The Uptake and Accuracy of Oral Kits for HIV Self-Testing in High HIV Prevalence Setting: A Cross-Sectional Feasibility Study in Blantyre, Malawi

Choko, Augustine; Desmond, Nicola; Webb, Emily L.; Chavula, Kondwani; Napierala, Sue; Gaydos, Charlotte A.; Makombe, Simon D; Chunda, Treza; Squire, S. Bertel; French, Neil; Mwapasa, Victor; Corbett, Elizabeth L.

doi:10.1371/journal.pmed.1001102

Cited by 281 publications

(437 citation statements)

References 29 publications

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“…Use of pictures is essential and, in some settings, additional local languages may be optimal. Other mechanisms for instruction should also be considered, such as community education sessions to demonstrate test steps (before distributing test kits) [8]. Designing a device and its presentation in a manner that is as intuitive and simple as possible to the intended user is critical [10], underscoring the need for piloting with the intended user population.…”

Section: Discussionmentioning

confidence: 99%

“…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.…”

Section: Discussionmentioning

confidence: 99%

“…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].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

et al. 2014

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HIV self-testing (HIVST) is increasingly being sought and offered globally, yet there is limited information about the test features that will be required for an HIV self-test to be easy to use, acceptable to users, and feasible for manufacturers to produce. We conducted formative usability research with participants who were naïve to HIVST using five prototypes in Kenya, Malawi, and South Africa. The tests selected ranged from early-stage prototypes to commercially ready products and had a diverse set of features. A total of 150 lay users were video-recorded conducting unsupervised self-testing and interviewed to understand their opinions of the test. Participants did not receive a test result, but interpreted standardized result panels. This study demonstrated that users will refer to the instructions included with the test, but these can be confusing or difficult to follow. Errors were common, with less than 25 % of participants conducting all steps correctly and 47.3 % of participants performing multiple errors, particularly in sample collection and transfer. Participants also had difficulty interpreting results. To overcome these issues, the ideal HIV self-test requires pictorial instructions that are easy to understand, simple sample collection with integrated test components, fewer steps, and results that are easy to interpret.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2014

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“…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].…”

mentioning

confidence: 99%

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

et al. 2014

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HIV self-testing (HIVST) is an emerging HIV testing strategy intended to address challenges of increasing access to preliminary knowledge of serostatus. It offers the potential for tests and testing to reach more people than previously possible, including those who do not seek testing in facilities. With approval of an HIV self-test kit in the USA, increasing evidence from public pilot programs in sub-Saharan Africa showing high acceptability and feasibility, and evidence of the informal sale of rapid HIV test kits in the private sector, options for individuals to access HIV self-testing, as well as consumer-demand, appear to be increasing. More recently WHO and UNAIDS have explored self-testing as an option to achieving greater HIV testing coverage to support global treatment targets. However, for resource-limited settings, technological development, diagnostic device regulation and quality assurance policies are lagging behind. This commentary will examine regulatory and policy issues with HIVST, given its increased prominence as a potential part of the global HIV/AIDS response.

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“…In 2012, the first OFT received approval by the Food and Drug Administration as a home-use HIV kit for self-testing. The use of an OFT as a self-testing strategy has been demonstrated to be highly acceptable and accurate in Africa [4,5]. …”

Section: Introductionmentioning

confidence: 99%

False‐negative HIV tests using oral fluid tests in children taking antiretroviral therapy from Harare, Zimbabwe

Olaru

McHugh

Dakshina

et al. 2017

Journal of the International AIDS Society

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Introduction: Rapid diagnostic tests (RDT) for HIV infection have high sensitivity and specificity, but in the setting of longstanding antiretroviral therapy (ART), can give false results that can lead to misinterpretation, confusion and inadequate management. The objective of this study was to evaluate the proportion of falsely negative results of a RDT performed on oral fluid in HIV-infected children on longstanding ART. Methods: One hundred and twenty-nine children with known HIV infection and receiving ART were recruited from the HIV Clinic at the Harare Central Hospital, Zimbabwe. HIV testing was performed on oral fluid and on finger-stick blood. Results and Discussion: Children included in the study had a median age of 12 years (IQR 10–14) and 67 (51.9%) were female. Median age at HIV diagnosis was 5 years (IQR 3–6) and the median time on ART was 6.3 years (IQR 4.3–8.1). The oral fluid test was negative in 11 (8.5%) patients and indeterminate in 2 (1.6%). Finger-stick blood test was negative in 1 patient. Patients with a negative oral fluid test had a higher CD4 cell count (967 vs. 723 cells/mm3, p = 0.016) and a longer time on ART (8.5 vs. 6 years, p = 0.016). Conclusions: This study found that a substantial proportion of false-negative HIV test results in children on longstanding ART when using an oral fluid test. This could lead to misinterpretation of HIV test results and in the false perception of cure or delayed diagnosis.

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The Uptake and Accuracy of Oral Kits for HIV Self-Testing in High HIV Prevalence Setting: A Cross-Sectional Feasibility Study in Blantyre, Malawi

Abstract: Augustine Choko and colleagues assess the uptake and acceptability of home-based supervised oral HIV self-testing in Malawi, demonstrating the feasibility of this approach in a high-prevalence, low-income environment.

Cited by 281 publications

References 29 publications

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

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

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

False‐negative HIV tests using oral fluid tests in children taking antiretroviral therapy from Harare, Zimbabwe

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