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PurposeWe hypothesized that an intervention designed to create girl-friendly drug shops would increase access to sexual and reproductive health products and services among adolescent girls and young women (AGYW) (ages 15-24 years) in Tanzania.MethodsWe conducted a four-month randomized trial at 20 drug shops in Shinyanga, Tanzania from August-December 2019 to determine if the Malkia Klabu ("Queen Club") intervention increased AGYW patronage and the provision of HIV self-testing (HIVST), contraception, and health facility referrals to AGYW (primary outcomes). Drug shops were randomized 1:1 to the intervention or comparison arm. All shops were provided with OraQuick HIVST kits to give to AGYW for free. Intervention shops implemented Malkia Klabu, a loyalty program for AGYW created using human-centered design through which AGYW could also access free contraception. We compared outcomes in intention-to-treat analyses using shop observations and shopkeeper records.ResultsBy endline, shops implementing Malkia Klabu had higher AGYW patronage than comparison shops (rate ratio: 4.4; 95% confidence interval: 2.0, 9.8). Intervention shops distributed more HIVST kits (median per shop: 130.5 vs. 58.5, P= .02) and contraceptives (325.5 vs. 7.0, P < .01) to AGYW and provided more referrals for HIV, family planning, or pregnancy services combined (3.5 vs. 0.5, P= .02) than comparison shops.DiscussionThe Malkia Klabu intervention increased AGYW patronage and the provision of HIVST kits, contraception, and referrals to AGYW at drug shops, despite HIVST kits being freely available at all participating shops. Enhancing drug shops with girl-friendly services may be an effective strategy to reach AGYW with sexual and reproductive health services.

High levels of HIV testing in men who have sex with men remain key to reducing the incidence of HIV. We aimed to assess whether the offer of a single, free HIV self-testing kit led to increased HIV diagnoses with linkage to care.SELPHI was an internet-based, open-label, randomised controlled trial that recruited participants via sexual and social networking sites. Eligibility criteria included being a man or trans woman (although trans women are reported separately); being resident in England or Wales, UK; being aged 16 years or older; having had anal intercourse with a man; not having a positive HIV diagnosis; and being willing to provide name, email address, date of birth, and consent to link to national HIV databases. Participants were randomly allocated (3:2) by computer-generated number sequence to receive a free HIV self-test kit (BT group) or to not receive this free kit (nBT group). Online surveys collected data at baseline, 2 weeks after enrolment (BT group only), 3 months after enrolment, and at the end of the study. The primary outcome was confirmed (linked to care) new HIV diagnosis within 3 months of enrolment, analysed by intention to treat. Those assessing the primary outcome were masked to allocation. This study is registered with the ISRCTN Clinical Trials Register, number ISRCTN20312003.10 111 participants (6049 in BT group and 4062 in nBT group) enrolled between Feb 16, 2017, and March 1, 2018. The median age of participants was 33 years (IQR 26-44 years); 9000 (89%) participants were White; 8118 (80%) participants were born in the UK; 81 (1%) participants were transgender men; 4706 (47%) participants were university educated; 1537 (15%) participants had never been tested for HIV; and 389 (4%) participants were taking pre-exposure prophylaxis. At enrolment, 7282 (72%) participants reported condomless anal sex with at least one male partner in the previous 3 months. In the BT group, of the 4511 participants for whom HIV testing information was available, 4263 (95%) reported having used the free HIV self-test kit within 3 months.Within 3 months of enrolment there were 19 confirmed new HIV diagnoses (0·31%) in 6049 participants in the BT group and 15 (0·37%) of 4062 in the nBT group (p=0·64).The offer of a single, free HIV self-test did not lead to increased rates of new HIV diagnoses, which could reflect decreasing HIV incidence rates in the UK. Nonetheless, the offer of a free HIV self-testing kit resulted in high HIV testing rates, indicating that self-testing is an attractive testing option for a large group of men who have sex with men.UK National Institute for Health and Care Research.

Objectives This proof of concept study was aimed to validate the hypothesis that the time of positivization of SARS-CoV-2 self-performed rapid diagnostic tests (RDTs) may reflect the actual viral load in the specimen. Methods A SARS-CoV-2 positive sample with high viral load was diluted and concomitantly assayed with molecular assay (Xpert Xpress SARS-CoV-2) and RDT (COVID-VIRO ALL IN RDT). The (mean cycle threshold; Ct) values and RDT positivization times of these dilutions were plotted and interpolated by calculating the best fit. The parameters of this equation were then used for converting the positivization times into RDT-estimated SARS-CoV-2 Ct values in routine patient samples. Results The best fit between measured and RDT-estimated Ct values could be achieved with a 2-degree polynomial curve. The RDT-estimated Ct values exhibited high correlation (r=0.996) and excellent Deming fit (y=1.01 × x − 0.18) with measured Ct values. In 30 consecutive patients with positive RDT test, the correlation between RDT positivization time and measured Ct value was r=0.522 (p=0.003). The correlation of RDT-estimated and measured Ct values slightly improved to 0.577 (Deming fit: y=0.44 × x + 11.08), displaying a negligible bias (1.0; 95% CI, −0.2 to 2.2; p=0.105). Concordance of RDT-estimated and measured Ct values at the Conclusions This proof of concept study demonstrates the potential feasibility of using RDTs for garnering information on viral load in patients with acute SARS-CoV-2 infection.

Background Evidence among key populations supports acceptability of HIV self-testing (HIVST) due to its privacy and convenience. However, insufficient research has been done among transgender women (TGW), especially in Latin America. Consequently, the aim of this study was to explore the acceptability, perceptions and recommendations for HIVST implementation among TGW in Buenos Aires. Methods A focus group was conducted in July 2019. Particpants were invited to touch and learn about a displayed HIVST kit. The following main topics were explored: acceptability, reasons for seeking self-testing, preferences for training, distribution, periodicity and recommendations for HIVST implementation. Results The sample consisted of 12 TGWs; mean age of 26 years (IQR = 22–28); 66% had history of sex-work. The main motivations for seeking HIVST were convenience, privacy, and usage to reduce stigma and discrimination by health-care providers. Recommendations for HIVST were: distribution from primary health centers and trans-sensitive centers; affordable price; assistance by peer health promoters; and the provision of clear written and video instructions. Conclusions Tailored implementation of HIVST can increase HIV testing rates, early detection, and linkage to HIV-care in this high-prevalence group. This study provided community-driven suggestions to inform and adapt an HIVST feasibility pilot study and future implementation in Argentina.

Rapid oral HIV self-tests (HIVST) have potential to increase the proportion of people who know their HIV status, especially among stigmatised populations. This study was embedded in two cohorts of female sex workers (FSW) in the Dominican Republic (DR) and Tanzania. Qualitative interviews with 40 FSW were conducted to explore perceived acceptability of HIVST. Interviews were analysed using inductive and deductive thematic coding. Emergent themes were organised by socio-ecological framework levels. FSW in both settings responded positively to the ease of use of HIVST but questioned test accuracy due to the use of saliva rather than blood. FSW in the DR had a more cautious response, while women in Tanzania had favourable perceptions expressing eagerness to use it. At the individual level, themes shaping participants' interest included autonomy, HIV risk perception, and emotional well-being for those with reactive test results, and self-efficacy. At the interpersonal level, privacy, confidentiality, sex work and HIV stigma and social support were salient. Structural level themes focused on health systems including linkages to HIV treatment, provider roles, and access (cost, travel, distribution). Understanding FSW's perceptions and acceptability of HIVST is essential to its integration into health systems and programmes using a community-driven approach.

Self-tests* to detect current infection with SARS-CoV-2, the virus that causes COVID-19, are valuable tools that guide individual decision-making and risk reduction

Background: Kenya’s Key and Affected Populations (KAP) – men who have sex with men (MSM), female sex workers, people who inject drugs (PWID), and young women aged 18-24 – often experience stigma and discrimination in Kenyan health care settings due to their identity and/or behaviors, which can deter facility-based testing for HIV. Kenya has promoted self-testing as a means to reach these communities. Objectives: To identify KAP perspectives on self-testing and place our findings within Kenya’s human rights and legal context. Methods: We conducted 4 focus group discussions (FGD) and 16 in-depth interviews (IDI). One FGD was conducted with each of the following communities: MSM, female sex workers, PWID, and young women aged 18-24. 1-4 IDI were conducted with each KAP community, and 1-3 IDI were conducted with health professionals working on HIV care in each study site. The semi-structured question guideline included one question soliciting opinions on self-testing. Results: KAP support self-testing in concept, however prevailing concerns among participants included access to pre- and posttest counseling services, as well as risk for harms (self-inflicted and otherwise) that might result from a positive result. Conclusion: Kenya should ensure that human rights are promoted and respected through implementing rights-based policies and practices for HIV self-testing, including pre- and post-test counseling. Keywords: Human Rights; HIV; Voluntary Counselling; Testing.

