Performance of self-performed SARS-CoV-2 rapid antigen test: a systematic review and meta-analysis.

Background: The aim of this study was to investigate the accuracy of self-tested SARS-CoV-2 rapid antigen tests. Methods: Databases of Pubmed, Embase, and Cochrane Library were searched for original studies investigating accuracy of self-tested SARS-CoV-2 rapid antigen tests, with RT-PCR as "gold standard." Results: Forty-five eligible studies were found after database searching and screening using pre-defined criteria. The accuracy results from 50,897 suspected COVID-19 patients were pooled, and the overall sensitivity, specificity and diagnostic odds ratio were 0.77, 1.00, and 625.95, respectively. Subgroup analysis showed higher sensitivity of rapid antigen tests in subgroups of Abbott Panbio, self-collected nasal swab samples, and use of nasopharyngeal or oropharyngeal swab and lower Ct cutoff value in RT-PCR. Conclusion: Fully self-performed SARS-CoV-2 rapid antigen tests showed overall high accuracy compared to "gold standard," and are reliable surrogates for the standard test of COVID-19 using nasopharyngeal or oropharyngeal samples and RT-PCR.

Leveraging HIV self-testing to achieve the UNAIDS 2025 targets in the South and Southeast Asia region.

INTRODUCTION: The South and Southeast Asia region has the second-highest number of people living with HIV globally. Despite progress in reducing HIV incidence and AIDS-related deaths, the region still has a long way to go in achieving the Joint United Nations Programme on HIV and AIDS (UNAIDS) 95-95-95 HIV testing, treatment and viral suppression targets. HIV self-testing (HIVST) is recommended by the World Health Organization as an additional approach to HIV testing. This paper provides a commentary on the implementation status, benefits, barriers and recommendations for HIVST implementation in South and Southeast Asia. Additionally, it presents perspectives from HIV testing service experts from 11 countries in the region to put forth recommendations to accelerate the implementation of HIVST in South and Southeast Asia. DISCUSSION: There is uneven progress in national HIVST policy development and implementation across the region. HIVST, as an additional testing approach, can help to enhance testing coverage, frequency and demand for follow-up HIV services among key populations. Key factors influencing the implementation and scale-up of HIVST include the degree of awareness of HIVST among general and key populations, the development and implementation of supportive national HIVST policies and the availability of public funding for HIVST. To address barriers and leverage enablers to HIVST implementation, generating evidence on cost-effectiveness and budget impact, developing multisectoral partnerships for market shaping, promoting differentiated and decentralized delivery models, and optimizing linkage to further testing and care are recommended. CONCLUSIONS: It is crucial to accelerate the implementation and scale-up of HIVST to differentiate and decentralize the delivery of HIV testing services in South and Southeast Asian countries. Sharing experiences among country experts is vital to foster the adoption of best practices and facilitate the trial-and-error process of HIVST implementation. Such collaborative approaches can help South and Southeast Asian countries attain the UNAIDS 95-95-95 targets, especially the first 95 on HIV diagnosis, and play a significant role in ending the global AIDS epidemic.

Comparative evaluation of swabbing sites for Omicron variant detection in PCR testing.

PURPOSE: The Omicron variant of SARS-CoV-2 raised concerns about the best sampling sites for PCR testing, with early indications suggesting throat swab samples were better than nasal swab samples. Our study evaluated the sensitivity of detecting SARS-CoV-2 across different swabbing sites. METHODS: Participants undergoing testing at NHS Test and Trace sites in England provided self-collected samples using nose only, throat only, and combined nose and throat swabs, which were analysed by realtime PCR. RESULTS: Among 815 participants, combined swabs had higher viral concentrations than nose only or throat only swabs. Sensitivity for detecting SARS-CoV-2 by PCR was 91 % for nose only and 97 % for throat only, relative to the combined approach. VC remained stable in nose swabs but declined in throat swabs with time. CONCLUSIONS: Combined nose and throat swabbing remains the most effective method for SARS-CoV-2 detection. If a single swab is used, a throat swab has a higher sensitivity than nose swabs, although VC in the throat decreases faster in later infection stages. The variations in VC over time and intra-person variation between sampling sites underscore the complexity of viral dynamics, highlighting the importance of considering both nose and throat samples for comprehensive testing.

Acceptability and Feasibility of Implementing a Home-Based HIV Pre-Exposure Prophylaxis Program in an Urban Clinic.

