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Clinical Performance Study field visit by the Principal Investigator

Principal Investigator, for the Self-Testing Africa Project (STAR) Dr Helen Ayles, on June 8 2016, joined the Clinical Performance Study (CPS) team in M’tendere Township, in Lusaka, one of the study sites of the project. The two-year programme funded by UNITAID to provide cost-effective solutions for expanding existing HIV testing services, is being conducted in Zambia, Malawi, and Zimbabwe.

Dr Ayles, who is the Zambart Research Director, wanted to get a hands-on view of how the Clinical Performance Study is being carried out and to learn some of the field challenges staff are experiencing. She also observed how participants conduct the self-test using the provided OraQuick® HIV self-test kit, and how they read and record their own results.

The study will determine whether oral fluid HIV self-tests can be used effectively and read accurately across different populations in Zambia. The study will compare the results of oral fluid tests with a laboratory-based blood test to determine the sensitivity and specificity (ability of the test to pick out true positives as positives (Sensitivity), and to pick out only the HIV anti-bodies specifically (Specificity). Further, CPS aims at establishing the accuracy of the HIV self-test when used by intended users, who include: adolescents and adults in urban and rural Zambian settings.

Captured in the picture above, Dr Alyes, looks on as a CPS Research Assistant, Debbie Sibayuni, enters data into an Electronic Data Capturing device, collected from a study participant in Kalikiliki area, a densely populated compound on the outskirts of M’tendere community. The client is asked questions about the self-test after she performed an HIV self-test using OraQuick®.

2OraQuick® is being piloted in M’tendere and Kanakantmpa communities in Lusaka and Chongwe districts respectively, to determine the acceptability of HIV self-testing. Self-testing can help to reach those who are unable to access HCT services because of various social, cultural and geographical challenges, and encourage re-testing among those at high-risk. It can also help to reach those unlikely to use current HIV testing services because of privacy issues or lack of convenience.

Zambart has engaged with a consortium of researchers and implementers to provide research expertise in Zambia for the use of HIV self-tests in populations with the greatest need. The consortium is led by Population Services International (PSI) led collaboration, which includes the Ministry of Health, and Society for Family Health as the main distributors of the OraQuick HIV Self-Test kits. Other partners ion the STAR project are the London School of Hygiene and Tropical Medicine (LSHTM), the Liverpool School of Tropical Medicine (LSTM), University College London, and the World Health Organisation (WHO), and the Ministry of Health.