Introduction Implementation data for digital unsupervised HIV self-testing (HIVST) are sparse. We evaluated the impact of an app-based, personalised, oral HIVST program offered by healthcare workers in Western Cape, South Africa. Methods In a quasirandomised study (n=3095), we recruited consenting adults with undiagnosed HIV infection from township clinics. To the HIVST arm participants (n=1535), we offered a choice of an offsite (home, office or kiosk based), unsupervised digital HIVST program (n=962), or an onsite, clinic-based, supervised digital HIVST program (n=573) with 24/7 linkages services. With propensity score analyses, we compared outcomes (ie, linkages, new HIV infections and test referrals) with conventional HIV testing (ConvHT) arm participants (n=1560), recruited randomly from geographically separated clinics. Results In both arms, participants were young (HIVST vs ConvHT) (mean age: 28.2 years vs 29.2 years), female (65.0% vs 76.0%) and had monthly income <3000 rand (80.8% vs 75%). Participants chose unsupervised HIVST (62.7%) versus supervised HIVST and reported multiple sex partners (10.88% vs 8.7%), exposure to sex workers (1.4% vs 0.2%) and fewer comorbidities (0.9% vs 1.9%). Almost all HIVST participants were linked (unsupervised HIVST (99.7%), supervised HIVST (99.8%) vs ConvHT (98.5%)) (adj RR 1.012; 95% CI 1.005 to 1.018) with new HIV infections: overall HIVST (9%); supervised HIVST (10.9%) and unsupervised HIVST (7.6%) versus ConvHT (6.79%) (adj RR 1.305; 95% CI 1.023 to 1.665); test referrals: 16.7% HIVST versus 3.1% ConvHT (adj RR 5.435; 95% CI 4.024 to 7.340). Conclusions Our flexible, personalised, app-based HIVST program, offered by healthcare workers, successfully linked almost all HIV self-testers, detected new infections and increased referrals to self-test. Data are relevant for digital HIVST initiatives worldwide. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information.

中文翻译：

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个性化、数字化、基于艾滋病毒自我检测应用程序的程序对南非乡镇人口的联系和新感染的影响

简介 数字无监督 HIV 自我检测 (HIVST) 的实施数据很少。我们评估了南非西开普省医护人员提供的基于应用程序的个性化口头 HIVST 计划的影响。方法 在一项半随机研究 (n=3095) 中，我们从乡镇诊所招募了未确诊 HIV 感染且同意的成年人。对于 HIVST 组参与者 (n=1535)，我们提供了一个选择：异地（基于家庭、办公室或信息亭）、无人监督的数字 HIVST 计划（n=962）或现场、基于诊所的、有监督的数字 HIVST 计划（ n=573) 提供 24/7 链接服务。通过倾向评分分析，我们将结果（即联系、新的 HIV 感染和检测转诊）与从地理上分开的诊所随机招募的传统 HIV 检测 (ConvHT) 组参与者（n=1560）进行了比较。结果在双臂中，参与者年轻（HIVST vs ConvHT）（平均年龄：28.2 岁 vs 29.2 岁），女性（65.0% vs 76.0%），月收入 <3000 兰特（80.8% vs 75%）。参与者选择了无人监督的 HIVST (62.7%) 与有监督的 HIVST，并报告了多个性伴侣（10.88% 对 8.7%）、接触性工作者（1.4% 对 0.2%）和较少的合并症（0.9% 对 1.9%）。几乎所有 HIVST 参与者都与新的 HIV 感染相关（无监督 HIVST (99.7%)、监督 HIVST (99.8%) 与 ConvHT (98.5%)）（调整 RR 1.012；95% CI 1.005 至 1.018）：总体 HIVST (9%) ; 有监督的 HIVST (10.9%) 和无监督的 HIVST (7.6%) 与 ConvHT (6.79%)（调整 RR 1.305；95% CI 1.023 至 1.665）；测试转诊：16.7% HIVST 与 3.1% ConvHT（调整 RR 5.435；95% CI 4.024 至 7.340）。结论 我们由医护人员提供的灵活、个性化、基于应用程序的 HIVST 计划，成功地将几乎所有艾滋病毒自我检测者联系起来，发现了新的感染并增加了自我检测的转介。数据与全球数字 HIVST 计划相关。可应合理要求提供数据。与研究相关的所有数据都包含在文章中或作为补充信息上传。与研究相关的所有数据都包含在文章中或作为补充信息上传。