Evaluation of a novel university-based testing platform to increase access to SARS-CoV-2 testing during the COVID-19 pandemic in a cohort study.

OBJECTIVE: We aimed to evaluate the feasibility and utility of an unsupervised testing mechanism, in which participants pick up a swab kit, self-test (unsupervised) and return the kit to an on-campus drop box, as compared with supervised self-testing at staffed locations. DESIGN: University SARS-CoV-2 testing cohort. SETTING: Husky Coronavirus Testing provided voluntary SARS-CoV-2 testing at a university in Seattle, USA. OUTCOME MEASURES: We computed descriptive statistics to describe the characteristics of the study sample. Adjusted logistic regression implemented via generalised estimating equations was used to estimate the odds of a self-swab being conducted through unsupervised versus supervised testing mechanisms by participant characteristics, including year of study enrolment, pre-Omicron versus post-Omicron time period, age, sex, race, ethnicity, affiliation and symptom status. RESULTS: From September 2021 to July 2022, we received 92 499 supervised and 26 800 unsupervised self-swabs. Among swabs received by the laboratory, the overall error rate for supervised versus unsupervised swabs was 0.3% vs 4%, although this declined to 2% for unsupervised swabs by the spring of the academic year. Results were returned for 92 407 supervised (5% positive) and 25 836 unsupervised (4%) swabs from 26 359 participants. The majority were students (79%), 61% were female and most identified as white (49%) or Asian (34%). The use of unsupervised testing increased during the Omicron wave when testing demand was high and stayed constant in spring 2022 even when testing demand fell. We estimated the odds of using unsupervised versus supervised testing to be significantly greater among those <25 years of age (p<0.001), for Hispanic versus non-Hispanic individuals (OR 1.2, 95% CI 1.0 to 1.3, p=0.01) and lower among individuals symptomatic versus asymptomatic or presymptomatic (0.9, 95% CI 0.8 to 0.9, p<0.001). CONCLUSIONS: Unsupervised swab collection permitted increased testing when demand was high, allowed for access to a broader proportion of the university community and was not associated with a substantial increase in testing errors.

Distribution of COVID-19 Home Testing Through Community Health Centers: Results of the COVID CoNOce MÁS Study.

OBJECTIVE: To assess acceptability and feasibility of rapid at-home COVID-19 testing and reporting of test results among individuals seeking care at community health centers (CHCs) and their household members. METHODS: Participants were recruited from 2 Community Health Centers during a clinic visit or a community event. Over-the-counter COVID-19 tests were distributed to participants for self-testing and to offer testing to household members. Separate surveys were administered to collect baseline information on the study participant and to collect test results on the study participant and household members. We calculated the proportion of individuals who agreed to complete COVID home testing, those who reported test results, and the test positivity. For household members, we calculated the proportion who completed and reported results and the positivity rate. We assessed reasons for undergoing COVID-19 testing and the action taken by participants who reported positive tests. RESULTS: A total of 2189 individuals were approached by CHC staff for participation and 1013 (46.3%) agreed to participate. Among the 959 participants with complete sociodemographic data, 88% were Hispanic and 82.6% were female. The proportion providing test results was 36.2% and the test positivity was 4.2%. Among the 1927 test reports, 35.3% for the index participant and 64.4% were for household members. The largest proportion of test results were for index participants (35.3%) and the second largest was for the participant's children (32.1%), followed by parents (16.9%), and spouse/partner (13.2%). The 2 most common reasons for testing were symptoms (29%) and attending family gatherings (26%). Among test-positive individuals (n = 80), most (83.3%) noted that they isolated but only 16.3% called their provider and 1.3% visited a clinic. CONCLUSION: Our results show interest in at-home COVID-19 testing of multiple household members, as we headed into the endemic phase of the pandemic. However, reporting of test results was modest and among test-positive individuals, reporting results to a provider was very low. These results underscore the challenges with reporting and following guidelines among people undergoing home testing for COVID-19, which may have implications for future pandemics.

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia.

