HIV testing is a cornerstone of both the National HIV/AIDS Strategy and the Ending the HIV Epidemic in the U.S. (EHE) initiative.^1,2 For people with undiagnosed HIV, testing is an important first step in accessing HIV treatment services, which can improve health and reduce HIV transmission, and increase testing and treatment for other sexually transmitted infections (STIs).^3,4 For people who do not have a diagnosis of HIV infection, testing provides an opportunity to be connected to HIV prevention services, including pre-exposure prophylaxis (PrEP) and STI services. There was a noticeable decrease in HIV testing during the COVID-19 pandemic, as the traditional, in-person testing services became less accessible.^5,6 HIV self-testing programs offer an innovative mechanism to ensure that HIV testing is simple and accessible for everyone.³ Furthermore, HIV self-testing can reduce the barriers associated with testing in clinical settings, thereby increasing HIV testing coverage.

In March 2020, Building Healthy Online Communities (BHOC), a consortium of public health organizations, launched an HIV home test kit ordering website (TakeMeHome.org) that was later scaled up nationally through a 2021 national demonstration project funded by the Centers for Disease Control and Prevention (CDC), called “Together TakeMeHome”.⁷ Although the TakeMeHome website can be accessed by anyone in a participating location, the self-test kits distribution program targets priority populations by sending in-kind messages through dating apps and other online sites primarily accessed by priority populations most at risk of HIV infection. The centralized systems of distributing rapid HIV self-test kits utilized partnerships with health jurisdictions for funding and private dating apps providers for promotion of the program. The website was developed leveraging relationships that BHOC had built over previous years with major gay dating apps. Previous research has indicated a high demand for HIV home testing among men who have sex with men (MSM) who use dating apps, a substantial portion of whom have never been tested for HIV.^8,9

Through the TakeMeHome program, individual health jurisdictions may participate and pay for HIV test kits, enabling eligible constituents to order the pre-purchased kits online at no cost to the constituents. The purpose of this study was to analyze the costs and impact of the TakeMeHome program, using program level data from a range of participating health jurisdictions. Our primary cost measures were the cost per HIV test kit delivered and the cost per new HIV diagnosis.

The collaborative TakeMeHome HIV home testing program provided direct access to HIV self-testing in 17 jurisdictions across 9 states, and the program identified 18 (0.6% positivity) confirmed new HIV diagnoses that were verified with HIV surveillance data. The cost per test delivered was estimated at $59, and the cost per person tested was $65; the cost per confirmed new HIV diagnosis was estimated to be $9,440.

Our cost estimates are within the range reported in a recent cost-effectiveness analysis of a self-testing intervention based on the randomized controlled trial (RCT) of HIV self-testing among MSM (eSTAMP).¹² The self-testing RCT reported the cost per test at $68 and cost per new HIV diagnoses at $10,480 (all costs in 2020 US$); the costs included incentives to participants for reporting test results.

This analysis was not intended to be a formal cost-effectiveness analysis of the costs and health consequences of an HIV testing program. However, formal cost-effectiveness studies have reported that the cost per new HIV diagnosis could be as much as $31,600 (much higher than our estimate of $9,440 for the TakeMeHome pgoram) for a testing program to be cost-saving and $87,100 for a program to be considered cost-effective in the United States (2020 US$).^12,13 In addition, our analysis provides cost estimates based on real-world implementation of self-testing, without offering any incentive to the participants who tested, thus reflecting a more realistic cost-effectiveness scenarios for scaling up self-testing nationally.

Furthermore, the cost of rapid HIV testing in outreach settings using mobile vans, which provide more access to HIV testing in communities who are medically underserved, ranged from $181–$323 per test and from $21,600–$27,300 per new HIV diagnosis.¹⁴ Although the testing cost may be lower ($22–$62/test) in health care settings, e.g., emergency departments and STI clinics,^15–17 individuals are required to travel to the clinics for testing and receipt of results, which requires additional effort and associated costs to patients, which can be a barrier to testing.

The cost of the rapid HIV self-test kits was a major cost driver. Although the unit cost of the self-test kit is largely stable in the private market, costing approximately $45 per kit in most community pharmacies ($45.99, OraQuick In-Home HIV Test, https://www.cvs.com/, accessed 7/1/2022), the TakeMeHome program obtained an average price per test kit of $23.45. This price is about 25% higher than that of the self-test kit used in eSTAMP trial ($18.65/test), where the price was negotiated between the project contractor and manufacturer, OraSure Technologies, Inc., and nearly half of the test kits (SURE CHECK HIV ½ Assay) were used under Investigational Device Exemption from the Food and Drug Administration.¹² When we reduced the self-test kit cost to the TakeMeHome program by 50% from the base case, the cost per test and per new diagnosis was reduced to $47 and $7,580, respectively. Should additional HIV self-tests be approved by the FDA, cost per test would likely drop due to increased competition, thereby enabling an increase in the number of tests each jurisdiction would be able to provide in their area.

