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.

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.

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.

HIV screening of migrants in the autonomous Province of Trento (north of 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.

Distribution of HIV Self-tests by Men Who have Sex with Men (MSM) to Social Network Associates.

Internet-recruited gay, bisexual, and other men who have sex with men (MSM) were offered HIV self-tests (HIVSTs) after completing baseline, 3-, 6-, and 9-month follow-up surveys. The surveys asked about the use and distribution of these HIVSTs. Among 995 who reported on their distribution of HIVSTs, 667 (67.0%) distributed HIVSTs to their social network associates (SNAs), which resulted in 34 newly identified HIV infections among 2301 SNAs (1.5%). The main reasons participants reported not distributing HIVSTs included: wanting to use the HIVSTs themselves (74.9%); thinking that their SNAs would get angry or upset if offered HIVSTs (12.5%); or not knowing that they could give the HIVSTs away (11.3%). Self-testing programs can provide multiple HIVSTs and encourage the distribution of HIVST by MSM to their SNAs to increase awareness of HIV status among persons disproportionately affected by HIV.

RESUMEN: Hombres gais, bisexuales y otros hombres que indicaron tener contacto sexual con hombres (MSM, por sus siglas en inglés) fueron reclutados por el Internet y se les ofreció autopruebas del VIH (HIVST, por sus siglas en inglés) después de completar una encuestas inicial y encuestas de seguimiento a los 3, 6 y 9 meses. Las encuestas recogieron datos sobre el uso y distribución de estas autopruebas del VIH. De los 995 MSM que indicaron distribuir las autopruebas, 667 (67.0%) distribuyeron las autopruebas a personas en sus redes sociales (SNA, por sus siglas en inglés), resultando en 34 nuevas infecciones por el VIH identificadas entre 2,301 SNA (1.5%). Las razones principales por las que algunos participantes no distribuyeron las autopruebas del VIH incluyen: el deseo de utilizar las autopruebas del VIH para sí mismos (74.9%); pensar que las SNA se enfadarían o molestarían si se les ofreciesen autopruebas del VIH (12.5%); o no saber que podían distribuir las autopruebas del VIH (11.3%). Los programas que proporcionen múltiples autopruebas del VIH podrían alentar la distribución de las autopruebas por parte de los MSM a las SNA para aumentar el conocimento sobre el estado del VIH entre personas afectadas de manera desproporcionada por el VIH.

Awareness of and willingness to use oral HIV self-test kits among Kenyan young adults living in informal urban settlements: a cross-sectional survey.

Self-administered HIV testing may be a promising strategy to improve testing in hard-to-reach young adults, provided they are aware of and willing to use oral HIV self-testing (HIVST). This study examined awareness of and willingness to use oral HIVST among 350 high-risk young adults, aged 18-22, living in Kenya's informal urban settlements. Bivariate and multivariate logistic regressions were used to examine differences in HIVST awareness and willingness by demographic and sexual risk factors. Findings showed that most participants were male (56%) and less than 20 years old (60%). Awareness of oral HIVST was low (19%). However, most participants (75%) were willing to use an oral HIV self-test in the future and ask their sex partner(s) to self-test before having sex (77%). Women (OR = 1.80, 95%CI:1.11, 2.92), older participants (aged 20+) (OR = 2.57, 95% CI:1.48, 4.46), and more educated participants (OR = 2.25, 95%CI:1.36, 3.70) were more willing to use HIVST as compared to men, teen-aged, and less educated participants, respectively. Young adults who reported recent engagement in high-risk sexual behaviors, such as unprotected sex, sex while high or drunk, or sex exchange, were significantly less likely to be willing to use an oral HIV self-test kit (OR = 0.34, 95%CI:0.13,0.86). Those with the highest monthly income (OR = 0.47, 95%CI: 0.25, 0.89) were also less willing to use HIVST. More community- and peer-based efforts are needed to highlight the range of benefits of HIVST (i.e., social, clinical, and structural) to appeal to various youth demographics, in addition to addressing concerns relating to HIVST.

Optimizing Peer Distribution of Syphilis Self-Testing Among Men Who Have Sex with Men in China: A Multi-City Pragmatic Randomized Controlled Trial.

