Universal and routine testing for human immunodeficiency virus (HIV) is critical in identifying undiagnosed individuals with HIV infection.1–3 The approval of the oral-fluid rapid HIV self-test (Orasure Technologies Inc, Bethlehem, PA), without professional supervision in the United States has expanded opportunities for HIV testing in nonclinical settings.4,5 Self-testing offers convenient HIV testing option and can minimize privacy concerns that an individuals may have about in-person testing at clinic settings. This possibility can result in earlier diagnosis of HIV infection, which in turn facilitates access to antiretroviral treatment and achievement of virological suppression to improve individual health and stem onward HIV transmission.6
Nevertheless, concerns about self-testing persist, including whether individuals will seek confirmation and care after an HIV-positive rapid self-test.4,7,8 In addition, the cost (US $40.00 to US $46.00 per test kit)9–12 in the United States may limit use in persons of lower socioeconomic status; among them, populations at high risk of HIV infection (aged ≤40 years and black or Hispanic men who have sex with men [MSM]).
In NYC, most HIV diagnoses occur among MSM, persons aged ≤40 years or blacks and Hispanic race/ethnicity.13 The NYC Department of Health and Mental Hygiene staff attempt to contact and offer HIV contact tracing, also known as partner services (PS) to all persons newly diagnosed with HIV. We analyzed PS program data of persons newly diagnosed with HIV and compared the sociodemographic characteristics of the PS clients by report of self-test technology use before their first confirmatory HIV diagnosis. We also assessed the timeliness with which persons who reported using self-test technology sought the HIV laboratory-based confirmatory test from a health care provider that prompted the provision of PS and HIV care.
The HIV Field Services Unit (FSU) within the NYC Department of Health and Mental Hygiene is staffed with disease intervention specialists (DIS). DIS identify persons needing PS via provider report, laboratory reports received by the HIV surveillance registry or self-referral by HIV-positive persons. Using a standard data collection form, DIS interview index cases to elicit their exposed sex or needle-sharing partners, partners are notified of their exposure to HIV and offered HIV testing. All HIV-positive index cases and partners are assisted with linkage to HIV care.14
During the interview and/or through medical record abstraction, DIS obtain information on the HIV-diagnosed persons' sociodemographic characteristics and HIV transmission risk (e.g., MSM, condomless sex, sex with previously HIV-diagnosed person, injection drug use). DIS also obtain persons' HIV testing history before diagnosis and HIV clinical stage at the time of diagnosis. Beginning in January 2013, we added questions to our standard data collection instrument so that DIS can elicit from interviewed persons or obtain via medical record abstraction whether persons had used HIV self-test before their first laboratory-based HIV diagnosis. For persons who report a history of self-testing before their confirmatory HIV-positive test results, DIS obtain the date and result of the last self-test preceding laboratory-based confirmatory testing. HIV confirmatory testing is defined as HIV diagnostic testing (e.g., fourth generation and Western blot testing technologies and/or HIV RNA viral load [VL]) by medical providers of persons who self-tested to establish the absence or presence of HIV infection.
We analyzed data from 2 sources: the FSU database and the NYC HIV surveillance registry. The FSU database is a case management database for tracking PS activities, including index case interview and partner notification and HIV testing. The NYC population-based registry of all persons diagnosed with acquired immune deficiency syndrome (AIDS) in NYC since 1981 and HIV since 2000 is continuously updated with incoming-matched HIV-related laboratory results, which since 2005 have included CD4 T-cell counts, VL results, nucleotide sequences from HIV genotypes, and positive HIV detection tests. Vital status for PLWH in the registry is updated through quarterly matches with local vital records data, and annual matches to the National Death Index and Social Security Death master File. A unique person-level identifier links PLWH across the FSU database and the registry.
We compared sociodemographic characteristics and risk behaviors of all HIV-diagnosed persons who reported self-testing (positive or negative result) to other persons referred for PS who did not report self-testing. We further compared persons whose last self-test results were positive to persons who reported negative self-test results. Sociodemographics include reported age, race/ethnicity, country of birth, sexual orientation, income level and education level. We examined the age distribution of our cohorts and found that due to the small sample size of persons who reported self-test, there were small proportions (1% or 4%) in the <20 or >49 years of age groups, respectively. The median/median ages of persons who did not report self-testing (37/34) years and persons who self-tested (33/31) were >30 years. Therefore, we created 2 age groups (<30 years and ≥30 years). In an attempt to assess income levels, we used United Health Fund (UHF) area-based poverty categories as a proxy. UHF area-based poverty is defined as the percent of the population in a given NYC ZIP code whose household income is below the federal poverty level. For all PS clients, we compared: (1) HIV-related risk behaviors in the 12 months preceding their confirmatory HIV diagnosis: MSM, condomless sex, and anal sex; (2) the number of times they tested for HIV in the past 2 years; and (3) the reasons they gave for seeking a laboratory-based HIV confirmatory test.
