Prevention in Focus

Fall 2020 

HIV self-testing: Learning from international program models to increase testing

By Amanda Giacomazzo

HIV self-testing (HIVST) refers to an individual taking their own sample for HIV testing and then performing the test and interpreting the results themselves.An HIV self-test can use either oral fluid collected with a swab or blood samples collected through a finger prick. An HIV self-test that uses a blood sample is currently under review for approval in Canada. HIVST has been incorporated into program models in a variety of ways in different countries around the world. This article will review some program models that have expanded the use of HIVST into diverse settings to reach diverse target populations.

What is the current state of HIV self-testing?

The World Health Organization (WHO) recommends offering HIV self-tests in addition to more traditional HIV testing approaches (e.g., blood draws, point-of-care testing).1 According to the WHO, 77 countries have policies related to HIVST.2 These countries include the United States, where HIVST using an oral fluid sample was approved in 2012,3 and the United Kingdom, where HIVST (using either oral fluid samples or blood samples) became available in 2015.4 Other countries have also approved HIVST using oral fluid samples or blood samples.

In Canada, the INSTI® HIV Self Test is currently under review for approval. It uses a blood sample collected through a finger prick. At the time of article publication, there are no HIVST policies in Canada.

More information on the effectiveness of HIV self-testing can be found in What are the challenges and opportunities associated with implementing HIV self-testing in Canada?.

What potential benefits and concerns should be considered when creating HIV self-testing programs?

HIVST has many potential benefits, including the following:

  • HIVST increases access to HIV testing among men who have sex with men (MSM),1 among people who are testing for the first time, among people who would otherwise not have tested for HIV and among people who are undertested (not testing as frequently as guidelines recommend).5
  • HIV self-tests can remove barriers associated with stigma and address confidentiality and privacy concerns, and they can make access to HIV testing more convenient.5,6
  • HIVST has been found to be acceptable, especially in key populations(e.g., MSM, people who use drugs), and can increase HIV testing in populations that are less likely to access other forms of testing.1
  • HIVST is beneficial for people who undergo frequent tests (e.g., MSM or serodiscordant couples), as it decreases the time required to complete an HIV test and the burden associated with testing.1

Even though HVST is now widely accepted internationally, it is important for organizations to be aware of the potential concerns regarding HIVST so that they can create programs that work to address them. Traditionally, concerns around HIVST are as follows:

  • There have been concerns about the ability to link people to confirmatory testing, treatment and care following a reactive self-test result5,7,8 and a lack of support while testing.1 Both of these concerns can be addressed through programmatic and other approaches.
  • There has been concern about the potential for misinterpretation of HIV self-test results by users. However, studies have shown that interpretation of HIV self-test results is similar to the interpretation of rapid test results by a trained tester.1
  • There has been concern about the potential for individuals to be coerced, or forced, to take an HIV self-test by an employer or family member and about the need for regulations that address potential issues of HIV self-test misuse and coercion.1,9
  • There has been concern about the potential for intimate partner violence or self-harm as a result of HIVST, although there are limited instances of this documented in the literature.1
  • The cost of the HIV self-test may be seen as a barrier to accessing HIVST.1,8  To improve uptake, it has been suggested that HIVST could be funded in a similar way to standard HIV testing.5
  • There have been concerns that HIVST is more likely to be adopted in low-risk populations (e.g., populations that are already connected to HIV prevention resources), which could limit potential benefits. It has been shown that HIVST uptake is similar to the uptake of community-based HIV testing among those with similar risk profiles when it is offered for free. Additionally, HIV self-tests may be used by people at higher risk for HIV, as compared to community-based testing, when they are free and distributed by peers.5

What HIV self-testing program models have been implemented?

Existing HIVST programs use HIV self-testing kits provided by a testing manufacturer; the kits contain the equipment needed to take the required sample (e.g., finger lancet, swab); instructions on how to collect the sample, process the sample and interpret the results (e.g., written instructions); and information on how to link to confirmatory testing or healthcare if the test is reactive (e.g., a 24-hour telephone hotline). HIV self-test kits can be supplemented by additional materials developed by individual programs, such as instructions on how to perform and interpret a test (e.g., pictorial instructions, videos on the test process) and/or additional information on how clients can link to care following a reactive test (e.g., supplemental information on how to connect with health navigators, digital health platforms or additional pre- and post-test counselling services).

Existing HIVST programs use either a directly assisted or unassisted approach.1 In a directly assisted approach, a health worker or a peer who has been trained demonstrates how to complete the test and interpret the results. In an unassisted approach, clients use the manufacturer’s instructions and in some cases additional instructional resources developed by a program to complete the HIV self-test on their own.