To compare the usability and acceptability of oral fluid- and blood-based HIV self-test kits among men who have sex with men in Australia.Randomised crossover trial.Gay, bisexual, and other men aged 18 years or older who have sex with men, who attended two metropolitan sexual health clinics in Sydney and Melbourne, 7 January - 10 December 2019.Ease of use of HIV self-test kits; preferred HIV self-test type; difficulties encountered during HIV self-testing.170 men were recruited (median age, 34 years; interquartile range, 29-43 years); 144 identified as gay (85%), 96 were born outside Australia (57%). Participants were more likely to report the oral fluid HIV self-test was easy to use than the blood-based self-test (oral fluid, 99%; blood, 86%; odds ratio [OR], 3.0; 95% confidence interval [CI], 1.4-6.6). The oral fluid test was preferred by 98 participants (58%; 95% CI, 50-65%), the blood-based test by 69 (41%; 95% CI, 33-48%). Difficulties with the oral fluid test kit identified by observing nurses included problems placing the buffer solution into the stand (40 of 170 participants, 24%) and not swabbing both gums (23 of 169, 14%); difficulties with the blood-based test kit included problems filling the device test channel (69 of 170, 41%) and squeezing the finger firmly enough to generate a blood drop (42 of 170, 25%). No participant received an invalid result with the oral fluid self-test; two of 162 participants (1%) received invalid results with the blood self-test. After adjusting for age, education level, and ethnic background, characteristics associated with higher odds of using HIV self-testing in the future were overseas birth (adjusted OR, 3.07; 95% CI, 1.42-6.64), and self-evaluated ease of use and confidence in using the kits.It is important to provide options for obtaining both oral fluid- and blood-based HIV self-tests. The usability and acceptability of both kits were high, but the ease of use and perceived accuracy influenced test kit preference.

OBJECTIVE: To determine the feasibility, acceptability, and implementation of a HIV self-test (HIVST) program through PrEP clients’ social and sexual networks. BACKGROUND: HIV testing is critical for treatment and prevention engagement. HIVST kits can overcome barriers to testing. A negative result is an opportunity to provide PrEP information. We describe implementation factors associated with engaging current Mobile PrEP (MP) clients to distribute HIVST kits and PrEP information through their networks. SETTING: Community venues in Miami-Dade County, Florida. METHODS: A baseline survey collected network information and explored distribution plans for offering HIVST kits. A follow-up survey evaluated use and distribution. A logic model describes the process of implementation and evaluation. Up to 4 Ora-Quick HIV ST kits were offered to 81 MP clients. A brief training included resources for post-test engagement. RESULTS: Forty-four percent of the kits were reported as distributed. Of 81 MP clients offered kits, 50 (62%) accepted. In a follow-up survey, 77% of MP clients distributed at least one kit. 56 (86%) social network (SN) members were Latino and 9 (14%) were Black. Three out of four MP clients engaged in PrEP discussions (77%) with SN members. Reported reasons for HIVST kit use included convenience, confidentiality, privacy concerns, and discomfort with going to a testing site. MP clients reported that kit distribution was impacted by the COVID-19 pandemic. CONCLUSION: HIV ST kits allowed PrEP users to engage others in their social and sexual networks for HIV testing and information regarding PrEP. Work to scale-up this intervention is underway.

Background Currently, the rapid antigen test (RAT) and reverse transcriptase–polymerase chain reaction (RT–PCR) are considered the main stakeholders in COVID-19 diagnosis. In RT–PCR, any of at least 2 evolutionary conserved genes (RdRP, E-, N-, ORF1ab gene) and S-gene of SARS-CoV-2 are endorsed, and in RAT, the nucleocapsid antigen (N-Ag) of SARS-CoV-2 is considered due to its stability and fewer chances of mutation effects. In the present work, we evaluated the performance of the AG-Q COVID-19 N-Ag self-test kit and conducted a validation study in comparison with the RT–PCR. Methods AG-Q COVID-19 N-Ag rapid test kit is an Indian Council of Medical Research (ICMR) approved product developed and marketed by Agappe Diagnostics Limited. The RT–PCR assay was performed with a COVIPATH COVID-19 RT–PCR kit from Thermo Fisher Scientific. Results We observed 19 false-negative results in antigen self-tests, including samples of threshold cycle (Ct) values 22/22 (N-gene/ORF1ab-gene) in RT–PCR, indicating inadequate sampling by the patients in self-tests, leading to false-negative results and increased chances of the disease spreading. Based on the RT–PCR Ct value vs antigen self-test comparison, it is evident that proper sampling is crucial in performing antigen self-tests. Also, there were weak positive results in antigen self-tests with a Ct value of 18/19 in RT–PCR. Conclusions Although the sensitivity and diagnostic accuracy offered by the AG-Q COVID-19 N-Antigen self-test in comparison with RT–PCR fulfills the ICMR tenets for RAT, this study recommends the laboratory/hospital-based RAT execution would be appropriate, rather than the self-test.

Metacognition is the knowledge and awareness about one’s cognition (Garner & Alexander, 1989; Schraw, 1998). Successful learners use metacognition to control their cognition processes (Schraw, 1998) in various educational settings (National Academies of Sciences, Engineering, and Medicine, 2018). Metacognition drives cognitive learning processes (Schleifer & Dull, 2009) and is especially critical to student achievement in online learning modalities (Azevedo, 2009; Broadbent & Poon, 2015; Hacker & Bol, 2019; Lehmann et al., 2014; Veenman, 2007; Zimmerman & Moylan, 2009). This inquiry focuses on two asynchronous online accounting courses at a public commerce school in the southeastern U.S., wherein the instructor identified students who likely needed to improve their metacognitive strategies related to self-testing, testing, and anxiety with the Learning and Study Strategies Inventory (LASSI). Through comprehensive course reviews, learner surveys, and learner semi-structured interviews, this case study investigated how students deployed strategies related to self-testing, testing, and anxiety and to what extent the course design supported students’ deployment of those strategies. Findings suggested that 1) these two courses are well-designed and provided ample resources and support for students to learn the content, 2) many students deployed self-testing and testing strategies in these courses, 3) many students experienced anxiety in these courses, and 4) the course structure and dialog may increase the transactional distance in these courses. These findings serve as the basis for recommendations in future course iterations.

Objectives To evaluate the performance of nasal mid-turbinate self-testing using rapid antigen detection tests (RDT) for persons with suspected coronavirus disease 2019 (COVID-19) in the community. Self-testing for COVID-19 infection with lateral flow assay severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RDT, provides rapid results and could enable frequent and extensive testing in the community, thereby improving the control of SARS-CoV-2. Methods Participants visiting a municipal SARS-CoV-2 testing centre, received self-testing kits containing either the BD Veritor System (BD-RDT) or Roche SARS-CoV-2 antigen detection test (Roche-RDT). Oro-nasopharyngeal swabs were collected from the participants for quantitative RT-PCR (qRT-PCR) testing. As a proxy for contagiousness, viral culture was performed on a selection of qRT-PCR positive samples to determine the Ct-value at which the chance of a positive culture dropped below 0.5 (Ct-value cut-off). Sensitivity and specificity of self-testing were compared to qRT-PCR with a Ct-value below the Ct value cut-off. Determinants independently associated with a false-negative self-test result were determined. Results A total of 3201 participants were included (BD-RDT n = 1595; Roche-RDT n = 1606). Sensitivity and specificity of self-testing compared with the qRT-PCR results with a Ct-value below the Ct-value cut-off were 78.4% (95% CI 73.2%–83.5%) and 99.4% (95% CI 99.1%–99.7%), respectively. A higher age was independently associated with a false-negative self-testing result with an odds ratio of 1.024 (95% CI 1.003–1.044). Conclusions Self-testing using currently available RDT has a high specificity and relatively high sensitivity to identify individuals with a high probability of contagiousness.