Three outcomes for persons reporting positive versus negative self-test results were examined: (1) time from last self-test to HIV laboratory-based confirmatory test which we categorized as “early” (≤1 month) or “delayed” (>1 month); (2) acute or recent HIV infection and late infection on confirmatory testing (AIDS diagnosis within 31 days of HIV diagnosis); and (3) timely linkage to HIV care, which is defined as the report of HIV VL RNA and/or CD4 T cell count within 91 days of HIV diagnosis.
Statistical significance of differences between groups was assessed using the χ2 test for proportions and Fisher exact test (P ≤ 0.05). All statistical analyses were conducted using SAS version 9.3 (Cary, NC).
From January 2013 to August 2016, 8032 HIV-positive persons were referred to FSU for PS, of whom 127 (2%) reported having used an HIV self-test before the new HIV diagnosis that prompted the provision of PS (Table 1). Of the 127 who self-tested, 115 (91%) were interviewed by DIS and reported history of self-test during the interviews; the self-test status of the remaining 12 (9%) persons was obtained through medical record review. Compared with the 7905 persons who did not report taking self-test before laboratory-based HIV testing, persons who self-tested were significantly (all P = <0.0001) more likely to be male (96% vs 78%), white/non-Hispanic (46% vs 16%), MSM (92% vs 58%), have college or postgraduate education (67% vs 35%), and reside in medium-high income ZIP codes of NYC (51% vs 44%) (Fig. 1).
Persons who self-tested were more likely to report anal sex in the 12 months before HIV diagnosis (58% vs 34%, P = <0.0001). Self-tested persons more frequently than persons who did not self-test reported routinely testing for HIV (50% vs. 23%, P = < 0.0001). Significantly more self-tested than non-self-tested persons reported having tested for HIV at least once in the past 2 years (69% vs. 40%, P = <0.0001) and were more frequently diagnosed with acute HIV infection (20% vs 11%, P = 0.0004). A higher proportion of persons who self-tested (91%) than persons who did not self-test (81%) linked to HIV care within 3 months of diagnosis as confirmed by the report of HIV RNA VL and/or CD4 T cell count to the HIV Registry.
Through interviews and medical record abstractions, we obtained the results of the last self-tests for 108 individuals; 67 (62%) and 41 (38%) reported self-testing positive or negative, respectively. We found no significant differences between persons in the two groups on sociodemographics and HIV transmission risk factors (Table 2). Among persons who provided the approximate date of their last self-tests, significantly (P<0.0001) more persons with positive (39/44, 89%) than negative (14/36, 39%) self-test results sought laboratory-based HIV test within 1 month of last self-testing. Significantly more persons who self-tested negative than persons who self-tested positive reported having tested for HIV at least once in the past 2 years (88% vs. 56%, P = <0.003) and were more frequently diagnosed with acute HIV infection (44% vs. 9%, P<0.0001). Similar proportions of persons who reported a positive (91%) or negative (90%) self-test result linked to care within 3 months of confirmatory HIV diagnosis.
Using PS program data, we assessed the sociodemographic characteristics of newly HIV-diagnosed persons who reported a rapid HIV self-test before their laboratory-based HIV testing and the timeliness with which they sought laboratory-based confirmation of HIV infection. We identified marked sociodemographic differences between persons who reported self-testing and those who did not self-test before their own HIV diagnosis. Although most individuals interviewed for PS were black/non-Hispanic or Hispanic, the vast majority of persons who self-tested were white/non-Hispanic MSM. This is consistent with prior reports that high proportions of certain populations (e.g., MSM) at high risk for HIV infection would use the self-test.8,10 Furthermore, compared with persons who did not report self-test, most persons who reported self-testing were well-educated and reside in medium- to high-income neighborhoods of NYC. This finding lends support to the concern that the cost of over-the-counter self-test kit might make it out of reach to certain populations (e.g., young Black MSM and Hispanics in NYC) at high risk of HIV infection and of lower economic status.9–12
In our study, greater proportions of persons who self-tested than persons who did not self-test reported testing for HIV in the past 2 years. CDC recommends that all persons aged 13 to 64 years be screened for HIV, and at a minimum, annual HIV testing of MSM.1 In NYC, overall rates of persons testing for HIV in the last year have been increasing. The significantly higher proportions of persons who self-tested than persons who did not self-test (69% vs. 40%), and were predominantly MSM (92% vs. 58%) is consistent with previous NYC estimates that found that MSM (60%) test for HIV more frequently than men who have sex with women (34%) or women who have sex with men (45%).15,16
Our study provides encouraging findings with regards to HIV confirmation after self-test and linkage to care once HIV infection is confirmed. Among our study sample, proportion of persons who self-tested positive more than persons who self-tested negative sought earlier HIV laboratory-based confirmatory testing. We observed that persons with negative self-test tested for HIV more frequently than person with positive self-test. We infer that they may have recognized their high-risk HIV acquisition behaviors (e.g., sex with HIV-positive persons, condomless and anal sex) and sought additional HIV screening and confirmatory testing from HIV providers.
