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1.
J Med Virol ; 93(12): 6686-6692, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1544320

ABSTRACT

To control the spread of the coronavirus disease 2019 (COVID-19) epidemics, it is necessary to have easy-to-use, reliable diagnostic tests available. The nasopharyngeal sampling method being often uncomfortable, nasal sampling could prove to be a viable alternative to the reference sampling method. We performed a multicentre, prospective validation study of the COVID-VIRO® test, using a nasal swab sampling method, in a point-of-care setting. In addition, we performed a multicentre, prospective, and usability study to validate the use of the rapid antigen nasal diagnostic test by laypersons. In March 2021, 239 asymptomatic and symptomatic patients were included in the validation study. Compared with reverse-transcription polymerase chain reaction on nasopharyngeal samples, the sensitivity and specificity of the COVID-VIRO® Antigen test combined with a nasal sampling method were evaluated as 96.88% and 100%, respectively. A total of 101 individuals were included in the usability study. Among these, 99% of the participants rated the instructions material as good, 98% of the subjects executed the test procedure well, and 98% of the participants were able to correctly interpret the test results. This study validates the relevance of COVID-VIRO® as a diagnostic tool from nasal specimens as well as its usability in the general population. COVID-VIRO® diagnostic performances and ease of use make it suitable for widespread utilization.


Subject(s)
COVID-19 Testing/methods , Diagnostic Tests, Routine/methods , Self-Testing , Adult , Antigens, Viral/blood , Humans , Male , Point-of-Care Testing , Prospective Studies , SARS-CoV-2/immunology , Sensitivity and Specificity
2.
BMJ Glob Health ; 6(9)2021 08.
Article in English | MEDLINE | ID: covidwho-1504511

ABSTRACT

INTRODUCTION: Implementation data for digital unsupervised HIV self-testing (HIVST) are sparse. We evaluated the impact of an app-based, personalised, oral HIVST program offered by healthcare workers in Western Cape, South Africa. METHODS: In a quasirandomised study (n=3095), we recruited consenting adults with undiagnosed HIV infection from township clinics. To the HIVST arm participants (n=1535), we offered a choice of an offsite (home, office or kiosk based), unsupervised digital HIVST program (n=962), or an onsite, clinic-based, supervised digital HIVST program (n=573) with 24/7 linkages services.With propensity score analyses, we compared outcomes (ie, linkages, new HIV infections and test referrals) with conventional HIV testing (ConvHT) arm participants (n=1560), recruited randomly from geographically separated clinics. RESULTS: In both arms, participants were young (HIVST vs ConvHT) (mean age: 28.2 years vs 29.2 years), female (65.0% vs 76.0%) and had monthly income <3000 rand (80.8% vs 75%).Participants chose unsupervised HIVST (62.7%) versus supervised HIVST and reported multiple sex partners (10.88% vs 8.7%), exposure to sex workers (1.4% vs 0.2%) and fewer comorbidities (0.9% vs 1.9%). Almost all HIVST participants were linked (unsupervised HIVST (99.7%), supervised HIVST (99.8%) vs ConvHT (98.5%)) (adj RR 1.012; 95% CI 1.005 to 1.018) with new HIV infections: overall HIVST (9%); supervised HIVST (10.9%) and unsupervised HIVST (7.6%) versus ConvHT (6.79%) (adj RR 1.305; 95% CI 1.023 to 1.665); test referrals: 16.7% HIVST versus 3.1% ConvHT (adj RR 5.435; 95% CI 4.024 to 7.340). CONCLUSIONS: Our flexible, personalised, app-based HIVST program, offered by healthcare workers, successfully linked almost all HIV self-testers, detected new infections and increased referrals to self-test. Data are relevant for digital HIVST initiatives worldwide.


