Findings from the First Year of a Federally Funded, Direct-to-Consumer HIV Self-Test Distribution Program — United States, March 2023–March 2024

Abstract

In September 2022, CDC funded a nationwide program, Together TakeMeHome (TTMH), to expand distribution of HIV self-tests (HIVSTs) directly to consumers by mail through an online ordering portal. To publicize the availability of HIVSTs to priority audiences, particularly those disproportionately affected by HIV, CDC promoted this program through established partnerships and tailored resources from its Let’s Stop HIV Together social marketing campaign. The online portal launched March 14, 2023, and through March 13, 2024, distributed 443,813 tests to 219,360 persons. Among 169,623 persons who answered at least one question on a postorder questionnaire, 67.9% of respondents were from priority audiences, 24.1% had never previously received testing for HIV, and 24.8% had not received testing in the past year. Among the subset of participants who initiated a follow-up survey, 88.3% used an HIVST themselves, 27.1% gave away an HIVST, 11.7% accessed additional preventive services, and 1.9% reported a new positive HIVST result. Mailed HIVST distribution can quickly reach large numbers of persons who have never received testing for HIV or have not received testing as often as is recommended. TTMH can help to achieve the goal of diagnosing HIV as early as possible and provides a path to other HIV prevention and care services. Clinicians, community organizations, and public health officials should be aware of HIVST programs, initiate discussions about HIV testing conducted outside their clinics or offices, and initiate follow-up services for persons who report a positive or negative HIVST result.

Introduction

Distributing HIV self-tests (HIVSTs) is an effective (1) and cost-effective (2,3) means of providing HIV testing for persons who could be living with undiagnosed HIV infection, including gay, bisexual, and other men who have sex with men (MSM). HIV self-testing is recommended as a testing strategy for diverse populations worldwide (4) and is considered an important strategy in the Ending the HIV Epidemic in the US (EHE) initiative (5,6). HIVSTs can also facilitate access to antiretroviral treatment, HIV preexposure prophylaxis (PrEP), and other prevention services (1,7). In September 2022, CDC funded Emory University and its partners, Building Healthy Online Communities (BHOC), OraSure Technologies, Signal Group, and NASTAD to expand a nationwide HIVST distribution program with a goal of distributing at least 1 million HIVSTs over 5 years.* CDC’s national Let’s Stop HIV Together campaign^† designed tailored promotions for priority audiences (i.e., persons disproportionately affected by HIV, including MSM, transgender women [of any race], and cisgender non-Hispanic Black or African American [Black] women)^§ to order HIVSTs. This report describes the first year of the program, Together TakeMeHome (TTMH),^¶ which launched March 14, 2023.

Methods

The TTMH program mails up to two Food and Drug Administration–approved HIVSTs at no cost to the participant to persons aged ≥17 years in the United States (including Puerto Rico) who place an order through the site, irrespective of health insurance or immigration status. After ordering and indicating whether they are willing to receive future communication, program participants are asked to describe themselves by answering a brief postorder questionnaire. Participants who opted into future communications received follow-up evaluation surveys 10 and 60 days after their order. Participants may reorder HIVSTs every 90 days. Demographic characteristics and previous HIV testing history were summarized for all persons who provided any postorder information after their first order from the program.** Among those who responded to a follow-up evaluation survey, percentages^†† of respondents who used an HIVST themselves, shared an HIVST with others, accessed other HIV and sexually transmitted infection (STI) prevention services, or received a positive HIV test result on an HIVST they used, were stratified by participant demographic characteristics and geographic information collected to process the order. All analyses were conducted using SAS software (version 9.4; SAS Institute). These programmatic activities were reviewed by CDC, deemed not research, and conducted consistent with applicable federal law and CDC policy.^§§

Results

During March 14, 2023–March 13, 2024, TTMH distributed 443,183 tests to 219,360 persons, including 16,365 (7.5%) who ordered from the program more than once. Overall, 86.0% of orders were for two HIVSTs; 14.0% were for only one test. Among 169,623 (77.3%) persons who completed at least one postorder question, the majority were aged <35 years (60.1%), cisgender men (71.5%), identified as Hispanic or Latino (Hispanic) or Black (54.7%), and lived in large central or fringe metropolitan counties (59.5%); one half lived in EHE focus jurisdictions^¶¶ (Table 1). Approximately two thirds (65.3%) of orders were placed by persons recruited from messaging tailored for gay and bisexual men on lesbian, gay, bisexual, transgender, and queer-plus (LGBTQ+)–focused dating apps. Overall, 54.6% of orders could be attributed to one of the priority audiences, and an additional 13.3% with missing information came to the program from promotions on an LBGTQ+ dating app. Few persons (7.3%) were currently using PrEP or had received an HIV diagnosis (2.4%); a message generated on the TTMH website encouraged these persons to give their HIVSTs to others who might benefit more from the test. Overall, 24.1% of persons had never previously received testing for HIV and 24.8% had not received testing within the previous year. The proportion who had never received testing varied substantially by age (from 45.4% among those aged 17–24 years to 13.2% among those aged 35–44 years), gender identity (from 35.2% among transgender men to 23.5% among cisgender men), and county population density (from approximately 31.0% in noncore and micropolitan [more rural] areas to 20.7% in large central metropolitan areas [urban centers or cities]). Among priority audiences, the highest percentage of persons who reported receiving testing during the previous 12 months (58.4%) were Black cisgender MSM.