INTRODUCTION: Multiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV)) and non-sexually transmitted pathogens (Schistosoma haematobium (Sh)). Chronic coinfections may lead to disability (female genital schistosomiasis) and death (cervical cancer). The Zipime-Weka-Schista (Do self-testing sister!) study aims to evaluate the validity, acceptability, uptake, impact and cost-effectiveness of multipathogen self-sampling for genital infections among women in Zambia. METHODS AND ANALYSIS: This is a longitudinal cohort study aiming to enrol 2500 non-pregnant, sexually active and non-menstruating women aged 15-50 years from two districts in Zambia with 2-year follow-up. During home visits, community health workers offer HIV and Tv self-testing and cervicovaginal self-swabs for (1) HPV by GeneXpert and, (2) Sh DNA detection by conventional (PCR)and isothermal (recombinase polymerase assay) molecular methods. Schistosoma ova and circulating anodic antigen are detected in urine. At a clinic follow-up, midwives perform the same procedures and obtain hand-held colposcopic images. High-risk HPV positive women are referred for a two-quadrant cervical biopsy according to age and HIV status. A cost-effectiveness analysis is conducted in parallel. ETHICS AND DISSEMINATION: The University of Zambia Biomedical Research Ethics Committee (UNZABREC) (reference: 1858-2021), the London School of Hygiene and Tropical Medicine (reference: 25258), Ministry of Health and local superintendents approved the study in September 2021.Written informed consent was obtained from all participants prior to enrolment. Identifiable data collected are stored securely and their confidentiality is protected in accordance with the Data Protection Act 1998.

HIV self-testing in India: implementation and qualitative evaluation of a web-based programme with virtual counsellor support.

INTRODUCTION: To achieve epidemic control of infectious diseases, engaging higher-burden populations with accessible diagnostic services is critical. HIV self-testing (HIVST) is a promising option. METHODS: We implemented an online HIVST programme for key populations across India. Eligible clients were 18 years or older, self-reported a negative or unknown HIV status and reported not taking antiretroviral therapy. Clients who reported a prior HIV diagnosis were not eligible to receive an HIVST kit. HIVST clients received kits via courier or in person at pre-determined pick-up points supported by trained counselling staff. Virtual counsellors engaged clients online and by phone and offered support to register, access, and complete HIVST free of cost. Virtual counsellors supported clients to report results and engage with follow-up services. Follow-up included linking clients with a positive result to confirmatory testing and HIV care services. We assessed programmatic data across HIV continuum outcomes and conducted a qualitative evaluation through interviews with purposively sampled clients. RESULTS: Between 30 June 2021 and 30 September 2022, 5324 clients ordered an HIVST kit (76% men, 13% women, 7% transgender people, 4% unknown gender). Of the 4282 clients reporting results (94% of those who received a kit), 6% screened positive, among whom 72% (n = 184) completed confirmatory testing. Themes from 41 client interviews included satisfaction about the convenience and privacy of services and the discreet nature of kit delivery. Respondents were drawn to the convenience of HIVST and appreciated gaining courage and comfort throughout the process from virtual counsellor support. For respondents who screened positive, challenges to care linkage included fearing judgemental questions from public providers and wanting more time before starting treatment. Clients shared concerns about kit accuracy and suggested that instructional materials be provided with more diverse language options. CONCLUSIONS: Web-based HIVST services with tailored support appeared to facilitate HIV service access and engagement of harder-to-reach populations across India. Assistance from a community-oriented counsellor proved important to overcome literacy barriers and mistrust  in order to support the HIVST process and service linkage. Learnings can inform global efforts to improve the critical step of diagnosis in achieving epidemic control for HIV and other infectious diseases.

Qualitative evaluation of digital vending machines to improve access to STI and HIV testing in South West England: using a Person-Based Approach.

