We searched for HIVST-associated studies that were conducted in China and published from January 1, 2010, to December 25, 2021, in 5 databases and 2 registration systems (PubMed, Web of Science, MEDLINE, WanFang, China National Knowledge Internet, ClinicalTrials.gov, and the Chinese Clinical Trial Registry) and then further reviewed them. Our search syntax was based on the following core concepts: “HIV,” “self-testing,” and “China” (see Multimedia Appendix 1 for details regarding the search strategy).

To qualify for inclusion, a research article had to meet the following criteria: (1) peer-reviewed articles reporting on the performance of rapid diagnostic HIV tests by those who self-tested, and (2) available numerator and denominator data to confirm rate values. Studies investigating foreign residents living within China were excluded.

Two reviewers (XX and YQ) independently screened and assessed the titles and abstracts of all articles identified via the search strategy. Each reviewer decided whether to exclude or include a study in accordance with a standardized form that defined the criteria for inclusion and exclusion. Data were independently extracted from individual studies by 3 reviewers (XX, YQ, and YB). If a dispute occurred, consensus was achieved through discussions with 3 other authors (HW, XH, and LW). EndNote reference management software (version X9.3.3; Clarivate) was used to filter duplicate studies. Microsoft Excel spreadsheet software (Microsoft Office 2016) was used to record the data extracted from eligible studies.

In all, 6 indicators were analyzed in this work: proportion of those who previously self-tested, proportion of actual uptake of HIVST, proportion of self-testing as lifetime first HIV screening, proportion of results feedback, reactive rate of HIVST, and proportion of linkage to care. The proportion of those who previously self-tested was defined as the number of individuals who have personal experience of HIVST among all the investigated people. The proportion of self-testing as lifetime first HIV screening was defined as the number of individuals who used self-testing as their first-ever HIV screening among people who have ever used HIVST. The proportion of results feedback was defined as the number of individuals who self-reported the results of HIVST or returned the images of HIVST to investigators or health institutions among those who self-tested for HIV. The reactive rate of HIVST was defined as the number of individuals receiving a positive reactive HIVST result among those who have self-tested for HIV. The proportion of linkage to care was defined as the number of patients who sought in-person confirmation of their HIV status (with or without accessing treatment) at local health facilities among individuals whose HIVST was reactive.

Meta-analyses of the pooled proportion estimates were carried out by the meta-package in R software (version 4.1.2; R Foundation for Statistical Computing). Statistical heterogeneity among the studies was estimated using Cochran Q test and the inconsistency index (I²). Very low, low, moderate, and high degrees of heterogeneity were defined as I² of ≤25%, 25% to ≤50%, 50% to ≤75%, and ≥75%, respectively.

The tool developed by Hoy et al [17] was used to assess the quality of the included studies [18]. The quality of each study was assessed according to 10 items with a maximum score of 10 (one point for a “Yes”). A total score of 0-5, 6-8, and 9-10 was considered high, moderate, and low risk of bias, respectively.

A total of 688 records was found based on the initial search, of which 213 were selected for full-text evaluation after the removal of duplicates and initial screening. Finally, 50 studies were included in the systematic review based on critical appraisal and were included in our systematic review (Figure 1). Among them, 30 articles were written in the English language, and 20 articles were published in Chinese-language journals. Of the 50 studies, 6 (12%) were found to show a low risk of bias, 36 (72%) were classified as having a moderate risk, and 8 (16%) were classified as having a high risk of bias. The characteristics of eligible studies are summarized in Table 1.

A total of 23 studies investigated the proportion of those who previously self-tested. Only 2 studies reported on the prevalence of HIVST used in the past in HIV high-risk populations other than men who have sex with men (MSM) [43,51], with the lowest proportion of those who previously self-tested being the male clients of female sex workers (2.6%), as reported by Lau et al [51]. The highest prevalence of HIVST use in the past was observed in the study by Jin et al [62], that is, 74.5% in HIV-negative MSM. The estimated pooled prevalence of HIVST use in China was 29.91% (95% CI 22.51%-37.88%), with a higher estimated pooled prevalence in 2018 or later (41.12%, 95% CI 24.98%-58.31%) than before 2018 (23.22%, 95% CI 17.89%-29.02%; Figure 2).