Shipping and handling of the test kits was another cost driver, accounting for 25% of the total program cost. Exploring other lower-cost options for fulfilling test kit orders, e.g., mailing multiple test kits, as in programs run by the eSTAMP trial,¹⁸ or mailing the test kits directly by the manufacturer to participants, as in Baltimore City Health Department and Public Health Institute at Denver Health,^19,20 could have a notable effect on the cost-effectiveness of the program.

Another important component of the self-testing program was recruitment of the participants by displaying appropriate ads on the networks of publisher websites and dating apps. This process often takes experience and proper selection of the websites and apps to reach prioritized populations, and the costs and effectiveness may vary substantially.^12,19,21,22 In our analysis, we used market price as an opportunity cost of posting the ads ($15 per 1000 impressions), although the program was able to secure in-kind contributions for posting ads and messages through the dating apps, based on the BHOC’s relationship with the partners providing the apps, built over many years.

Our cost analysis provides early estimates of the program costs since the TakeMeHome program was launched in March 2020, and some jurisdictions were implementing the self-testing program only for a few months. As the program continues, the health jurisdictions may find better ways to implement the program and potentially improve efficiency and reduce costs. One limitation of this analysis was that we did not include health jurisdictions’ costs, aside from their contractual payments for the test kits. However, these costs would likely be very low, as the program was designed to be low burden for health jurisdictions, with BHOC taking on the promotion, ordering, shipping and other fulfillment logistics, and data gathering for health jurisdictions. The main additional cost to the jurisdictions, other than the contract itself, would be the time spent on the contracting process and, for those with the capacity, surveillance case matching. The public-private partnership was critical in TakeMeHome for matching HIV diagnoses with the cases already reported in the health department HIV surveillance data and determine if those were newly diagnosed HIV cases. This type of partnership or a similar arrangement can help ensure an accurate accounting of all new HIV diagnoses and could promote linkage to HIV treatment.⁷

An important feature of TakeMeHome is that the HIV test kits can be made available to constituents in specific zip codes, thereby allowing program resources to be directed to areas most at need. Furthermore, the test kits and subsequent services were provided free of charge to the recipient, which could support improving access to HIV testing among disproportionately affected groups. This program was scaled up through CDC’s 2021 national demonstration project, called “Together TakeMeHome,” which was a national initiative to promote the distribution of free HIV self-tests within the most affected populations.⁷ A large number of EHE jurisdictions are covered in the TakeMeHome program, and these locations were prioritized for promotion within the Together TakeMeHome project.²³

Our analysis is based on data from a real-world implementation of rapid HIV self-testing in 17 jurisdictions. We accounted for all relevant costs, including test kits, supplies, shipping and handling, recruitment ads, administrative overhead, and building an interactive internet site. However, our analysis considered only the costs incurred during the first year of the program. Although we annuitized the substantial start-up costs over a five-year period, we still might have overestimated these costs in the long term if only relatively minor maintenance costs are required in future years (and not major start-up costs every five years as we assumed).

Further, we note that if the TakeMeHome program was expanded to more jurisdictions or scaled up nationally, the relative importance of the fixed costs would decrease, as would the cost per HIV test delivered. Of note, a key feature of the TakeMeHome program is that participating jurisdictions do not bear the fixed costs, thereby preventing a possible barrier to participation. In fact, as the program finished its second year, it increased the number of kits distributed from around 5,300 kits in year 1 to 9,000 kits in year 2. However, we did not include data from year 2 in this analysis of the HIV testing component of the TakeMeHome program because there were additional costs of the program in year 2 to offer full lab-based HIV and STI testing and Spanish translation of the materials. Based on the lessons learned from TMH, the CDC funded “Together TakeMeHome”, a national scale demonstration project, with the goal of distributing up to 1 million free HIV self-tests over five years.

The collaborative TakeMeHome HIV home testing program provides direct access to HIV self-testing at a relatively low cost. The program can be scaled up regionally or even nationally to support the Ending the HIV Epidemic in the U.S initiative. The data we present show that the program can deliver HIV testing at a fairly low cost, comparable with or below HIV testing in other health care and non-health care settings. The public-private collaboration can be a viable mechanism to deliver self-tests to persons who might not seek or access HIV testing otherwise. By collaborating with health jurisdictions, persons with a diagnosed HIV infection can be linked to HIV care, and those without a diagnosed infection can be connected to HIV prevention services, including PrEP and STI services.