OBJECTIVES: To report the development, implementation, acceptability and feasibility of vending machines offering HIV and sexually transmitted infection (STI) testing kits. DESIGN: A qualitative study using the Person-Based Approach with patient and public involvement workshops and stakeholder involvement and interviews with machine users, sexual health service (SHS) staff, venue staff and local authority sexual health commissioners. Transcripts were analysed thematically. SETTING: Bristol, North Somerset and South Gloucestershire (BNSSG). PARTICIPANTS: 15 machine users, 5 SHS staff, 3 venue staff and 3 local authority commissioners. INTERVENTION: Four vending machines dispensing free HIV self-testing and STI self-sampling kits in publicly accessible venues across BNSSG were introduced to increase access to testing for groups at higher risk of HIV and STI infection who are less likely to access SHS clinic testing services (young people, people from black communities, and gay, bisexual and other men who have sex with men). RESULTS: Machine users reported the service was convenient, easy to use and accessible; however, concerns regarding privacy related to machine placement within the venues and issues of maintenance were raised. Promotional material was inclusive and informative; however, awareness of the service through the promotional campaign was limited. Vending machines were acceptable to venue staff once clear processes for their management were agreed with the SHS. SHS staff identified challenges with the implementation of the service related to the limited involvement of the whole SHS team in the planning and development. CONCLUSIONS: The codeveloped vending machine service was acceptable, addressing some barriers to testing. Resources and protected staff time are needed to support greater involvement of the whole SHS team and service providers in venues. Adopting a similarly robust coproduction approach to the implementation of the machines could avoid the challenges reported. The placement of the machines to assure users privacy and repeated, targeted promotion could encourage service use among target groups.

Decentralized HIV testing: comparing peer and mail-based distribution strategies to improve the reach of HIV self-testing among people who use drugs in Florida.

INTRODUCTION: People who use drugs (PWUD) are at increased risk for HIV infection. HIV self-testing (HIVST) is a promising method for identifying new infections, but optimal distribution strategies remain understudied. METHODS: To characterize PWUD by HIVST distribution strategy (peers vs. mail), we examined data from July 2022 to June 2023 collected from a real-world HIVST program led by the non-profit, Florida Harm Reduction Collective. We used descriptive statistics and Poisson regressions with robust error variance to compare those who received HIVST through peers or via mail by socio-demographics, Ending the HIV Epidemic (EHE) county designation, and HIV testing experience. RESULTS: Among 728 participants, 78% received HIVST from peers, 47% identified as cisgender female, 48% as heterosexual, and 45% as non-White; 66% resided in an EHE county, and 55% had no HIV testing experience. Compared to those who received an HIV self-test from peers, those who received tests via mail were less likely to be cisgender male (vs. cisgender female; prevalence ratio [PR] = 0.59, 95% confidence interval [CI]: 0.43, 0.81), non-Hispanic Black (vs. non-Hispanic White; PR = 0.57, 95% CI: 0.36, 0.89) or from EHE counties (vs. non-EHE counties; PR = 0.33, 95% CI: 0.25, 0.44). Those who received tests via mail were also more likely to identify their sexual orientation as "Other/Undisclosed" (vs. straight/heterosexual; PR = 2.00, 95% CI: 1.51, 2.66). CONCLUSION: Our findings support the role of community-based HIVST distribution strategies in increasing HIV testing coverage among PWUD. Additional research could help inform the equitable reach of HIVST.

Improving linkage to HIV care following a reactive HIV self-testing result among men in KwaZulu-Natal, South Africa.