Background Prior to the COVID-19 pandemic, warfarin users were required to complete in-person training in order to participate in approved international normalized ratio (INR) patient self-testing (PST) programs. To minimize in-person contact during the pandemic, a federal waiver of the in-person training requirement allowed new patients to begin PST after completing virtual training. However, it was uncertain whether such patients achieved comparable levels of INR control to patients receiving in-person training. Methods INR results for patients receiving virtual training upon PST commencement between April 1, 2020, and December 31, 2020, were compared to those of patients initiating PST with in-person training between April 1, 2019, and December 31, 2019. The primary outcome was the difference in warfarin time in therapeutic range (TTR) between the groups, with secondary outcomes including differences in the percentages of INR values within individually prescribed INR range and of critical INR values. Results The records of 33,683 patients were included in the analysis (13,568 in the “In-Person” sample; 20,115 in the “Virtual” sample). Patients in the Virtual sample achieved a TTR of 66.78%, compared to the In-Person sample (64.19%; absolute difference 2.59; 95% confidence interval [CI] = 2.50–2.68, p < 0.001). The TTR values were also statistically significantly higher in all subgroups evaluated across categories of patient age, gender, geography, and indication. Similarly favorable results were achieved for INR values in range and critical values. Conclusion Virtual education for PST for warfarin therapy is effective and should continue to be an option for patients and providers throughout the pandemic, and possibly beyond.

The mechanical heart valve is a crucial solution for many patients. However, it cannot function on the state of blood as human tissue valves. Thus, people with mechanical valves are put under anticoagulant therapy. A good measurement of the state of blood and how long it takes blood to form clots is the prothrombin time (PT); moreover, it is an indicator of how well the anticoagulant therapy is, and of whether the response of the patient to the drug is as needed. For a more specific standardized measurement of coagulation time, an international normalized ratio (INR) is established. Clinical testing of INR and PT is relatively easy. However, it requires the patient to visit the clinic for evaluation purposes. Many techniques are therefore being developed to provide PT and INR self-testing devices. Unfortunately, those solutions are either inaccurate, complex, or expensive. The present work approaches the design of an anticoagulation self-monitoring device that is easy to use, accurate, and relatively inexpensive. Hence, a two-channel polymethyl methacrylate-based microfluidic point-of-care (POC) smart device has been developed. The Arduino based lab-on-a-chip device applies optical properties to a small amount of blood. The achieved accuracy is 96.7%.

OBJECTIVE. The objective of this study is to conduct a pilot program for self-testing for HIV during the SARS-CoV-2 pandemic. The target population was the partners of newly diagnosed HIV persons. The premise of the program was to offer such partners a test that they could perform in the conditions, at the time, and with the assistance of persons they themselves selected. MATERIAL AND METHODS. The self-test kits were sent to an outpatient clinic providing care for people living with HIV, where, after taking a preliminary history, the physician who treats the newly diagnosed HIV patients handed them over for use by the partner of the patient. Only the persons who reported having relations with their sexual partner were included in the study. Information on whether the partner accepted the test kit and the self-test result were obtained at the subsequent visit. RESULTS AND DISCUSSION. Between June 2020 and March 2021, the total number of handed out test kits was 48 kits intended for 24 persons, included 11 women, average age of participants: 35, sexual orientation: 20 persons reported heterosexual orientation, two persons reported homosexual orientation, two failed to provide information on their sexual orientation. All persons tested negative. The pilot program found that self-testing kits are a method for HIV screening in partners of newly diagnosed HIV persons that is simple to apply and easy to accept.

IMPORTANCE: The US Food and Drug Administration (FDA) authorized SARS-CoV-2 rapid at-home self-test kits for individuals with and without symptoms. How appropriately users interpret and act on the results of at-home COVID-19 self-tests is unknown. OBJECTIVE: To assess how users of at-home COVID-19 self-test kits interpret and act on results when given instructions authorized by the FDA, instructions based on decision science principles, or no instructions. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was conducted of 360 adults in the US who were recruited in April 2021 to complete an online survey on their interpretation of at-home COVID-19 self-test results. Participants were given 1 of 3 instruction types and were presented with 1 of 4 risk scenarios. Participants were paid $5 and had a median survey completion time of 8.7 minutes. Data analyses were performed from June to July 2021. INTERVENTION: Participants were randomized to receiving either the FDA-authorized instructions (authorized), the intervention instructions (intervention), or no instructions (control), and to 1 of 4 scenarios: 3 with a high pretest probability of infection (COVID-19 symptoms and/or a close contact with COVID-19) and 1 with low pretest probability (no symptoms and no contact). The intervention instructions were designed using decision science principles. MAIN OUTCOMES AND MEASURES: Proportion of participants in the high pretest probability scenarios choosing to quarantine per federal recommendations and perceived probabilities of infection given a negative or positive COVID-19 test result. A Bonferroni correction accounted for multiple comparisons (3 instruction types × 4 scenarios; α = 0.004). RESULTS: After excluding 22 individuals who completed the survey too quickly, the responses of 338 participants (median [IQR] age, 38 [31 to 48] years; 154 (46%) women; 215 (64%) with a college degree or higher) were included in the study analysis. Given a positive test result, 95% (322 of 338; 95% CI, 0.92 to 0.97) of the total participants appropriately chose to quarantine regardless of which instructions they had received. Given a negative test result, participants in the high pretest probability scenarios were more likely to fail to quarantine appropriately with the authorized instructions (33%) than with the intervention (14%; 95% CI for the 19% difference, 6% to 31%; P = .004) or control (24%; 95% CI for the 9% difference, −4% to 23%; P = .02). In the low pretest probability scenario, the proportion choosing unnecessary quarantine was higher with the authorized instructions (31%) than with the intervention (22%; 95% CI for the 9% difference, −14% to 31%) or control (10%; 95% CI for the 21% difference, 0.5% to 41%)—neither comparison was statistically significant (P = .05 and P = .20 respectively). CONCLUSIONS AND RELEVANCE: The findings of this randomized clinical trial indicate that at-home COVID-19 self-test kit users relying on the authorized instructions may not follow the Centers for Disease Control and Prevention’s quarantine recommendations, producing unintended risks and unnecessary disruptions. Redesigned instructions that follow decision science principles may improve compliance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04758299

There is a demand for patients to self-diagnose their sexually transmitted infections (self- testing), particularly during the coronavirus pandemic to prevent infection spread. We enrolled a cohort of Saudi women in a single-visit prospective study, which was the first of its kind performed in the country. Our aim was to evaluate the OSOM® Trichomonas (OSOM) test, a single-use, point-of-care rapid test, for its efficacy and accessibility as a self-test for Trichomonas vaginalis (Trichomonas) infection. At a public hospital's gynecology clinic, women received sufficient training on specimen collection and OSOM self-testing. The women's infection status was re-evaluated using direct wet mount microscopy and clinician performed OSOM using additional swabs. Specimens with discordant results were sorted using an in- house polymerase chain reaction (PCR). 174 women aged 18 to 35 were registered and self- tested at the clinic under the supervision of a gynecologist between June and December 2020, with 84.4 percent (147/174) having a valid result on the first or repeat OSOM. Infection was detected in 12.2% (18/147) of participants, with two-thirds of them symptomatic. Young age, low education, the existence of vaginitis symptoms, and unemployment were identified as key risk factors for infection in the study population, with statistically significant differences seen among women only in terms of education level and employment status (p0.001). The OSOM self-test performed well (83.3% sensitivity and 98.4% specificity), outperforming the wet mount microscopy (72.2% sensitivity and 100% specificity) and comparable to the clinicians' OSOM (88.8% sensitivity and 100% specificity). The patients' and clinicians' OSOM tests were strongly correlated, with a kappa of 0.89 and a 97.9% agreement. Self-collection of vaginal swabs was accepted and preferred by most women (94%) over the clinician-collection. Overall, our study's findings may have important consequences for the implementation of Trichomonas screening based on OSOM self-testing approach in the study's population.

This research qualitatively explored user preferences for an app-based mHealth approach to support HIV self-testing and linkage to HIV prevention or care services developed for men who have sex with men (MSM) in China. We conducted 12 online focus group discussions with MSM participants (N = 48) about their preferences for using an app to meet their HIV self-testing and service linkage needs. Data were examined using thematic analysis. Participants specified four domains to align program delivery with their preferences for app-based intervention: (1) expanding HIV prevention/antiretroviral therapy concepts beyond basic knowledge; (2) enhancing the style and presentation of app-based messages; (3) incorporating interactive and dynamic app-engagement features; and (4) creating a “one station” app that covers the continuum of HIV services. Given the changing landscapes of HIV knowledge and community/user preferences for app-based interaction, findings underscore how engagement with end-user participants is essential to optimize mHealth interventions for HIV.