Subject(s)
HIV Infections , Mobile Applications , Adult , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Testing , Humans , Self-Testing , South Africa/epidemiology
3.
J Clin Microbiol ; 59(11): e0264620, 2021 10 19.
Article in English | MEDLINE | ID: covidwho-1480240

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic reduced the sexually transmitted infection (STI) testing volume due to social-distancing and stay-at-home orders, among other reasons. These events highlighted previously known benefits of at-home STI self-testing or specimen self-collection and accelerated testing demand via telemedicine. We review testing outside traditional clinical settings. We focus on three curable bacterial STIs among the top 10 U.S. nationally notifiable conditions with screening recommendations: syphilis, gonorrhea (Neisseria gonorrhoeae, also known as the gonococcus [GC]), and chlamydia (Chlamydia trachomatis). At least 19 million GC/C. trachomatis (GC/CT) screening or diagnostic tests are performed annually, presenting a considerable challenge during the pandemic. Unlike for HIV, STI at-home tests are currently not commercially available. However, innovative telemedicine providers currently offer services where specimen self-collection kits are mailed to patients at home who then ship them to laboratories for processing. We discuss technical and regulatory aspects of modifications for home-based specimen self-collection. The telemedicine provider typically manages and communicates results, provides linkage to care, and is responsible for billing and case reporting. We also describe rapid testing devices in development that may present an opportunity for future self-testing. In summary, COVID-19 has accelerated the evaluation and development of STI self-tests and specimen self-collection. The remaining obstacles are high price, regulatory approval, support for laboratories offering the service, and uncertainty regarding whether target populations with the greatest need are reached effectively. However, increased testing, convenience, and privacy are potential benefits that may enhance uptake and outlast the pandemic.


Subject(s)
COVID-19 , Chlamydia Infections , Gonorrhea , Sexually Transmitted Diseases , Chlamydia Infections/epidemiology , Chlamydia trachomatis , Gonorrhea/epidemiology , Humans , Laboratories , Mass Screening , Neisseria gonorrhoeae , Pandemics , SARS-CoV-2 , Self-Testing , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology
4.
BMJ Glob Health ; 6(Suppl 4)2021 07.
Article in English | MEDLINE | ID: covidwho-1476481

ABSTRACT

BACKGROUND: HIV self-testing (HIVST) has been shown to be acceptable, feasible and effective in increasing HIV testing uptake. Novel testing strategies are critical to achieving the UNAIDS target of 95% HIV-positive diagnosis by 2025 in South Africa and globally. METHODS: We modelled the impact of six HIVST kit distribution modalities (community fixed-point, taxi ranks, workplace, partners of primary healthcare (PHC) antiretroviral therapy (ART) patients), partners of pregnant women, primary PHC distribution) in South Africa over 20 years (2020-2039), using data collected alongside the Self-Testing AfRica Initiative. We modelled two annual distribution scenarios: (A) 1 million HIVST kits (current) or (B) up to 6.7 million kits. Incremental economic costs (2019 US$) were estimated from the provider perspective; assumptions on uptake and screening positivity were based on surveys of a subset of kit recipients and modelled using the Thembisa model. Cost-effectiveness of each distribution modality compared with the status-quo distribution configuration was estimated as cost per life year saved (estimated from life years lost due to AIDS) and optimised using a fractional factorial design. RESULTS: The largest impact resulted from secondary HIVST distribution to partners of ART patients at PHC (life years saved (LYS): 119 000 (scenario A); 393 000 (scenario B)). However, it was one of the least cost-effective modalities (A: $1394/LYS; B: $4162/LYS). Workplace distribution was cost-saving ($52-$76 million) and predicted to have a moderate epidemic impact (A: 40 000 LYS; B: 156 000 LYS). An optimised scale-up to 6.7 million tests would result in an almost threefold increase in LYS compared with a scale-up of status-quo distribution (216 000 vs 75 000 LYS). CONCLUSION: Optimisation-informed distribution has the potential to vastly improve the impact of HIVST. Using this approach, HIVST can play a key role in improving the long-term health impact of investment in HIVST.