This article provides examples of different program models used for HIVST from jurisdictions where it is approved for use. Available research evidence on program models from countries that have an HIV epidemic similar to Canada’s comes largely from the United States, where an HIV self-test that uses oral fluid samples has been in use since 2012.

Distributing HIV self-test kits in community-based venues

Programs have used community-based venues to target high-risk populations for HIV testing; for example, HIV self-test kits have been distributed in bathhouses or saunas by staff or through use of an onsite vending machine.10–12 These approaches target MSM populations and have brought the option of HIVST to venues that were already providing point-of-care HIV testing onsite (although this is not a requirement).10,11 Issues identified with this approach include concerns about clients getting a reactive result in isolation and concerns that clients who access HIVST in these venues may miss out on comprehensive screening for other sexually transmitted infections (STIs).11

Vending machines that distribute HIV self-test kits in community-based venues

A program in downtown Los Angeles, California, installed two vending machines in bathhouses to distribute HIV self-test kits to MSM.10 The vending machines were located either in an onsite STI testing room or in a lounge, and they dispensed HIV self-test kits that used an oral fluid sample. The HIV self-test kits were free and clients could get as many kits as they wanted.

The HIV self-test kits had instructions for use, which included graphical information on how to interpret the test results in addition to the manufacturer’s instructions. Kits also included manufacturer’s instructions on obtaining medical assistance if the test was reactive along with an additional flyer with information on a 24-hour linkage to care hotline provided by a local HIV/AIDS service organization. In the event of a reactive test, participants could use either of these methods to connect to medical assistance.

A study found that the program distributed a high number of HIV self-test kits to MSM with a high positivity rate, however, linkage to confirmatory testing and HIV treatment was below 50%. The observational study took place between January 2016 and July 2017, and documented that 1,398 HIV self-test kits were distributed through the vending machines. Participants were provided with survey information in the HIV self-test kits and the study did not specify a timeframe in which surveys needed to be completed. Therefore it was not possible to specify the timeframe in which confirmatory testing or linkage to care took place. In total, 110 people completed a survey (a survey was completed for 7.9% of the kits that were distributed). Results indicated the following:

  • In total, 92% (101/110) of survey participants reported that the kit was used and 95% (96/101) of those who reported using the kit reported that they used it themselves.
  • Of the 101 people who reported using the kit, 17% (17/101) reported a reactive result.
  • Of the 17 reporting a reactive result, 41% (7/17) had obtained confirmatory testing or visited a doctor and 24% (4/17) had initiated HIV treatment at the time they completed the survey.

Survey participants were invited to take part in a follow-up survey and 11% (12/110) participated. All 12 participants said the process of using the vending machines was “positive” or “very positive” and all would recommend the program to a friend.

Distributing HIV self-test kits using peers

Peer-based programs that use a social network strategy to increase conventional HIV testing (non-HIVST) (i.e., programs in which a client is motivated to test for HIV by a person in their social network) have been shown to be effective in engaging people at risk for HIV in HIV testing.13 Using a social network strategy, or peers, to assist in the distribution of HIV self-test kits could increase testing in populations that are at higher risk for HIV and potentially reach populations that would be missed by conventional testing.14 There are examples of peer HIVST programs in the USA15 and in parts of Europe16 and Africa.14

A social network strategy to distribute HIV self-test kits

A program in Alameda County, California (a large urban/suburban county), recruited African American MSM, Latino MSM and transgender women as peer recruiters to distribute HIV self-test kits to their friends and networks. Peer recruiters self-identified as having recently had sex with a man and as being comfortable discussing HIV with others. Peer recruiters received a three-hour training session on HIV basics, how HIVST kits work, how to support people who test positive and link them to care, where to direct people for information on HIV confirmatory testing and treatment and how to collect data. Peer recruiters were paid $100 to participate in training. Each peer recruiter was provided with five to eight oral HIV self-test kits and asked to share them with friends who they believed had not tested for HIV in the last year. Peer recruiters received an additional $150 if they distributed at least five tests.15

A study found that the program reached more people who had not previously tested or had not tested in the past year than a point-of-care testing program in the same community. It also had a significantly higher positivity rate. The observational study took place between January 2016 and March 2017 and involved the completion of an online survey by 114 people who received an HIV self-test kit from a peer recruiter (total of 165 kits distributed). This information was compared with 2015 data from the Alameda County community-based HIV testing program, which focused on providing rapid point-of-care testing to particular populations (e.g., gay men and other MSM). It included venue-based and mobile testing, with testing provided by trained HIV test counsellors.15 The comparison found the following:

  • Participants in the HIVST program were significantly less likely to report a previous HIV test (89%) than those in the community-based testing program (94%) and were significantly more likely to report that their last HIV test was more than a year ago (72% versus 21%, respectively).
  • Significantly more people in the HIVST program reported a positive test (6%) than in the community-based testing program (2%).

