Virginia, Arizona, and New York City have piloted the delivery of home test kits and have found that this process enabled them to reach individuals who hadn’t tested recently. In some cases, they have succeeded in reaching a higher positivity rate than traditional testing strategies.  

•     New York City: 28% of testers hadn’t tested in the previous year and 14% hadn’t ever tested. They reported a positivity rate of 0.3%
•     Virginia: 29% of testers hadn’t tested in the previous year and 21% hadn’t ever tested. They reported a positivity rate of 1.3%; 88% of new positives were linked to care within 30 days.

•     Arizona reported a positivity rate of 1.2%.

For more information about home testing from the CDC, including study results from other home testing programs, click here.

For the time being, the national resource will focus on the 30% of all MSM who haven’t tested for HIV in at least one year. Promotion will happen predominantly through gay dating apps. Health departments will soon have the opportunity to promote this program to whichever populations they choose and will have greater flexibility to choose their eligibility criteria. We are looking to expand our target populations as the program evolves.

Individuals will get information in their test kits about what to do in the case of a positive result.  This will include how to obtain a confirmatory test at a local clinic, and the number of OraSure’s hotline if needed. (Some states or jurisdictions may already have or want to create a hotline for this purpose.)

Following a preliminary positive result at home, when an individual comes in for confirmatory testing, they will be known to the jurisdiction’s HIV care and surveillance systems.

Once dried blood spot testing is implemented, users can access their results through a client portal. The health department will also receive positive results through a secure file.

If a user is ineligible, either because he does not live in a participating jurisdiction or because he has been tested within the past 12 months, TakeMeHome will link them to gettested.cdc.gov/ to find test sites near them. The site also has information regarding prevention strategies.

They are given information about testing sites near them, through the CDC-maintained database.

TakeMeHome is expanding to offer STI self-collection. We estimate launching this in fall 2020. For at home collection of syphilis samples, Molecular will provide a DBS card and microtainer (especially for those with a known history of syphilis).
The DBS sample is first tested using an EIA assay for the qualitative detection of IgG antibodies to T. pallidum.  If negative, then the sample is reported as “not detected.” If positive, then the sample is repeated in duplicate using the EIA assay.  If at least one of the duplicate repeats are positive, the microtainer sample reflexes to RPR qualitative (POS or NEG). If the RPR is positive, then a full titer is performed.

TakeMeHome and its delivery subcontractor takes care of all that. It is handled by a company that we have a contract with.  All of these services are included in the cost. Each health department orders the number of kits they want; TakeMeHome takes care of the rest, as well as promotion. Additionally, health departments may modify the numbers of tests they order during a given time period.

You can use PS18-1802 funds or other funds for this program. Payment is made through NASTAD.

We will make the following data available:

• # of people from each jurisdiction who visited to the TakeMeHome website 
• Client-level detail for each kits sent out, including: Name, Mailing address (including zip code), Email, number of kits ordered, Age, Sex at Birth, Time since last HIV test
• # of kits sent out
• Follow-up client surveys include: Race/ethnicity, Gender identity, Number of anal and/or vaginal sex partners, Transmission category, Where their most recent HIV test was, Whether they took the test, Test result information, Linkage information, Access to PrEP, Access to STI testing, Feedback about their experience

We are currently building into the system the following additional metrics to include the following:

• # of ad impressions, clicks, and click-through rates
• Cost-per-click
• # of views of those sites provided to users and average session durations
• # of people who start to fill out the eligibility survey
• # determined to be eligible, by jurisdiction 
• # STI or HIV DBS results returned for lab-based testing 
  • % of lab-based testing samples returned properly

• positivity rate (# new cases identified), by jurisdiction
  • linkage to care among new positives
• # of people who complete the post-test survey
• completion rate for post-test survey

We have worked closely with our Compliance Officer, IT,  and legal teams to ensure the highest quality data security and HIPAA practices. Our lab testing partner, MTL, has a secure lab portal for STI results (when this feature becomes available) and they ensure HIPAA protections are in place for all of their services. We have a signed BAA in place with MTL that covers all participating jurisdictions. Each participating jurisdiction will get a copy of this BAA for their records.

Yes, jurisdictions could opt between allowing participants to order just one test for themselves or two.  In the future, we are open to expanding this more widely, based on requests from jurisdictions.

Evidence has pointed to increased positivity rates among individuals who give test kits to their partners and peers.

It’s helpful to remember that at any point, anyone in your jurisdiction can walk into a Walgreens and purchase this test over the counter or order one online.  The only difference is that your state is now supporting MSM who haven’t tested recently to get easier access to these tests. Your surveillance team will know about these positives as individuals come in for confirmatory testing.

We are building the platform with that in mind. We will have multiple opportunities for participating jurisdictions to put in their own campaign messages.