ImportanceHIV self-testing (HIVST) is a promising strategy to expand the HIV care continuum, particularly among priority populations at high risk of HIV infection. However, little is known about HIVST uptake among men who have sex with men (MSM) outside of clinical trial settings.ObjectiveTo evaluate HIVST use among urban MSM in the US who reported testing within the past 12 months.Design, Setting, and ParticipantsA cross-sectional study of adult MSM in the 2017 National HIV Behavioral Surveillance system, which used venue-based sampling methods to collect data related to HIV testing, receipt of prevention services, and risk factors for HIV, was conducted at 588 venues in 23 urban areas in the contiguous US and Puerto Rico. All participants were offered HIV testing. Adult cisgender MSM who reported HIV-negative or unknown HIV status and obtained HIV testing in the past 12 months were included. Data for this study were collected between June 4, 2017, and December 22, 2017, and analyzed between October 23, 2020, and August 20, 2021.Main Outcomes and MeasuresSelf-reported HIVST in the past year. Adjusted prevalence ratios (aPRs) using survey weights were calculated to assess factors associated with HIVST.ResultsA total of 6563 MSM in 23 urban areas met inclusion criteria, of whom 506 (7.7%) individuals reported HIVST in the past year. The median age of self-testers was 29 (IQR, 25-35) years, 52.8% had completed college, and 37.9% reported non-Hispanic White race. One self-tester reported seroconverting in the prior 12 months, and an additional 10 self-testers were diagnosed with HIV during the survey. HIVST was associated with sexual orientation disclosure (aPR, 10.27; 95% CI, 3.45-30.60; P P = .01), younger age (aPR, 0.74; 95% CI, 0.66-0.84; P P = .01), and higher income levels (aPR, 1.18; 95% CI, 1.04-1.32; P = .009). No association was noted with condomless anal sex (aPR, 0.96; 95% CI, 0.88-1.06, P = .88), sexually transmitted infections (aPR, 0.96; 95% CI, 0.70-1.30; P = .77), or preexposure prophylaxis use (aPR, 0.99; 95% CI, 0.75-1.30; P = .92).Conclusions and RelevanceIn this study, HIVST was relatively uncommon in this sample of urban MSM. HIVST may not be reaching those with lower socioeconomic status or who have not disclosed their sexual identity. The findings of this study suggest that efforts to increase HIVST should focus on engaging underserved and vulnerable subgroups of MSM.

Background In 2020, almost 20% of people living with HIV (PLHIV) in Morocco are still unaware of their HIV status. Under these circumstances, HIV self-test (HIVST) can be an efficient additional tool for improving the testing rates in Morocco and reaching the first objective of the UNAIDS 95–95-95 goal. ALCS, a Community-based organization, involved in HIV Testing since 1992, and the Ministry of Health of Morocco conducted, a study on the acceptability and usability of HIVST among Female sex workers (FSW) and MSM (men who have sex with men), using a salivary rapid test. To our knowledge, this is the first study in Morocco exploring these parameters. Methods We conducted a pilot study on the usability of the OraQuick HIV-1/2 salivary self-test among MSM and FSW visiting the ALCS centers for standard HIV rapid testing in five Moroccan cities. Participants chose whether or not to be assisted by lay provider HIV testing. The counselors sampled them to perform a standard rapid test and then invited them to a private room to perform the HIV self-test simultaneously. In addition, a questionnaire was administered to collect socio-demographic data and to assess their opinion about the usability of the salivary HIVST. Results Our study was carried out for 5 months and included 492 participants (257 MSM and 233 FSW). The average age of the participants was 29 years among MSM vs 34 years among FSW. The FSW have a lower educational level, 28,8% of them are Illiterate vs. 6,1% of the MSM. Only 18% of participants were aware of the existence of the HIVST, nevertheless, we recorded a very high rate of acceptability (90,6%) of the HIVST. Performing the HIVST was deemed very easy for 92,2% of MSM versus 80,6% of FSW. Although it was found very difficult for six participants, including five FSW, 4 of them could not read or write. Overall, the study registered a high HIV positivity rate (3,8%) and 100% of concordance between HIVST participants’ interpretation and standard HIV testing performed by ALCS lay provider HIV testing. Conclusion Our study shows very high acceptability of HIVST among FSWs and MSM in Morocco, HIV self-testing is still unknown by key populations in Morocco, and the low level of education of FSWs may be a barrier to the use of this test, but with the proposed assistance and adapted demonstration tools, the HIV self-testing will certainly improve access to testing in Morocco.

Early diagnosis is key to achieving the goal of eliminating transmission of HIV and hepatitis B and C. We assessed the uptake, acceptability and interpretability of self-testing using a 3-in-1 rapid diagnostic test (RDT) in facility-based services.Stand-alone testing services were provided free of charge to consenting individuals aged ≥15 years in five facilities in northern Thailand. Clients were invited to choose between self-testing by fingerprick or venepuncture by a healthcare worker (HCW). In each facility, several clients could simultaneously self-test in separate private areas using TriQuik™ (Genlantis, San Diego, CA, USA), a single immunochromatographic cassette detecting HIV-1/2 antibody, hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCAb). An interactive program on a tablet computer was developed to collect socio-demographic, behavioural and satisfaction data and provide information to guide the self-test process, including video instructions, results interpretation and a picture of the cassette for immediate remote review by the HCW. When the HCW interpreted an HIV self-test as positive, the HCW collected blood by venepuncture for immediate confirmation.Between October 2020 and April 2022, 4119 clients presented for testing for the first time as part of the project. Of them, 3462 (84.0%) opted for self-testing. Among self-testers, 1801 (52.0%) were born female, the median age was 27 years (interquartile range, 22-36), 661 (19.1%) belonged to at least one key population and 2124 (61.4%) had never been tested for HIV; 3329 (99.8% of those who answered) reported being "very satisfied" or "satisfied" with the testing process. The proportions of test results interpreted as positive by self-testers among those interpreted as positive by HCWs were 95% for HIV-1/2 antibody, 95% for HBsAg and 78% for HCAb.These proportions were higher than those observed in a previous study evaluating another 3-in-1 RDT for HIV, HBsAg and HCAb, possibly due to the use of video instructions instead of paper-based instructions, lower prevalence and co-infection rates, or lower percentages of clients with low education level. Multiplex self-testing simplified and streamlined the service delivery process and was well accepted. HCW assistance proved to be essential in a limited number of cases.

Funder: National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research (CLAHRC), Funder: National Institute for Health Research Oxford Biomedical Research Centre, Funder: Primary Care Research Trust, OBJECTIVE: To determine the accuracy of self-testing for proteinuria during pregnancy. DESIGN: Diagnostic accuracy study. SETTING: Antenatal clinics, maternity assessment units and inpatient wards at three hospital sites. POPULATION OR SAMPLE: 345 pregnant women. METHODS: Pregnant women self-tested in-clinic for urinary protein using visually read dipsticks with samples then sent for laboratory estimation of the spot protein-creatinine ratio (PCR) (primary reference test). Secondary index tests included testing by antenatal healthcare professionals and an automated colorimetric reader. MAIN OUTCOME MEASURES: Sensitivity, specificity, negative predictive value, positive predictive value and likelihood ratios were calculated for self-testing (primary index test) along with healthcare professional and colorimetric testing compared to the primary reference test (PCR). RESULTS: 335/345 (97%) had sufficient data to be included in the analysis. Self-testing had a sensitivity of 0.71 (95% confidence interval [CI] 0.62-0.79) and a specificity of 0.89 (95% CI 0.84-0.92) compared to PCR. Sensitivity and specificity of testing by healthcare professionals and the colorimetric reader were similar: sensitivity 0.73 (95% CI 0.64-0.80) and 0.78 (95% CI 0.69-0.85), respectively; specificity 0.88 (95% CI 0.82-0.92) and 0.83 (95% CI 0.78-0.88), respectively. CONCLUSION: Pregnant women can visually read a dipstick for urinary protein with similar accuracy to antenatal healthcare professionals. Automated colorimetric testing was not significantly different, in contrast to some previous studies. Self-testing has the potential to form part of a self-monitoring regime in pregnancy.

HIV self-testing (HIVST) shows promise to improve HIV diagnosis among those seeking privacy and anonymity in HIV testing. This may include sexual and gender diverse populations, who experience disproportionately high burdens of stigma and HIV globally. To inform potential scale-up of HIVST in Myanmar, we implemented a community-led, mixed-methods randomized trial in Yangon. Adult trans-feminine individuals and cisgender men who have sex with men were recruited via respondent-driven sampling. Participants (N = 577) completed a baseline survey and were randomized to community-based HIV testing services (HTS) or HIVST. One-third of participants reported lifetime HIV testing. Over half (59.4%) returned for a second study visit to report their test result and test acceptability, which was lower among HTS-assigned participants compared to those assigned to HIVST (55.6% vs. 63.1%; p = 0.096). Participants reported that both HIVST and HTS were easy to access, test, and interpret/understand the results of their HIV test. Ninety percent of HTS-assigned participants indicated they would test regularly if they could access HIVST. Qualitative participants (N = 20) described that the convenience and privacy afforded by HIVST may increase the availability and coverage of testing. Taken together, these results suggest HIVST is an acceptable, low-barrier complement to community-based HTS for key populations in Myanmar.