Personal and structural barriers to HIV pre-exposure prophylaxis (PrEP) care result in its underutilization and premature discontinuation. A home-based PrEP program comprised of telemedicine visits and/or self-administered lab testing may address some of these barriers. Our objective was to assess the acceptability and feasibility of a home-based PrEP program among stakeholders at an urban HIV and primary care clinic. We used the consolidated framework for implementation research to evaluate determinants of successful implementation of the program. We surveyed and interviewed PrEP patients and their health care team. In a baseline survey of PrEP users (n = 112) administered between May 2021 and August 2022, 65% expressed interest in switching to the home-based PrEP program. Seventeen patients over the course of follow-up through December 2023 started home-based PrEP, including 12 patients who completed both a telemedicine visit and a self-administered lab kit, and 5 patients who completed only a telemedicine visit. Of these, over 80% had positive feedback on the telemedicine visits. Survey results demonstrated excellent acceptability and feasibility of the lab kits. Patients indicated in interviews that the home-based PrEP program provided the strong advantage of convenience. Despite mixed feelings from PrEP providers on telemedicine visits (n = 5), most felt that the program made PrEP care delivery easier for patients and would encourage their patients to use the program if it were a good fit. Barriers to program success included shipping delays and staff turnover during program implementation. In conclusion, uptake of the home-based program was low but program participants expressed high acceptability.

Exploring Facilitators and Barriers to STD/STI/HIV Self-Testing Among College Students in the United States: A Scoping Review.

BACKGROUND: HIV affects 1.2 million Americans, with 20% of new diagnoses being 13 to 24-year-olds. Young adult college students are more likely than the general population of 18 to 24-year-olds in the U.S. to engage in sexual practices that increase their risk of STIs. OBJECTIVES: This scoping review explores factors that promote or hinder STD/STI/HIV self-testing among U.S. college students. SEARCH METHODS: A scoping review of original, experimental (randomized or nonrandomized), observational (longitudinal and cross-sectional), and qualitative or mixed-methods U.S. research was conducted using OVID Medline, OVID Embase, PubMed, CINAHL, Web of Science Core Collection, and Cochrane CENTRAL. English-language studies measured STD/STI/HIV self-test kits and college student testing. SELECTION CRITERIA: Inclusion and exclusion criteria were used to narrow down articles that addressed barriers and facilitators to STD/STI/HIV testing, and self-testing among college students in the U.S. RESULTS: Database searches yielded 8,373 articles. After removing duplicates, 6173 items remained. After independent dual-title/abstract screening, 100 papers were full-text reviewed. Seven retrieved articles were unavailable, and 93 were selected for full-text screening. After reviewing the whole text, 89 papers did not fulfill the inclusion requirements and were deleted, leaving 4 articles in the final analysis. CONCLUSION: Additional research on self-testing among college students in the U.S. is urgently required. The results should guide university health policies on the need to cater to the unique requirements of college students by increasing the availability of healthcare and embracing STD/STI/HIV self-testing. This can enhance testing rates, diminish stigmas, and ultimately contribute to wider endeavors to reduce the transmission of infections in the U.S.

Amplification-free nucleic acids detection with next-generation CRISPR/dx systems.

CRISPR-based diagnostics (CRISPR/Dx) have revolutionized the field of molecular diagnostics. It enables home self-test, field-deployable, and point-of-care testing (POCT). Despite the great potential of CRISPR/Dx in diagnoses of biologically complex diseases, preamplification of the template often is required for the sensitive detection of low-abundance nucleic acids. Various amplification-free CRISPR/Dx systems were recently developed to enhance signal detection at sufficient sensitivity. Broadly, these amplification-free CRISPR/Dx systems are classified into five groups depending on the signal enhancement strategies employed: CRISPR/Cas12a and/or CRISPR/Cas13a are integrated with: (1) other catalytic enzymes (Cas14a, Csm6, Argonaute, duplex-specific nuclease, nanozyme, or T7 exonuclease), (2) rational-designed oligonucleotides (multivalent aptamer, tetrahedral DNA framework, RNA G-quadruplexes, DNA roller machine, switchable-caged guide RNA, hybrid locked RNA/DNA probe, hybridized cascade probe, or "U" rich stem-loop RNA), (3) nanomaterials (nanophotonic structure, gold nanoparticle, micromotor, or microbeads), (4) electrochemical and piezoelectric plate biosensors (SERS nanoprobes, graphene field-effect transistor, redox probe, or primer exchange reaction), or (5) cutting-edge detection technology platforms (digital bioanalysis, droplet microfluidic, smartphone camera, or single nanoparticle counting). Herein, we critically discuss the advances, pitfalls and future perspectives for these amplification-free CRISPR/Dx systems in nucleic acids detection. The continued refinement of these CRISPR/Dx systems will pave the road for rapid, cost-effective, ultrasensitive, and ultraspecific on-site detection without resorting to target amplification, with the ultimate goal of establishing CRISPR/Dx as the paragon of diagnostics.

