BACKGROUND: HIV self-testing has gained momentum following the approval of self-testing methods and novel technological advancements. Digital HIV self-testing involves completing an oral or blood-based HIV self-test with support from a digital innovation. OBJECTIVE: We conducted a systematic review on the existing data analyzing digital HIV self-testing accuracy while updating research on digital HIV self-test acceptability, preference, feasibility, and impact. METHODS: We searched Embase and PubMed for records on HIV self-testing with digital support. Included studies significantly incorporated a form of digital innovation throughout the HIV self-test process and reported quantitative data. For accuracy measures, the search spanned January 1, 2013, to October 15, 2024
for patient-centered and impact outcomes, we updated existing literature (June 16, 2021, to October 15, 2024) reported in a previous systematic review. Studies' quality was assessed using the QUADAS 2 Tool, Newcastle-Ottawa Scale, and Cochrane Risk of Bias Tool 2. RESULTS: Fifty-five studies (samples ranging 120-21,035, median 1267 participants) were summarized from 19 middle- to high-income countries. Seven studies reported on the accuracy of HIV self-testing with innovations from >
5000 participants. Diagnostic performance metrics, including point estimates of specificity, sensitivity, positive predictive value, and negative predictive value were measured (n=3), and ranged from: 96.8% to 99.9%, 92.9% to 100.0%, 76.5% to 99.2%, and 99.2% to 100.0%, respectively. The percentage of invalid test results for oral and blood-based self-tests ranged from 0.2% to 12.7% (n=4). Fifty-one studies reported data on metrics beyond accuracy, including acceptability, preference, feasibility, and impact outcomes from >
30,000 participants. Majority (38/51, 74.5%) were observational studies, while 25.5% (13/51) reported data from randomized controlled trials. Acceptability and preference outcomes varied from 64.5% to 99.0% (14/51) and 4.6% to 99.3% (8/51), respectively. Feasibility outcomes included test uptake (30.9% to 98.2%
28/51), response rate (26.0% to 94.8%
7/51), and visits to web-based providers (43.0% to 70.7%
n=4). Impact outcomes assessed new infections (0.0% to 25.8%
31/51), first-time testers (2.0% to 53.0%
26/51), result return proportions (22.1% to 100.0%
24/51), linkage to care as both connections to confirmatory testing and counseling (53.0% to 100.0%
16/51), and referrals for treatment initiation (44.4% to 98.1%
8/51). The quality of studies varied, though they generally demonstrated low risk of bias. CONCLUSIONS: Digital innovations improved the accuracy of HIV self-test results, and were well-accepted and preferred by participants. Operationally, they were found to be feasible and reported impacting the HIV self-testing process. These findings are in favor of the use of digital HIV self-test innovations as a promising support tool and suggest that digital HIV self-tests' service delivery models hold promise in not only facilitating HIV testing but also impacting operational outcomes that are crucial to reaching Joint United Nations Program on HIV/AIDS targets in middle- to high-income countries. TRIAL REGISTRATION: PROSPERO CRD42020205025
https://www.crd.york.ac.uk/prospero/CRD42020205025.