In Botswana, HIV prevalence is 20.3% among those between 15 and 49 years old, and in sub-Saharan Africa, higher income has been associated with increased HIV risk. We qualitatively explored barriers to HIV testing and acceptability of HIV self-testing (HIVST) among higher socio-economic status (SES) men in Botswana. Twenty higher SES men (10 tested, 10 not tested recently) participated in semi-structured interviews and 10 men participated in asynchronous online focus groups (FGs) about HIV testing barriers and HIVST acceptability. Results indicated that stigma, inconvenience and perceived lack of confidentiality were barriers to HIV testing, as were masculinity-related concerns (e.g. fear of losing status if they accessed testing or were found to be HIV positive). Men said that HIVST reduced barriers to testing and that test kits could be placed in public spaces for pick-up and used in private. Overall, HIVST was seen as acceptable and feasible among higher SES men in Botswana.

Introduction: Heterosexual couples are at high risk for HIV acquisition in sub-Saharan Africa, and HIV self-testing (HST) is an additional approach to expand access to HIV testing services. However, it is not well known how gender equality is associated with HST.Methods: We used intervention-arm data from a cluster-randomised controlled HST intervention trial (N = 1 618) conducted in Uganda to determine the association between attitudes towards intimate partner violence (IPV), decision-making power and male partner’s uptake of HST among heterosexual couples expecting a child in south-central Uganda. The original study question was to assess the impact of providing pregnant women with HST kits to improve male partner’s HIV testing rates. For this analysis, the primary exposures were gender equality (measured by male partner’s and female partner’s attitudes towards IPV and the female partner’s household decision-making power), and the primary outcome was the male partner’s uptake of HST. Multivariate logistic regression was used for analysis.Results: We found that male partner HST uptake did not vary depending on male partner’s attitudes towards IPV or decision-making power; however, male partner HST uptake did depend on the female partner’s attitude towards IPV, with 1.76 times more testing (95% CI 1.06–2.92) in couples where the woman had “medium” versus “high” acceptance of IPV, and 1.82 times more testing (95% CI 1.08–3.08) in couples where the woman had “low” versus “high” acceptance of IPV.Conclusions: This study shows the importance of appropriate negative attitudes by women to IPV in increasing male partner’s HST uptake to integrate HST into national health care policies.

Despite the ongoing transmission of sexually transmitted infections (STIs) and HIV, many people became unable to access testing due to COVID-19. To address this, we created a mail-out HIV self-test kit, which could be delivered without restrictions in our region. The uptake and feedback from this project made us realize that comprehensive STI testing was being sought. To ensure testing occurred correctly—that is, it would be targeted at the persons most affected by STIs/HIV—we automated clinical decision-making. We built this model based on a 2-by-2 matrix that plots the risk of STI/HIV transmission and risk of STI/HIV exposure. The intercept of these two measures classifies a person as low, medium, or high risk. After automating this logic, 16 expert clinicians in STI/HIV care tested this system with over 400 test patient cases and refined the algorithm until it yielded the exact outcomes that these clinicians would offer patients based on guidelines. Findings of interest are that the scale of the y-axis is exponential, in that risk factors for exposure do not climb cumulatively but do so according to a quadratic equation. This helps ensure that testing services are targeted at those who are most inequitably burdened by these infections.

To determine the feasibility and acceptability of a telehealth offer and contactless delivery of human papillomavirus (HPV) cervical screening self-test during the 2021 COVID-19 Level 4 lockdown in Auckland, New Zealand.A small proof-of-concept study was undertaken to test telehealth approaches in never-screened, due or overdue Māori and Pacific women enrolled in a local Primary Health Organisation (PHO). Study invitation, active follow-up, nurse-led discussions, result notification and a post-test questionnaire were all delivered through telehealth.A sample of 197 eligible Māori and Pacific women were invited to take part, of which 86 women were successfully contacted. Sixty-six agreed to take part. Overall uptake was 61 samples returned (31.8%) and uptake of all contactable women was 70.9%. Six of the 61 HPV self-tests (9.8%) were positive, all for non 16/18 types, and were referred for cytology. Three had negative cytology results, and three with positive cytology results were referred for colposcopy.The offer of HPV self-testing during COVID-19 lockdown was both feasible and highly acceptable for Māori and Pacific women. Importantly, HPV self-testing via telehealth and mail-out, alongside other options, offers a potential pro-equity approach for addressing the impact of deferred screens due to COVID-19 and other longstanding coverage issues.

It is important to document the performance of rapid antigen tests (Ag-RDTs) in detecting SARS-CoV-2 variants.To compare the performance of Ag-RDTs in detecting the Delta (B.1.617.2) and Omicron (B.1.1.529) variants of SARS-CoV-2.Secondary analysis of a prospective cohort study that enrolled participants between 18 October 2021 and 24 January 2022. Participants did Ag-RDTs and collected samples for reverse transcriptase polymerase chain reaction (RT-PCR) testing every 48 hours for 15 days.The parent study enrolled participants throughout the mainland United States through a digital platform. All participants self-collected anterior nasal swabs for rapid antigen testing and RT-PCR testing. All Ag-RDTs were completed at home, whereas nasal swabs for RT-PCR were shipped to a central laboratory.Of 7349 participants enrolled in the parent study, 5779 asymptomatic persons who tested negative for SARS-CoV-2 on day 1 of the study were eligible for this substudy.Sensitivity of Ag-RDTs on the same day as the first positive (index) RT-PCR result and 48 hours after the first positive RT-PCR result.A total of 207 participants were positive on RT-PCR (58 Delta, 149 Omicron). Differences in sensitivity between variants were not statistically significant (same day: Delta, 15.5% [95% CI, 6.2% to 24.8%] vs. Omicron, 22.1% [CI, 15.5% to 28.8%]; at 48 hours: Delta, 44.8% [CI, 32.0% to 57.6%] vs. Omicron, 49.7% [CI, 41.6% to 57.6%]). Among 109 participants who had RT-PCR-positive results for 48 hours, rapid antigen sensitivity did not differ significantly between Delta- and Omicron-infected participants (48-hour sensitivity: Delta, 81.5% [CI, 66.8% to 96.1%] vs. Omicron, 78.0% [CI, 69.1% to 87.0%]). Only 7.2% of the 69 participants with RT-PCR-positive results for shorter than 48 hours tested positive by Ag-RDT within 1 week; those with Delta infections remained consistently negative on Ag-RDTs.A testing frequency of 48 hours does not allow a finer temporal resolution of the analysis of test performance, and the results of Ag-RDTs are based on self-report.The performance of Ag-RDTs in persons infected with the SARS-CoV-2 Omicron variant is not inferior to that in persons with Delta infections. Serial testing improved the sensitivity of Ag-RDTs for both variants. The performance of rapid antigen testing varies on the basis of duration of RT-PCR positivity.National Heart, Lung, and Blood Institute of the National Institutes of Health.

Background People who inject drugs (PWID) are disproportionally affected by hepatitis C virus (HCV) infection and many remain undiagnosed. HCV self-testing (HCVST) may be an effective approach to increase testing uptake, but has rarely been used among PWID. We assessed the usability and acceptability of HCVST among PWID in Kenya. Methods We conducted a cross-sectional study nested within a cohort study between August and December 2020 on Kenya’s North Coast region. Participants were handed a prototype oral fluid HCVST kit and asked to conduct the test relying on the instructions for use. Usability was assessed by documenting errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. Results Among 150 participants, 19% were female and 65.3% had primary level education or lower. 71.3% made at least one error, 56.7% experienced some difficulty during at least one step, and the majority of participants (78%) required assistance during at least one step of the procedure. Most common errors occurred when placing the tube into the stand (18%), collecting the oral fluid sample (24%) and timing of reading results (53%). There was a strong association between presence of symptoms of opiate withdrawals and observed errors (94% vs 62%; p = 0.016) in a sub-group of 74 participants assessed. Inter-reader and inter-operator concordance were 97.7% (kappa: 0.92) and 99.2% (kappa: 0.95), respectively. Acceptability assessed by asking whether participants would choose to use HCVST prior to and after conducting HCVST was 98% and 95%, respectively. Conclusions We found a high acceptability of oral fluid HCVST among PWID. User errors were common and were associated with the presence of withdrawal symptoms among users. Despite errors, most participants were able to obtain and interpret results correctly. These findings suggest that this group of users may benefit from greater messaging and education including options to receive direct assistance when self-testing for HCV.