BACKGROUND: Despite the many interventions that have been implemented in sub-Saharan Africa to improve the uptake of HIV testing and antiretroviral (ART) initiation services, the rates at which men are tested for HIV and initiated on ART have remained consistently lower compared to those for women. We aim to investigate barriers and facilitators for linkage to care following HIVST positive results among men aged between 18 and 49 years, and use these findings to design an intervention to improve linkage to care among men in a high-HIV prevalent district in KwaZulu-Natal province, South Africa. METHODS: This multi-method study will be conducted over 24 months in eight purposively selected HIV testing and treatment facilities from December 2023 to November 2025. For the quantitative component, a sample of 197 HIV positive men aged 18-49 years old who link to care after HIV self-test (HIVST) will be recruited into the study. HIVST kits will be distributed to a minimum of 3000 men attending community services through mobile clinics that are supported by the Health Systems Trust, at different service delivery points, including schools, taxi ranks and other hotspots. The qualitative component will consist of in-depth interviews (IDIs) with 15 HIVST users and IDIs with 15 key informants. To design and develop acceptable, feasible, effective, and sustainable models for improving linkage to care, three groups of HIVST users (2*positive (N = 12) and 1*negative (N = 12)) will be purposively select to participate in a design workshop. Chi square tests will be used to identify social and demographic factors associated with linkage, while logistic regression will be used to identify independent factors. Kaplan Meier curves and cox proportional hazard models will be used to identify factors associated with time to event. Content and thematic approaches will be used to analyze the qualitative data. DISCUSSION: There remains an urgent need for designing and implementing innovative intervention strategies that are convenient and tailored for addressing the needs of men for improving HIV testing and linkage to care at early stages in resource-limited settings, to improve individual health outcomes, reduce transmission from HIV and minimize HIV-related mortality rates. Our proposed study offers several important innovations aimed at improving linkage to care among men. Our study targets men, as they lag the HIV continuum but are also under-researched in public health studies.

HIV self-testing adoption and post-test linkage to care among men who have sex with men in China: a nationwide cross-sectional survey.

BACKGROUND: HIV self-testing (HIVST) was recommended to improve HIV testing services. China initiated some of the first HIVST pilots in the world, providing a unique opportunity for implementation research. We aim to investigate HIVST adoption and its following linkage to care among Chinese men who have sex with men (MSM). METHODS: Data were collected using an online questionnaire distributed on major social media platforms in 2018, one year after HIVST was officially endorsed and allowed for sale. MSM who were at least 16 years old, assigned as male at birth, and ever tested for HIV were eligible. Primary outcome, adoption was defined as ever use of HIVST. Bivariate and multivariable logistic regressions were performed to explore the association between HIVST adoption and sociodemographic and behavioral factors. Linkage to care was also described via the following sequential events as indicators: (1) receiving result after recent test (2), seeking care from healthcare facility if test result was positive or indeterminate, and (3) delayed time before seeking care. RESULTS: A total of 540 participants were included with an average age of 27.4 ± 6.6. Most were never married (87.4%) and half completed college (52.2%). Overall, 75.2% had adopted HIVST. Self-test kits were commonly obtained from community-based organizations (54.4%) and from online (46.6%). HIVST adoption was positively associated with having college or higher education (OR = 1.66, 95%CI: 1.07-2.57), and negatively associated with age older than 30 (AOR = 0.52, 95%CI: 0.32-0.84). Adoption was not associated with other socio-demographic or behavioral factors. After receiving HIV-positive or indeterminate results, 25/25 of HIVST adopters sought care while 3 out of 7 (42.9%) non-adopters sought care (p < 0.001). Delays before seeking care were not significantly different between HIVST adopters compared to non-adopters (P = 0.366). CONCLUSION: Many MSM adopted HIVST shortly after its launch. Our findings suggested that HIVST linkage to care is promising among MSM in China. Integration of HIVST with other essential sexual health services is needed.

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.

Noninvasive and Multiplex Self-Test of Kidney Disease Biomarkers with Graphene-Based Lab-on-a-Chip (G-LOC): Toward Digital Diagnostics in the Hands of Patients.

