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.

BACKGROUND: Primary Human Papilloma Virus (HPV) testing offers higher sensitivity and specificity over Visual Inspection using Acetic acid (VIA) in cervical cancer screening. Self-sampling is a promising strategy to boost participation and reduce disparities. However, concerns about the initial costs hinder HPV testing adoption in low and middle-income countries. This study assesses the cost-utility of home-based HPV self-sampling versus VIA for cervical cancer screening in India.
METHODS: A cross-sectional study was conducted in East district, Sikkim, India, comparing the costs and utility outcomes of population-based cervical cancer screening through VIA and primary HPV screening through self-sampling. Cost-related data were collected from April 2021 to March 2022 using the bottom-up micro-costing method, while utility measures were collected prospectively using the EuroQoL-5D-5L questionnaire. The utility values were converted into quality-adjusted life days (QALDs) for an 8-day period. The willingness to pay threshold (WTP) was based on per capita GDP for 2022. If the calculated Incremental Cost-Effectiveness Ratio (ICER) value is lower than the WTP threshold, it signifies that the intervention is cost-effective.
RESULTS: The study included 95 women in each group of cervical cancer screening with VIA & HPV self-sampling. For eight days, the QALD was found to be 7.977 for the VIA group and 8.0 for the HPV group. The unit cost per woman screened by VIA and HPV self-testing was ₹1,597 (US$ 19.2) and ₹1,271(US$ 15.3), respectively. The ICER was ₹-14,459 (US$ -173.6), which was much below the WTP threshold for eight QALDs, i.e. ₹ 4,193 (US$ 50.4).
CONCLUSIONS: The findings support HPV self-sampling as a cost-effective alternative to VIA. This informs policymakers and healthcare providers for better resource allocation in cervical cancer screening in Sikkim.

OBJECTIVE: To compare preferences, uptake, and cofactors for unassisted home-based oral self-testing (HB-HIVST) versus clinic-based rapid diagnostic blood tests (CB-RDT) for maternal HIV retesting.
METHODS: Prospective cohort.
METHODS: Between November 2017 and June 2019, HIV-negative pregnant Kenyan women receiving antenatal care were enrolled and given a choice to retest with HB-HIVST or CB-RDT. Women were asked to retest between 36 weeks gestation and 1-week post-delivery if the last HIV test was <24 weeks gestation or at 6 weeks postpartum if ≥24 weeks gestation, and self-report on retesting at a 14-week postpartum.
RESULTS: Overall, 994 women enrolled and 33% (n = 330) selected HB-HIVST. HB-HIVST was selected because it was private (n = 224, 68%), convenient (n = 211, 63%), and offered flexibility in the timing of retesting (n = 207, 63%), whereas CB-RDT was selected due to the trust of providers to administer the test (n = 510, 77%) and convenience of clinic testing (n = 423, 64%). Among 905 women who reported retesting at follow-up, 135 (15%) used HB-HIVST. Most (n = 595, 94%) who selected CB-RDT retested with this strategy, compared to 39% (n = 120) who selected HB-HIVST retesting with HB-HIVST. HB-HIVST retesting was more common among women with higher household income and those who may have been unable to test during pregnancy (both retested postpartum and delivered <37 weeks gestation) and less common among women who were depressed. Most women said they would retest in the future using the test selected at enrollment (99% [n = 133] HB-HIVST; 93% [n = 715] CB-RDT-RDT).
CONCLUSIONS: While most women preferred CB-RDT for maternal retesting, HB-HIVST was acceptable and feasible and could be used to expand HIV retesting options.

