2. Rationale
• We propose a South African developmental
programme for the evaluation of HIV self-test
products that will address:
– Test performance and regulatory approval
– Acceptability, usability, public acceptance
– Packaging, labelling, promotional and educational
materials
3. Objectives…1
Evaluation of at least three promising candidates for HIV self-testing,
with the assistance of the NHLS, by:
• Assessing the technical and user-ability aspects of the device in target
local populations
• Working with WHO PQ group during initial study design, to ensure
studies are rigorously conducted and acceptable
• Independently evaluating the sensitivity and specificity of each
product with the NHLS
• Assisting and evaluating packaging and materials
• Evaluating the devices specifically within key, under-tested
populations
• Assisting with price assessments, access to markets, and commercial
advocacy.
• Investigating marketing beyond conventional pharmacy ‘’over-the-
counter’’ models
4. Objectives…2
Assess support needs and any social harms, by:
• Establishing a helpline with trained staff that can handle queries
pertaining to any of the devices being tested
• Linking the helpline to a social-harms reporting and investigation
dedicated process
• Documenting extent and nature of helpline usage
• Critically assessing and intervening around social harm issues
• Evaluate sexual behaviors surrounding the use of self-testing
• Evaluating self-testing acceptability, usage and linkage to care, using
m-Health approaches
5. Objectives…3
Advocate for quality HIV self-testing within South Africa and the
region, by
• Hosting expert advisory meetings comprising international and local
experts, including major stakeholder organisations
• Supporting, promoting and advocating around anticipated WHO’s
self-testing future guidelines
• Developing local guidelines together with key local stakeholders, to
support WHO guidelines
• Advocating for the use of self-testing in critical environments,
including the workplace and within the state sector
• Having a media strategy that will advocate for and provide
information around quality HIV self-testing
• Advocating action on unregulated HIV self-tests on the market
• Forging links with regional bodies to promote HIV self-testing as a
mechanism to achieve 90-90-90 targets
• Exploring cost-effectiveness
6. Design
We propose a multi-phase approach for evaluation of the devices:
• Phase 1: Evaluation of the devices in the hands of skilled, trained users
such as clinical health workers, including nurses and pharmacists.
• Phase 2: Evaluation of the devices in the hands of unskilled but
trained users, such as research participants, patients or HIV
counselors.
• Phase 3: Evaluation of the devices in the hands of unskilled, untrained
users from the general population.
• Phase 4: Evaluation in untrained key populations/hard to reach
populations
7. Timeline
• Protocol completion: October 2015
• First Advisory Group meeting: November 2015
• Phase 1 recruitment commencing in Jan 2016