Syphilis testing uptake is low among men who have sex with men (MSM) around the world. Syphilis self-testing (SST) may complement facility-based testing; the distribution model is yet to be explored. This study aimed to investigate the effectiveness of peer distribution of syphilis self-testing on promoting syphilis testing. We conducted a three-arm, unblinded, parallel individually randomized controlled trial among MSM in three cities in Guangdong, China. Inclusion criteria were: men who were born biologically male, aged 18 or above, have ever had sex with a man, will refer the interventions to peers, and will take the three-month follow-up survey. Enrolled indexes were randomly assigned in a 1:1:1 ratio into standard-of-care arm (SOC arm), standard SST delivery arm (S-SST arm), and a web-based referral link SST delivery arm (RL-SST arm). The primary outcome was the number of returned photograph-verified syphilis testing results per index. A total number of 300 indexes were enrolled, with 100 indexes in each arm. The number of verified syphilis tests per index conducted by alters was 0.05 in the control arm, 0.51 in the S-SST arm, and 0.31 in the RL-SST arm. The cost per alter tested was $760.60 for SOC, $83.78 for S-SST, and $93.10 for RL-SST. Minimal adverse event was reported among both indexes and alters during the study. This study showed that peer distribution of SST could improve syphilis testing uptake among MSM in China compared to facility-based testing. This approach warrants further consideration as part of expanding syphilis self-testing.

Agreement between a mobile applet-based visual acuity self-test program and the conventional method for distance and near visual acuity tests.

BACKGROUND: To investigate the agreement between a mobile applet-based visual acuity (VA) self-test program and the conventional VA tests. METHODS: This consecutive case series study included 121 children and adults (242 eyes). Patients were classified into three groups according to age (children, adolescents, and adults). They underwent uncorrected distance visual acuity (UDVA) testing, distance visual acuity with available spectacle correction (DVA with ASC) testing at 2.5-m distance, uncorrected near visual acuity (UNVA) testing, and near visual acuity with available spectacle correction (NVA with ASC) testing at a 0.4-m distance using a mobile applet-based VA self-test program and conventional VA tests in two eyes. RESULTS: Correlations among UDVA, DVA with ASC, UNVA, and NVA with ASC between the two methods were significant in all subjects (all p < 0.001). The intraclass correlation coefficient were 0.960, 0.845, 0.960, and 0.669, respectively (all p < 0.001). The proportions of bias outside the 95% confidence interval limit of agreements were 6.20%, 4.82%, 7.08%, and 6.10%, respectively. There were significant differences in NVA with ASC between the two methods (p < 0.05) in the adolescent group, but no differences in measured parameters were found among children and adult groups. CONCLUSIONS: There is good agreement between the mobile applet-based VA self-test program and the conventional VA tests. The VA self-test has good practical value especially in the current pandemic, allowing self-screening of visual acuity, myopia control, and remote management of visual impairment in ocular morbidity.

Implementation Cascade of a Social Network-Based HIV Self-testing Approach for Men Who Have Sex With Men: Cross-sectional Study.

BACKGROUND: HIV testing is the cornerstone of strategies for achieving the fast-track target to end the AIDS epidemic by 2030. Self-testing has been proven to be an effective health intervention for men who have sex with men (MSM). While social network-based approaches for distributing HIV self-tests are recommended by the World Health Organization, their implementation consists of multiple steps that need to be properly evaluated. OBJECTIVE: This study aimed to assess the implementation cascade of a social network-based HIV self-test approach for reaching MSM who had never undergone testing in Hong Kong. METHODS: This is a cross-sectional study. Seed MSM participants were recruited through different web-based channels, who in turn invited their peers to participate in this study. A web-based platform was set up to support the recruitment and referral process. Participants could request for an oral fluid or a finger-prick HIV self-test, with or without real-time support, after completing a self-administered questionnaire. Referrals could be made upon uploading the test result and passing the web-based training. Characteristics of participants completing each of these steps and their preferences for the type of HIV self-test were evaluated. RESULTS: A total of 463 MSM were recruited, including 150 seeds. Participants recruited by seeds were less likely to have previously been tested for HIV (odds ratio [OR] 1.80, 95% CI 1.06-3.04, P=.03) and have lower confidence in performing self-tests (OR 0.66, 95% CI 0.45-0.99, P=.045). Almost all (434/442, 98%) MSM who completed the questionnaire requested a self-test, of whom 82% (354/434) had uploaded their test results. Participants requesting support were new to self-testing (OR 3.65, 95% CI 2.10-6.35, P<.001) and less confident in carrying out the self-test correctly (OR 0.35, 95% CI 0.22-0.56, P<.001). More than half (216/354, 61%) of the eligible participants initiated the referral process by attempting the web-based training with a passing rate of 93% (200/216). They were more likely to have sought sex partners (OR 2.20, 95% CI 1.14-4.25, P=.02), especially through location-based networking apps (OR 2.13, 95% CI 1.31-3.49, P=.002). They also gave higher usability scores along the implementation cascade (median 81 vs 75, P=.003). CONCLUSIONS: The social network approach was effective in diffusing HIV self-tests in the MSM community and reaching nontesters. Support and option to choose a preferable type of self-test are essential to address users' individual needs when delivering HIV self-tests. A positive user experience throughout the processes along the implementation cascade is vital to transform a tester into a promoter. TRIAL REGISTRATION: ClinicalTrials.gov NCT04379206; https://clinicaltrials.gov/ct2/show/NCT04379206.