As expected, significantly, more people who self-tested negative than people who self-tested positive were diagnosed with acute HIV infection, thus reducing the period of undiagnosed infection. Nevertheless, almost one fourth of persons with negative self-test received concurrent HIV/AIDS diagnosis after laboratory-based testing and provider evaluation. Previous studies found that understanding and correctly completing the complex instructional steps of self-testing, and interpreting the results might be challenging, especially for persons with low literacy.17–19
This report has two main limitations. Our data are based on self-report with its inherent recall bias, including incomplete or missing information on dates and results of last self-test. Further, our findings are based on persons who sought HIV diagnosis after performing self-tests, and therefore may not be generalized to all self-testers. Overall, our results show that the rapid HIV self-test is in use by MSM who have high HIV acquisition risk and persons who self-tested positive sought timely confirmation of HIV infection and linkage to care.
Efforts must be made to make HIV testing, including self-tests, accessible to populations at high risk for HIV infection, among them young Black and Hispanic MSM, and those of lower socioeconomic status. HIV self-test has the potential to make HIV testing more accessible to certain populations, thereby reducing the proportion of people currently unaware of their infection. However, the financial burden may be a barrier to accessibility for the most vulnerable populations. The notified partners reached by FSU's PS program are persons, especially MSM, blacks, and Hispanics with direct exposure to HIV-diagnosed persons, who are therefore at highest risk for HIV acquisition, and would benefit from HIV testing. In response, since 2013, the FSU has offered self-test kits at no cost to persons notified of HIV exposure, who refuse HIV testing by DIS, and express unwillingness to seek HIV-testing from a medical provider.
1. Final Update Summary: Human Immunodeficiency Virus (HIV) Infection: Screening. U.S. Preventive Services Task Force. July 2015. http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/human-immunodeficiency-virus-hiv-infection-screening
. Accessed April 23, 2016.
2. Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006; 55:1–17.
3. Granich RM, Gilks CF, Dye C, et al. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: A mathematical model. Lancet 2009; 373:48–57.
4. Paltiel AD, Walensky RP. Home HIV testing: Good news but not a game changer. Ann Intern Med 2012; 157:744–746.
5. Myers JE, Elsadr WM, Zerbe A, et al. Rapid HIV self-testing: Long in coming but opportunities beckon. AIDS 2013; 27:1687–1695.
6. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365:493–505.
7. Thurn MW, Gardner EM, Rietmeijer CA. Home HIV testing: If you build it, will they come? AIDS 2013; 27:1825–1826.
8. Lippman SA, Moran L, Sevelius J, et al. Acceptability and feasibility of HIV self-testing among transgender women in San Francisco: A mixed methods pilot study. AIDS Behav 2016; 20:928–938.
9. OraSure Technologies. Where to buy. 2015. http://www.oraquick.com/where-to-buy
. Accessed March 2, 2017.
10. Myers JE, Bodach S, Cutler BH, et al. Acceptability of home self-tests for HIV in New York City, 2006. Am J Public Health 2014; 104:e46–e48.
11. Rosales-Statkus ME, Belza-Egozcue MJ, Fernandez-Balbuena S, et al. Who and how many of the potential users would be willing to pay the current or a lower price of the HIV self-test? The opinion of participants in a feasibility study of HIV self-testing in Spain. Enferm Infecc Microbiol Clin 2014; 32:302–305.
12. Nunn A, Chan P, Towey C, et al. Acceptability and affordability of self HIV testing in an urban neighborhood with 3% seroprevalence . Paper presented at 21st Conference on Retroviruses and Opportunistic Infections, Boston; 2014.
13. HIV Epidemiology and Field Services Program. HIV Surveillance Annual Report, 2015. New York City Department of Health and Mental Hygiene: New York, NY. December 2016. http://www1.nyc.gov/assets/doh/downloads/pdf/dires/hiv-surveillance-annualreport-2015.pdf
. Accessed March 2, 2017.
14. Udeagu CC, Shah D, Shepard CW, et al. Impact of a New York City Health Department initiative to expand HIV partner services outside STD clinics. Public Health Rep 2012; 127:107–114.
15. Edelstein ZR, Myers JE, Cutler BH, et al. HIV testing experience in New York City: Offer of and willingness to test in the context of new legal support of routine testing. J Acquir Immune Defic Syndr 2015; 68:S45–S53.
16. Ransome Y, Terzian A, Addison D, et al. Expanded HIV testing coverage is associated with decreases in late HIV diagnoses. AIDS 2015; 29:1369–1378.
17. Frye V, Wilton L, Hirshfied S, et al. Just because it’s out there, people aren’t going to use it. HIV self-testing among young, black MSM, and transgender women. AIDS Patient Care STDS 2015; 29:617–624.
18. Catania JA, Fortenberry D, Orellana R, et al. Translation of “at-home” HIV testing: response to Katz et al. and Hurt and Powers. Sex Transm Dis 2014; 41:454.
19. Peck RB, Lim JM, van Rooyen H, et al. What should the ideal HIV self-test look like? A usability study of test prototypes in unsupervised HIV self-testing in Kenya, Malawi, and South Africa. AIDS Behav 2014; 18:S422–S432.