Chronic kidney disease is one of the major health issues worldwide. However, diagnosis is now highly centralized in large laboratories, resulting in low access to patient monitoring and poor personalized treatments. This work reports the development of a graphene-based lab-on-a-chip (G-LOC) for the digital testing of renal function biomarkers in serum and saliva samples. G-LOC integrates multiple bioelectronic sensors with a microfluidic system that enables multiplex self-testing of urea, potassium, sodium, and chloride. The linearity, limit of detection (LOD), accuracy, and coefficient of variability (CV) were studied. Accuracy values higher than 95.5% and CV lower than 9% were obtained for all of the biomarkers. The analytical performance was compared against three reference lab benchtop analyzers by measuring healthy- and renal-failure-level samples of serum. From receiver operating characteristic (ROC) plots, sensitivities (%) of 99.7, 97.6, 99.1, and 89.0 were obtained for urea, potassium, sodium, and chloride, respectively. Then, the test was evaluated in noninvasive saliva samples and compared against reference methods. Correlation and Bland-Altman plots showed good correlation and agreement of the G-LOC with the reference methods. It is noteworthy that the precision of G-LOC was similar to better than benchtop lab analyzers, with the advantage of being highly portable. Finally, a user testing study was conducted. The analytical performance obtained with untrained volunteers was similar to that obtained with trained chemists. Additionally, based on a user experience survey, G-LOC was found to have very simple usability and would be suitable for at-home diagnostics.

Primary Technology Enhanced Care Home HbA1c Testing (PTEC HAT) programme: a feasibility pilot study in Singapore.

BACKGROUND: Considering time-consuming, cost-related limitations of laboratory-based HbA1c testing and follow-up clinic visits for diabetes management, it is important to explore alternative care models which incorporate point-of-care testing for HbA1c to monitor glycaemic control and related management. METHODS: Therefore, we adopted an implementation perspective to conduct one group pre- and post-intervention feasibility pilot assessing feasibility, acceptability and satisfaction with conducting home HbA1c test by patients with type 2 diabetes coupled with telemonitoring and teleconsultations (i.e., the Primary Technology Enhanced Care (PTEC) Home HbA1c Testing (HAT) Programme) in Singaporean primary care setting. The secondary objective was to compare the HbA1c, blood pressure and primary care visits at the end or during intervention, vs. 6 months before. Adult patients with type 2 diabetes with HbA1c ≤ 8% without any diabetes complications and having phone compatibility were recruited. Data was collected via patient self-reports and electronic medical records extraction. While summary statistics and paired t-test were computed for quantitative data, open-ended feedback was analysed using content analysis. RESULTS: A total of 33 participants completed the intervention out of 37 (33/37 = 89%) recruited from 73 eligible (37/73 = 51%). Most were either 51 to 60 years old (46.9%) or more than 60 years (37.5%), with more males (53.1%) and majority Chinese (93.8%). Majority (81.3%) felt that home HbA1c testing was beneficial with most commonly reported benefit of not having a clinic visit. A key finding was the average of diabetes-related visits being significantly lower post-intervention with comparable HbA1c values pre- and post-intervention. The most commonly reported challenge was using Bluetooth to transmit the reading (43.7%), followed by having too many steps to remember (28.1%). While participants reported being overall satisfied with the intervention, only 22% were willing to pay for it. CONCLUSION: Our findings support home HbA1c testing by patients coupled with telemonitoring and teleconsultations. Following are practical recommendations for the implementation scaling phase: offering PTEC HAT Programme to suitable patients who are self-motivated and have adequate digital literacy, provision of adequate educational and training support, sending reminders and exploring enabling manual submission of HbA1c readings considering Bluetooth-related challenges.

Accuracy of and preferences for blood-based versus oral-fluid-based HIV self-testing in Malawi: a cross-sectional study.