Formalized peer referral to HIV pre-exposure prophylaxis supported with self-testing: a mixed-methods pilot study among young Kenyan women.

Background: The uptake of daily oral HIV pre-exposure prophylaxis (PrEP)-a highly effective intervention-remains low among African adolescent girls and young women (AGYW) who could benefit. AGYW who initiate PrEP often do so through informal peer referral, which may be enhanced with formalized peer referral and peer-delivered HIV self-testing (HIVST). To understand the feasibility of this PrEP referral model among AGYW, we conducted a pilot study in Kenya. Method: From March to May 2022, we recruited AGYW (≥16-24 years) using PrEP (i.e., "peer providers") from public healthcare clinics in Kiambu County and trained them on HIV prevention, HIVST use, and peer-supported linkage to clinic-based HIV services. Following training, peer providers received eight HIVST kits and were encouraged to refer four peers (i.e., "peer clients") to PrEP. We completed surveys with peer providers and clients one month following intervention delivery to assess PrEP initiation among peer clients. Later, we conducted focus group discussions (FGDs) with peer providers and clients to identify factors that facilitated or challenged intervention outcomes. Results: We trained 16 peer providers (median age: 23 years, IQR 21-24) who reported delivering the intervention to 56 peer clients; 30 peer clients (median age: 21 years, IQR 19-22) contacted the study team and were enrolled. Most of the enrolled peer clients reported behaviors associated with HIV risk (e.g., condomless sex; 80%, 24/30) and were PrEP-naïve (87%, 26/30). At one-month, PrEP initiation among eligible PrEP-naïve peer clients was high, as reported by providers (78%, 43/55) and clients (85%, 22/26); recent HIVST use was also high among peer clients (provider report: 95%, 53/56; client report: 97%, 29/30). In the FGDs, participants reported that intervention outcomes were facilitated by close preexisting relationships, HIVST assistance, and being escorted to clinic-based HIV services by peer providers; intervention barriers included conflicting priorities and limited HIVST experience. Conclusion: A formalized model of peer referral with HIVST delivery supported PrEP initiation among Kenyan AGYW. These findings demonstrate the potential for peer-delivered interventions to engage AGYW in HIV prevention services; however, more research is needed on the effectiveness and sustainability of this approach at scale.

Breaking Down Barriers to a Suicide Prevention Helpline: Web-Based Randomized Controlled Trial.

Background: Every month, around 3800 people complete an anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline. Although 70% score high on the severity of suicidal thoughts, <10% navigate to the web page about contacting the helpline. Objective: This study aimed to test the effectiveness of a brief barrier reduction intervention (BRI) in motivating people with severe suicidal thoughts to contact the suicide prevention helpline, specifically in high-risk groups such as men and middle-aged people. Methods: We conducted a fully automated, web-based, randomized controlled trial. Respondents with severe suicidal thoughts and little motivation to contact the helpline were randomly allocated either to a brief BRI, in which they received a short, tailored message based on their self-reported barrier to the helpline (n=610), or a general advisory text (care as usual as the control group: n=612). Effectiveness was evaluated using both behavioral and attitudinal measurements. The primary outcome measure was the use of a direct link to contact the helpline after completing the intervention or control condition. Secondary outcomes were the self-reported likelihood of contacting the helpline and satisfaction with the received self-test. Results: In total, 2124 website visitors completed the Suicidal Ideation Attributes Scale and the demographic questions in the entry screening questionnaire. Among them, 1222 were randomized into the intervention or control group. Eventually, 772 respondents completed the randomized controlled trial (intervention group: n=369; control group: n=403). The most selected barrier in both groups was "I don't think that my problems are serious enough." At the end of the trial, 33.1% (n=122) of the respondents in the intervention group used the direct link to the helpline. This was not significantly different from the respondents in the control group (144/403, 35.7%; odds ratio 0.87, 95% CI 0.64-1.18, P=.38). However, the respondents who received the BRI did score higher on their self-reported likelihood of contacting the helpline at a later point in time (B=0.22, 95% CI 0.12-0.32, P≤.001) and on satisfaction with the self-test (B=0.27, 95% CI 0.01-0.53, P=.04). For male and middle-aged respondents specifically, the results were comparable to that of the whole group. Conclusions: This trial was the first time the helpline was able to connect with high-risk website visitors who were hesitant to contact the helpline. Although the BRI could not ensure that those respondents immediately used the direct link to the helpline at the end of the trial, it is encouraging that respondents indicated that they were more likely to contact the helpline at a later point in time. In addition, this low-cost intervention provided greater insight into the perceived barriers to service. Follow-up research should be focused on identifying the added value of other components (eg, video or photo material) in the BRI and increasing its effectiveness, especially for men and middle-aged people.