In all, 8 studies investigated the proportion of HIVST uptake after distributing HIVST kits to their study populations. The proportion of actual uptake of HIVST ranged from 48.29% to 88.48% across studies. It was shown that the pooled estimate of the proportion of HIVST was 69.97% (95% CI 51.19%-80.25%). Subgroup analysis revealed that the proportion of actual oral mucosal fluid–based HIVST was 71.6% (95% CI 52.97%-84.95%). The proportion of actual blood-based HIVST was 67.06% (95% CI 57.69%-78.82%). Heterogeneity among the studies was found to be statistically significant (I²=98%; P<.001; Figure 3). To analyze the source of heterogeneity, we conducted a meta-regression to evaluate the impact that the categories of HIVST kits had on the substantial heterogeneity between the studies reporting actual HIVST uptake. However, we found no statistically significant difference in uptake of HIVST using either oral mucosal fluid– or blood-based HIVST kits (P=.45).

In all, 7 studies examined individuals who used HIVST as their first-ever HIV-screening experience. The pooled proportion of individuals using HIVST as their lifetime first HIV screening was 47.48% (95% CI 37.23%-57.84%) but had high heterogeneity (I²=97%; P<.001; Figure 4).

Figure 5 presents the proportion of results feedback among those self-tested for HIV among 18 studies. The overall estimate of the feedback rate was 92.1% (95% CI 85.6%-95.8%) among those who self-tested for HIV. Cochran Q testing indicated substantial heterogeneity among the studies (I²=99%; P<.001; Figure 5).

In all, 25 studies showed the reactive rate of HIVST. The pooled reactive rate of HIVST was 4.24% (95% CI 3.08%-5.82%). Interestingly, the pooled reactive rate of HIVST before 2018 was 5.3% (95% CI 2.96%-9.51%), which is higher than that in 2018 or later (3.32%, 95% CI 2.07%-5.34%). The included studies showed high heterogeneity (I²=96%; P<.001; Figure 6).

Among the 25 studies reporting the reactive rate of HIVST, 8 studies reported the incidence of linkage to care in HIV-positive self-tested individuals. The pooled proportion of linkage to care among HIV-positive individuals was 81.26% (95% CI 70.93%-91.59%; Figure 7).

Although only studies with moderate and low risk of bias were included, the pooled proportion of HIVST used previously (29.49%, 95%CI 19.99%-40%), the pooled proportion of actual uptake of HIVST (68.29%, 95% CI 51.02%-81.66%), the pooled proportion of individuals using HIVST as their lifetime first HIV screening (47.48%, 95% CI 37.23%-57.84%), the pooled feedback rate (91.38%, 95% CI 82.51%-95.97%), the pooled reactive rate of HIVST (4.21%, 95% CI 2.91%-6.09%), and the pooled proportion of linkage to care (74.68%, 95% CI 62.44%-86.92%) were similar to results obtained when including all studies (Multimedia Appendix 2).

Funnel plots for the outcomes are shown in Multimedia Appendix 3. The P values obtained from the Egger test for asymmetry of the funnel plot were not significant for the pooled proportion of HIVST used previously (P=.59), the pooled proportion of actual uptake of HIVST (P=.15), the pooled proportion of individuals using HIVST as their lifetime first HIV screening (P=.56), the pooled feedback rate (P=.28), and the pooled proportion of linkage to care (P=.58). Using the Egger test, a significant publication bias was observed in studies concerning the reactive rate of HIVST (P=.003), which is concerning since this tends to undermine, to a degree, the validity of the method that was used to measure the reactive rate of HIVST.

HIV testing is a key entry point for HIV prevention and treatment programs. Previous studies have shown that HIVST may enhance HIV testing uptake, increase HIV testing frequency, and limit potential harm among key populations [9,43]. According to Figueroa et al [65], when using HIV rapid diagnostic tests with high accuracy, those who self-test may obtain results similar to those obtained by health care workers in health care settings.

The potential factors influencing the use of HIVST include the demographic characteristics of population, age, level of education, and marital status [16,66,67]. In China, only 8% of female sex workers had ever tested for HIV using self-test kits [43]. HIVST uptake among MSM is much more prevalent than in other populations [15,31]. The higher uptake of HIVST in MSM may be attributable to HIV awareness raising by MSM-associated social organizations. For instance, crowdsourcing has been an effective strategy for enhancing HIVST uptake in MSM, especially in low- and middle-income countries [29]. Furthermore, the rate of HIVST use among MSM who use pre-exposure prophylaxis (PrEP), especially among those on daily PrEP, was observed to be high in a multicenter trial in China [68]. Thus, more extensive and specific applications of HIVST, such as using HIVST during the follow-up of PrEP users, may generate improved data for HIVST uptake and use. All forms of sex work are illegal in China, which restricts female sex workers and their male clients from actively seeking relevant and valuable knowledge regarding HIV. Therefore, inventive strategies are required to enhance the uptake of HIVST in key populations who are at high risk of HIV infection but possess limited knowledge of HIV prevention. In the 23 studies reporting the proportion of those who previously self-tested, only 2 studies [14,23] reported on the number of oral fluid–based HIVST used by self-testers (13.87% and 29%, respectively). Although it has been reported in the past that oral fluid–based HIVST is valid, acceptable, and accurate [5], the practical application of this testing method remains a challenge in China. Notably, oral fluid–based HIVST kit users in China were more likely to make errors during the oral HIVST testing procedure. Data gleaned from statistical meta-regression suggest that the category of the testing kit may not be the main or only reason for the actual difference in uptake between oral and blood-based HIVST kits.