BACKGROUND: HIV self-testing (HIVST) can use either oral-fluid or blood-based tests. Studies have shown strong preferences for self-testing compared to facility-based services. Despite availability of low-cost blood-based HIVST options, to date, HIVST implementation in sub-Saharan Africa has largely been oral-fluid-based. We investigated whether users preferred blood-based (i.e. using blood sample derived from a finger prick) or oral fluid-based HIVST in rural and urban Malawi. METHODS: At clinics providing HIV testing services (n = 2 urban; n = 2 rural), participants completed a semi-structured questionnaire capturing sociodemographic data before choosing to test using oral-fluid-based HVST, blood-based HIVST or provider-delivered testing. They also completed a self-administered questionnaire afterwards, followed by a confirmatory test using the national algorithm then appropriate referral. We used simple and multivariable logistic regression to identify factors associated with preference for oral-fluid or blood-based HIVST. RESULTS: July to October 2018, N = 691 participants enrolled in this study. Given the choice, 98.4% (680/691) selected HIVST over provider-delivered testing. Of 680 opting for HIVST, 416 (61.2%) chose oral-fluid-based HIVST, 264 (38.8%) chose blood-based HIVST and 99.1% (674/680) reported their results appropriately. Self-testers who opted for blood-based HIVST were more likely to be male (50.3% men vs. 29.6% women, p < 0.001), attending an urban facility (43% urban vs. 34.6% rural, p = 0.025) and regular salary-earners (49.5% regular vs. 36.8% non-regular, p = 0.012). After adjustment, only sex was found to be associated with choice of self-test (adjusted OR 0.43 (95%CI: 0.3-0.61); p-value < 0.001). Among 264 reporting blood-based HIVST results, 11 (4.2%) were HIV-positive. Blood-based HIVST had sensitivity of 100% (95% CI: 71.5-100%) and specificity of 99.6% (95% CI: 97.6-100%), with 20 (7.6%) invalid results. Among 416 reporting oral-fluid-based HIVST results 18 (4.3%) were HIV-positive. Oral-fluid-based HIVST had sensitivity of 88.9% (95% CI: 65.3-98.6%) and specificity of 98.7% (95% CI: 97.1-99.6%), with no invalid results. CONCLUSIONS: Offering both blood-based and oral-fluid-based HIVST resulted in high uptake when compared directly with provider-delivered testing. Both types of self-testing achieved high accuracy among users provided with a pre-test demonstration beforehand. Policymakers and donors need to adequately plan and budget for the sensitisation and support needed to optimise the introduction of new quality-assured blood-based HIVST products.

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines).

OBJECTIVE: Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities. DESIGN: We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction). SETTING: We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings-namely, workplace and healthcare facilities. RESULTS: Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04-3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58-87% for countries with off-site self-testing (outside the workplace, for example, home) and 15-50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29-35%) versus off-site self-testing (7-27%). CONCLUSIONS: Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

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.

Performance evaluation of a self-administered point-of-care test for anal HPV screening in PrEP users: data from a community-based PrEP service.

OBJECTIVES: In this study, we compared the performance of a self-administered point-of-care test (POCT) for anal human papillomavirus (HPV) screening with laboratory gold-standard test in pre-exposure prophylaxis (PrEP) users and evaluated its feasibility. METHODS: We enrolled PrEP users from a local community-based PrEP service. Each participant self-collected an anal swab to test anal HPV with a PCR POCT capable of detecting 14 high-risk HPV genotypes. Anonymous questionnaires on self-sampling feasibility were completed. Participants were then referred to local clinics to undergo standard viral genotyping. Concordance between POCT and gold-standard test was measured with absolute agreement and Cohen's kappa. Receiver operating characteristic (ROC) curves were used to calculate POCT sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). RESULTS: 179 subjects got a valid POCT result, most of them men (98.3%) and men who have sex with men (90.4%). 68.2% tested positive for at least one high-risk HPV genotype on POCT. 150 feasibility questionnaires were collected: 92.7% of compilers found the self-swab easy to perform. For 178 subjects, a gold-standard test valid result was also available: 77% tested positive for at least one high-risk HPV genotype. The median time elapsed between the two tests was 9.8 months, due to COVID-19-related service interruptions. Agreement between POCT and gold-standard test was 79.3% (Cohen's kappa=0.49). POCT showed a sensitivity of 81.0%, a specificity of 73.8%, a PPV of 91.0% and an NPV of 54.4%. CONCLUSIONS: POCT showed a moderate agreement with gold-standard test and a discrete sensitivity and specificity, suggesting that it could be a useful and feasible additional tool for HPV screening, especially in low-resource and community-based settings.