Usability and acceptability of self-testing for hepatitis C virus exposure in a high-prevalence urban informal settlement in Karachi, Pakistan.

BACKGROUND: Hepatitis C virus (HCV) antibody self-testing (HCVST) may help expand screening access and support HCV elimination efforts. Despite potential benefits, HCVST is not currently implemented in Pakistan. This study aimed to assess the usability and acceptability of HCVST in a high HCV prevalence informal settlement in Karachi, Pakistan. METHODS: We performed a cross-sectional study in a hepatitis C clinic from April through June 2023. Participants were invited to perform a saliva-based HCVST (OraSure Technologies, USA) while following pictorial instructions. A study member evaluated test performance using a standardized checklist and provided verbal support if a step could not be completed. Perceived usability and acceptability were assessed using a semi-structured questionnaire. The HCVST was considered successful if the participant was able to complete all steps and correctly interpret test results. Overall concordance and positive and negative agreement were estimated in comparison with the HCVST result read by the study member (inter-reader concordance and agreement) and result of a second rapid HCV test (Abbott Diagnostics Korea Inc, South Korea) performed by a trained user (inter-operator concordance and agreement). RESULTS: The study included 295 participants of which 97 (32%) were illiterate. In total, 280 (95%, 95% CI 92-97%) HCVSTs were successful. Overall, 38 (13%) people performed the HCVST without verbal assistance, 67 (23%) needed verbal assistance in one step, 190 (64%) in two or more. Assistance was most often needed in managing the test buffer and test reading times. The inter-reader concordance was 96% and inter-operator concordance 93%. Inter-reader and inter-operator positive percent agreement were 84 and 70%, respectively. All participants reported they would use HCVST again and would recommend it to friends and family. CONCLUSION: Saliva-based HCVST was very well accepted in this clinic-based setting. However, many people requested verbal support in several steps, highlighting the need for clear instructions for use and test devices that are simple to use, particularly in low literacy settings. Moderately low positive percent agreement with the results of a rapid test performed by a trained user highlights potential uncertainty in the accuracy of HCVST in the hands of lay users.

[How do women in Réunion Island want to perform HPV test on vaginal sampling as part of cervical cancer screening?] / Modalités préférées des femmes à la Réunion pour le dépistage du cancer du col de l'utérus par prélèvement vaginal.

BACKGROUND: Since the introduction of HPV testing as a first-line screening method for women aged 30 and over, vaginal sampling (VS) by a healthcare professional or self-sampling (SS) is now possible for women who have not responded to the organized screening program using cervical uterine sampling. The aim of this study was to understand the choices made by a sample of women from La Reunion would like to perform their VS, and the content of the instructions they would like to receive. METHODS: We conducted a cross-sectional descriptive study using a single-answer questionnaire. Patients were either interviewed in doctors' office or offered the possibility to answer an online questionnaire. We included women aged 30 to 65 in La Reunion who were concerned by CC screening. We compared the answers of women who were up to date with their screening with those of women who were not. RESULTS: We included 202 women. The study showed that 64.9% of patients wished to collect the VS kit from a healthcare professional, 80.8% wished to perform SS and 52.5% wished to return it to the laboratory. The preferred language of the instruction was French, with pictures and drawings for 48.5% of patients. There was no significant difference between the answers of women who were up to date with their screening and those who were not. CONCLUSION: In a sample of women eligible for CC screening in La Reunion, the preferred methods for CC screening were to collect the PV kit from a healthcare professional, perform the SS at home and then return it to the laboratory. These responses differed from other studies. A feasibility study on a part of La Reunion's eligible population for CC screening would enable us to assess the feasibility and generalizability of a screening modality based on SS.

