Explore the vast range of titles available.

Quality assurance programs are critical to ensuring the consistency and reliability of point-of-care surveillance test results. In 2022, we launched Laos’ inaugural quality control (QC) and external quality assessment (EQA) program for national HIV recent infection surveillance. Our study aims to implement the first QC and EQA program for national HIV recent infection surveillance in Laos, utilizing non-infectious dried tube specimens (DTS) for quality control testing. This initiative seeks to monitor and assure the quality of HIV infection surveillance. We employed the Asante HIV-1 Rapid Test for Recent Infection (HIV-1 RTRI) point-of-care kit, using plasma specimens from the Thai Red Cross Society to create dried tube specimens (DTS). The DTS panels, including HIV-1 negative, HIV-1 recent, and HIV-1 long-term samples, met ISO 13528:2022 standards to ensure homogeneity and stability. These panels were transported from the Thai National Institute of Health (Thai NIH) to the Laos National Center for Laboratory and Epidemiology (NCLE) and subsequently shipped to 12 remote laboratories at ambient temperature. The laboratory results were electronically transmitted to Thai NIH 15 days after receiving the panel for performance analysis. The concordance results with the sample types were scored, and laboratories that achieved 100% concordance across all sample panels were considered to have satisfactorily met the established standards. Almost all laboratories demonstrated satisfactory results with 100% concordance across all sample panels during all three rounds of QC: 11 out of 12 (92%) in June, 10 out of 12 (83%) in July, and 11 out of 12 (91%) in August. The two rounds of EQA performed in June and August 2022 were satisfied by 8 out of 11 (72%) and 5 out of 10 (50%) laboratories, respectively. QC and EQA monitoring identified errors such as testing protocol mistakes and insufficient DTS panel dissolution, leading to improvements in HIV recency testing quality. Laboratories that reported errors were corrected and implemented further preventive actions. The QC and EQA program for HIV-1 RTRI identified errors in HIV recent infection testing. Implementing a specialized QC and EQA program for DTS marks a significant advancement in improving the accuracy and consistency of HIV recent infection surveillance. Continuous assessment is vital for addressing recurring issues.

PurposeThe goal of 90-90-90 first requires the expansion of access to HIV testing. Our aim was to record frequencies of HIV indicator conditions (ICs) and identify missed opportunities for an early HIV diagnosis.MethodsWe retrospectively identified ICs in a population of 231 people living with HIV with known infection dates who attended our clinic. The study population was divided into four groups: (1) those self-tested pre-emptively (47/231, 20.3%), (2) those offered targeted testing based on risk factors (67/231, 29%), (3) those tested after an IC (73/231, 31.6%) and (4) those who were not offered testing after an IC (44/231, 19%). HIV acquisition dates were estimated by molecular clock analysis.ResultsA total of 169 healthcare contacts (HCCs) were recorded. The most frequent HCC was mononucleosis-like syndrome (20.1%), unexplained weight loss (10.7%) and STIs (10.1%). AIDS-defining conditions were detected in 11.8%. Only 62.4% (73/117) of those with an IC were offered testing after their first HCC. Patients in group 4 had statistically significant delay in diagnosis compared with group 3 (109.1 weeks (IQR 56.4–238.6) vs 71.6 weeks (IQR 32.3–124.6)). The proportion of patients diagnosed as late presenters in each group was: (1) 16/47 (34%), (2) 37/67 (55.2%), (3) 43/73 (58.9%) and (4) 27/44 (61.4%) (p=0.027).ConclusionsOur study uses a combination of molecular and clinical data and shows evidence that late presentation occurs in a high proportion of patients even in the presence of an IC. Given that risk-based targeted testing has low coverage, IC-guided testing provides a reasonable alternative to facilitate earlier HIV diagnosis and to improve late diagnosis across Europe and globally.

