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Background We update a previous systematic review to inform new World Health Organization HIV self-testing (HIVST) recommendations. We compared the effects of HIVST to standard HIV testing services to understand which service delivery models are effective for key populations. Methods We did a systematic review of randomised controlled trials (RCTs) which compared HIVST to standard HIV testing in key populations, published from 1 January 2006 to 4 June 2019 in PubMed, Embase, Global Index Medicus, Social Policy and Practice, PsycINFO, Health Management Information Consortium, EBSCO CINAHL Plus, Cochrane Library and Web of Science. We extracted study characteristic and outcome data and conducted risk of bias assessments using the Cochrane ROB tool version 1. Random effects meta-analyses were conducted, and pooled effect estimates were assessed along with other evidence characteristics to determine the overall strength of the evidence using GRADE methodology. Results After screening 5909 titles and abstracts, we identified 10 RCTs which reported on testing outcomes. These included 9679 participants, of whom 5486 were men who have sex with men (MSM), 72 were trans people and 4121 were female sex workers. Service delivery models included facility-based, online/mail and peer distribution. Support components were highly diverse and ranged from helplines to training and supervision. HIVST increased testing uptake by 1.45 times (RR=1.45 95% CI 1.20, 1.75). For MSM and small numbers of trans people, HIVST increased the mean number of HIV tests by 2.56 over follow-up (mean difference = 2.56; 95% CI 1.24, 3.88). There was no difference between HIVST and SoC in regard to positivity among tested overall (RR = 0.91; 95% CI 0.73, 1.15); in sensitivity analysis of positivity among randomised HIVST identified significantly more HIV infections among MSM and trans people (RR = 2.21; 95% CI 1.20, 4.08) and in online/mail distribution systems (RR = 2.21; 95% CI 1.14, 4.32). Yield of positive results in FSW was not significantly different between HIVST and SoC. HIVST reduced linkage to care by 17% compared to SoC overall (RR = 0.83; 95% CI 0.74, 0.92). Impacts on STI testing were mixed; two RCTs showed no decreases in STI testing while one showed significantly lower STI testing in the intervention arm. There were no negative impacts on condom use (RR = 0.95; 95% CI 0.83, 1.08), and social harm was very rare. Conclusions HIVST is safe and increases testing uptake and frequency as well as yield of positive results for MSM and trans people without negative effects on linkage to HIV care, STI testing, condom use or social harm. Testing uptake was increased for FSW, yield of positive results were not and linkage to HIV care was worse. Strategies to improve linkage to care outcomes for both groups are crucial for effective roll-out.

The HIV epidemic is rapidly growing among men who have sex with men (MSM) in China, yet HIV testing remains suboptimal. We aimed to determine the impact of HIV self-testing (HIVST) interventions on frequency of HIV testing among Chinese MSM and their sexual partners. This randomized controlled trial was conducted in 4 cities in Hunan Province, China. Sexually active and HIV-negative MSM were recruited from communities and randomly assigned (1:1) to intervention or control arms. Participants in the control arm had access to site-based HIV testing (SBHT); those in the intervention arm were provided with 2 free finger-prick-based HIVST kits at enrollment and could receive 2 to 4 kits delivered through express mail every 3 months for 1 year in addition to SBHT. They were encouraged to distribute HIVST kits to their sexual partners. The primary outcome was the number of HIV tests taken by MSM participants, and the secondary outcome was the number of HIV tests taken by their sexual partners during 12 months of follow-up. The effect size for the primary and secondary outcomes was evaluated as the standardized mean difference (SMD) in testing frequency between intervention and control arms. Between April 14, 2018, and June 30, 2018, 230 MSM were recruited. Mean age was 29 years; 77% attended college; 75% were single. The analysis population who completed at least one follow-up questionnaire included 110 (93%, 110/118) in the intervention and 106 (95%, 106/112) in the control arm. The average frequency of HIV tests per participant in the intervention arm (3.75) was higher than that in the control arm (1.80; SMD 1.26; 95% CI 0.97-1.55; P < 0.001). This difference was mainly due to the difference in HIVST between the 2 arms (intervention 2.18 versus control 0.41; SMD 1.30; 95% CI 1.01-1.59; P < 0.001), whereas the average frequency of SBHT was comparable (1.57 versus 1.40, SMD 0.14; 95% CI -0.13 to 0.40; P = 0.519). The average frequency of HIV tests among sexual partners of each participant was higher in intervention than control arm (2.65 versus 1.31; SMD 0.64; 95% CI 0.36-0.92; P < 0.001), and this difference was also due to the difference in HIVST between the 2 arms (intervention 1.41 versus control 0.36; SMD 0.75; 95% CI 0.47-1.04; P < 0.001) but not SBHT (1.24 versus 0.96; SMD 0.23; 95% CI -0.05 to 0.50; P = 0.055). Zero-inflated Poisson regression analyses showed that the likelihood of taking HIV testing among intervention participants were 2.1 times greater than that of control participants (adjusted rate ratio [RR] 2.10; 95% CI 1.75-2.53, P < 0.001), and their sexual partners were 1.55 times more likely to take HIV tests in the intervention arm compared with the control arm (1.55, 1.23-1.95, P < 0.001). During the study period, 3 participants in the intervention arm and none in the control arm tested HIV positive, and 8 sexual partners of intervention arm participants also tested positive. No other adverse events were reported. Limitations in this study included the data on number of SBHT were solely based on self-report by the participants, but self-reported number of HIVST in the intervention arm was validated; the number of partner HIV testing was indirectly reported by participants because of difficulties in accessing each of their partners. In this study, we found that providing free HIVST kits significantly increased testing frequency among Chinese MSM and effectively enlarged HIV testing coverage by enhancing partner HIV testing through distribution of kits within their sexual networks. Chinese Clinical Trial Registry ChiCTR1800015584.