Molecular Gene Expression Testing to Identify Alzheimer's Disease with High Accuracy from Fingerstick Blood.

Background: There is no molecular test for Alzheimer's disease (AD) using self-collected samples, nor is there a definitive molecular test for AD. We demonstrate an accurate and potentially definitive TempO-Seq® gene expression test for AD using fingerstick blood spotted and dried on filter paper, a sample that can be collected in any doctor's office or can be self-collected. Objective: Demonstrate the feasibility of developing an accurate test for the classification of persons with AD from a minimally invasive sample of fingerstick blood spotted on filter paper which can be obtained in any doctor's office or self-collected to address health disparities. Methods: Fingerstick blood samples from patients clinically diagnosed with AD, Parkinson's disease (PD), or asymptomatic controls were spotted onto filter paper in the doctor's office, dried, and shipped to BioSpyder for testing. Three independent patient cohorts were used for training/retraining and testing/retesting AD and PD classification algorithms. Results: After initially identifying a 770 gene classification signature, a minimum set of 68 genes was identified providing classification test areas under the ROC curve of 0.9 for classifying patients as having AD, and 0.94 for classifying patients as having PD. Conclusions: These data demonstrate the potential to develop a screening and/or definitive, minimally invasive, molecular diagnostic test for AD and PD using dried fingerstick blood spot samples that are collected in a doctor's office or clinic, or self-collected, and thus, can address health disparities. Whether the test can classify patients with AD earlier then possible with cognitive testing remains to be determined.

Shifting Grounds-Facilitating Self-Care in Testing for Sexually Transmitted Infections Through the Use of Self-Test Technology: Qualitative Study.

BACKGROUND: Chlamydia remains prevalent worldwide and is considered a global public health problem. However, testing rates among young sexually active people remain low. Effective clinical management relies on screening asymptomatic patients. However, attending face-to-face consultations of testing for sexually transmitted infections is associated with stigmatization and anxiety. Self-testing technology (STT) allows patients to test themselves for chlamydia and gonorrhea without the presence of health care professionals. This may result in wider access to testing and increase testing uptake. Therefore, the sexual health clinic at Odense University Hospital has designed and developed a technology that allows patients to get tested at the clinic through self-collected sampling without a face-to-face consultation. OBJECTIVE: This study aimed to (1) pilot-test STT used in clinical practice and (2) investigate the experiences of patients who have completed a self-test for chlamydia and gonorrhea. METHODS: The study was conducted as a qualitative study inspired by the methodology of participatory design. Ethnographic methods were applied in the feasibility study and the data analyzed were inspired by the action research spiral in iterative processes using steps, such as plan, act, observe, and reflect. The qualitative evaluation study used semistructured interviews and data were analyzed using a qualitative 3-level analytical model. RESULTS: The findings from the feasibility study, such as lack of signposting and adequate information, led to the final modifications of the self-test technology and made it possible to implement it in clinical practice. The qualitative evaluation study found that self-testing was seen as more appealing than testing at a face-to-face consultation because it was an easy solution that both saved time and allowed for the freedom to plan the visit independently. Security was experienced when the instructions balanced between being detail-oriented while also being simple and illustrative. The anonymity and discretion contributed to preserving privacy and removed the fear of an awkward conversation or being judged by health care professionals thus leading to the reduction of intrusive feelings. CONCLUSIONS: Accessible health care services are crucial in preventing and reducing the impact of sexually transmitted infections and STT may have the potential to increase testing uptake as it takes into account some of the barriers that exist. The pilot test and evaluation have resulted in a fully functioning implementation of STT in clinical practice.

Level of knowledge and intention to use oral fluid HIV self-testing and associated factors among Ethiopian health care workers in southern Ethiopia.