Subject(s)
HIV Infections , Self-Testing , Cost-Benefit Analysis , Female , HIV Infections/diagnosis , HIV Infections/drug therapy , HIV Infections/epidemiology , Humans , Mass Screening , Pregnancy , South Africa/epidemiology
5.
Contemp Clin Trials ; 110: 106585, 2021 11.
Article in English | MEDLINE | ID: covidwho-1446486

ABSTRACT

Background Widely available population testing is critical to public health efforts to control the ongoing COVID-19 pandemic. However, COVID-19 testing has been low in underserved communities disproportionately affected by COVID-19. One approach to increase testing rates is through the secondary distribution of self-collection kits, where an individual distributes test kits to contacts in their social network and encourages them to self-collect test specimens. We outline a randomized clinical trial, COVID-19 Self-testing Through Rapid Network Distribution (C-STRAND), and a cohort study of individuals with COVID-19, to determine the impact of a secondary distribution strategy on COVID-19 testing among medically underserved populations. Methods The clinical trial will seek to enroll 1048 adult index participants from federally health qualified centers in Philadelphia, PA seeking COVID-19 testing. Eligible participants will be randomized 1:1 to receive multiple self-collection test kits or multiple referrals for standard clinic-based tests to distribute to contacts within their social network. The primary outcome will be testing among at least two network contacts at 8 weeks. Index participants and network contacts who test positive for COVID-19 from C-STRAND will be eligible to join the COVID-19 Close Contact Self-testing Study (CloseST), assessing the secondary distribution of self-collection test kits among individuals with COVID-19. The primary outcome of this cohort will be the number of close contacts who test positive at 8 weeks. Conclusion Novel strategies to promote COVID-19 testing are necessary, particularly among underserved populations most affected by COVID-19. We will determine the efficacy of a self-testing secondary distribution strategy. The results may inform efforts to increase testing rates during the current pandemic.


Subject(s)
COVID-19 , Pandemics , Adult , COVID-19 Testing , Cohort Studies , Humans , Medically Underserved Area , SARS-CoV-2 , Self-Testing , Vulnerable Populations
6.
J Prim Care Community Health ; 12: 21501327211047782, 2021.
Article in English | MEDLINE | ID: covidwho-1443780

ABSTRACT

OBJECTIVES: The United Kingdom and a number of European Union countries are offering and distributing rapid antigen detection tests (RADTs) for self-test use to detect SARS-CoV-2. For instance, Greece, in the midst of its third wave of COVID-19, announced the provision of RADTs for self-testing through retail pharmacies. With the aim to determine the acceptability and feasibility of COVID-19 self-testing, we ran a cross-sectional survey on residents of Greece and Cyprus, aged over 18 years. METHODS: An online survey using the JISC platform was distributed to 1000 individuals who completed the survey anonymously. Data was collated and analyzed for complete responses by chi-squared and logistic regression analyses. RESULTS: A total of 248 complete responses were obtained, with balanced gender distribution and particular demographics representative of the 2 countries. The majority of participants (79%; n = 196) reported willingness to self-test and the remaining individuals reported no (10.5%; n = 26) or don't know (10.5%; n = 26). Being a university graduate significantly predicted the likelihood of being willing to self-test (odds ratio [OR] = 3.455, P < .001). Pearson Chi-square test found significant differences between university graduates versus non-graduates on the type of COVID-19 test preferred (χ2 = 8.95, df = 3, P < .03); graduates were more likely to prefer saliva testing and less likely to prefer the finger prick test than non-graduates. CONCLUSIONS: Our survey data evidences the acceptability of home-based self-testing, with a preference for saliva as choice of biological material for sampling. A number of factors, such as accessible reporting, contact tracing infrastructures, central registration, and validation for the implementation of different RADTs need to be taken collectively into consideration before self-testing can be universally and reliably scaled up.


Subject(s)
COVID-19 , Pandemics , Adult , Cross-Sectional Studies , Humans , Middle Aged , SARS-CoV-2 , Self-Testing
7.
MMWR Morb Mortal Wkly Rep ; 70(38): 1322-1325, 2021 Sep 24.
Article in English | MEDLINE | ID: covidwho-1436413