Suboptimal uptake of HIV testing remains a primary bottleneck to HIV prevention and treatment for men who have sex with men (MSM) and transgender women (TGW) in Thailand. The World Health Organization has recommended HIV self-testing (HIVST) as an additional strategic HIV service. However, HIVST has not been fully endorsed and implemented in many countries in Southeast Asia. The aim of this study was to assess the uptake of oral fluid-based HIVST in MSM and TGW populations in Thailand. During 2017 and 2018, we conducted a cross-sectional study using convenience sampling to enroll 2,524 participants from three major urban areas. Participants were recruited during outreach and online activities and were offered unassisted or assisted HIVST, or referral to HIV testing services. A descriptive analysis was performed for summarizing data. A total of 2,502 participants (1,422 MSM and 1,082 TGW) were included in the analysis with about one-third (36.1%) of them being first-time testers. Among all participants enrolled in the study, a total of 2,486 participants (99.3%) selected HIVST versus referral to HIV testing services. Of those who selected HIVST, 2,095 (84.3%) opted for assisted HIVST while the rest opted for unassisted HIVST: 1,148 of 1,411 MSM (81.4%) and 947 of 1,075 TGW (88.1%) selected assisted HIVST. While no serious adverse events were reported during the study, we found that among 179 participants who needed a confirmatory test and were referred to HIV testing services, 108 (60.3.4%) accessed these later services. This study demonstrated a high uptake of oral fluid-based HIVST among MSM and TGW populations in Thailand and that HIVST could be scaled up through the national epidemic control program. However, a better understanding of HIV testing-seeking behavior and innovative follow-up solutions are needed to improve and monitor linkages to services for people who undertake HIVST.