BACKGROUND: The World Health Organization has recommended a new method for HIV self-testing (HIVST) using oral fluid, intending to increase HIV testing rates, and linking individuals to medical care. Healthcare workers are chief health advocates in the community who need adequate knowledge and intention to use the newly recommended HIVST approach. However, studies on awareness and the intention to use oral fluid for HIV self-testing among Ethiopian healthcare workers are limited. Therefore, this study aimed to assess healthcare workers' knowledge of and intentions to use oral fluid for HIV self-testing in Hadiya Zone public hospitals in southern Ethiopia in 2022. METHODS: We conducted a facility-based cross-sectional study among a sample of 352 healthcare workers from 1 to 30 June 2022. The data were entered into Epidata version 4.2 and exported to SPSS version 23 for analysis. We used a logistic regression model with a 95% confidence interval for the interpretation of adjusted odds ratios (AORs) with P < 0.05. RESULTS: Of the total participants, 40.3% had good knowledge, and 63.1% intended to use oral fluid (HIVST). Approximately 92% of healthcare workers had not received training, and 48.3% had heard about HIVST. Only 12.3% knew about the availability of the kit in hospitals, and 19.9% had ever used HIVST. Being male (AOR = 2.28; 95% CI 1.33-3.95), receiving support for the implementation of HIVST (AOR = 2.07; 95% CI 1.21-3.56), hearing about HIVST (AOR = 5.05; 95% CI 2.89-8.81), having prior experience using HIVST (AOR = 2.94; 95% CI 1.71-5.05), having a spouse or partner (AOR = 2.78; 95% CI 1.14-6.82), and having multiple sexual partners (AOR = 2.76; 95% CI 1.13-6.78) were associated with good knowledge of oral HIVST. Being aged 25-29 years (AOR = 2.54; 95% CI 1.18, 5.41), perceiving the high cost of the HIVST kit (AOR = 0.37; 95% CI 0.16-0.84), and having poor knowledge (AOR = 1.91; 95% CI 1.13-3.23) were significantly associated with the intention to use the oral fluid for HIVST. CONCLUSION: This study highlights the need for technical updating training for healthcare workers to increase their knowledge of and intention to use oral fluid for HIVST. Promoting oral fluid HIVST through targeted education, supporting initiatives, and addressing cost concerns related to the testing kit may increase the uptake of oral fluid HIVST among healthcare workers.

Double testing with lateral flow antigen test devices for COVID-19: does a second test in quick succession add value?

BACKGROUND/OBJECTIVES: We investigated if performing two lateral flow device (LFD) tests, LFD2 immediately after LFD1, could improve diagnostic sensitivity or specificity for detecting severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) antigen. STUDY DESIGN: Individuals aged ≥16 years attending UK community testing sites (February-May 2021) performed two successive LFD tests and provided a nose-and-throat sample for a polymerase chain reaction (PCR) test. Using the PCR result as the reference diagnosis, we assessed whether improvements could be achieved in sensitivity (by counting a positive result in either LFD as a positive overall test result) or specificity (by using LFD2 as confirmatory test). RESULTS: Overall, 2231 participants were included with 159 (7 %) having a positive PCR test. Of 2223 participants who completed both LFD tests, LFD results were highly concordant both with each other and with PCR tests (>97 %). The proportion of discord LFD results decreased significantly over the study period. Combined LFD usage achieved a sensitivity of 68.6 %, versus 67.1 % for either LFD individually. The specificity increased from 99.5 % to 99.8 % when using LFD2 as confirmatory test. Observed increases in sensitivity and specificity were not statistically significant. Void results were recorded for 31 (1.4 %) LFD1s, 19 (0.9 %) LFD2s and 6 (0.3 %) combined LFD tests. CONCLUSIONS: LFD tests were highly reproducible even when they were performed by untrained users following only written instructions and without supervision. While performing two LFD tests of the same type in quick succession marginally increased sensitivity or specificity, statistically significant improvements were not detected in our study.

A qualitative assessment of the acceptability of human papillomavirus self-sampling and informational materials among diverse populations.

BACKGROUND: Disparities in cervical cancer screening rates among marginalized groups is a driver of inequalities in cervical cancer. Self-sampling for human papillomavirus (HPV) testing is a newly emerging alternative to clinician-performed testing to screen for cervical cancer, and has high potential to reduce screening barriers in under-screened and marginalized groups. We study the acceptability in of HPV self-sampling and informational materials among Black/African American, Hispanic/Spanish speaking, American Indian/Alaska Native and transgender/nonbinary populations. METHODS: We conducted qualitative interviews with patients, ages 30-65, who were Black/African American, Hispanic, American Indian, and/or transgender/nonbinary individuals assigned female at birth. Telephone interviews were conducted in English or Spanish. Patients did not complete the test, rather were asked about the attractiveness, comprehensibility, and acceptability of the HPV self-test, instructions, and messaging. RESULTS: Among 23 completed interviews (5 American Indian/Alaska Native, 7 Hispanic [2 bilingual, 5 Spanish-speaking], 5 Black/African American, and 6 transgender/nonbinary), patients from all groups thought the test was straightforward and convenient, and they would complete the test at home or in clinic. The transgender/nonbinary patients preferred at-home testing. American Indian and transgender/nonbinary patients liked that the test might avoid pain, discomfort, and invasiveness. All patients liked the letter and instructions. All groups had specific suggestions for making the materials more culturally acceptable. CONCLUSIONS: The HPV self-test and the instructions and materials for use were acceptable for a diverse group of patients. Tailored outreach and messaging should be considered to reduce screening disparities among groups that have been historically underserved by the medical system.