BACKGROUND: HIV self-testing (HIVST) has been shown to increase the uptake of HIV testing and help achieve the UNAIDS 95-95-95 targets. This study assessed the acceptability, usability (ease of use and result interpretation) and the willingness to pay for HIVST kits distributed through three distribution models, namely the community-based, PLHIV network-led and private practitioners models, in India.
METHODS: This cross-sectional study was implemented across 14 states in India between September 2021 and June 2022. All participants could choose between blood-based or oral-fluid-based test kits. Participants were shown a test-kit usage demonstration video, and pre- and post-test counselling was provided for all. Participants were followed-up after testing, and if reported reactive, were further supported for linkage to confirmatory testing and antiretroviral therapy (ART) initiation.
RESULTS: Among the 90,605 participants found eligible, 88,080 (97%) accepted an HIVST kit. Among the 87,976 who reported using an HIVST kit, 45,207 (51%) preferred a blood-based kit, and 42,120 (48%) reported testing for the first time. For future testing, 77,064 (88%) reported preferring HIVST over other HIV testing methods. Among those who used the kit, 83,308 (95%) found the kit easy to use, and 83,237 (95%) reported that the test results were easy to interpret. Among those who preferred HIVST for future use, 52,136 (69%) were willing to pay for the kit, with 35,854 (69%) of those willing to pay less than US$ 1.20. Only one instance of social harm was reported, with a participant reporting suicidal tendencies due to discord with their partner. Out of 328 participants (0.4%) who tested reactive with HIVST, 291 (89%) were linked to confirmatory testing; of these, 254 were confirmed HIV positive, and 216 (85%) successfully initiated ART.
CONCLUSIONS: Overall, we report that nearly all participants were willing to accept HIVST, found the test kits easy to use and interpret, and about two-thirds were willing to pay for HIVST. Given the high levels of acceptance and the ability to reach a large proportion of first-time testers, HIVST in India could contribute to achieving the UNAIDS first 95 and ending the HIV epidemic.

UNASSIGNED: This pilot study aimed to assess the feasibility, accuracy, and repeatability of unsupervised, at-home, multi-day glaucoma testing using the Olleyes VisuALL Virtual Reality Platform (VRP) and the iCare HOME handheld self-tonometer.
UNASSIGNED: Participants were trained to use two U.S. Food and Drug Administration-registered or approved devices before conducting self-tests at home over 3 consecutive days. The iCare HOME intraocular pressure (IOP) measurements were collected four times daily per eye, and VRP visual field tests were performed once daily. The results were compared with one in-clinic Humphrey Field Analyzer (HFA) visual field test performed on the day of device training, iCare HOME measurements by the trainer, and the last five Goldmann applanation tonometer (GAT) results.
UNASSIGNED: Of 15 enrolled participants, nine of them (60%) completed the study. The six excluded participants could not self-measure using iCare HOME. There was significant correlation between the average mean deviation (MD) values of the at-home VRP tests and in-clinic HFA test (r2 = 0.8793, P < 0.001). Additionally, the average of the sensitivities in five of six Garway-Heath sectors were significantly correlated. VRP test duration was also shorter than in-clinic HFA testing (P < 0.001). Finally, at-home tonometry yielded statistically similar values compared to trainer-obtained iCare HOME values. The mean and range of at-home tonometry were also statistically similar to those for in-clinic GAT, but at-home tonometry demonstrated higher maximum IOP values (P = 0.0429).
UNASSIGNED: Unsupervised, at-home, multi-day glaucoma testing using two devices resulted in the capture of higher maximum IOPs than in the clinic and good MD correlation of VRP with HFA. However, 40% of participants could not self-measure IOP using iCare HOME.
UNASSIGNED: The study findings suggest that at-home remote glaucoma monitoring correlates with in-office testing and could provide additional information for glaucoma management, although patients had more difficulty with the iCare HOME than the VRP.