A Machine Learning Model for Identifying Sexual Health Influencers to Promote the Secondary Distribution of HIV Self-Testing Among Gay, Bisexual, and Other Men Who Have Sex With Men in China: Quasi-Experimental Study.

BACKGROUND: Sexual health influencers (SHIs) are individuals actively sharing sexual health information with their peers, and they play an important role in promoting HIV care services, including the secondary distribution of HIV self-testing (SD-HIVST). Previous studies used a 6-item empirical leadership scale to identify SHIs. However, this approach may be biased as it does not consider individuals' social networks. OBJECTIVE: This study used a quasi-experimental study design to evaluate how well a newly developed machine learning (ML) model identifies SHIs in promoting SD-HIVST compared to SHIs identified by a scale whose validity had been tested before. METHODS: We recruited participants from BlueD, the largest social networking app for gay men in China. Based on their responses to the baseline survey, the ML model and scale were used to identify SHIs, respectively. This study consisted of 2 rounds, differing in the upper limit of the number of HIVST kits and peer-referral links that SHIs could order and distribute (first round ≤5 and second round ≤10). Consented SHIs could order multiple HIV self-testing (HIVST) kits and generate personalized peer-referral links through a web-based platform managed by a partnered gay-friendly community-based organization. SHIs were encouraged to share additional kits and peer-referral links with their social contacts (defined as "alters"). SHIs would receive US $3 incentives when their corresponding alters uploaded valid photographic testing results to the same platform. Our primary outcomes included (1) the number of alters who conducted HIVST in each group and (2) the number of newly tested alters who conducted HIVST in each. We used negative binomial regression to examine group differences during the first round (February-June 2021), the second round (June-November 2021), and the combined first and second rounds, respectively. RESULTS: In January 2021, a total of 1828 men who have sex with men (MSM) completed the survey. Overall, 393 SHIs (scale=195 and ML model=198) agreed to participate in SD-HIVST. Among them, 229 SHIs (scale=116 and ML model=113) ordered HIVST on the web. Compared with the scale group, SHIs in the ML model group motivated more alters to conduct HIVST (mean difference [MD] 0.88, 95% CI 0.02-2.22; adjusted incidence risk ratio [aIRR] 1.77, 95% CI 1.07-2.95) when we combined the first and second rounds. Although the mean number of newly tested alters was slightly higher in the ML model group than in the scale group, the group difference was insignificant (MD 0.35, 95% CI -0.17 to -0.99; aIRR 1.49, 95% CI 0.74-3.02). CONCLUSIONS: Among Chinese MSM, SHIs identified by the ML model can motivate more individuals to conduct HIVST than those identified by the scale. Future research can focus on how to adapt the ML model to encourage newly tested individuals to conduct HIVST. TRIAL REGISTRATION: Chinese Clinical Trials Registry ChiCTR2000039632; https://www.chictr.org.cn/showprojEN.html?proj=63068. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12889-021-11817-2.

Communicating the Imperfect Diagnostic Accuracy of COVID-19 Rapid Antigen Self-Tests: An Online Randomized Experiment.