HIV self-testing knowledge, attitudes, and practices among Asian-born gay, bisexual, and other men who have sex with men in Australia: a qualitative study.

Background: Achieving virtual elimination of HIV transmission in Australia requires a combination of high treatment rates and high testing coverage among individuals at risk of acquiring HIV. HIV self-testing (HIVST) is an additional testing approach for key populations. Objective: We aimed to examine the knowledge, attitudes, and practices of HIVST among Asian-born gay, bisexual and other men who have sex with men (GBMSM). Methods: This qualitative study used semi-structured interviews of overseas-born GBMSM of Asian background in Australia. Participants were recruited from personal networks, social media platforms, snowballing, and the Melbourne Sexual Health Centre. Twenty-five participants were purposively sampled with a range of ages and previous levels of experience with HIVST. Interview transcripts were imported into Nvivo 12 for data management. Results: The age of the participants ranged from 19 to 44 years, with a median of 30 years. Most were unaware of HIVST before the interview, and only a few had ever used one. All had limited sexual health knowledge (i.e., HIV testing, PrEP) before they arrived in Australia. Upon learning about HIVST during the interview, many expressed willingness to use HIVST, but in limited circumstances, such as traveling overseas, interim testing while taking on-demand PrEP, and point-of-sex testing. Almost all were open to distributing HIVST to their casual partners or friends, especially those they knew who engaged in high-risk sexual practice (i.e., condomless anal sex) and were not engaged in sexual healthcare. About half still preferred conventional serology testing because of regular HIV testing as part of PrEP prescription and the need for testing for other sexually transmitted infections. Conclusion: HIVST may be an acceptable additional testing approach for HIV testing among Asian-born GBMSM. Peer education and secondary distribution may help raise HIVST awareness and use.

Community-Identified Implementation Strategies for Promoting the Adoption of HIV Self-Testing in a Southern California American Indian community: A Rapid Qualitative Analysis.

HIV incidence increased by 18% between 2015 and 2019 among American Indians (AIs) despite declining rates in other racial/ethnic groups. Culturally-appropriate implementation of prevention programs is needed to address the intersectional conditions contributing to HIV vulnerabilities experienced by AIs. The objectives of this study were to understand factors influencing HIV testing decisions and identify implementation strategies to promote the acceptability of HIV self-testing (HIVST) in a southern California AI community. A total of 15 semi-structured interviews were completed with adult community members of a southern California AI reservation. Analysis used a rapid analytic approach that was guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and expert recommendations for implementing change (ERIC) compilation. Two team members applied a standardized summary template to elucidate implementation determinants and implementation strategies for adopting HIVST. Barriers to HIV testing identified by community members included HIV-related stigma and privacy concerns within their community. Community members expressed positive perceptions of the acceptability of HIVST, with many identifying ease of use and privacy as appealing attributes. Several implementation strategies were suggested for facilitating the adoption of HIVST, including increasing access to tests by mailing kits to community members and increasing demand for kits through media campaigns (e.g., local flyers, social media posts, and booths at tribal events). Community members also recommended discreet packaging of kits and cultural adaptation of accompanying materials (e.g., educational videos featuring community members). The qualitative input from AI community members facilitated identification of implementation strategies that may promote the acceptability and culturally-appropriateness of HIVST.