In terms of the HIVST program, more participants who were recruited by an HIV-positive peer recruiter reported a positive test result (15.6%) than those who were recruited by an HIV-negative peer recruiter (2.4%).

Mailing out HIV self-test kits

Mailing out free HIV self-test kits to individuals who request them online is seen as a distribution method that can increase HIV testing. This strategy allows people to complete tests in their own homes. It can provide confidentiality and privacy for people who may experience stigma related to HIV testing in more traditional settings. Although previous programs using mail-out HIV testing have required clients to mail their samples to a laboratory for processing, thereby addressing potential linkage to care issues by having follow-up completed by a medical professional, HIVST allows clients to interpret their results at home and therefore requires new approaches to link people to care.5 Mail-out HIVST programs have taken place in the USA7 and Australia,17 and a large program and study is currently underway in the United Kingdom.6,9

The Home Test Giveaway program

The Home Test Giveaway program in New York State mailed free at-home oral HIV self-test kits to MSM, transgender and gender non-conforming people who have sex with men. The program started in New York City and later expanded to other parts of the state.7,18

The Home Test Giveaway program used targeted online advertisements through social media (e.g., Grindr, Facebook, Scruff) to recruit people who then completed an online eligibility questionnaire. Eligible people provided their email address and were emailed a “discount code” that could be redeemed on a website for a free oral HIV self-test kit that was mailed directly to them from the test manufacturer. Participants received HIV self-test kits in non-descript packaging that included information on post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), HIV testing window periods and symptoms of acute HIV.18

Several campaigns took place from November 2015 to February 2018. Later campaigns were improved to include more relevant advertisements featuring the program’s target populations (e.g., MSM, transgender people). The program also expanded assistance to include linkage to care, partner notification, HIV prevention (e.g., PrEP referrals) and support services (e.g., further HIV testing) in later campaigns.7

Results of a study found that a large number of kits were distributed and the majority of the people who received a test used it themselves. Reactive tests were found in fewer than 1% of participants, with high rates of confirmatory testing and linkage to care. The observational study took place between November 2015 and February 2018 and included results from five testing campaigns. Participants were emailed a follow-up survey two months after HIV self-tests were distributed and received a $25 gift card if they completed the survey. A total of 17,383 eligible participants received a discount code for an HIV self-test via email, and there were 12,182 discount code redemptions for the HIVST kit. Forty-six percent (7,935) of those eligible responded to the follow-up survey. Survey results indicated that18:

  • 7,336 (92%) of survey respondents received an HIV self-test kit
  • 5,903 (80%) of those who received a test used the test themselves, 5% reported using the test for someone else and 14% reported not using the test (90% of whom said that they would use it at a later time)
  • 43/5,903 (0.73%) of survey respondents received a reactive test result using the HIV self-test and 32 reported no previously known HIV diagnosis

Of those without a previously known diagnosis, 25 (78%) reported receiving confirmatory testing, and 84% of these people self-reported a positive result. At the time of the follow-up survey, 95% of those with a confirmed positive diagnosis had had their first HIV care appointment and 85% of those who had had an appointment had started treatment. Finally, 96% (mean across all five campaigns included in the study) of survey respondents reported that the likelihood that they would recommend the program to a friend was high. The majority of the participants also said that they liked the privacy and convenience of at-home HIV self-test.

What do these programs tell us about the development of HIV self-testing programs in Canada?

 An HIV self-test is currently in the approval process in Canada and, if approved, service providers should be prepared for the test to become widely available. Service providers need to determine ways to support clients who wish to use HIV self-tests and could consider developing or adapting program models to assist in the distribution of HIV self-test kits (e.g., by mail, from a community health program, using peers). Considerations can include the context in which the service providers work and how best to reach populations that could benefit from HIVST (i.e., those that may not be accessing testing otherwise, those that require frequent testing). Issues around access to tests and costs associated with tests must also be considered, as a lack of public funding for HIVST in jurisdictions has the potential to hamper the use of HIV self-tests.

The developers of HIVST programs should ensure that they address potential concerns related to HIVST. Here are some of the questions that should be considered:

  • How will clients be counselled and linked to confirmatory testing and HIV care and treatment? How will people be linked to HIV prevention and other sexual health services?
  • How can the ability of testers to successfully complete an HIV self-test and interpret the test result be maximized? For example, programs could use peer navigators, provide self-test procedure videos, distribute written or pictorial instructions or provide demonstrations from health workers.
  • How will issues such as coercion and disclosure be addressed? For example, testers could be provided with information on their rights surrounding HIVST and support services (e.g., counselling, linkage to broader social services) when needed.
*The WHO guidelines on self-testing and partner notification define the following groups as key populations: men who have sex with men, people who inject drugs, people in prisons and other closed settings, sex workers and transgender people.