OBJECTIVE: To investigate the potential impacts of optimizing coronavirus disease 2019 (COVID-19) rapid antigen test (RAT) self-testing diagnostic accuracy information. DESIGN: Online randomized experiment using hypothetical scenarios: in scenarios 1 to 3 (RAT result positive), the posttest probability was considered to be very high (likely true positives), and in scenarios 4 and 5 (RAT result negative), the posttest probability was considered to be moderately high (likely false negatives). SETTING: December 12 to 22, 2022, during the mixed-variant Omicron wave in Australia. PARTICIPANTS: Australian adults. Intervention: diagnostic accuracy of a COVID-19 self-RAT presented in a health literacy-sensitive way; usual care: diagnostic accuracy information provided by the manufacturer; control: no diagnostic accuracy information. MAIN OUTCOME MEASURE: Intention to self-isolate. RESULTS: A total of 226 participants were randomized (control n = 75, usual care n = 76, intervention n = 75). More participants in the intervention group correctly interpreted the meaning of the diagnostic accuracy information (P = 0.08 for understanding sensitivity, P < 0.001 for understanding specificity). The proportion who would self-isolate was similar across scenarios 1 to 3 (likely true positives). The proportion was higher in the intervention group than in the control for scenarios 4 and 5 (likely false negatives). These differences were not statistically significant. The largest potential effect was seen in scenario 5 (dinner party with confirmed cases, the person has symptoms, negative self-RAT result), with 63% of the intervention group and 49% of the control group indicating they would self-isolate (absolute difference 13.3%, 95% confidence interval: -2% to 30%, P = 0.10). CONCLUSION: Health literacy sensitive formatting supported participant understanding and recall of diagnostic accuracy information. This may increase community intentions to self-isolate when there is a likely false-negative self-RAT result. Trial registration: Australia New Zealand Clinical Trial Registry (ACTRN12622001517763). HIGHLIGHTS: Community-based diagnostic accuracy studies of COVID-19 self-RATs indicate substantially lower sensitivity (and higher risk of false-negative results) than the manufacturer-supplied information on most government public Web sites.This online randomized study found that a health literacy-sensitive presentation of the imperfect diagnostic accuracy COVID-19 self-RATs supported participant understanding and recall of diagnostic accuracy information.Health literacy-sensitive presentation may increase community intentions to self-isolate after a negative test result where the posttest probability is still moderately high (i.e., likely false-negative result).To prevent the onward spread of infection, efforts to improve communication about the high risk of false-negative results from COVID-19 self-RATs are urgently needed.

At-Home Diagnostics Solutions for Chlamydia and Gonorrhea.

This Viewpoint discusses the US Food and Drug Administration's authorization of marketing an at-home testing system for chlamydia and gonorrhea as a good first step in boosting access to screening and treatment and in reducing infection rates.

Lessons learned from implementation of four HIV self-testing (HIVST) distribution models in Zambia: applying the Consolidated Framework for Implementation Research to understand impact of contextual factors on implementation.

BACKGROUND: Although Zambia has integrated HIV-self-testing (HIVST) into its Human Immunodeficiency Virus (HIV) regulatory frameworks, few best practices to optimize the use of HIV self-testing to increase testing coverage have been documented. We conducted a prospective case study to understand contextual factors guiding implementation of four HIVST distribution models to inform scale-up in Zambia. METHODS: We used the qualitative case study method to explore user and provider experiences with four HIVST distribution models (two secondary distribution models in Antenatal Care (ANC) and Antiretroviral Therapy (ART) clinics, community-led, and workplace) to understand factors influencing HIVST distribution. Participants were purposefully selected based on their participation in HIVST and on their ability to provide rich contextual experience of the distribution models. Data were collected using observations (n = 31), group discussions (n = 10), and in-depth interviews (n = 77). Data were analyzed using the thematic approach and aligned to the four Consolidated Framework for Implementation Research (CFIR) domains. RESULTS: Implementation of the four distribution models was influenced by an interplay of outer and inner setting factors. Inadequate compensation and incentives for distributors may have contributed to distributor attrition in the community-led and workplace HIVST models. Stockouts, experienced at the start of implementation in the secondary-distribution and community-led distribution models often disrupted distribution. The existence of policy and practices aided integration of HIVST in the workplace. External factors complimented internal factors for successful implementation. For instance, despite distributor attrition leading to excessive workload, distributors often multi-tasked to keep up with demand for kits, even though distribution points were geographically widespread in the workplace, and to a less extent in the community-led models. Use of existing communication platforms such as lunchtime and safety meetings to promote and distribute kits, peers to support distributors, reduction in trips by distributors to replenish stocks, increase in monetary incentives and reorganisation of stakeholder roles proved to be good adaptations. CONCLUSION: HIVST distribution was influenced by a combination of contextual factors in variable ways. Understanding how the factors interacted in real world settings informed adaptations to implementation devised to minimize disruptions to distribution.

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.