Surveillance of SARS-CoV-2 infection based on self-administered swabs, Denmark, May to July 2022: evaluation of a pilot study.

BackgroundDuring the COVID-19 pandemic, the Danish National Institute for Infectious Disease, Statens Serum Institute (SSI) developed a home-based SARS-CoV-2 surveillance system.AimsWe wanted to determine whether a cohort of individuals performing self-administered swabs for PCR at home could support surveillance of SARS-CoV-2, including detection and assessment of new variants. We also aimed to evaluate the logistical setup.MethodsFrom May to July 2022, 10,000 blood donors were invited to participate, along with their household members. Participation required performing a self-swab for 4 consecutive weeks and answering symptom questionnaires via a web app. Swabs were sent by post to SSI for PCR analysis and whole genome sequencing. After study completion, participants were asked to complete a questionnaire concerning their experience.ResultsIn total, 2,186 individuals enrolled (47.4% blood donors), and 1,333 performed self-swabbing (53.0 blood donors), of whom 48 had at least one SARS-CoV-2-positive sample. Fourteen different Omicron subvariants, primarily BA.5 subvariants, were identified by whole genome sequencing (WGS). In total, 29 of the 63 SARS-CoV-2-positive samples were taken from individuals who were asymptomatic at the time of swabbing. Participants collected 2.9 swabs on average, with varying intervals between swabs. Transmission within households was observed in only three of 25 households.ConclusionParticipants successfully performed self-swabs and answered symptom questionnaires. Also, WGS analysis of samples was possible. The system can support surveillance of respiratory pathogens and also holds potential as a diagnostic tool, easing access to test for at-risk groups, while also reducing the burden on healthcare system resources.

SARS-CoV-2 self-test uptake and factors associated with self-testing during Omicron BA.1 and BA.2 waves in France, January to May 2022.

BackgroundFollowing the SARS-CoV-2 Omicron variant spread, the use of unsupervised antigenic rapid diagnostic tests (self-tests) increased.AimThis study aimed to measure self-test uptake and factors associated with self-testing.MethodsIn this cross-sectional study from 20 January to 2 May 2022, the case series from a case-control study on factors associated with SARS-CoV-2 infection were used to analyse self-testing habits in France. A multivariable quasi-Poisson regression was used to explore the variables associated with self-testing among symptomatic cases who were not contacts of another infected individual. The control series from the same study was used as a proxy for the self-test background rate in the non-infected population of France.ResultsDuring the study period, 179,165 cases who tested positive through supervised tests were recruited. Of these, 64.7% had performed a self-test in the 3 days preceding this supervised test, of which 79,038 (68.2%) were positive. The most frequently reported reason for self-testing was the presence of symptoms (64.6%). Among symptomatic cases who were not aware of being contacts of another case, self-testing was positively associated with being female, higher education, household size, being a teacher and negatively associated with older age, not French by birth, healthcare-related work and immunosuppression. Among the control series, 12% self-tested during the 8 days preceding questionnaire filling, with temporal heterogeneity.ConclusionThe analysis showed high self-test uptake in France with some inequalities which must be addressed through education and facilitated access (cost and availability) for making it a more efficient epidemic control tool.

Self-assessment of olfactory function using the "Sniffin' Sticks".