BACKGROUND: Late presentation with advanced HIV disease (LP-AHD) remains a significant challenge to Human Immunodeficiency Virus (HIV) care, contributing to increased morbidity, mortality, and healthcare costs. Despite global efforts to enhance early diagnosis, a considerable proportion of individuals with HIV infection are unaware of being infected and therefore present late for HIV care. For the first time in Ghana, this study assessed the prevalence of LP-AHD and associated factors among people diagnosed with HIV (PDWH).
METHODS: This bi-center retrospective cross-sectional study included 315 PDWH at the Aniniwah Medical Centre and Komfo Anokye Teaching Hospital, both in Kumasi, Ghana. A well-structured questionnaire was used to collect data on sociodemographic, clinical, lifestyle and psychosocial factors from the study participants. Statistical analyses were done in SPSS version 26.0 and GraphPad Prism version 8.0 at significant p-value of < 0.05 and 95% confidence interval. Predictors of LP-AHD were assessed using binary logistic regression models.
RESULTS: This study observed that, 90 out of the 315 study PDWH (28.6%) reported late with advanced HIV disease (AHD). Participants within the age group of 36-45 years (adjusted Odds Ratio [aOR]: 0.32, 95% CI: 0.14-0.69; p = 0.004) showed a significantly decreased likelihood of LP-AHD. However, participants who perceived cost of HIV care to be high (aOR: 7.04, 95% CI: 1.31-37.91; p = 0.023), who were diagnosed based on clinical suspicion (aOR: 13.86, 95 CI: 1.83-104.80; p = 0.011), and missed opportunities for early diagnosis by clinicians (aOR: 2.47, 95% CI: 1.30-4.74; p = 0.006) were significantly associated with increased likelihood of LP-AHD.
CONCLUSIONS: The prevalence of LP-AHD among PDWH in Ghana is high. Efforts to improve early initiation of HIV/AIDS care should focus on factors such as the high perceived costs of HIV care, diagnosis based on clinical suspicion, and missed opportunities for early diagnosis by physicians.

BACKGROUND: Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor.
METHODS: DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020.
RESULTS: Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events.
CONCLUSIONS: In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation.
BACKGROUND: Janssen Pharmaceuticals.

BACKGROUND: Understanding how HIV self-testing (HIVST) can meet the testing needs of gay, bisexual and other men who have sex with men (GBMSM) and trans people whose social networks vary is key to upscaling HIVST implementation. We aim to develop a contextual understanding of social networks and HIV testing needs among GBMSM (cis and transgender) and trans women in SELPHI (An HIV Self-testing Public Health Intervention), the UK\'s largest randomised trial on HIVST.
METHODS: This study re-analysed qualitative interviews conducted from 2015 to 2020. Forty-three in-person interviews were thematically analysed using the Framework Method. Our analytic matrix inductively categorised participants based on the unmet needs for HIV testing and the extent of social network support. The role of social networks on HIVST behaviour was explored based on individuals\' testing trajectories.
RESULTS: Four distinct groups were identified based on their unmet testing needs and perceived support from social networks. Optimisation advocates (people with high unmet needs and with high network support, n = 17) strived to tackle their remaining barriers to HIV testing through timely support and empowerment from social networks. Privacy seekers (people with high unmet needs and with low network support, n = 6) prioritised privacy because of perceived stigma. Opportunistic adopters (people with low unmet needs and with high network support, n = 16) appreciated social network support and acknowledged socially privileged lives. Resilient testers (people with low unmet needs and with low network support, n = 4) might hold potentially disproportionate confidence in managing HIV risks without sustainable coping strategies for potential seroconversion. Supportive social networks can facilitate users\' uptake of HIVST by: (1) increasing awareness and positive attitudes towards HIVST, (2) facilitating users\' initiation into HIVST with timely support and (3) affording participants an inclusive space to share and discuss testing strategies.
CONCLUSIONS: Our proposed categorisation may facilitate the development of differentiated person-centred HIVST programmes. HIVST implementers should carefully consider individuals\' unmet testing needs and perceived levels of social support, and design context-specific HIVST strategies that link people lacking supportive social networks to comprehensive HIV care.