RESUMEN: Entre 2015 y 2019, la incidencia del VIH entre los indígenas norteamericanos (INs) aumentó un 18%, a pesar de que en otros grupos étnicos y raciales se observaron reducciones. La implementación culturalmente apropiada de programas preventivos es fundamental para abordar las circunstancias interseccionales que contribuyen a la vulnerabilidad al VIH entre INs. Los objetivos de este estudio fueron comprender los factores que influyen en la decisión de hacerse la prueba del VIH e identificar estrategias para fomentar la aceptabilidad de las auto pruebas, en una comunidad de INs en el Sur de California. Se realizaron 15 entrevistas semiestructuradas con los miembros adultos de una reserva situada en el Sur de California. El análisis se realizó utilizando un método cualitativo rápido, basado en el marco Exploration, Preparation, Implementation and Sustainment (EPIS) (español: Exploración, Preparación, Implementación y Sostenimiento) así como una recopilación de sugerencias de expertas en implementación de intervenciones, conocida como ERIC. Dos miembros del equipo de investigación utilizaron una plantilla estandarizada resumida para investigar factores determinantes y estrategias para la adopción de las auto pruebas del VIH. Los miembros de la reserva de INs identificaron el estigma asociado al VIH, así como preocupación por la privacidad entre la comunidad, como barreras para realizarse las pruebas del VIH. Los miembros reaccionaron positivamente a la aceptabilidad de las auto pruebas del VIH, destacándola facilidad del uso y la privacidad asociadas con estas pruebas. También, se sugirieron varias estrategias para facilitar la adopción de las auto pruebas, incluyendo el envío de pruebas a miembros de la comunidad y el aumento de la demanda de pruebas a través de difusión (e.g., folletos, publicaciones en las redes sociales, y puestos en eventos tribales). Los miembros también recomendaron que los empaques de las auto pruebas sean discretos, y que contengan materiales educativos culturalmente apropiados. Las contribuciones cualitativas de la comunidad INs ayudaron identificar estrategias de implementación que pueden fomentar la aceptabilidad de las auto pruebas del VIH en una manera culturalmente apropiada.

HIV screening of migrants in the autonomous Province of Trento (North-Eastern Italy).

Abstract: Migrants have accounted for more than 40% of new HIV diagnoses in Europe in 2022. Among the population of asylum seekers currently present in the Trento Province, screening for HIV infection is poorly carried out for various reasons. Here we report our experience about screening for HIV infection in asylum seekers present in that area using rapid self HIV-testing.

Experience of social harms among female sex workers following HIV self-test distribution in Malawi: results of a cohort study.

BACKGROUND: In Malawi, female sex workers (FSW) have high HIV incidence and regular testing is suggested. HIV self-testing (HIVST) is a safe and acceptable alternative to standard testing services. This study assessed; whether social harms were more likely to be reported after HIVST distribution to FSW by peer distributors than after facility-based HIV testing and whether FSW regretted HIVST use or experienced associated relationship problems. METHODS: Peer HIVST distributors, who were FSW, were recruited in Blantyre district, Malawi between February and July 2017. Among HIVST recipients a prospective cohort was recruited. Interviews were conducted at baseline and at end-line, 3 months later. Participants completed daily sexual activity diaries. End-line data were analysed using logistic regression to assess whether regret or relationship problems were associated with HIVST use. Sexual activity data were analysed using Generalised Estimating Equations to assess whether HIVST use was temporally associated with an increase in social harms. RESULTS: Of 265 FSW recruited and offered HIVST, 131 completed both interviews. Of these, 31/131(23.7%) reported initial regret after HIVST use, this reduced to 23/131(17.6%) at the 3-month follow-up. Relationship problems were reported by 12/131(9.2%). Regret about HIVST use was less commonly reported in those aged 26-35 years compared to those aged 16-25 years (OR immediate regret-0.40 95% CI 0.16-1.01) (OR current regret-0.22 95% CI 0.07 - 0.71) and was not associated with the HIVST result. There was limited evidence that reports of verbal abuse perpetrated by clients in the week following HIVST use were greater than when there was no testing in the preceding week. There was no evidence for increases in any other social harms. There was some evidence of coercion to test, most commonly initiated by the peer distributor. CONCLUSIONS: Little evidence was found that the peer distribution model was associated with increased levels of social harms, however programmes aimed at reaching FSW need to carefully consider possible unintended consequences of their service delivery approaches, including the potential for peer distributors to coerce individuals to test or disclose their test results and alternative distribution models may need to be considered.

Comparative Diagnostic Utility of SARS-CoV-2 Rapid Antigen and Molecular Testing in a Community Setting.

BACKGROUND: SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood. METHODS: This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct). RESULTS: From February to December 2022, 5757 participants reported 17 572 Ag-RDT results and completed 12 674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR positive. Overall sensitivity and specificity were 53.0% (95% confidence interval [CI], 49.6%-56.4%) and 98.8% (95% CI, 98.5%-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4-7 days after symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result. CONCLUSIONS: Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high risk for SARS-CoV-2 infection.