BackgroundWomen and girls are relatively under-represented across the HIV treatment cascade. Two conditions unique to women, pregnancy and cervical cancer/dysplasia, share a common acquisition mode with HIV. This scoping review aimed to explore HIV testing practices in voluntary termination of pregnancy (TOP) and colposcopy services.MethodsThe scoping review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We searched articles published up to 20 December 2020 using three electronic databases (PubMed/Medline, Embase, Google Scholar) and including the keywords “HIV Testing”, “Abortion, Induced”, “Colposcopy”, “HIV screen*” and “termination of pregnancy”.ResultsA total of 1496 articles were identified, of which 55 met the inclusion criteria. We included studies providing background HIV prevalence in addition to prevalence in the study population and studies of women seeking TOP rather than presenting with TOP complications. This limited our review to high-income, low HIV prevalence settings. We observed two study phases: studies pre-antiretroviral therapy (ART) using unlinked anonymous testing data and examining HIV risk factors associated with positive HIV tests and studies post-ART using routine testing data and exploring HIV testing uptake. HIV prevalence was estimated at >0.2% in most TOP settings and >1% (range 1.7%–11.4%) in colposcopy services. Many TOP providers did not have local HIV testing policies and HIV testing was not mentioned in many specialist guidelines. Testing uptake was 49%–96% in TOP and 23%–75% in colposcopy services.ConclusionGiven the estimated HIV prevalence of >0.1% among women attending TOP and colposcopy services, HIV testing would be economically feasible to perform in high-income settings. Explicit testing policies are frequently lacking in these two settings, both at the local level and in specialist guidelines. Offering HIV testing regardless of risk factors could normalise testing, reduce late HIV presentation and create an opportunity for preventive counselling.

Background Index-linked HIV testing for children, whereby HIV testing is offered to children of individuals living with HIV, has the potential to identify children living with undiagnosed HIV. The “Bridging the Gap in HIV Testing and Care for Children in Zimbabwe” (B-GAP) study implemented and evaluated the provision of index-linked HIV testing for children aged 2–18 years in Zimbabwe. We conducted a process evaluation to understand the considerations for programmatic delivery and scale-up of this strategy. Methods We used implementation documentation to explore experiences of the field teams and project manager who delivered the index-linked testing program, and to describe barriers and facilitators to index-linked testing from their perspectives. Qualitative data were drawn from weekly logs maintained by the field teams, monthly project meeting minutes, the project coordinator’s incident reports and WhatsApp group chats between the study team and the coordinator. Data from each of the sources was analysed thematically and synthesised to inform the scale-up of this intervention. Results Five main themes were identified related to the implementation of the intervention: (1) there was reduced clinic attendance of potentially eligible indexes due to community-based differentiated HIV care delivery and collection of HIV treatment by proxy individuals; (2) some indexes reported that they did not live in the same household as their children, reflecting the high levels of community mobility; (3) there were also thought to be some instances of ‘soft refusal’; (4) further, delivery of HIV testing was limited by difficulties faced by indexes in attending health facilities with their children for clinic-based testing, stigma around community-based testing, and the lack of familiarity of indexes with caregiver provided oral HIV testing; (5) and finally, test kit stockouts and inadequate staffing also constrained delivery of index-linked HIV testing. Conclusions There was attrition along the index-linked HIV testing cascade of children. While challenges remain at all levels of implementation, programmatic adaptations of index-linked HIV testing approaches to suit patterns of clinic attendance and household structures may strengthen implementation of this strategy. Our findings highlight the need to tailor index-linked HIV testing to subpopulations and contexts to maximise its effectiveness.