BACKGROUND: A precise and reliable test of the olfactory function is indispensable for the diagnosis of the olfactory disorder (OD). Despite of this, in a clinical context, often there is no place in daily routine for time-consuming procedures. This study aimed to examine if the assessment of olfactory function using the "Sniffin' Sticks" is suitable for self-assessment. METHODS: Participants comprised 84 healthy control subjects (HC) and 37 OD patients. The "Sniffin' Sticks" test battery consisting of odor threshold (T), discrimination (D) and identification (I) tests was used for self- and assisted assessments. To save time, we applied the 8-item wide step version of the T test and the 8-item D test, whereas the I task remained the same as the original version. The whole test included two sessions, with each session comprising a self-assessment part performed by the participants themselves, and an assisted-assessment part performed by the examiner. RESULTS: Sniffin' Sticks self-assessment was efficient in distinguishing between self-reported HC subjects and OD patients (p's < 0.01), and the scores did not differ significantly from the assisted-assessment (p's > 0.05). In the self-administered I and TDI tests, there was a moderate to excellent test-retest reliability (ICC = 0.51-0.93, p's < 0.01), and a strong to excellent correlation with the assisted assessment (r = 0.71-0.92, p's < 0.01). However, the self-administered T and D tests only exhibited low to moderate test-retest reliability (ICC = 0.30-0.72, p's < 0.05) and correlations with the assisted test (r = 0.31-0.62, p's < 0.05). CONCLUSIONS: The Identification self-test is appropriate to be solely applied, and is therefore an easy-to-use alternative for olfactory screening in a larger segment of patients. The whole "Sniffin' Sticks" self-test also shows good measurement properties and is therefore a suitable backup in clinical practice, but improvement is needed due to the simplified D and T self-test.

[Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation].

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Evaluation of a new "all in one" SARS-CoV-2 antigen-detecting rapid diagnostic test and self-test: Diagnostic performance and usability in child and adult populations.

The control of the COVID-19 epidemics has been one global health priorities for the last 2 years. To that end, more reliable and easy-to-use, regardless of age, diagnostic tests are necessary. Considering that, we evaluated an innovative two-step self-test, the AAZ COVID-VIRO ALL IN®, switching from the classic nasal swab to a nasal sponge. We performed a multicenter study, on 124 adults and children, in a point-of-care setting. Sensitivity, specificity and overall acceptance of the COVID-VIRO ALL IN® self-test compared to reverse transcriptase polymerase chain reaction (RT-PCR) on nasopharyngeal samples were of 93.0%, 100%, and 97.5%, respectively. We then performed a multicenter, usability study to evaluate the ease of use of COVID-VIRO ALL IN® on 68 laypersons adults. A vast majority of participants correctly executed and interpreted the test. The usability was then specifically investigated on 40 children and teenagers, comparing COVID-VIRO® first generation to the new COVID-VIRO ALL IN®. They all found COVID-VIRO ALL IN® more comfortable and easier to use. For young children, the new self-test seems safer (less risk of trauma and no liquid exposure), and faster than saliva-based RT-PCR. Moreover, the COVID-VIRO ALL IN® can easily be adapted as a multiplex self-test for other respiratory viruses, opening new perspectives of simultaneous, rapid and massive detection of respiratory infections, especially among vulnerable populations like children and elderly people.

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention.

BACKGROUND: Asian American women face disproportionate burden of cervical cancer (CC) than non-Hispanic white women in the U.S. The goal of this study was to assess the feasibility and impact of a culturally tailored intervention to promote Human papillomavirus (HPV) self-sampling test among hard-to-reach Asian American women. METHODS: We adopted the community-based participatory research (CBPR) approach to conduct this efficacy study. A total of 156 female participants (56 Chinese, 50 Korean, and 50 Vietnamese) were recruited from community-based organizations (CBOs) in the greater Philadelphia metropolitan area. The intervention components included HPV-related education, HPV self-sampling test kit and instructions, group discussions, and patient navigations, all available in Asian languages. We examined several outcomes, including the completion of HPV self-sampling, HPV-related knowledge, perceived social support, self-efficacy, and comfort with the self-sampling test at post-intervention assessment. RESULTS: The majority of Asian American women had low annual household income (62.3% earned less than $20,000) and low educational attainment (61.3% without a college degree). We found significant increase in participants' knowledge on HPV (baseline: 2.83, post: 4.89, P <.001), social support (baseline: 3.91, post: 4.09, P < .001), self-efficacy (baseline: 3.05, post: 3.59, P < .001), and comfortable with HPV self-sample test (baseline: 3.62, post: 4.06, P < .001). CONCLUSION: To the best of our knowledge, this is the first intervention study that promoted HPV self-sampling test among Asian American women. Our findings showed that CBPR culturally tailored intervention of self-sampling was highly effective in empowering low-income Asian American women to conduct HPV self-sampling tests.