Program ROSE (removing obstacles to cervical screening) is a primary HPV-based cervical screening program that incorporates self-sampling and digital technology, ensuring that women are linked to care. It was developed based on the principles of design thinking in the context of Malaysia. The program illustrates the importance of collaborative partnerships and addressing the multi-faceted barriers from policy changes, and infrastructure readiness to the implementation of a radically new cervical screening program in communities. The paradigm shift in cervical cancer requires a monumental and concerted effort in educating both the healthcare providers and the general public. In this short review, we highlight how Pilot Project ROSE incorporated evidence-based tools that rapidly scaled up to Program ROSE. These ideas and solutions can be adapted and adopted by other countries. Notwithstanding the impact of COVID-19, it is incumbent on countries to pave the road towards the elimination of cervical cancer with pre-existing footpaths.

Background Brazil is among the countries in South America where the COVID-19 pandemic has hit the general population hardest. Self-testing for SARS-CoV-2 infection is one of the community-based strategies that could help asymptomatic individuals at-risk of COVID-19, as well as those living in areas that are difficult for health personnel to reach, to know their infectious status and contribute to impeding further transmission of the virus. Methods A population-based survey was conducted in November 2021, to assess the acceptability of rapid SARS-CoV-2 antigen self-testing among the population of São Paulo. Survey respondents were approached at more than 400 different street-points that were randomly selected using a five-stage randomization process. A 35-item structured questionnaire was used. Dependent variables for our analyses were the likelihood to use and willingness to pay for self-testing, and the likelihood of taking preventive measures to prevent onward transmission of SARS-CoV-2 following a reactive self-test result. Bivariate and multivariate regression analyses were performed. Results Overall, 417 respondents (44.12% female) participated; 19.66% had previously had COVID-19 disease. A minority (9.59%) felt at high-risk of COVID-19. The majority of both females and males (73.91% and 60.09%, respectively) were in favor of the idea of SARS-CoV-2 self-testing. Overall, if self-tests were available, almost half of the sample would be very likely (n = 54, 12.95%) or likely (n = 151, 36.21%) to use one if they felt they needed to. Upon receiving a positive self-test result, the majority of respondents would communicate it (88.49%), request facility-based post-test counseling (98.32%), self-isolate (97.60%), and warn their close contacts (96.64%). Conclusion Rapid SARS-CoV-2 antigen self-testing could be an acceptable screening tool in São Paulo. The population would be empowered by having access to a technology that would allow them to test, even if asymptomatic, when traveling, or going to work or school. If there is a surge in the incidence of cases, self-testing could be a good approach for mass case detection by Brazil’s already overstretched Unified Health System.

To control the spread of the coronavirus disease 2019 (COVID‐19) epidemics, it is necessary to have easy‐to‐use, reliable diagnostic tests available. The nasopharyngeal sampling method being often uncomfortable, nasal sampling could prove to be a viable alternative to the reference sampling method. We performed a multicentre, prospective validation study of the COVID‐VIRO® test, using a nasal swab sampling method, in a point‐of‐care setting. In addition, we performed a multicentre, prospective, and usability study to validate the use of the rapid antigen nasal diagnostic test by laypersons. In March 2021, 239 asymptomatic and symptomatic patients were included in the validation study. Compared with reverse‐transcription polymerase chain reaction on nasopharyngeal samples, the sensitivity and specificity of the COVID‐VIRO® Antigen test combined with a nasal sampling method were evaluated as 96.88% and 100%, respectively. A total of 101 individuals were included in the usability study. Among these, 99% of the participants rated the instructions material as good, 98% of the subjects executed the test procedure well, and 98% of the participants were able to correctly interpret the test results. This study validates the relevance of COVID‐VIRO® as a diagnostic tool from nasal specimens as well as its usability in the general population. COVID‐VIRO® diagnostic performances and ease of use make it suitable for widespread utilization.

OBJECTIVE To develop an in-depth understanding of HPV self-testing cervical screening clinical pathways for never-/under-screened Māori women. METHODS Based on a community-based cluster randomized controlled trial in Aotearoa (New Zealand), a Kaupapa Māori (by Māori, for Māori) qualitative study enrolled Māori women who met the eligibility criteria of the HPV trial intervention (aged 25-69 years, no screen in >4 years). In total, 28 were recruited (22 had a negative test, six had a positive test and colposcopy). They were asked about their clinical pathway. RESULTS The HPV self-test was seen as empowering and promoting bodily autonomy, although some women expressed fears or misconceptions about this new technology. While those with a negative test were relieved, for the six women who had a positive test, there were many fears, compounded by seeking out information on the Internet. When attending colposcopy, the importance of support and responsive care was emphasized. CONCLUSION HPV self-testing has the potential to improve access to cervical screening and reduce inequities for Māori. Care must be taken in the delivery of screening and colposcopy results. Primary care and colposcopy services need to take special care with never-/under-screened Māori women to provide sensitive, responsive care, and mitigate trauma.

BACKGROUND: Emergency departments (ED) interface with large numbers of patients that are often missed by conventional HIV testing approaches. ED-based HIV self-testing (HIVST) is an innovative engagement approach which has potential for testing gains among populations that have failed to be reached. This systematic review and meta-analysis evaluated acceptability and uptake of HIVST, as compared to standard provider-delivered testing approaches, among patients seeking care in ED settings. METHODS: Six electronic databases were systematically searched (Dates: January 1990 – May 2021). Reports with data on HIVST acceptability and/or testing uptake in ED settings were included. Two reviewers identified eligible records (kappa=0.84); quality was assessed using formalized criteria. Acceptability and testing uptake metrics were summarized, and pooled estimates were calculated using random-effects models with assessments of heterogeneity. RESULTS: Of 5,773 records identified, seven met inclusion criteria. The cumulative sample was 1,942 subjects, drawn from three randomized control trials (RCTs) and four cross-sectional studies. Four reports assessed HIVST acceptability. Pooled acceptability of self-testing was 92.6% (95% confidence interval [CI]:88.0%−97.1%). Data from two RCTs demonstrated that HIVST significantly increased testing uptake as compared to standard programs (risk ratio [RR]=4.41, 95% CI:1.95–10.10, I(2)=25.8%). Overall, quality of evidence was low (42.9%) or very low (42.9%), with one report of moderate quality (14.2%). CONCLUSIONS: Available data indicate that HIVST may be acceptable and may increases testing among patients seeking emergency care, suggesting that expanding ED-based HIVST programs could enhance HIV diagnosis. However, given the limitations of the reports, additional research is needed to better inform the evidence-base.

Background and Aims Because of COVID-19 public health restrictions, telemedicine has replaced conventional outpatient follow up for most patients with chronic immune-mediated inflammatory disorders treated with biologic drugs. Innovative solutions to facilitate remote therapeutic drug monitoring are therefore required. Low-volume intracapillary blood sampling can be undertaken by patients at home and samples returned by post to central laboratories. We sought to report the effect of the COVID-19 pandemic on requests for therapeutic drug monitoring and the equivalence, acceptability and effectiveness of low volume Patient-led Remote IntraCapillary pharmacoKinetic Sampling [fingerPRICKS] compared to conventional venepuncture. Methods We undertook a cross-sectional blood sampling methods comparison study and compared sample types using linear regression models. Drug and antidrug antibody levels were measured using standard ELISAs. Acceptability was assessed using a purpose-designed questionnaire. Results Therapeutic drug monitoring requests for adalimumab (96.5 [70.5–106] per week to 52 [33.5–57.0], p < 0.001) but not infliximab (184.5 [161.2–214.2] to 161 [135–197.5], p = 0.34) reduced during the first UK stay-at-home lockdown compared with the preceding 6 months. Fingerprick sampling was equivalent to conventional venepuncture for adalimumab, infliximab, vedolizumab and ustekinumab drug, and anti-adalimumab and anti-infliximab antibody levels. The median [interquartile range] volume of serum obtained using intracapillary sampling was 195 µL [130–210]. More than 87% [90/103] of patients agreed that intracapillary testing was easy and 69% [71/103] preferred it to conventional venepuncture. In routine care, 75.3% [58/77] of patients returned two blood samples within 14 days to permit remote assessment of biologic therapeutic drug monitoring. Conclusions Therapeutic drug monitoring can be undertaken using patient-led remote intracapillary blood sampling and has the potential to be a key adjunct to telemedicine in patients with immune-mediated inflammatory diseases.

