Are Participants in a Street-Based HIV Testing Program Able to Perform Their Own Rapid Test and Interpret the Results?

Abstract

ObjectiveAvailability of over-the-counter rapid HIV tests could improve access to testing those reluctant or unable to use current services. We aimed to evaluate the feasibility of HIV self-testing using a finger-stick whole-blood rapid test (Determine™ HIV Combo) to detect both antigen and antibody.MethodsBefore being tested, 313 participants in a street-based testing program were given adapted instructions and a test kit, and performed the self-test without supervision. These participants, together with another 207 who performed supervised self-testing, received additional instructions on how to interpret the test results shown in six colour photos and filled out a questionnaire. Logistic regression and generalized estimating equations (GEE) were used in the statistical analysis.ResultsAbout 8.0% (95%CI:4.8%–11.2%) obtained an invalid self-test. An invalid result was inversely associated with male participants who had sex with men (OR = 0.3;95%CI:0.1–1.0). Of the 3111 photos interpreted,4.9% (95%CI:4.1–5.7) were incorrect. Only 1.1% (95%CI:0.3–1.8) of the positive results were interpreted as negative. Age 30 or older (OR = 2.1; 95%CI:1.2–3.7), having been born in Latin America (OR = 1.6; 95%CI:1.1–2.2),and not having university education (OR = 2.1;95%CI:1.2–3.7) were associated with misinterpreting test results in the GEE. Participant's perceptions of both their proficiency when conducting the test and interpretation were related with actual outcomes. Most participants (83.9%) were more motivated than before to use the self-test in the future, and 51.7% would pay >10 Euros for the test if it was sold in pharmacies.ConclusionsThis is the first study showing that blood-based self-testing with current technology is feasible in HIV-negative participants demanding the test and without prior training or supervision. Bearing in mind that it was conducted under difficult weather conditions and using a complex kit, over-the-counter tests could be a feasible option to complement current diagnostic strategies. More studies are needed to accommodate technology, minimise interpretation mistakes and provide on-line support.

What Should the Ideal HIV Self-Test Look Like? A Usability Study of Test Prototypes in Unsupervised HIV Self-Testing in Kenya, Malawi, and South Africa

“…Therefore, improved instructions with clear language and graphics, increased detail on proper swab collection, less complicated swab collection procedure, and color-coded or ergonomic devices to facilitate proper handling of the device could improve usability of oral fluid tests. Problems with blood sampling using a sample transfer device have been reported previously by health workers [22,23] as well as lay users who otherwise found the kit easy to use and the instructions easy to understand [6].Due to this, one study site chose to modify the instructions so that participants were instructed to put the sample directly onto the test, and good results were obtained [7,8]. This study corroborates these results and finds that technologies and test methods that integrate sample volume measurement with sample transfer into the test cassette increase the opportunity for the naïve test user to conduct the steps properly.…”

“…However, 85 % failed to perform all steps correctly, especially blood sampling, and 56 % received invalid results [6]. Another study in Spain with 313 participants conducting unsupervised HIVST using wholeblood with adapted instructions found that only 8 % obtained an invalid self-test, with 1.1 % of positive results interpreted as negative [7]. High levels of accuracy (99.2 %) were obtained in Malawian communities from unsupervised oral HIVST with the use of illustrated instructions, after a brief product demonstration [8].…”

Approval and Potential Use of Over-the-Counter HIV Self-Tests: The Opinion of Participants in a Street Based HIV Rapid Testing Program in Spain

“…Since 2006 a program, run by a non-governmental organization (NGO), has been using a mobile unit to offer free and rapid HIV testing in the streets of different areas throughout Spain [35]. From November 2010 to June 2012, the program was implemented in the city of Madrid, in three coastal cities of southeast Spain and two cities of the Canary Islands.…”

“…Reasons were chosen based on prior publications. We also took into consideration our previous experience when evaluating basic HIV test program characteristics opinions in a similar population [36], as well as a first pilot assessment made in a previous feasibility HIV self-test study [35], where participants could choose between several reasons for not wanting to use the test in the future and were given the possibility to write additional reasons. Reasons were not interrelated to constitute a construct and were not part of a scale.…”

HIV Self-Testing in Resource-Limited Settings: Regulatory and Policy Considerations

“…As such, they must meet minimum performance standards, and diagnoses are made only through validated, multi-test algorithms [2,7]. Nevertheless, benefits of HIVST within specific settings and populations have now been documented in literature reviews [8][9][10], pilot studies [11][12][13], meeting reports [14], technical updates [15], and interim data and research [16][17][18].…”