group, 25 new infections were reported, compared with 11 in the control group, a statistically significant difference (see table). After the study, eight additional cases (five in the self-test group and three in the control group), were reported.

The authors noted that they did not receive dried blood spot cards from all participants who reported a positive self-test result, and, consequently, they were only able to confirm results with lab testing in 18 of 44 (40.9%) cases.

They also found that most of the infections were reported in the first three months of the study.

"These results also reinforce the importance of the screening recommendations: participants who had not tested in the past year accounted for nearly half of the newly identified infections in the study," MacGowan and colleagues wrote.

Highlights of eSTAMP: Positive results
Study measure Self-testing group (n = 1,325) Control group (n = 1,340) p-value for difference
No. of new HIV infections 25 (1.9%) 11 (0.8%) 0.02
Infections reported in first 3 months of study 12 (0.9%) 2 (0.1%) < 0.01
Source: MacGowan et al, JAMA Internal Medicine.

Need for follow-up

With self-testing, there have been concerns about whether people who get a positive result follow up with professionals in person. In eSTAMP, telephone counseling was provided for people who had positive results, and more than 70% reported getting healthcare. The researchers also did not see an increase in sexually risky behavior.

Positive results were more common in the participants' social networks than among the participants themselves.

"Hence, this approach may be a useful strategy to reach MSM, especially those who are not testing at least annually, and those who have never accessed existing HIV testing services," MacGowan and colleagues wrote.

They advised that further research is needed on how to implement programs for HIV self-testing to identify cost-effective approaches in public health programs.

The study demonstrates that free self-tests facilitate HIV testing in a high-risk population, Dr. Julia Janssen, University of California, San Francisco internist, and Dr. Mitchell Katz, CEO of NYC Health + Hospitals, wrote in an accompanying editorial, also published November 15 in JAMA Internal Medicine.

"The self-testing kits targeting individuals at high risk of acquiring HIV complement the use of PrEP [preexposure prophylaxis], and are another way to accelerate the end of the epidemic," Janssen and Katz wrote.

Vela wins FDA clearance for HIV-1 genotyping NGS assay
Vela Diagnostics USA has garnered U.S. Food and Drug Administration (FDA) marketing approval for its Sentosa SQ HIV-1 genotyping assay, a test designed...
Mylan, Atomo 15-minute HIV self-test gets WHO backing
Mylan and Atomo Diagnostics' handheld, rapid HIV test has received prequalification approval from the World Health Organization (WHO), which signifies...
Will new HIV recommendations boost test volume?
New recommendations released June 11 from the U.S. Preventive Services Task Force continue to strongly advise HIV screening for adolescents and adults,...
STD test market grows with incidence, new tech
The need to make screening and testing of sexually transmitted diseases (STDs) more accessible worldwide is creating opportunities for manufacturers of...
Quest sells STD tests directly to consumers
Quest Diagnostics has launched new test packages for sexually transmitted diseases (STDs) that will be sold directly to consumers as part of its QuestDirect...

Copyright © 2019 LabPulse.com

Last Updated np 11/15/2019 5:08:49 PM



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email