ABSTRACT

During 2019, approximately 34,800 new HIV infections occurred in the United States (1), and it is estimated that approximately 80% of HIV transmission occurs from persons who either do not know they have HIV infection or are not receiving regular care (2). Since 2006, CDC has recommended that persons who are disproportionately affected by HIV (including men who have sex with men [MSM]) should test for HIV at least annually (3,4). However, data from multiple sources indicate that these recommendations are not being fully implemented (5,6). TakeMeHome, a novel public-private partnership to deliver HIV self-testing kits to persons seeking HIV testing in the United States, was launched during March 2020 as home care options for testing became increasingly important during the COVID-19 pandemic. The initiation of the program coincided with the national COVID-19 Public Health Emergency declaration, issuance of stay-at-home orders, and other restrictions that led to disruption of traditional HIV testing services. During March 31, 2020-March 30, 2021, 17 state and local health departments participating in the program allowed residents of their jurisdictions to order test kits. Marketing for TakeMeHome focused on reaching gay, bisexual, and MSM through messages and embedded links in gay dating applications. Most participants in the program reported that they had either never tested for HIV (36%) or that they had last tested >1 year before receiving their self-test kit (56%). After receiving the self-test kit, >10% of respondents reported accessing additional prevention services. Health departments can increase options for HIV testing by distributing publicly funded self-test kits to persons without proximate access to clinic-based testing or who prefer to test at home. Increased and regular HIV testing among MSM will help meet annual testing goals.


Subject(s)
Direct-To-Consumer Screening and Testing , HIV Testing/statistics & numerical data , Health Services Accessibility/statistics & numerical data , Self-Testing , Adolescent , Adult , Female , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Testing/methods , Humans , Male , Middle Aged , United States/epidemiology , Young Adult
8.
BMJ Open ; 11(9): e053850, 2021 09 02.
Article in English | MEDLINE | ID: covidwho-1394122

ABSTRACT

OBJECTIVES: Successful implementation of asymptomatic testing programmes using lateral flow tests (LFTs) depends on several factors, including feasibility, acceptability and how people act on test results. We aimed to examine experiences of university students and staff of regular asymptomatic self-testing using LFTs, and their subsequent behaviours. DESIGN AND SETTING: A qualitative study using semistructured remote interviews and qualitative survey responses, which were analysed thematically. PARTICIPANTS: People who were participating in weekly testing feasibility study, between October 2020 and January 2021, at the University of Oxford. RESULTS: We interviewed 18 and surveyed 214 participants. Participants were motivated to regularly self-test as they wanted to know whether or not they were infected with SARS-CoV-2. Most reported that a negative test result did not change their behaviour, but it did provide them with reassurance to engage with permitted activities. In contrast, some participants reported making decisions about visiting other people because they felt reassured by a negative test result. Participants valued the training but some still doubted their ability to carry out the test. Participants were concerned about safety of attending test sites with lots of people and reported home testing was most convenient. CONCLUSIONS: Clear messages highlighting the benefits of regular testing for family, friends and society in identifying asymptomatic cases are needed. This should be coupled with transparent communication about the accuracy of LFTs and how to act on either a positive or negative result. Concerns about safety, convenience of testing and ability to do tests need to be addressed to ensure successful scaling up of asymptomatic testing.


Subject(s)
COVID-19 , Self-Testing , COVID-19 Testing , Humans , Perception , SARS-CoV-2 , Students , Universities
9.
Diagn Microbiol Infect Dis ; 101(2): 115469, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1385401

ABSTRACT

Alternatives to nasopharyngeal sampling are needed to increase capacity for SARS-CoV-2 testing. Among 275 participants, we piloted the collection of nasal mid-turbinate swabs amenable to self-testing, including polyester flocked swabs as well as 3D-printed plastic lattice swabs, placed into viral transport media or an RNA stabilization agent. Flocked nasal swabs identified 104/121 individuals who were PCR-positive for SARS-CoV-2 by nasopharyngeal sampling (sensitivity 87%, 95% CI 79-92%), missing those with low viral load (<106 viral copies/mL). 3D-printed nasal swabs showed similar sensitivity. When nasal swabs were placed directly into RNA preservative, the mean 1.4 log decrease in viral copies/uL compared to nasopharyngeal samples was reduced to <1 log, even when samples were left at room temperature for up to 7 days. We also evaluated pooling strategies that involved pooling specimens in the lab versus pooling swabs at the point of collection, finding both successfully detected samples with >105 viral copies/mL.