INTRODUCTION The lack of quality control procedures for home point-of-care (POC) international normalized ratio (INR) devices is a concern. Concomitant laboratory and POC INR testing may be proposed to overcome the lack of quality control. However, a difference between the POC INR and the laboratory INR is not necessarily due to failure of the POC device. This study aimed to identify variables associated with a significant deviation between the POC INR and the laboratory INR. METHODS Children included in this retrospective cohort study performed at least one concomitant laboratory and POC INRs. Clinical and laboratory variables were assessed for an association with significant deviation within pairs of INR. RESULTS A significant deviation was noted for 30 (15.3%) of the 196 pairs of INR measurements from 124 children. Relative to patients without deviations, patients with deviations were younger (odds ratio =0.91; P = .020), less experienced in the use of POC INR devices (odds ratio =0.89; P = .098), and more likely to have received an INR result from a laboratory using animal thromboplastin (odds ratio =2.81 vs. 0.37 for laboratories using human thromboplastin; P = .016). In a multivariate analysis, younger age and the laboratory's use of animal thromboplastin were associated with significant deviations. CONCLUSIONS Although most children had coherent pairs of INR values, the occurrence of deviations raises the question of the origin of the thromboplastin used in the laboratory and emphasizes the need to provide specific quality control procedures for POC INR devices.

Summary: Background: Secondary distribution of HIV self-testing (HIVST) kits by patients attending clinic services to their partners could improve the rate of HIV diagnosis. We aimed to investigate whether secondary administration of HIVST kits, with or without an additional financial incentive, via women receiving antenatal care (ANC) or via people newly diagnosed with HIV (ie, index patients) could improve the proportion of male partners tested or the number of people newly diagnosed with HIV. Methods: We did a three-arm, open-label, pragmatic, cluster-randomised trial of 27 health centres (clusters), eligible if they were a government primary health centre providing ANC, HIV testing, and ART services, across four districts of Malawi. We recruited women (aged ≥18 years) attending their first ANC visit and whose male partner was available, not already taking ART, and not already tested for HIV during this pregnancy (ANC cohort), and people (aged ≥18 years) with newly diagnosed HIV during routine clinic HIV testing who had at least one sexual contact not already known to be HIV-positive (index cohort). Centres were randomly assigned (1:1:1), using a public selection of computer-generated random allocations, to enhanced standard of care (including an invitation for partners to attend HIV testing services), HIVST only, or HIVST plus a US$10 financial incentive for retesting. The primary outcome for the ANC cohort was the proportion of male partners reportedly tested, as ascertained by interview with women in this cohort at day 28. The primary outcome for the index cohort was the geometric mean number of new HIV-positive people identified per facility within 28 days of enrolment, as measured by observed HIV test results. Cluster-level summaries compared intervention with standard of care by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03705611. Findings: Between Sept 8, 2018, and May 2, 2019, nine clusters were assigned to each trial arm, resulting in 4544 eligible women in the ANC cohort (1447 [31·8%] in the standard care group, 1465 [32·2%] in the HIVST only group, and 1632 [35·9%] in HIVST plus financial incentive group) and 708 eligible patients in the index cohort (234 [33·1%] in the standard care group, 169 [23·9%] in the HIVST only group, and 305 [42·9%] in the HIVST plus financial incentive group). 4461 (98·2%) of 4544 eligible women in the ANC cohort and 645 (91·1%) of 708 eligible patients in the index cohort were recruited, of whom 3378 (75·7%) in the ANC cohort and 439 (68·1%) in the index cohort were interviewed after 28 days. In the ANC cohort, the mean proportion of reported partner testing per cluster was 35·0% (SD 10·0) in the standard care group, 73·0% in HIVST only group (13·1, adjusted risk ratio [RR] 1·71, 95% CI 1·48–1·98; p

Objectives To evaluate the implementation and acceptability of the self-collection cervical screening pathway since commencement of the renewed National Cervical Screening Program (rNCSP), from the perspectives of screening participants and primary care practitioners. Design, setting, participants Qualitative study; individual semi-structured interviews with 45 screening participants and 18 primary care practitioners in Victoria who had engaged with the self-collection pathway during the first 17 months of the rNCSP (1 December 2017 - 30 April 2019). Results The self-collection pathway was highly acceptable as an alternative cervical screening pathway for most participating screening participants and practitioners. Some screening participants indicated that they would not have been screened had the pathway not been available. Acceptability was lower among those who had tested positive for HPV types not 16/18, a result that requires additional testing of a clinician-collected cervical sample. Use of the self-collection pathway is driven more by practitioners than their patients. Interpretations of the self-collection guidelines varied between practices. Barriers to expanding promotion of the pathway by practitioners included difficulties with identifying eligible participants. Conclusions Increasing the accessibility of the self-collection pathway to under- and never screened women could reduce inequities in cervical cancer outcomes for those not participating in the main screening pathway. Practitioners should be provided resources to integrate self-collection into routine practice and to efficiently implement the entire self-collection pathway, in order to maximise its use and to optimise the experience for screening participants.

Since the beginning of the HIV epidemic, there have been more than 75 million cases. Currently, there about 1.2 million living with HIV in the USA. Despite current testing recommendations, test rates continue to be suboptimal. Investigators have studied the use of digital technology to promote HIV testing, especially among high-risk populations. Purpose of Review This non-systematic review provides an overview of the scientific research between 2015 and 2020 focused on the use of digital technology to bolster HIV testing and suggests novel technologies for exploration. Recent Findings A total of 40 studies were included in the review that span a wide range of available technology. Studies effectively increased HIV testing among study participants. Generally, participants in the intervention/exposure groups had significantly higher rates of HIV test uptake compared to participants in the comparison groups at study follow-up. Summary For a variety of reasons (e.g., differences in ways the technologies were used and study design), no digital tool clearly performed better than others, but each have the capacity to increase outreach and self-testing. An exploration of the potential use of nascent technologies is also discussed, as well as the authors’ experiences using a number of these technologies in our research.

OBJECTIVE/PURPOSE The aim of the study was to determine the level of interest in human papillomavirus (HPV) self-sampling as a method of cervical cancer screening in a population of women affiliated with a primary care clinic. MATERIALS AND METHODS A survey was given to women (N = 182) between the ages of 25 and 69 years attending a family medicine clinic in Edmonton, Canada. Primary outcome measures include (1) the percentage of women who feel that HPV self-sampling should be available and (2) the percentage of women who would prefer HPV self-sampling to the Pap test. Secondary outcomes include the percentage of women aware of HPV self-sampling and factors associated with a preference for HPV self-sampling using logistic regression. RESULTS Most women (84%) were up-to-date on Pap testing, and most (85%) had had postsecondary education (either completed or in progress). The percentage of the women who moderately or strongly felt that HPV self-sampling should be available was 60%; the percentage of the women who would prefer HPV self-sampling was 24%. Only 7% of the women reported being previously aware of HPV self-sampling. The factor associated with a preference for HPV self-sampling was the Pap comfort score, with an odds ratio of 1.51 (95% CI = 1.05-2.16, p = .026). CONCLUSIONS In this population of well-educated women who were mostly up-to-date on cervical screening, there was a clear interest to have the option of HPV self-sampling. It is important for cancer screening programs to take this into account, given that women are the ultimate beneficiaries of these programs.

ImportanceWidespread distribution of rapid antigen tests is integral to the US strategy to address COVID-19; however, it is estimated that few rapid antigen test results are reported to local departments of health.ObjectiveTo characterize how often individuals in 6 communities throughout the United States used a digital assistant to log rapid antigen test results and report them to their local departments of health.Design, Setting, and ParticipantsThis prospective cohort study is based on anonymously collected data from the beneficiaries of the Say Yes! Covid Test program, which distributed more than 3 000 000 rapid antigen tests at no cost to residents of 6 communities (Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O’ahu, Hawaii; Ann Arbor and Ypsilanti, Michigan; and Chattanooga, Tennessee) between April and October 2021. A descriptive evaluation of beneficiary use of a digital assistant for logging and reporting their rapid antigen test results was performed.InterventionsWidespread community distribution of rapid antigen tests.Main Outcomes and MeasuresNumber and proportion of tests logged and reported to the local department of health through the digital assistant.ResultsA total of 313 000 test kits were distributed, including 178 785 test kits that were ordered using the digital assistant. Among all distributed kits, 14 398 households (4.6%) used the digital assistant, but beneficiaries reported three-quarters of their rapid antigen test results to their state public health departments (30 965 tests reported of 41 465 total test results [75.0%]). The reporting behavior varied by community and was significantly higher among communities that were incentivized for reporting test results vs those that were not incentivized or partially incentivized (90.5% [95% CI, 89.9%-91.2%] vs 70.5%; [95% CI, 70.0%-71.0%]). In all communities, positive tests were less frequently reported than negative tests (60.4% [95% CI, 58.1%-62.8%] vs 75.5% [95% CI, 75.1%-76.0%]).Conclusions and RelevanceThese results suggest that application-based reporting with incentives may be associated with increased reporting of rapid tests for COVID-19. However, increasing the adoption of the digital assistant may be a critical first step.

