JMIR Publications

ABSTRACT

Background:

Human immunodeficiency virus (HIV) self-testing (HIVST) has gained momentum in recent years following the approval of self-testing methods and novel technological advancements. Digital HIVST involves completing an oral- or blood-based HIV self-test with the support of a digital innovation.

Objective:

We conducted a systematic review on the existing data analyzing digital HIVST accuracy, while updating research on digital HIVST acceptability, preference, feasibility, and impact.

Methods:

We searched two databases (Embase and PubMed) for records on HIVST with digital supports. For accuracy measures, the search spanned January 1st, 2013, to May 15th, 2023; for patient-centered and impact outcomes, we updated existing literature (June 16th, 2021, to May 15th, 2023) reported in a previous systematic review. Quality of studies was assessed using the QUADAS 2 Tool, Newcastle-Ottawa Scale, and Cochrane Risk of Bias Tool 2.

Results:

39 studies total were summarized, reporting sample sizes varying from 120-21,035 (median 1235) study participants, from 12 middle- to high-income countries. Five studies reported on accuracy of HIV self-testing with innovations from >5000 participants. Diagnostic performance metrics, including point estimates of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were measured for oral-based HIVST (n = 1): 92.9%, 96.8%, 76.5%, and 99.2%, respectively. The percentage of invalid test results for oral- and blood-based self-tests ranged from 0.2%-12.7% (n = 4). 37 studies reported data on metrics beyond accuracy, including acceptability, preference, feasibility, and impact outcomes from >30,000 participants. Majority (83.8%; 31/37) were observational studies, while 16.2% (6/37) reported data from randomized controlled trials (RCTs). Acceptability and preference outcomes varied from 64.5%-99.0% (n = 11) and 4.6%-99.3% (n = 6), respectively. Feasibility outcomes included test uptake (42.2%-98.2%; n = 19), response rate (26.0%-94.8%; n = 6), and visits to web-based providers (43.0%-70.7%; n = 3). Impact outcomes assessed new infections (0.0%-25.8%; n = 23), first-time testers (0.0%-45.0%; n = 20), result return proportions (22.1%-97.5%; n = 16), and linkage to care as both connections to confirmatory testing and counselling (56.4%-100.0%; n = 10) and referrals for treatment initiation (44.4%-98.1%; n = 6). The quality of studies varied, though generally demonstrated low risk of bias.

Conclusions:

Digital innovations improved the accuracy of HIVST results, and were well-accepted and preferred by participants. Operationally, they were found to be feasible and reported impacting the HIVST process. These findings support digital HIVST innovations as promising support tools and suggest that digital HIVST service delivery models hold promise in not only facilitating HIV testing, but also impacting operational outcomes, that are crucial to reaching UNAIDS targets in middle- to high-income countries.