1. UNITAID PSI HIV SELF-TESTING AFRICA
Usability and Validity of Oral Fluid Self-Tests Among Intended Users: Experiences from Malawi, Zambia And Zimbabwe
Dr Euphemia Sibanda – on behalf of STAR researchers

2. Presentation outline Need for optimisation of user instructions
How optimisation was done in STAR
Accuracy of oral fluid tests among intended users
Planned work with blood- based tests

3. Instructions for use need optimisation
Understandable instructions for use (IFU) critical for accuracy
We conducted research to
explore participant understanding of IFU
optimise IFU
Methods included
Cognitive interviewing
Video - recording of unassisted self- testing
Accuracy studies comparing user results vs professional result
Findings informed toolkit development

4. Cognitive interviews Population Urban & rural
“Tell me what you think it means.” ….
“Now go ahead and do what you think it says.”
Zimbabwe
Malawi
Zambia
Population
Urban & rural
Source of initial IFU version
Adapted by Researcher
Manufacturer*
Information provided to ppt
IFU only
Demonstration + IFU
# Recruited 14 29 17
IFU changes
Several
One
None
* Incorporated Zimbabwe findings

5. Findings from cognitive interviews
Challenges interpreting symbols
Layout critical for understanding
Organisation of packaging
Spatial instructions inadequate
Importance of good translation
Purpose and use of equipment
“Looks like a plate on a stove”
Man aged 27, Zimbabwe
“…but the picture doesn’t make sense. What does the cutlery mean?” Man aged 20, Malawi
Intended
Observed

6. Accuracy studies Self-test results compared with national algorithm
Zimbabwe
(n=303)
Malawi
(n=291)
Zambia
(2552)
Population and recruitment sites
Urban & rural
HTC static and mobile facilities
Rural household survey
household & health facility
Information provided
IFU, several iterations
Demonstration + one IFU
Observation during testing
Video (n=262)
None
Video, n>100
Recruitment dates
Jul 2014 –
Jul 2015
May 2016 –
Aug 2016
June 2016 – June 2017

7. Accuracy Results
Self-test results compared with finger-prick RDTs (SOC)
Zimbabwe (n=40)
2 HIV+ve
37 HIV-ve
Malawi (n=291)
13 HIV+ve,
277 HIV-ve
Zambia (n=2552)
240 HIV+ve
2312 HIV-ve
% Agreement
92.3%
99.3%
99.1%
Sensitivity
95% CI
100%
15.5% -100%
92.9%
66.1% %
94.2%
90.4%-96.8%
Specificity
91.9%
78.1%–98.3%
99.6%
98%-100%
99.7%
99.3% %
Accuracy improved with demonstration
Lower accuracy among rural participants
**Results exclude invalid self-tests**

8. How about clinical performance vs 4th Generation Laboratory gold standard?
See poster TUPEC0842
2nd generation (IgG antibody only) tests have inherent limitations in sensitivity…
E.g. Early HIV infection
Important as we get closer to the first 90
Zambian study used 4th Gen Abbott & BioRad as alternative reference standard
Mention PopART publication on misclassification (H.Ayles)
OraQuick versus 4th Generation lab algorithm
Agreement 98.5%, Cohen's kappa p<0.001
Sensitivity 87.6* (95% CI )
Specificity (95% CI )
* Sensitivity of standard of care finger-prick RDT vs 4th Gen Lab: 93.5% ( )

9. Conclusions and recommendations
Optimisation of IFUs is important for each context
Can be marked urban:rural differences
Iterative cognitive interviews and accuracy studies – recommended in STAR toolkit under development
In Malawi, Zambia and Zimbabwe IFU alone insufficient – need for demonstration
With demonstration accuracy was good against Standard of Care reference (finger-prick RDTs)
Short video clip was adequate for this purpose
However, against 4th Generation Reference standard
Poor sensitivity for both Standard of Care and Oral Fluid HIVST
Mainly reflecting limitations of 2th Gen RDTs

10. Planned work in Malawi and Zimbabwe
IFU optimisation for two blood based tests
Including one 3rd Gen test
Accuracy among general population and female sex workers
Comparison of user preference and accuracy of the two tests

11. Acknowledgements Study participants
Ministries of Health in Malawi, Zambia and Zimbabwe