Subject(s)
COVID-19 Nucleic Acid Testing/methods , COVID-19/diagnosis , SARS-CoV-2/isolation & purification , Health Resources/supply & distribution , Humans , Limit of Detection , Nasopharynx/virology , RNA, Viral/genetics , SARS-CoV-2/genetics , Self-Testing , Specimen Handling/instrumentation , Specimen Handling/methods , Turbinates/virology , Viral Load
11.
Euro Surveill ; 26(34)2021 08.
Article in English | MEDLINE | ID: covidwho-1376683

ABSTRACT

This study evaluates the performance of the antigen-based anterior nasal screening programme implemented in all Austrian schools to detect SARS-CoV-2 infections. We combined nationwide antigen-based screening data obtained in March 2021 from 5,370 schools (Grade 1-8) with an RT-qPCR-based prospective cohort study comprising a representative sample of 244 schools. Considering a range of assumptions, only a subset of infected individuals are detected with the programme (low to moderate sensitivity) and non-infected individuals mainly tested negative (very high specificity).


Subject(s)
COVID-19 , SARS-CoV-2 , Austria , Humans , Prospective Studies , Schools , Self-Testing
13.
BMC Health Serv Res ; 21(1): 875, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1371965

ABSTRACT

BACKGROUND: Warfarin treatment requires frequent monitoring of INR (international normalized ratio) to adjust dosage in a therapeutic range. In China, patients living in small towns usually go to tertiary hospitals to get warfarin monitoring and dosing, resulting in low frequencies of follow-ups and high incidence of complications. Influenced by the COVID-19 pandemic, patients on warfarin have further reduced their visits to healthcare institutions. While patient self-testing (PST) via using a point-of-care testing device for INR measuring at home has been widely used in developed countries and demonstrated improved clinical outcomes compared to usual care in clinics, it is rarely applied in developing countries, including China. This proposed study will develop and assess the "Safe Multidisciplinary App-assisted Remote patient-self-Testing (SMART) model" for warfarin home management in China during the COVID-19 pandemic. METHODS: This is a multi-center randomized controlled trial. We will carry out the study in three county hospitals, three small tertiary hospitals and three large tertiary hospitals with anticoagulation clinics in Hunan province of China. Eligible patients will be randomly assigned to the SMART model group (n = 360) or the control group (usual care clinic group, n = 360; anticoagulation clinic group, n = 120). Patients in the SMART model group do PST at home once every two to 4 weeks. Controls receive usual care in the clinics. All the patients will be followed up through outpatient clinics, phone call or online interviews at the 3rd, 6th, 9th and 12th month. The percentage of time in therapeutic range (TTR), incidence of warfarin associated major bleeding and thromboembolic events and costs will be compared between the SMART model group and control groups. DISCUSSION: Patients in the SMART model group would show improved TTR, lower incidence of complications and better quality of life compared to the control groups. Our design, implementation and usage of the SMART model will provide experience and evidence in developing a novel model for chronic disease management to solve the problem of healthcare service maldistribution, an issue particularly obvious in developing countries during the COVID-19 pandemic. TRIAL REGISTRATION: ChiCTR, ChiCTR 2000038984 . Registered 11 October, 2020.


Subject(s)
COVID-19 , Mobile Applications , Anticoagulants/adverse effects , Humans , International Normalized Ratio , Multicenter Studies as Topic , Pandemics/prevention & control , Quality of Life , Randomized Controlled Trials as Topic , SARS-CoV-2 , Self-Testing , Warfarin/adverse effects
14.
Front Public Health ; 9: 653565, 2021.
Article in English | MEDLINE | ID: covidwho-1346426