ABSTRACT Objectives: to develop and validate an educational video on rapid HIV testing for young black people. Methods: technological production research, developed through the following stages: 1) literature review; 2) script development; 3) content validity; 4) video development; and 5) appearance validity. The Content Validity Index (CVI), Concordance Index (CI) and exact binomial test were calculated, considering p>0.05 and a proportion of 0.80 of agreement. Results: the video was three minutes and 22 seconds long and covered rapid HIV testing with a visual design that included animation, subtitles, and narration in Brazilian Sign Language (LIBRAS). The overall CVI of the video was 0.90 (p-value=0.38; 95% CI: 0.46-0.90), confirming its suitability and validity. Conclusions: the educational technology, in the form of a video, on rapid HIV testing for young black people is valid in terms of content and appearance, with potential usefulness for health education actions. RESUMEN Objetivos: crear y validar un vídeo educativo sobre pruebas rápidas de VIH para jóvenes negros. Métodos: investigación de producción tecnológica, desarrollada a través de las siguientes etapas: 1) revisión de literatura; 2) construcción del guión; 3) validación de contenido; 4) construcción de video; y 5) validación de la apariencia. Se calculó el Índice de Validez de Contenido (IVC), Índice de Concordancia (IC) y prueba binomial exacta, considerando p>0,05 y la proporción de concordancia de 0,80. Resultados: el vídeo tiene una duración de tres minutos y 22 segundos, abarca la prueba rápida del VIH y el diseño visual incluye animación, subtítulos y narración en Lengua de Señas Brasileña (LIBRAS). El CVI total del vídeo fue de 0,90 (p-valor=0,38; IC 95%: 0,46-0,90), lo que confirma su idoneidad y validez. Conclusiones: la tecnología educativa, en formato de vídeo, sobre la prueba rápida del VIH para jóvenes negros, es válida en términos de contenido y apariencia, con potencial utilidad para acciones de educación en salud. RESUMO Objetivos: construir e validar vídeo educativo sobre testagem rápida anti-HIV para jovens negros. Métodos: pesquisa de produção tecnológica, desenvolvida pelas etapas: 1) revisão da literatura; 2) construção de roteiro; 3) validação de conteúdo; 4) construção do vídeo; e 5) validação deaparência. Calcularam-se os Índices de Validade de Conteúdo (IVC), Índice de Concordância (IC) e teste exato de binomial, considerando p>0,05 e a proporção de 0,80 de concordância. Resultados: o vídeo apresentou duração de três minutos e 22 segundos, abordando testagem rápida anti-HIV e design visual abrangendo animação, legendação e narração na Linguagem Brasileira de Sinais (LIBRAS). O IVC total do vídeo foi de 0,90 (valor de p=0,38; IC 95%: 0,46-0,90), confirmando a adequabilidade e validade. Conclusões: a tecnologia educacional, do tipo vídeo, sobre testagem rápida para HIV para jovens negros, é válida quanto ao conteúdo e à aparência, com potencial utilidade para ações de educação em saúde.

There are approximately 300,000 people in the United States who are co-infected with HIV and HCV. Several organizations recommend that individuals who are HCV infected, as well as persons over the age of 13, should be HIV tested. Comorbidities associated with HCV can be reduced with early identification of HIV. Our objective was to determine whether providers routinely followed HIV testing guidelines for patients who tested HCV positive (HCV+). A retrospective chart review was conducted of all patients in primary care at an academic health system from 7/2015-3/2017 who tested HCV+. As part of a primary database, HCV testing data was collected; HIV testing data was abstracted manually. We collected and described the intervals between HCV and HIV tests. To determine associations with HIV testing univariable and multivariable analyses were performed. We identified 445 patients who tested HCV+: 56.6% were tested for HIV, the mean age was 57 ± 10.9 years, 77% were from the Birth Cohort born 1945-1965 (BC); 61% were male; and 51% were Black/AA. Patients in the BC were more likely to be HIV tested if they were: male (p = 0.019), Black/AA (p<0.001), and had Medicaid (p = 0.005). These differences were not found in the non-BC. Six patients who were tested for both HIV and HCV were found to be newly HIV positive at the time of testing. As demonstrated, providers did not routinely follow CDC recommendations as almost half of the HCV+ patients were not correctly tested for HIV. It is important to emphasize that six persons were tested HIV positive simultaneously with their HCV+ diagnosis. If providers did not follow the CDC guidelines, then these patients may not have been identified. Improvements in EHR clinical decision support tools and provider education can help improve the HIV testing rate among individuals who are HCV+.