Objectives: To understand the public’s perceptions around rapid SARS-CoV-2 antigen self-testing in Kenya, including the drivers of acceptability, willingness to pay, and adherence to hygiene and prevention recommendations following a positive self-test.Methods: A household-based, cross-sectional survey, using a 35-item questionnaire, was conducted in Mombasa and Taita–Taveta counties, Kenya, during August 2021. Individuals aged ≥18 years were enrolled using a stratified sampling approach.Results: There were 419 participants (mean age 35.7 years). A minority (10.5%) had ever tested for SARS-CoV-2. If SARS-CoV-2 self-testing were available, 39.9% and 41.5% would be likely and very likely, respectively, to use it. If unavailable free-of-charge, 63.01% would pay for it. Multivariate analyses suggested that people in rural areas (Coefficient 0.30, 95%CI: 0.11–0.48, p = 0.002), aged 36–55 (Coefficient 0.21, 95%CI: 0.03–0.40, p = 0.023), and employed full time (Coefficient 0.32, 95%CI: 0.06–0.58, p = 0.016) would have more odds to adhere to recommended hygiene and prevention actions.Conclusion: SARS-CoV-2 self-testing was considered acceptable. Availability of self-testing could expand access to COVID-19 testing in Kenya, particularly among rural communities who have limited access to testing, and among mildly symptomatic individuals.

Prostate-specific antigen (PSA) screening remains the mainstay for early detection of prostate cancer. Although PSA is a nonspecific prostate cancer biomarker, its specificity for high grade prostate cancer can be enhanced by pre-biopsy liquid biomarkers including the Exosome Dx Prostate IntelliScore (EPI) test. EPI is a stand-alone urine genomic test that measures 3 exosome-derived gene expression signatures without the need for digital rectal examination (DRE) or inclusion of standard of care parameters in the test algorithm. EPI has broad clinical utility as a risk stratification tool for clinically significant high grade prostate cancer in men considering diagnostic prostate biopsy (MRI-targeted and systematic biopsy). During the COVID-19 pandemic, the EPI At-Home Collection Kit was introduced and quickly became an important component of tele-urology. The EPI test has emerged as a prioritization tool for primary care referral to urologists and for prostate biopsy scheduling. EPI provides an objective and actionable genomic risk assessment tool for high grade prostate cancer and is a critical part of the informed decision-making regarding biopsy (targeted, systematic or both) in both urology and primary care practices.

Māori, Pasifika and Asian women are less likely to attend cervical screening and Māori and Pasifika women are more likely to be diagnosed with later-stage cervical cancer than other women in Aotearoa New Zealand. This study-with under-screened women taking part in a randomized-controlled trial comparing self-testing and standard screening-explored the acceptability of a human papillomavirus (HPV) self-test kit and the preferred method for receiving it.Māori, Pasifika and Asian women (N= 376) completed a cross-sectional postal questionnaire. Twenty-six women who had not accepted the trial invitation were interviewed to understand their reasons for nonparticipation.Most women found the self-test kit easy and convenient to use and reported that they did not find it painful, uncomfortable or embarrassing. This was reflected in the preference for a self-test over a future smear test on the same grounds. Most women preferred to receive the kit by mail and take the test themselves, rather than having it done by a doctor or nurse. There was a range of preferences relating to how to return the kit. Phone calls with nonresponders revealed that, although most had received the test kit, the reasons for not choosing to be involved included not wanting to, being too busy or forgetting.HPV self-testing was acceptable for Māori, Pasifika and Asian women in Aotearoa New Zealand. HPV self-testing has considerable potential to reduce the inequities in the current screening programme and should be made available with appropriate delivery options as soon as possible.This study explored the acceptability of HPV self-testing and their preferences for engaging with it among Māori, Pasifika and Asian women. Thus, women from these underserved communities were the participants and focus of this study.

Regular, accurate, rapid, and inexpensive self-testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is urgently needed to quell pandemic propagation. The existing at-home nucleic acid testing (NAT) test has high sensitivity and specificity, but it requires users to mail the sample to the central lab, which often takes 3-5 days to obtain the results. On the other hand, rapid antigen tests for the SARS-CoV-2 antigen provide a fast sample to answer the test (15 min). However, the sensitivity of antigen tests is 30 to 40% lower than nucleic acid testing, which could miss a significant portion of infected patients. Here, we developed a fully integrated SARS-CoV-2 reverse transcription loop-mediated isothermal amplification (RT-LAMP) device using a self-collected saliva sample. This platform can automatically handle the complexity and can perform the functions, including (1) virus particles' thermal lysis preparation, (2) sample dispensing, (3) target sequence RT-LAMP amplification, (4) real-time detection, and (5) result report and communication. With a turnaround time of less than 45 min, our device achieved the limit of detection (LoD) of 5 copies/μL of the saliva sample, which is comparable with the LoD (6 copies/μL) using FDA-approved quantitative real-time polymerase chain reaction (qRT-PCR) assays with the same heat-lysis saliva sample preparation method. With clinical samples, our platform showed a good agreement with the results from the gold-standard RT-PCR method. These results show that our platform can perform self-administrated SARS-CoV-2 nucleic acid testing by laypersons with noninvasive saliva samples. We believe that our self-testing platform will have an ongoing benefit for COVID-19 control and fighting future pandemics.

Research has clearly demonstrated that some study strategies (for example, self-testing and spaced studying) are effective, yet students often report studying ineffectively. Our focus with the current study is to update and extend the current literature on how college students study. We surveyed 484 introductory psychology students at a small liberal arts college—a different type of school from prior studies. Our survey built on an existing study strategies questionnaire used to assess a variety of student study behaviors and beliefs. Additionally, we asked new questions about multitasking and study scheduling. Overall, we found that the current sample reported studying in similar ways to what past research suggested; students used both effective and ineffective strategies, some of which correlated with grade point average (GPA). However, some differences emerged. For example, our students were more likely to report learning how to study from a teacher. Additionally, a majority of students believed that multitasking was ineffective, yet most reported multitasking while studying. Finally, an important, but exploratory, analysis demonstrated that study strategies were similar before and after COVID-19 forced classroom changes. We highlight the need for future research on study strategies to recruit participants from more diverse institutions.

Background HIV self-testing (HIVST) is recommended by the World Health Organization as a valid approach to routine HIV testing services. The scale of HIVST use has gradually been expanded in China over the past 5 years. To take a closer look at the role of HIVST in China, we reviewed the promotion and application of HIVST within China. Objective The main objective of this study was to systematically analyze the proportion of past use and actual uptake of HIVST within China. Moreover, we aimed to quantify the effect of HIVST on HIV prevention and treatment. Methods In all, 5 medical databases and 2 registration systems, including PubMed, Web of Science, MEDLINE, WanFang, China National Knowledge Internet, ClinicalTrials.gov, and the Chinese Clinical Trial Registry were systematically searched for studies reporting the prevalence of HIVST use from January 1, 2010, to December 25, 2021. Meta-analyses of the pooled proportion estimates were carried out by the meta-package in R software (version 4.1.2). Statistical heterogeneity among the studies was estimated using Cochran Q test and the inconsistency index (I2). Results A total of 50 studies were included in our systematic review. The estimated pooled prevalence of HIVST use in China was 29.9% (95% CI 22.5%-37.9%). Among individuals who have ever used HIVST, 47.5% (95% CI 37.2%-57.8%) were tested for HIV for the first time. The pooled reactive rate of HIVST was 4.2% (95% CI 3.1%-5.8%). When HIVST revealed a reactive result, 81.3% (95% CI 70.9%-91.6%) of individuals sought medical care. Conclusions In recent times, HIVST has become a valuable tool for HIV prevention in China. The widespread use of HIVST in non–men who have sex with men populations needs to be endorsed and promoted. The long-term applications of HIVST and the potential consequences of self-financing of HIVST in China have yet to be explored. Trial Registration PROSPERO CRD42022304846; https://tinyurl.com/54d9pxy8

Purpose of Review HIV self-testing (HIVST) has the potential to expand access to and uptake of HIV pre-exposure prophylaxis (PrEP) delivery. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. Recent Findings After screening 1055 records, we included eight: three randomized trials and five values and preferences studies. None measured PrEP initiation. Most studies occurred in Sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly clinic visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly clinic visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. Summary HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.