HIV self-testing (HIVST) is an innovative HIV testing approach that effectively reaches those who do not otherwise test, including key populations (KPs). Despite potential benefits, HIVST is not currently implemented in Pakistan. The high risk of HIV among transgender (TGs) persons is among the highest risk group for HIV in Pakistan, yet knowledge of HIV status remains low in this key population group. We conducted a pilot project to assess the acceptability and feasibility of distributing HIVST to TGs in Larkana. Eligible participants were 18 years or above and self-identified as transgender (\"hijra\"). One oral fluid HIVST kit per person was distributed free of cost in the community by trained transgender peer outreach workers (ORW). Participants could request a demonstration of the HIVST procedure before performing self-testing which was provided by the trained ORW. Demographic characteristics of participants were collected. The ORW followed up with phone calls two days later to record if HIVST kits were used, the results, and whether assistance was required. Between November 2020 and February 2021, 150 HIVST kits were distributed to eligible TGs. The average age of participants was 25.5 years (standard deviation: 7.0). Over a third (52, 34.7%) had no formal education, while (16, 10.6%) had attended at least five years of schooling. Over one-third (58, 38.6%) of participants were first-time testers. One hundred and thirty-nine (92.7%) participants reported their results within two days. For the remaining 11 participants, ORWs had to contact them. All participants reported using HIVST kits within three days. A majority (141, 94%) used the kit in their homes, and the remaining nine (6%) used it at the community-based organization's office. Overall, a small proportion (11, 7.3%) of participants requested a demonstration of the test procedure before performing HIVST. Four (2.7%) participants who had performed unsupervised self-tests reported reactive HIVST results; all were linked to treatment within five working days once their HIV result was confirmed. The majority (136, 90.6%) of participants felt that self-testing was easy to perform independently, and 143 (95%) reported that they would recommend HIVST to their peers. HIVST is acceptable among TGs and identified by first-time testers as undiagnosed infections. Peer-led distribution appears to be a feasible approach for implementation in this setting. HIVST should be considered for routine implementation and scale up to reduce testing gaps among Pakistan's key population, particularly TGs.

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. 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. 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. 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. 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. PROSPERO CRD42020205025; https://www.crd.york.ac.uk/prospero/CRD42020205025.

HIV self-sampling and -testing (HIVSS/ST) reduces testing barriers and potentially reaches populations who may not test otherwise. In the Netherlands, at-home HIV tests became commercially available around 2016, but data on user experiences are limited. This study aimed to explore characteristics of users and their experiences with HIVSS/ST. In 2022 and 2023, a survey was distributed among users of one online commercial provider and one community-based provider; either users ordered a commercial online HIVSS/ST or they sought a free-of-charge HIVST via the community-based provider. Questions included usability, preferences, and barriers of HIVSS/ST-testing. We compared characteristics and experiences of users between providers, risk groups and first-time and repeat testers. In total, 133 users completed the survey; 89 (67%) via the commercial provider and 44 (33%) via the community-based provider. Response rates per provider were 2% and 26%, respectively. Users who bought their test at the commercial provider were more often Gay and Bisexual Men (GBM) (42%), 35 + years (43%), and born in the Netherlands (89%), compared to those recruited through the community-provider (respectively 27%, 25%, 14%). GBM were more often repeat and recent HIVSS/ST-testers, and using pre-exposure prophylaxis (PrEP). Women and heterosexual men were more likely to buy an HIVSS/ST as part of a combination Sexually Transmitted Infections (STI) test package. Overall, main reasons for choosing HIVSS/ST were saving time (42%), anonymity (36%) and not having to talk to a GP (35%). Twenty-two percent of the study participants experienced some problems performing the HIVSS/ST, the most reported problem was obtaining sufficient blood through the finger prick (71%). Recommendations to improve accessibility of HIVSS/ST included more awareness (advertising by trustful providers), more access locations (pharmacies/supermarkets/schools) and lower costs. Our findings indicate that HIVSS/ST is a valuable additional HIV testing method for users, but more insight into the contribution of HIVSS/ST to HIV prevention policies is needed.

Background In 2016 the WHO declared HIV self-testing and self-sampling an effective and safe test option that can reduce testing barriers. HIV self-tests and self-sampling kits (HIVST/HIVSS) are available for purchase at Dutch community pharmacies since 2019. We investigated the availability and accessibility of HIVST/HIVSS in community pharmacies, and factors associated with test availability. Methods An online survey among all Dutch community pharmacies (n = 1,987) was conducted between April and June 2021. Availability of HIVST/HIVSS and experiences of pharmacists with the test offer were analyzed with descriptive statistics. The association of pharmacy and pharmacists’ characteristics with HIVST/HIVSS availability was explored by logistic regression analysis. Results In total, 465 pharmacists completed the questionnaire. Of the responding pharmacists, 6.2% (n = 29) offered HIVST/HIVSS. The majority (82.8%) sold between 0 and 20 tests per year. In total, pharmacies sold an estimated 370 HIVST/HIVSS per year. Pharmacies having HIVST/HIVSS available were less often located in moderately-urbanized to rural neighborhoods (OR 0.35, 95%CI 0.16–0.77 versus highly-urbanized), and were less often located in moderate-to-low SES neighborhoods (OR 0.40, 95%CI 0.18–0.88 versus high-SES). Reasons for not offering HIVST/HIVSS by pharmacists were no or little demand (69.3%), and not being familiar with these tests (17.4%). 52% of the pharmacists provided information about testing to test buyers. Reported options to improve the test offer were giving advice about (performing) the test to test buyers (72.4%), placing tests visible on the counter (51.7%), and advertisement (37.9%). Conclusion HIVST/HIVSS have a limited practical availability in Dutch community pharmacies since their introduction in 2019, especially in lower-urbanized and lower-SES areas. Further research is needed to explore how to expand access to HIVST/HIVSS through community pharmacies in the Netherlands, and how to tailor it to the needs of pharmacy clients.

