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PROVIDING USER SUPPORT FOR HIV SELF-TESTING BEYOND INSTRUCTIONS-FOR-USE IN MALAWI
Pitchaya Indravudh1, Moses Kumwenda1, Melissa Neuman2, Blessings Chisunkha1, Karin Hatzold3, Chiwawa Nkhoma4, Thokozani Kalua5, Cheryl Johnson6, Miriam Taegtmeyer7, Liz Corbett8
1Malawi–Liverpool–Wellcome Trust Clinical Rsr Prog, Blantyre, Malawi,2London Sch of Hygiene & Trop Med, London, UK,3Pop Services Intl, Harare, Zimbabwe,4Pop Services Intl, Blantyre, Malawi,5Malawi Dept of HIV and AIDS, Lilongwe, Malawi,6WHO, Geneva, Switzerland,7Liverpool Sch of Trop Med, Liverpool, UK,8London Sch of Hygiene & Trop Med, Blantyre, Malawi
HIV self-testing (HIVST) devices provide a convenient option for home-based testing, but comprehension of standard manufacturer instructions-for-use can be highly variable.
Commercial OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test Kits packaged for HIVST were procured with pictorial IFUs accompanied by text in both English and ChiChewa. Ease-of-use was assessed through cognitive interview with literate adults (age ≥16 years) attending HIV testing services in rural and urban Blantyre. Participants were provided with the packaged kits containing IFUs but no other assistance. A standardised questionnaire and observation record was administered during self-testing. Feasibility was then evaluated in two rural villages, with 342 participants from randomly-selected households and community peer groups (age ≥16 years and not on antiretrovirals). Respondents were offered the options of self-testing, receiving standard HIV testing, or not testing and were administered baseline and exit questionnaires. Respondents opting to self-test received a brief demonstration on kit content and usage. HIVST results were compared to a reference standard (2 parallel rapid blood-based kits by a trained professional).
Numerous problems occurred in 20 cognitive interviews, including difficulty in package opening and misinterpretation of translated phrases ('two pouches'; 'test stand') and imagery. Abstract symbolisation (e.g. knife and fork for eating; traffic crosses for 'do not') was poorly recognised. Although 18/20 completed HIVST, these difficulties greatly affected timeliness and confidence in validity. In contrast, all 291 feasibility participants (80.0% literate) who opted to self-test completed the test following standardised demonstration. Self-read results agreed with reference for 12/13 HIV-positive participants (sensitivity 92.9%, 95%CI 66.1%-99.8%) and 276/277 HIV-negative participants (specificity 99.60%, 95%CI 98%-100%). Uptake was high, with 85.1% of participants opting to self-test. Respondents also reported high levels of ease and satisfaction, with 100% recommending HIVST to friends and family.
In settings where commercially packaged self-assembly products are rarely encountered, literacy may not guarantee ability to follow HIVST IFUs unless accompanied by demonstration of use. Cognitive interviewing provides a rapid and convenient way to alert self-testing implementers of this need in their communities.