Among the 14,217 HIVST recipients who responded to at least one question on either the 10- or 60-day follow-up survey, 88.3% reported that they had used an HIVST themselves; 27.1% gave away an HIVST; 11.7% (1,171 of 10,048) accessed additional preventive services (including 4.8% who accessed PrEP services); and 8.6% accessed additional STI testing after ordering from TTMH (Table 2). Sharing HIVSTs with others was more commonly reported by persons aged >35 years; those living in small metropolitan, micropolitan, or noncore counties; and Black cisgender women. Among priority audiences, the largest percentages to access PrEP and STI testing were cisgender MSM (6.5%) and transgender women (11.3%), respectively. Among 7,893 persons who used the HIVST themselves and who had not reported a previous HIV diagnosis, 151 (1.9%) reported receiving a positive test result; nearly every demographic group included at least one person who reported receiving a positive test result. The highest percentages of persons who reported receiving a positive test result were transgender women (3.6%), Black MSM (3.0%), and Hispanic MSM (2.9%); the lowest percentage was reported by Black cisgender women (0.8%).

Discussion

In its first year, TTMH distributed approximately 440,000 tests, which exceeded the program’s initial expectations of 200,000 for that year as well as the number reported for all other CDC-funded test sites considered nonclinical settings in 2021, combined (8). The percentage of persons reporting new positive HIVST results in TTMH was also approximately twice as high as that reported for all CDC-funded HIV testing in in-person settings (8). These data demonstrate that providing HIV self-tests was an effective option to reduce barriers for persons who are not otherwise receiving testing in clinic- or community-based settings. The program reached many persons who had not previously received testing for HIV as well as persons who had not received testing during the previous year, even among populations most affected by HIV. Nearly all persons who ordered from TTMH used an HIVST themselves, and approximately one quarter gave an HIVST to others, thereby extending the reach of the program. Within a relatively short time after ordering from TTMH, approximately 12% of participants sought out additional HIV and STI services, which demonstrates that mailed HIVSTs have not only the potential to increase HIV testing, but also might lead to additional important prevention and care-seeking behaviors.

The outcomes achieved by TTMH were the result of partnerships with LGBTQ+ dating apps (led by BHOC) and advertising implemented through CDC’s Let’s Stop HIV Together campaign.*** These efforts included marketing to populations disproportionately affected by HIV, including geographically based promotions within EHE jurisdictions. Tailored approaches helped the program address health equity by specifically attempting to reach populations disproportionately affected by HIV, including MSM (especially Black and Hispanic MSM), Black cisgender women, and transgender women. In addition, the program reached groups that included very high percentages of persons who reported never having received testing for HIV before they accessed the program, including young adults, transgender men, and other gender-diverse persons. Reaching these populations with HIV testing is critical to ensuring equitable access to care and prevention services. These populations might experience increased barriers to traditional in-person HIV testing methods, such as travel time and distance, cost, medical mistrust, and stigma. Mailed HIVSTs remove some of these barriers and thereby have the potential to expand equitable access to HIV testing.

Limitations

The findings in this report are subject to at least two limitations. First, only 63.2% of all participants (138,698 of 219,360) provided sufficient demographic and sexual behavior information to permit ascertainment of whether they belonged to a priority audience. However, 73.0% of participants (22,572 of 30,925) who did not provide this information were recruited from LGBTQ+ dating apps, which suggests that those with missing demographic or sex behavior data are likely members of a priority audience. Combined, approximately two thirds (67.9%) of first-time orders were classified as being from priority audiences, but this might not directly correlate with their risk for acquiring HIV. Second, compared with in-person HIV testing programs, HIV self-testing programs face additional challenges of documenting traditional testing outcomes, including laboratory testing and subsequent HIV care or prevention services. TTMH, the Let’s Stop HIV Together campaign, and the materials in the HIVST packaging offer multiple resources to help users interpret their HIVST results and access services after testing; data from CDC-funded self-testing research has indicated that persons who use self-tests seek follow-up care at rates similar to those of persons using community-based testing (1). However, the low response rate for the 10- and 60-day follow-up surveys limits the data available to evaluate who is accessing these services and might have introduced bias in the evaluation of the program if, for example, persons who completed the follow-up survey were more likely to have had a positive self-test result or to have sought additional services. The low response to the follow-up surveys suggests a need to identify other supplemental evaluation approaches, such as cross-sectional surveys of randomly selected participants. In addition, health care providers can document patient-reported previous HIVST use when providing HIV testing to their patients; the HIV surveillance system case report form^††† has been updated to document use of HIV self-tests among persons with newly diagnosed HIV infections.

Implications for Public Health Practice

HIV self-testing is, and will continue to be, an important means for increasing awareness of HIV status and facilitating access to HIV prevention and care. Clinicians, community organizations, and public health officials need to be aware of HIVST programs, initiate discussions about HIV testing conducted outside their clinics or offices, and initiate follow-up services for persons who report a positive or negative HIVST result.