HIV self-testing allows people to take an HIV test and find out their result in their own home or other private location. The availability of HIV self-tests in the US may help increase awareness of HIV infection for people who wouldn’t otherwise get an HIV test. While HIV self-tests are available for retail purchase by consumers, CDC encourages health departments to consider HIV self-testing as an additional testing strategy to reach persons most affected by HIV. Findings from self-testing research and additional resources provided below may be helpful if you are considering offering HIV self-testing in your program.
Home Specimen Collection Kit
A home specimen collection kit can be used to test for HIV and sexually transmitted infection (STI). Home collection kits can be ordered by physicians and are covered by most insurance plans. Some laboratories have validated protocols for testing home-collected samples for the panel of tests required for those initiating or continuing PrEP.
Specimen kits are mailed to the patient’s home and contain supplies to collect blood from a fingerstick or other appropriate method (e.g. self-collected swabs and urine). The kit is then mailed back to the lab with test results returned to the clinician who acts on results accordingly. This laboratory-conducted test is sensitive enough to detect recent HIV infection.
More information on home specimen collection kits for HIV and other tests required for PrEP patients will be added to this Web page as it becomes available, including additional laboratories providing this service.
Self-Testing for PrEP
CDC has developed guidance for providing PrEP when facility-based services and in-person patient-clinician contact is limited. Quarterly HIV testing should be continued for patient safety. While lab-only visits for assessment of HIV infection and other indicated tests for the provision of PrEP are preferred, when these are not available or feasible, CDC recommends considering two additional options: home specimen collection kits, which are sensitive enough to detect recent HIV infection; or self-testing via an oral swab-based test.
Although HIV self-tests are usually not recommended for PrEP patients due to their lower sensitivity in detecting recent HIV infection during PrEP use, clinicians could consider use of these tests when other options are not available.
Evaluation of HIV Self-Testing Among Men who have Sex with Men Project (eSTAMP) (2019)
eSTAMP was a national randomized controlled trial designed to evaluate the public health benefits of mailing HIV self-tests to Internet-recruited gay, bisexual and other men who have sex with men (MSM) in the US during 2015-2016 (1). Compared to men in the control arm, men who were mailed HIV self-tests:
- tested themselves more frequently
- identified significantly more prevalent HIV infections
- did not increase sexual risk behaviors
- shared the study HIV self-test with members of their social network, resulting in many more persons becoming aware of their HIV infection.
Mail distribution of HIV self-tests effectively increased diagnosis of HIV infection among gay and bisexual men and identified infections among their social network members. Reaching gay and bisexual men via the Internet for HIV test kit distribution could provide an efficient mechanism for implementing HIV self-testing programs. HIV program planners should consider mailing out HIV self-tests to Internet-recruited gay and bisexual men as an additional component of their HIV prevention portfolio. A smaller trial conducted by Katz et al (2) among gay and bisexual men living in Seattle also found those receiving self-tests tested more frequently but that self-testing did not increase either the report of behaviors that increase risk of HIV infection or the diagnosis of other sexually transmitted infections.
TTMH is an HIV self-testing project with the goal of distributing at least 1 million free HIV self-tests over the next five years. TTMH expands on a prior program where CDC, Emory, Building Healthy Online Communities (BHOC), and other partners distributed 100,000 free HIV self-tests in eight months. As a result of this success, CDC expanded the model to work toward achieving the Ending the HIV Epidemic in the U.S. initiative’s goal of reducing new infections by 90% by 2030. Priority audiences for the program and the Let’s Stop HIV Together campaign outreach include populations with disproportionately high HIV incidence, including gay, bisexual, and other men who have sex with men, particularly Black/African American and Hispanic/Latino gay and bisexual men, Black/African American cisgender women, and transgender women of all races and ethnicities.
TTMH is supported by CDC, in partnership with Emory University, BHOC, National Alliance of State and Territorial AIDS Directors (NASTAD), Signal Group, and OraSure Technologies.
Consumer update: First Rapid Home-Use HIV Kit Approved for Self-Testing
FDA describes the potential impact of this test and the messages that FDA wants to send consumers.
