HIV Self Test Kit for screening of HIV infection in adults belonging to HIV and sexually transmitted infection key populations

General Track – Cycle 2 | Clinical Equipment and Devices

HTA Council Recommendation (as of 18 June 2025)

The HTA Council positively recommends the government financing of HIV Self Test Kit for screening of HIV infection in adults belonging to HIV and sexually transmitted infection key populations*.

The HTA Council strongly recommends that implementation of HIV health technologies should follow the WHO testing strategy for HIV diagnosis (i.e., serial assay testing) to ensure that HIV cases are detected within the HIV diagnosis window period. Additionally, it should be coupled with information dissemination and awareness campaigns, with clear messaging pointing out the advantages and disadvantages of the test. Information on the specific use cases of these tests, especially among other populations for whom the test may be made accessible (e.g., individuals with tuberculosis but without HIV, or pregnant women without HIV) must be made clear to prevent misinterpretation, reduce stigma, and specifically for HIV self test kit, encourage reporting of results. Further, the HTA Council highlights the importance of informed consent for the implementation of these tests.

In addition to this, the HTA Council recommends that the Department of Health refer to existing and future WHO target product profiles (TPPs) when selecting tests for procurement. In the absence of target product profiles, WHO prequalification may be used as a requirement to ensure the quality of the test to be procured.

*key populations include:

  • Adolescents
  • high-risk individuals who have not been tested recently
  • partners, infants and children of people living with HIV
  • patients showing signs and symptoms consistent with AIDS defining illness
  • patients with sexually transmitted infections
  • patients with Hepatitis B and C
  • patients with undernutrition not responsive to interventions
  • all confirmed tuberculosis patients
  • all pregnant women regardless of risk;
  • MSM;
  • people in prisons and other closed settings;
  • people who inject drugs;
  • sex workers;
  • transgender men and women

(See below for more details)

Relevant Information

  1. Status: With Final HTA Council Recommendation
  2. Topic Assignment: Internal Assessment
  3. Policy Question: Should HIV Self Test Kit for screening of HIV infection in adults belonging to HIV and sexually transmitted infection key populations be funded by the government?
  4. Secretary of Health Decision: Approved for government financing

Evidence and Relevant Documents

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