According to our meta-analysis, it is estimated that approximately half (47.48%) of all individuals who were tested for HIV in China used HIVST as their first-ever test. HIVST has the potential to reach high-risk populations who have never been tested for HIV or who refuse voluntary counseling and testing. Qin et al [23], in contrast, observed that MSM who find sexual partners through the internet prefer medical facility–based testing rather than self-testing as their first-ever HIV test. This finding might be attributable to the fact that MSM who use the internet may have legitimate concerns regarding the accuracy of self-test kits after coming across relevant information on the internet, given their regular and routine access to internet-based information, in this instance, related to the overall quality and validity of HIVST kits on the internet [23]. HIVST with digital support may be an effective way to engage with those who self-test for HIV for the first time and some hard-to-reach populations, according to McGuire et al [69]. HIVST along with web-based counseling may be an effective strategy to increase the prevalence of HIV testing and reduce sexual risk behaviors [70], especially during the COVID-19 pandemic, when accessing HIV testing may have structural, regulatory, and psychological public health–related barriers [71,72]. Therefore, raising awareness of the accuracy and reliability of HIVST in a web-based digital manner might be desirable. In addition, monetary incentives combined with peer referral in the MSM population is also an effective manner to encourage first-time testing [73]. However, it is essential that other novel and inventive approaches for the promotion of first-time HIV testing are further explored.

The overall result feedback rate in those who self-test for HIV is known to be relatively high. Jin et al [37] compared the behaviors between those who did and those who did not submit their results after self-testing and observed, curiously, that individuals at lower HIV risk were more reluctant to submit their test results [37]. The lower feedback rate among individuals at lower HIV risk may lead to an inaccurate estimation of HIV prevalence in these populations. In this meta-analysis, we found that the cost of participants acquiring self-testing kits did not play a significant role in influencing results feedback.

The pooled reactive rate of HIVST among MSM in our study is similar to the overall national prevalence of HIV among MSM from 2001 to 2018, as estimated by Dong et al [74] (4.6%, 95% CI 3.2%-6.5% vs 5.7%, 95% CI 5.4%-6.1%). One recent study suggested that the lower reactive rate of HIVST is likely to be associated with a wider participant base in the study, and participants are not necessarily restricted to potential high-risk individuals only [3]. Our findings support the aforementioned speculation—that the reactive rate in China has declined steadily along with the widespread use of HIVST after 2018. However, beyond that, the reduced reactive rate may also reflect a demonstration of the significance of HIVST for HIV prevention.

Choko et al [75] indicated that financial incentives and partner-delivered approaches may likely increase male linkage into posttest HIV care. Among the studies providing self-test kits (excluding 2 studies with small sample size [48,60]; n≤10), those providing self-test kits distributed by sexual partners [53] showed a higher linkage-to-care rate among HIV-positive patients (81.9%), whereas for those studies only distributing testing kits by post [37,40], the linkage-to-care rate was from 53.6% to 72.4%. Our review observed that sexual partners may play a critical role in accessing timely medical intervention for their partners with HIV-positive self-tests.

We acknowledge several limitations to our study. First, most of the data used in our study were derived from the MSM population, and our analysis is based exclusively on this data. Therefore, the results of our study provide only limited outcomes and knowledge with respect to the application of HIVST in other high-risk populations. Second, data associated with the use of HIVST over extended periods are limited. One recent longitudinal study observed that HIVST adherence reduced to a paltry 10% during 1-year of follow-up [76]. Thus, the potential role of HIVST use over prolonged periods requires further exploration. Third, HIVST kits provided by research sponsors were available for free or on a refundable basis in the included studies. The effect of actual cost of access to HIVST kits in the real world in China was, therefore, not assessed or commented upon in our discussion.

In summary, HIVST has evolved over recent years into an important pillar of HIV prevention in China. However, the use of HIVST in non-MSM populations requires sustained upscaling. The long-term applications of HIVST and the effects of self-financing of HIVST in China have yet to be explored.