Accuracy of Oral HIV Self-tests in Kenya

Type Report
Title Accuracy of Oral HIV Self-tests in Kenya
Publication (Day/Month/Year) 2014
Knowledge of HIV status is key to earlier access to HIV treatment and prevention services. As an HIV
prevention strategy, voluntary counseling and testing (VCT) is cost effective (Menzies et al., 2009; Sweat et
al., 2000). It is also the fundamental entry point to an effective seek, test, treat and retain (STTR) paradigm,
which has the potential to bend the curve of the HIV pandemic (Granich, Gilks, Dye, De Cock, & Williams,
2009). In resource limited settings such as in sub-Saharan Africa, the shortage of health care workers has
been identified as a barrier in the effort to scale up HIV prevention and treatment services (WHO, 2010).
According to population-based surveys in low- and middle-income countries (LMIC), the median
percentage of people living with HIV who know their status is estimated at <40% (WHO, 2010). Given the
public health implications of unknown HIV status, availability of self-testing for rapid scale up of HIV
testing is compelling; increasing awareness of HIV status is an important step towards reducing HIV
transmission and enabling antiretroviral therapy (ART) that reduces mortality as well as secondary HIV
Data from studies conducted in Malawi (Choko et al., 2011) and the US (Gaydos et al., 2011) show
that self-testing in the general population is feasible, acceptable, and accurate. Availability of self-testing is
one of several options to increase access to testing especially in higher-risk subpopulations that may not
access current forms of HIV testing, such as HIV-discordant couples, men who have sex with men (MSM),
sex workers (SWs), people who inject drugs (PWID), and high-risk youth. Currently available options
include voluntary counseling and testing (VCT), provider-initiated counseling and testing (PICT), homebased
counseling and testing (HBCT), and self-testing home specimen collection. In the US, where
approximately 1 in 5 people do not know that they are infected (CDC, 2011), the Food and Drug
Administration (FDA) approved the OraQuick In-Home HIV test kit, the first HIV self-test (HST) kit for
sale directly to consumers over-the-counter (OTC) and online (FDA, 2012). The target population for this
test is individuals who would not normally access HIV testing services for a variety of reasons that mayinclude privacy concerns, stigma, or other barriers to accessing HIV services. The US HST kit contains
extensive resources such as detailed instructions on use, test result interpretation, and access to a customer
support center (available 24/7) for any HIV/AIDS questions and referral to a health care provider in their
area if needed. However, such an approach has not yet been implemented as a standard option for nonhealth
professionals in LMIC countries, e.g., sub Saharan Africa, where two-thirds of all people living with
HIV infection globally reside.
Kenya has been a leader in innovative approaches to HIV prevention and care. The recent KAIS
(NASCOP, September 2013) national survey found that levels “of HIV testing have increased with 72% of
adults aged 15-64 years in 2012 reporting ever having been tested for HIV, a significant increase from 34%
in 2007.” Ambitious population coverage targets for HIV serostatus knowledge have been set, yet even with
large-scale home-based counseling and testing (HBCT) programs, voluntary counseling and testing (VCT)
scale up, and other approaches, there still remains a coverage gap as noted by KAIS (one that is larger for
men than women). This suggests that HST has a place as part of a comprehensive testing strategy. Kenya
has successfully piloted HST among health workers (Kalibala et al., 2011) and is the first African country to
develop policy guidelines (NASCOP, 2009) around HST for the general public.AIMS AND OBJECTIVE
Our objective was to evaluate the performance and accuracy parameters of oral fluid HIV self-testing in the
general population of Kenya. The study aims were to determine (1) the ability of participants with unknown
HIV status to correctly perform and interpret a rapid oral fluid (OF) HIV test and to determine accuracy of
HST results compared to staff/lab testing (i.e., sensitivity and specificity measures of validation), and (2)
participant attitudes towards OF self-testing (i.e., OF HST acceptability and feasibility). A secondary
objective included exploring linkage to care (i.e. whether the proportion of those who attend clinic within
one month of their confirmed positive HIV result differed between individuals who tested using the OF
HST in comparison to those who tested through regular VCT).

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