Introduction Misclassification errors have been reported in rapid diagnostic HIV tests (RDTs) in sub‐Saharan African countries. These errors can lead to missed opportunities for prevention‐of‐mother‐to‐child‐transmission (PMTCT), early infant diagnosis and adult HIV‐prevention, unnecessary lifelong antiretroviral treatment (ART) and wasted resources. Few national estimates or systematic quantifications of sources of errors have been produced. We conducted a comprehensive assessment of possible sources of misclassification errors in routine HIV testing in Zimbabwe. Methods RDT‐based HIV test results were extracted from routine PMTCT programme records at 62 sites during national antenatal HIV surveillance in 2017. Positive‐ (PPA) and negative‐percent agreement (NPA) for HIV RDT results and the false‐HIV‐positivity rate for people with previous HIV‐positive results (“known‐positives”) were calculated using results from external quality assurance testing done for HIV surveillance purposes. Data on indicators of quality management systems, RDT kit performance under local climatic conditions and user/clerical errors were collected using HIV surveillance forms, data‐loggers and a Smartphone camera application (7 sites). Proportions of cases with errors were compared for tests done in the presence/absence of potential sources of errors. Results NPA was 99.9% for both pregnant women (N = 17224) and male partners (N = 2173). PPA was 90.0% (N = 1187) and 93.4% (N = 136) for women and men respectively. 3.5% (N = 1921) of known‐positive individuals on ART were HIV negative. Humidity and temperature exceeding manufacturers’ recommendations, particularly in storerooms (88.6% and 97.3% respectively), and premature readings of RDT output (56.0%) were common. False‐HIV‐negative cases, including interpretation errors, occurred despite staff training and good algorithm compliance, and were not reduced by existing external or internal quality assurance procedures. PPA was lower when testing room humidity exceeded 60% (88.0% vs. 93.3%; p = 0.007). Conclusions False‐HIV‐negative results were still common in Zimbabwe in 2017 and could be reduced with HIV testing algorithms that use RDTs with higher sensitivity under real‐world conditions and greater practicality under busy clinic conditions, and by strengthening proficiency testing procedures in external quality assurance systems. New false‐HIV‐positive RDT results were infrequent but earlier errors in testing may have resulted in large numbers of uninfected individuals being on ART.

HIV self-testing (HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre- and posttest counseling, reporting results, and linking to care. Digital interventions for HIVST, a type of Software as a Medical Device (SaMD), have been shown to address these challenges, but there is currently no standardized system for regulating or approving these interventions. The World Health Organization Prequalification Program (WHOPQ) is an international regulatory body that approves vaccines, medications, and in vitro diagnostics (IVDs) for low- and middle-income countries that do not have the capacity to do their own approvals. This paper explores whether WHOPQ could be used to prequalify digital interventions for HIVST. Over half the World Health Organization (WHO) member states have national regulatory bodies for medical devices, but low- and middle-income countries, especially in Africa, do not have the capacity to regulate medical devices, let alone SaMD. This gap parallels the gap in vaccine regulation that initially led to the development of WHOPQ, and while sophisticated artificial intelligence (AI)–enabled SaMD are being developed, digital interventions for HIVST could be used as a low-risk test case for prequalification of SaMD. The WHOPQ already has a strong history with HIV; over half the WHOPQ funding is from HIV-related funders and half of all prequalified medicines and IVDs are for treatment and diagnosis of HIV; however, only 2% are manufactured in Africa. If digital interventions for HIVST become prequalified, this could improve interoperability and ensure quality, accelerating their adoption at scale. However, care must be taken to remove barriers for African developers and ensure that prequalification does not delay access to people testing for HIV.

