This document summarizes the UNITAID/PSI HIV STAR Project, which aims to stimulate and shape the market for HIV self-testing in Africa. The project will distribute over 2.7 million low-cost, quality-assured HIV self-test kits across Malawi, South Africa, Zambia, and Zimbabwe over two phases. It also aims to develop global guidelines for HIV self-testing, integrate self-testing into national HIV testing algorithms, and reduce prices for quality-assured self-test products. The project will evaluate uptake of first-time and repeat testing, equitable coverage, user demand and preferences, impact on prevention and treatment, and conduct accuracy and economic studies among general and key populations.

1. Stimulating and shaping the market for HIV self‐
testing in Africa
UNITAID/PSI HIV STAR Project
Dr Karin Hatzold, Project Director
Population Services International
Status and Future for HIVST Meeting
BMGF
Seattle , 27th of February 2015

2. Framework to Catalyze the
Market
50% PLHIV
unaware of
status;
limited
access to
confidential
HTC
High price of
HIVST kits;
limited
demand; lack
of
competition;
unsupportive
policies
Establish
policy
framework;
demonstrate
demand &
supply;
quantify
market size
Lower
market
barriers
achieve
intended
market
effects
Greater
coverage of
HTC & more
people
tested in
vulnerable
and remote
communities
Case for intervention Pathway from market to public health impact
Intended market effects
Increased product availability Product quality improvement
Price reduction Improved product delivery
Barnighausen et al. Health policy and Planning 2011

3. HIV STAR Project
Increased Access
Distribute low cost, quality‐assured products
Optimised for safe scale‐up & effective linkage into care & prevention
Both general and key populations
Informed demand
Define the best market strategies and packaging for HIVST
Based on consumer preferences, accuracy, uptake among target
groups, and cost‐effectiveness data
Strategic barriers
Support the full integration of HIVST into National policy & algorithms
Underpinned by WHO recommendations and guidelines
Inclusion of HIVST in global HIV planning and projection tools
Structural barriers
Encourage market entry and competition
Through estimation HIVST market size & growth projections
Support a harmonised regional regulatory approval framework

4. STAR Project Goals
1) Develop global normative
HIVST guidelines
– Informed by project evaluation
– Released by WHO
2) National HTC guidelines and
algorithms to accommodate
HIVST in all countries by the
end of project
3) ≥1 HIVOFT products packaged
for HIVST added to approved
diagnostics list for donors
4) Price reductions for ≥1 quality
assured HIVST product
Country Phase 1 Phase 2
Malawi 172,754 420,466
South Africa 0 36,000
Zambia 200,478 404,522
Zimbabwe 359,190 1,069,810
Total 732,422 1,930,798
2.7 million kits in 2 Phases of 2 years
Phase 2 contingent on resubmission at the end of Year 2
Number of HIV self‐tests distributed

5. Uptake: first time &
repeat‐testing
Equitable HTC
coverage
Social Harms
User demand &
preferences
Value for Money
HIV prevention
(VMMC) uptake
Treatment and care
uptake
Impact
Research Agenda
Malawi
172,754 + 420,466
Zimbabwe
359,190 + 1,069,810
Zambia
200,478 + 404,522
Diagnostic Accuracy Optimised instructions‐for‐use. Accuracy studies
Qualitative and economic studies: General and Key Populations
I
Impact evaluation of multiple different delivery models
• Malawi: 10 intervention and 10 matched control communities
• Zimbabwe: randomised trial of 80 intervention‐control areas
• Zambia: before‐after HIVST in 30 established outreach sites
All countries will evaluate
• Safety, unintended consequences
• Demand for ART and VMMC as well as HTC coverage
Community reporting systems. Long‐term follow‐up with sex workers
Market size, Cost‐effectiveness, Decision / SPECTRUM Modelling
Target
Populations
Rural & Peri‐urban, Urban communities, sex workers, MSM