UNASSIGNED: The management of warfarin therapy presents clinical challenges due to its narrow therapeutic index. We aimed to evaluate the comparative effectiveness of different management strategies in patients using warfarin.
UNASSIGNED: PubMed, Embase, Cochrane CENTRAL, CINAHL, and EBSCO Open Dissertation were searched from inception to 8 May 2024. Randomized controlled trials that compared the following interventions: patient self-management (PSM), patient self-testing (PST), anticoagulation management services (AMS), and usual care in patients prescribed warfarin for any indication were included. Risk ratios (RR) with 95% confidence interval (CI) were estimated using a random-effects model. Surface under the cumulative ranking curves (SUCRA) were used to rank different interventions. The certainty of evidence was assessed using the Confidence in Network Meta-Analysis (CINeMA) online platform. This study is registered with PROSPERO (CRD42023491978).
UNASSIGNED: Twenty-eight trials involving 8100 participants were included, with follow-up periods of 1-24 months. Mean warfarin dosages were 4.9-7.2 mg/day. Only PSM showed a significant reduction of major TE risk compared with usual care (RR = 0.41; 95% CI: 0.24, 0.71; I2 = 0.0%) with moderate certainty of evidence. The 97.6% SUCRA also supported the beneficial effects of PSM over other interventions. The combined direct and indirect evidence showed significantly higher TTR in PSM compared with usual care (MD = 7.39; 95% CI: 2.39, 12.39), with very low certainty. However, direct evidence showed non-significant TTR improvement (MD = 6.49; 95% CI: -3.09, 16.07, I2 = 96.1%). No differences across various strategies were observed in all-cause mortality, major bleeding, stroke, transient ischemic attack, and hospitalization.
UNASSIGNED: PSM reduces the risk of major TE events compared with usual care, tends to improve anticoagulation control, and should be considered where appropriate.
UNASSIGNED: Agency for Healthcare Research and Quality (grant ID 5R18HS027960).

BACKGROUND: Social network strategies, in which social networks are utilized to influence individuals or communities, are increasingly being used to deliver human immunodeficiency virus (HIV) interventions to key populations. We summarized and critically assessed existing research on the effectiveness of social network strategies in promoting HIV self-testing (HIVST).
METHODS: Using search terms related to social network interventions and HIVST, we searched five databases for trials published between 1st January 2010 and 30th June 2023. Outcomes included uptake of HIV testing, HIV prevalence and linkage to antiretroviral therapy (ART) or HIV care. We used network meta-analysis to assess the uptake of HIV testing through social network strategies compared with control methods. A pairwise meta-analysis of studies with a comparison arm that reported outcomes was performed to assess relative risks (RR) and their corresponding 95% confidence intervals (CI).
RESULTS: Among the 4496 manuscripts identified, 39 studies fulfilled the inclusion criteria, including one quasi-experimental study, 22 randomized controlled trials and 16 observational studies. Networks HIVST testing was organized by peers (distributed to known peers, 15 studies), partners (distributed to their sexual partners, 16 studies) and peer educators (distributed to unknown peers, 8 studies). Among social networks, simulating the possibilities of ranking position, peer distribution had the highest uptake of HIV testing (84% probability), followed by partner distribution (80% probability) and peer educator distribution (74% probability). Pairwise meta-analysis showed that peer distribution (RR 2.29, 95% CI 1.54-3.39, 5 studies) and partner distribution (RR 1.76, 95% CI 1.50-2.07, 10 studies) also increased the probability of detecting HIV reactivity during testing within the key population when compared to the control.
CONCLUSIONS: All of the three social network distribution strategies enhanced the uptake of HIV testing compared to standard facility-based testing. Linkage to ART or HIV care remained comparable to facility-based testing across the three HIVST distribution strategies.
CONCLUSIONS: Network-based HIVST distribution is considered effective in augmenting HIV testing rates and reaching marginalized populations compared to facility-based testing. These strategies can be integrated with the existing HIV care services, to fill the testing gap among key populations globally.
UNASSIGNED: CRD42022361782.