Pressure to Use HIV Self-Tests Among Men Who Have Sex With Men, United States, 2015-2016.

To assess whether pressuring others to use HIV self-tests is prevalent among US men who have sex with men (MSM), we analyzed data from a randomized controlled trial of HIV self-testing. Among 752 online-recruited MSM who received HIV self-tests and responded to a 12-month survey, 8.5% (60/709) reported pressuring someone to use an HIV self-test: 29 pressured a friend, 28 pressured a sexual partner, and 1 pressured a family member. Conversely, 2.1% (15/715) reported being pressured to self-test: 12 by a sexual partner and 3 by a friend. No physical harm was reported. HIV prevention programs that use HIV self-tests to reach populations at risk for HIV may be reassured by our findings because, despite reports of pressure to use HIV self-tests, no physical abuse was reported between sex partners. These programs should, however, include messages emphasizing the voluntary use of HIV self-tests and be prepared to address concerns of persons who have been pressured to use HIV self-tests. This trial is registered at www.clinicaltrials.gov (NCT02067039) and the date of registration is February 5, 2014.

RESUMEN: Analizamos los datos de un ensayo controlado aleatorio (ECA) de 12 meses para evaluar si presionar a alguien a que utilice la autoprueba del VIH es una ocurrencia frecuente entre hombres estadounidenses que tienen sexo con hombres (HSH) reclutados via el internet. Entre 752 HSH que recibieron por correo autopruebas del VIH y que respondieron a una encuesta a los 12 meses del ECA, el 8.5% (60/709) informó haber presionado a alguien a que usara una autoprueba del VIH: 29 presionaron a un amigo, 28 presionaron a una pareja sexual y uno presionó a un miembro de su familia. Por el contrario, el 2.1% (15/715) informó haber sido presionado a usar la autoprueba: 12 por una pareja sexual y 3 por un amigo. Ningun participante reporto daños físicos. Los programas de prevención del VIH que utilizan autopruebas del VIH para alcanzar a poblaciones a riesgo de contraer el VIH, pueden sentirse tranquilizados por nuestros hallazgos porque, a pesar de los reportes de presión para usar las autopruebas del VIH, no se reporto abuso físico entre parejas sexuales. Sin embargo, los programas deben incluir mensajes que enfaticen el uso voluntario de las autopruebas del VIH y estar preparados para calmar las preocupaciones de las personas que han sido presionadas a usar las autopruebas del VIH. El ensayo está registrado en www.clinicaltrials.gov (NCT02067039) y la fecha de registro es el 5 de febrero de 2014.

Autonomy and Care in Context: The Paradox of Sex Workers' Acceptability of HIV Self-Tests in São Paulo, Brazil.

Cisgender female sex workers (CFSW) continue to face structural barriers to HIV prevention. We analyzed the acceptability of the oral HIV self-test (HIV-ST) among CFSW as part of a pragmatic trial on HIV prevention in Brazil. Data from in-depth interviews conducted with 12 women from diverse sex worker contexts and participant observation were analyzed using thematic analysis. CFSW valued autonomy in their workplaces and saw the HIV-ST as a possibility for self-care. Some feared clients' reactions, manager reprimands, and a positive result. HIV and sex work stigma largely drove self-care practices and perceived acceptability of the self-test. We argue that the autonomy offered by the self-test presents a paradox: increasing autonomy on the one hand while risking sidestepping structural dimensions of HIV vulnerability on the other. These nuances must be considered in interventions promoting the HIV-ST by considering the specificities of sex worker contexts, addressing stigma, and effectively involving CFSW and their organizations in intervention development.

HIV oral self-screening test among HIV/STD/TB clinic attendees: A mixed-method pilot investigation examining merit for larger evaluation.