Background HIV self-testing (HIVST) has been found to be highly effective, but no cost analysis has been undertaken to guide the design of affordable and scalable implementation strategies. Methods Consecutive HIV self-testers and facility-based testers were recruited from participants in a community cluster-randomised trial ( ISRCTN02004005 ) investigating the impact of offering HIVST in addition to facility-based HIV testing and counselling (HTC). Primary costing studies were undertaken of the HIVST service and of health facilities providing HTC to the trial population. Costs were adjusted to 2014 US$ and INT$. Recruited participants were asked about direct non-medical and indirect costs associated with accessing either modality of HIV testing, and additionally their health-related quality of life was measured using the EuroQol EQ-5D. Results A total of 1,241 participants underwent either HIVST (n = 775) or facility-based HTC (n = 446). The mean societal cost per participant tested through HIVST (US$9.23; 95 % CI: US$9.14-US$9.32) was lower than through facility-based HTC (US$11.84; 95 % CI: US$10.81-12.86). Although the mean health provider cost per participant tested through HIVST (US$8.78) was comparable to facility-based HTC (range: US$7.53-US$10.57), the associated mean direct non-medical and indirect cost was lower (US$2.93; 95 % CI: US$1.90-US$3.96). The mean health provider cost per HIV positive participant identified through HIVST was higher (US$97.50) than for health facilities (range: US$25.18-US$76.14), as was the mean cost per HIV positive individual assessed for anti-retroviral treatment (ART) eligibility and the mean cost per HIV positive individual initiated onto ART. In comparison to the facility-testing group, the adjusted mean EQ-5D utility score was 0.046 (95 % CI: 0.022-0.070) higher in the HIVST group. Conclusions HIVST reduces the economic burden on clients, but is a costlier strategy for the health provider aiming to identify HIV positive individuals for treatment. The provider cost of HIVST could be substantially lower under less restrictive distribution models, or if costs of oral fluid HIV test kits become comparable to finger-prick kits used in health facilities.

Increasing HIV testing and treatment coverage among people living with HIV (PLHIV) is essential for achieving global HIV epidemic control. However, compared to women, cis-gender heterosexual men living with HIV are significantly less likely to know their HIV status, initiate anti-retroviral therapy (ART) and achieve viral suppression. This is particularly true in South Africa, where men are also at increased risk of mortality resulting from AIDS-related illnesses. While there is growing knowledge of Treatment as Prevention or the concept Undetectable = Untransmittable (U = U) among PLHIV in Western and high-income countries, the reach and penetration of the U = U message in sub-Saharan Africa remains limited, and few studies have evaluated the impact of accessible and relatable U = U messages on ART initiation and adherence. To address these gaps, rigorous evaluations of interventions that incorporate U = U messages are needed, especially among men in high prevalence settings. Building on our U = U messages that we previously developed for men using behavioral economics insights and a human-centered design, we will conduct two sequential hybrid type 1 effectiveness-implementation trials to evaluate the impact of U = U messages on men's uptake of community-based HIV testing and ART initiation (Trial 1), and retention in care and achievement of viral suppression (Trial 2). For trial 1, a cluster randomized trial will be implemented with HIV testing service site-days (each day at one testing site) randomized to U = U or standard-of-care (SoC) messages inviting men to test for HIV. For trial 2, an individual-level randomized control trial will be implemented, with men initiating ART at six government clinics randomized to receive U = U counselling or SoC treatment adherence messaging. We will incorporate a multi-method evaluation to inform future implementation of U = U messaging interventions. The study will be conducted in the Buffalo City Metro Health District of the Eastern Cape Province and in the Cape Town Metro Health District in the Western Cape Province in South Africa. These trials are the first to rigorously evaluate the impact of U = U messaging on HIV testing uptake, ART initiation and achievement of viral suppression among African men. If effective, these messaging interventions can shape global HIV testing, treatment and adherence counselling guidelines and practices.