@Article{info:doi/10.2196/63110,
author="Beecroft, Ashlyn
and Vaikla, Olivia
and Engel, Nora
and Duchaine, Thomas
and Liang, Chen
and Pant Pai, Nitika",
title="Evidence on Digital HIV Self-Testing From Accuracy to Impact: Updated Systematic Review",
journal="J Med Internet Res",
year="2025",
month="Mar",
day="4",
volume="27",
pages="e63110",
keywords="digital HIV self-testing; impact; linkage; outcomes; HIV; HIV infection; HIV self-testing; self-testing; digital innovation; systematic review; accuracy; patient-centered; middle- to high-income countries; digital health; mHealth; health education; sexually transmitted diseases; sexual behavior",
abstract="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 ",
issn="1438-8871",
doi="10.2196/63110",
url="https://www.jmir.org/2025/1/e63110",
url="https://doi.org/10.2196/63110",
url="http://www.ncbi.nlm.nih.gov/pubmed/40053740"
}