Background & objectives: Globally, several countries consider HIV self-test as an important element in the toolbox to end AIDS by 2030. Against this background, the present investigation was conducted to pilot test the performance of an indigenous HIV oral self-test (HIVOST) and explore its acceptability. The overall purpose was to examine if this kit could serve as a promising tool and merit future larger clinical evaluation. Methods: A concurrent mixed-method investigation was undertaken during March-October 2019. One hundred and thirty two consecutive HIV/sexually transmitted diseases/tuberculosis clinic attendees were invited for participation; of whom, 100 were enrolled, and among them, 40 provided consent for qualitative in-depth interviews. The HIVOST kit assessed for its performance served as the 'index test', which worked on the principle of lateral flow chromatography. The results of the HIVOST were interpreted independently by the study physicians and participants at 20 min. HIVOST kit performance was assessed against the HIV confirmatory blood test result based on the national algorithm (3 rapid test or 1 ELISA and 2 rapid test) serving as the 'reference'. Sensitivity, specificity, positive predictive value, negative predictive value and inter-rater agreement were estimated. The voices and concerns of the study participants were coded followed by identification of qualitative themes and ideas. Results: The sensitivity and specificity of the index test at the end of 20 min as interpreted by the participants were 83.3 per cent [95% confidence interval (CI): 69.8 to 92.5] and 98 per cent (95% CI: 89.4 to 99.5), respectively. Study physicians and participants independently interpreted HIVOST results with substantial inter-rater agreement (kappa value 0.88; 95% CI: 0.78-0.97). All HIVOST test strips were valid. Majority of the participants preferred saliva over blood for HIV self-test. 'Comfort', 'confidentiality' and 'convenience' were the perceived advantages of HIVOST. Some of the participants wished the package inserts contained 'how-to-do instructions in local languages', 'expiry date (if any)' and 'contact helpline number'. A few of them highlighted the need for a confirmatory HIV result following oral self-test. Concerns of the participants revolved around potential self-harm following HIVOST-positive result and safe disposal of kits. Interpretation & conclusions: Two major highlights of the present investigation are (i) high level of concordance in HIVOST results interpreted by participants and physicians, and (ii) encouraging level of acceptance of HIVOST. These findings and encouraging HIVOST performance statistics lend support towards large-scale clinical evaluation of this index test.

Human papillomavirus self-testing among unscreened and under-screened Maori, Pasifika and Asian women in Aotearoa New Zealand: A preference survey among responders and interviews with clinical-trial nonresponders.

INTRODUCTION: Maori, Pasifika and Asian women are less likely to attend cervical screening and Maori 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. METHODS: Maori, 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. RESULTS: 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. CONCLUSION: HPV self-testing was acceptable for Maori, 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. PATIENT OR PUBLIC CONTRIBUTION: This study explored the acceptability of HPV self-testing and their preferences for engaging with it among Maori, Pasifika and Asian women. Thus, women from these underserved communities were the participants and focus of this study.

Benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer's perspective.

BACKGROUND: The aim of this study is to quantify the health benefits, risks, and cost-effectiveness of COVID-19 self-tests from a consumer's perspective in Germany. METHODS: The analysis is based on a modelling approach using secondary data. The clinical endpoints considered in this analysis are avoided SARS-CoV-2 infections and secondary severe clinical events (death, intensive care unit (ICU) admission, and long COVID syndrome). The study determines the number of self-tests that need to be conducted under a 7-day incidence of 75 per 100,000 population to prevent one infection or severe clinical event. Furthermore, the study calculates the cost of testing per avoided clinical event and quality-adjusted life year (QALY) gained from a consumer perspective. RESULTS: Disregarding the rate of unreported COVID-19 cases, 4556 self-tests need to be conducted (over 12 years) in order to avoid one undesirable event (death, intensive care unit stay, or long COVID syndrome). Ninety percent of infections are not avoided among direct contacts but along the chain of infection. The costs per quality-adjusted life year gained from a consumer's perspective are €5870. This ratio is particularly sensitive to the 7-day incidence, effective reproduction number, and the age of contacts. CONCLUSIONS: The benefits of self-testing in the general population at a 7-day incidence rate of 75 per 100,000 appear to be minor. Nevertheless, cost-effectiveness may still be acceptable in the presence of higher-risk contacts given the low costs of self-test kits in Germany.