OraQuick In-Home HIV Test
OraSure Technologies provides detailed information about their HIV self-test product, OraQuick In-Home HIV Test. On this page, consumers can find information about the product, written and video instructions of how to use the test, help on how to interpret a result, and the 24/7 customer support phone number.
How to Start an HIV Self-Testing Program
As part of CDC’s HIV Capacity Building Assistance for Health Departments, the New York City Department of Health provided a description of their self-testing programs and considerations for other health departments that want to set up similar programs in May 2019. Learn more about the Home HIV Test Giveaway.
A Summary of HIV Self-Testing Program Models and Lessons Learned
In an effort to document HIV self-testing (HIVST) program models in the United States pdf ico [PDF – 273 KB], two capacity building agencies (CBAs) funded by CDC: Denver Prevention Training Center (PTC) and Washington University St. Louis (WashU), contacted CDC-funded health departments (HDs) and community based organizations (CBOs) that were conducting HIVST. Between July and September 2020, the CBAs had telephone discussions about program implementation from 42 agencies (23 state HDs and 19 CBOs), and collected HIVST standard operating procedures and training materials.
Conversations covered topics such as (1) if/how agencies screen for eligibility, (2) type of HIV test used, (3) distribution methods, (4) follow-up and linkage to prevention/care resources, (5) data collection and management, and (6) incentives. Discussions were summarized to produce this executive summary and a descriptive table (See Appendix A).
HIV Self-Testing in the World
In 2016, WHO published the first global guidelines on HIV self-testing, in which HIV self-testing was recommended to be offered as an additional approach to HIV testing services. WHO also coordinates the HIV self-testing research and policy hub which monitors the use of HIV self-tests around the world.
Testing Beyond the Clinic Webinar Series
The Testing Beyond the Clinic webinar series is designed to provide ongoing information about non clinic-based, self-collected HIV and STD testing logistics and program implementation. This resource will be updated regularly with webinar recordings from the series. Presented by the National Coalition of STD Directors.
Hogenson E, Jett-Goheen M, Gaydos CA. An Analysis of User Survey Data for an Internet Program for Testing for Sexually Transmitted Infections, I Want the Kit, in Maryland and Washington, DC. Sex Transm Dis. 2019;46(12):768‐770. https://pubmed.ncbi.nlm.nih.gov/31663978/
Katz DA, Golden MR, Hughes JP, Farquhar C, Stekler JD. HIV Self-Testing Increases HIV Testing Frequency in High-Risk Men Who Have Sex With Men: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):505-512. https://pubmed.ncbi.nlm.nih.gov/29697595/
MacGowan RJ, Chavez PC, Borkowf CB, Owen SM, Purcell DW, Mermin JH, Sullivan PS, for the eSTAMP Study Group. Effect of internet-distributed HIV self-tests on HIV diagnosis and behavioral outcomes in men who have sex with men: a randomized clinical trial. JAMA Intern Med. Published online November 18, 2019. https://pubmed.ncbi.nlm.nih.gov/31738378/
Peterman, T.A., et al., Preparing for the Chlamydia and Gonorrhea Self-Test. Sex Transm Dis, 2018. 45(3): p. e7-e9. https://pubmed.ncbi.nlm.nih.gov/29420452/
Rotblatt, H., et al., There’s no place like home: first-year use of the “I Know” home testing program for chlamydia and gonorrhea. Am J Public Health, 2013. 103(8): p. 1376-80. https://pubmed.ncbi.nlm.nih.gov/23327247/
Sharma, A., et al., Acceptability and Feasibility of Self-Collecting Biological Specimens for HIV, Sexually Transmitted Infection, and Adherence Testing Among High-Risk Populations (Project Caboodle!): Protocol for an Exploratory Mixed-Methods Study. JMIR Res Protoc, 2019. 8(5): p. e13647. https://pubmed.ncbi.nlm.nih.gov/31045502/
Siegler, A.J., et al., An Electronic Pre-Exposure Prophylaxis Initiation and Maintenance Home Care System for Nonurban Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc, 2019. 8(6): p. e13982. https://pubmed.ncbi.nlm.nih.gov/31199326/
Siegler AJ, Mayer KH, Liu AY, et al. Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program. Clin Infect Dis. 2019;68(3):501‐504. https://pubmed.ncbi.nlm.nih.gov/29982304/