Related resources

Reaching the first 90: how HIV self-testing can help us end the HIV epidemic (CATIE Blog)

I Know My HIV Status (CATIE)

Task-shifting in HIV testing services (CATIE)

Peer distribution of HIV self-test kits (CATIE)

References

  1. World Health Organization. Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. Geneva: World Health Organization; 2016. Available from: https://www.who.int/hiv/pub/self-testing/hiv-self-testing-guidelines/en/
  2. World Health Organization. HIV self-testing. Geneva: World Health Organization; nd. Available from: https://www.who.int/hiv/topics/self-testing/en/
  3. US Food and Drug Administration. Facts about in-home HIV testing. Silver Spring (MD): US Food and Drug Administration; 2014. Available from: https://www.fda.gov/consumers/consumer-updates/first-rapid-home-use-hiv-kit-approved-self-testing
  4. Public Health England. HIV testing and self-testing: information update. London: Public Health England; 2015 Nov. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/769460/HIV_Self-Testing_PHE_Position_v13_-_Nov_15_updated.pdf
  5. Steehler K, Siegler AJ. Bringing HIV self-testing to scale in the United States: a review of challenges, potential solutions, and future opportunities. Journal of Clinical Microbiology. 2019;57(11):e00257-19.
  6. Witzel TC, Bourne A, Burns FM, et al. HIV self-testing intervention experiences and kit usability: results from a qualitative study among men who have sex with men in the SELPHI (Self-Testing Public Health Intervention) randomized controlled trial in England and Wales. HIV Medicine. 2020;21:189-97.
  7. Johnson MCChung RLeung SJ, et al. Combating stigma through HIV self-testing: New York State’s HIV home test giveaway program for sexual minorities. Journal of Public Health Management and Practice. 2020 Feb 3.
  8. Pant Pai N, Smallwood M, Gulati D, et al. What do key stakeholders think about HIV self-testing in Canada? Results from a cross-sectional survey. AIDS and Behavior. 2018;22:606-15.
  9. Gabriel MM, Dunn DT, Speakman A, et al. Protocol, rationale and design of SELPHI: a randomised controlled trial assessing whether offering free HIV self-testing kits via the internet increases the rate of HIV diagnosis. BMC Infectious Diseases. 2018;18:531.
  10. Stafylis C, Natoli LJ, Murkey JA, et al. Vending machines in commercial sex venues to increase HIV self-testing among men who have sex with men. mHealth. 2018;4:51.
  11. Rojas JHV, Suneeta S, Pollard A, et al. Acceptability and feasibility of using digital vending machines to deliver HIV self-tests to men who have sex with men. Sexually Transmitted Infections. 2019;95(8):557-61.
  12. Wood Wj, Lippman SA, Agnew E et al. Bathouse distribution of HIV self-testing kits reaches diverse, high-risk population. AIDS Care. 2016;28(S1):111-113.
  13. Centers for Disease Control and Prevention. Social network strategy for HIV testing recruitment. Atlanta: Centers for Disease Control and Prevention; nd. Available from: https://www.cdc.gov/hiv/effective-interventions/diagnose/social-network-strategy/index.html
  14. Okoboi S, Lazarus O, Castelnuovo B, et al. Peer distribution of HIV self-test kits to men who have sex with men to identify undiagnosed HIV infection in Uganda: a pilot study. PLoS ONE. 2020;15(1):e0227741.
  15. Lightfoot MA, Campbell CK, Moss N, et al. Using a social network strategy to distribute HIV self-test kits to African American and Latino MSM. Journal of Acquired Immune Deficiency Syndromes. 2018;79(1):38-45.
  16. Op de Coul E, den Daas C, Spijker R, et al. Web-supported social network testing for HIV among men who have sex with men with a migration background: protocol for a mixed methods pilot study. JMIR Research Protocols. 2020;9(2):e14743.
  17. Bell SFE, Dean JA, Lemoire J, et al. Integrated HIV self-testing (HIVST) service delivery in Queensland for policy and service development: study protocol. AIDS Care. 2019;31(2):207-15.
  18. Edelstein ZR, Wahnich A, Purpura LJ, et al. Five waves of an online HIV self-test giveaway in New York City, 2015 to 2018. Sexually Transmitted Diseases. 2020;47(5S):S41-S47.

About the author(s)

Amanda Giacomazzo is CATIE’s knowledge specialist, treatment and prevention programming. She holds a Master’s degree in health science with specialised training in health services and policy research, and has previously worked in knowledge translation and public health at the provincial level.