Background: Ending the HIV epidemic requires increasing HIV testing among at-risk persons, including addressing the limitations of venue-based testing. Using a community-based intervention (My Test/My Choice; MT/MC), we delivered free oral HIV self-tests (OHSTs) through LGBTQ+ businesses in Multnomah County, OR. We examined if disseminating OHST negatively impacted other segments of the HIV testing system. Methods: We compared dissemination rates for Multnomah County's clinic-based and online HIV testing programs across three periods: (i) preintervention (July-September 2022), (ii) MT/MC intervention period (October 2022-March 2023), and (iii) postintervention (April-July 2023). We used analysis of variance to examine for changes in county programs during/after MT/MC. Data from all other Oregon counties were analyzed to distinguish county-specific and statewide changes in testing. Results: MT/MC disseminated slightly more HIV tests (n = 2698; 50%/6 months) to the county system than clinic-based dissemination (n = 2561; 48%) and substantially more than online dissemination (n = 78; 2%). There were no significant changes in clinic-based dissemination over time in the county [F(2,10) = 1.83; P = 0.21]. Significant declines in online dissemination occurred in Multnomah County [F(2,10) = 5.95; P = 0.02] and other Oregon counties [F(2,10) = 4.5; P = 0.04], suggesting that statewide, an unknown factor negatively influenced online dissemination. Conclusions: MT/MC positively impacted the local HIV testing system by adding new clients, rather than reducing the number of clients attending other testing programs. Our study provides unique data on the effects of disseminating a new health program on ongoing programs of a similar nature. Ending the HIV epidemic in the United States requires providing high levels of HIV testing among at-risk persons and addressing limitations of venue-based testing programs (e.g. HIV testing clinics). We developed a community-based intervention to disseminate free OHST kits through a network of local LGBTQ+ businesses in Multnomah County (Portland), Oregon. In this study, we compared HIV test dissemination through the intervention with dissemination through other HIV testing programs in the county (health department clinic and free online OHST program) over three periods: preintervention (July-September 2022), MT/MC intervention period (October 2022-March 2023), and postintervention (April-July 2023). During the intervention period, more HIV tests were disseminated through MT/MC (n = 2698) than through clinic-based (n = 2561) and online testing programs (n = 78). The MT/MC intervention contributed 50% of the total HIV tests performed in Multnomah County, and did not reduce the number of clients seeking testing through other county programs. We also analyzed similar data for other counties in Oregon and found that a common external (nonintervention) factor may have influenced online OHST dissemination across the state. Our study demonstrates that community-based OHST dissemination programs can successfully supplement local HIV testing systems without negatively influencing other HIV testing programs. Keywords: dissemination; HIV self-testing; LGBTQ+; community network; HIV testing system

The ability to self-test for HIV is vital to preventing transmission, particularly when used in concert with HIV biomedical prevention modalities, such as pre-exposure prophylaxis (PrEP). In this paper, we review recent developments in HIV self-testing and self-sampling methods, and the potential future impact of novel materials and methods that emerged through efforts to develop more effective point-of-care (POC) SARS-CoV-2 diagnostics. We address the gaps in existing HIV self-testing technologies, where improvements in test sensitivity, sample-to-answer time, simplicity, and cost are needed to enhance diagnostic accuracy and widespread accessibility. We discuss potential paths toward the next generation of HIV self-testing through sample collection materials, biosensing assay techniques, and miniaturized instrumentation. We discuss the implications for other applications, such as self-monitoring of HIV viral load and other infectious diseases.