Table 2.

Excerpt from the National Guidelines for HIV Testing and Counselling in Kenya, 2009

The basic principle of self-testing has been used before for other non-invasive tests, such as in pregnancy tests. Clients can access test kits [for HIV] from pharmacies and other approved suppliers. Self-testing is different from the traditional HTC strategies as the client does not receive basic education, or pre-test counselling. But in order to strengthen support systems for self-testing, there is a need for basic standards. These standards include:

Test kits must be evaluated and approved for use in Kenya;

Test kits must be used before the expiry date;

Storage conditions must be adequate;

Test kits must pass quality control standards in Kenya;

Pharmacists must be trained and approved to dispense, counsel  and demonstrate the use of the test kit to clients and patients as  the need arises;

Follow-up and referral services, including confirming positive test  results, must be accessible for clients.

The vendor should be able to provide the client with step-by-step instructions for

1. How to conduct the test;

2. How to correctly interpret the test results; and

3. Where to access follow-up and support services in the  surrounding area.

Persons must also be informed that the results are not confirmed until a second, confirmatory test is conducted. This information should also be made available on a package insert, to be included on all HIV tests sold or distributed in Kenya, along with the minimum standards mentioned above.

Pharmacists and other suppliers of self-test materials should undergo HTC training and be certified by the Ministry of Health. They must provide a private room for clients who may need further information, counselling and social support. Utmost care should be taken to avoid cases of misuse of test kits, as well as to prevent negative social outcomes.

Source: Ministry of Public Health and Sanitation of Kenya [27].

Abbreviations: HIV, human immunodeficiency virus; HTC, HIV testing and counseling.