ABSTRACT

Background: The ATLAS program promotes and implements HIVST in Côte d'Ivoire, Mali, and Senegal. Priority groups include members of key populations-female sex workers (FSW), men having sex with men (MSM), and people who use drugs (PWUD)-and their partners and relatives. HIVST distribution activities, which began in mid-2019, were impacted in early 2020 by the COVID-19 pandemic. Methods: This article, focusing only on outreach activities among key populations, analyzes quantitative, and qualitative program data collected during implementation to examine temporal trends in HIVST distribution and their evolution in the context of the COVID-19 health crisis. Specifically, we investigated the impact on, the adaptation of and the disruption of field activities. Results: In all three countries, the pre-COVID-19 period was marked by a gradual increase in HIVST distribution. The period corresponding to the initial emergency response (March-May 2020) witnessed an important disruption of activities: a total suspension in Senegal, a significant decline in Côte d'Ivoire, and a less pronounced decrease in Mali. Secondary distribution was also negatively impacted. Peer educators showed resilience and adapted by relocating from public to private areas, reducing group sizes, moving night activities to the daytime, increasing the use of social networks, integrating hygiene measures, and promoting assisted HIVST as an alternative to conventional rapid testing. From June 2020 onward, with the routine management of the COVID-19 pandemic, a catch-up phenomenon was observed with the resumption of activities in Senegal, the opening of new distribution sites, a rebound in the number of distributed HIVST kits, a resurgence in larger group activities, and a rebound in the average number of distributed HIVST kits per primary contact. Conclusions: Although imperfect, the program data provide useful information to describe changes in the implementation of HIVST outreach activities over time. The impact of the COVID-19 pandemic on HIVST distribution among key populations was visible in the monthly activity reports. Focus groups and individual interviews allowed us to document the adaptations made by peer educators, with variations across countries and populations. These adaptations demonstrate the resilience and learning capacities of peer educators and key populations.


Subject(s)
COVID-19 , HIV Infections , Sex Workers , Sexual and Gender Minorities , Cote d'Ivoire/epidemiology , Female , HIV Infections/diagnosis , Homosexuality, Male , Humans , Male , Mali/epidemiology , Pandemics , SARS-CoV-2 , Self-Testing , Senegal/epidemiology
15.
Sci Rep ; 11(1): 14604, 2021 07 16.
Article in English | MEDLINE | ID: covidwho-1315611

ABSTRACT

While there has been significant progress in the development of rapid COVID-19 diagnostics, as the pandemic unfolds, new challenges have emerged, including whether these technologies can reliably detect the more infectious variants of concern and be viably deployed in non-clinical settings as "self-tests". Multidisciplinary evaluation of the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW, a widely used rapid antigen test, included limit of detection, variant detection, test performance across different age-groups, and usability with self/caregiver-administration. While BinaxNOW detected the highly infectious variants, B.1.1.7 (Alpha) first identified in the UK, B.1.351 (Beta) first identified in South Africa, P.1 (Gamma) first identified in Brazil, B.1.617.2 (Delta) first identified in India and B.1.2, a non-VOC, test sensitivity decreased with decreasing viral loads. Moreover, BinaxNOW sensitivity trended lower when devices were performed by patients/caregivers themselves compared to trained clinical staff, despite universally high usability assessments following self/caregiver-administration among different age groups. Overall, these data indicate that while BinaxNOW accurately detects the new viral variants, as rapid COVID-19 tests enter the home, their already lower sensitivities compared to RT-PCR may decrease even more due to user error.


Subject(s)
COVID-19 Serological Testing , COVID-19/diagnosis , Point-of-Care Systems , Self-Testing , Humans , Limit of Detection , SARS-CoV-2 , Sensitivity and Specificity
16.
Health Res Policy Syst ; 19(Suppl 1): 50, 2021 Apr 21.
Article in English | MEDLINE | ID: covidwho-1291055

ABSTRACT

BACKGROUND: In Lebanon, HIV is concentrated in both native and refugee communities of men who have sex with men (MSM). For over 10 years, the National AIDS Program (NAP) has offered HIV voluntary counselling and testing through a partnership with nongovernmental organizations (NGOs). In 2018, implementation of HIV self-tests (HIVST) was introduced, and this self-care intervention has been further scaled up during the coronavirus disease 2019 (COVID-19) pandemic. This paper (1) describes the effectiveness of implementing HIVST in Lebanon, and (2) discusses how the success of HIVST implementation has been reflected during the COVID-19 pandemic. METHODS: The NAP conducted a series of workshops (July-November 2018) to introduce HIVST services for healthcare workers working at different NGOs. The workshops highlighted that HIVST would be distributed for free, that it would be confidential and voluntary, and that participants were encouraged to notify the NGOs of their results, which would be kept strictly confidential. NGOs collected data anonymously and confidentially from beneficiaries (age, consistency of condom use and HIV testing history), who were asked to call back with the results of their HIVST. At the NAP, data were combined, aggregated and analysed. RESULTS: In 2019, the NGOs distributed 1103/1380 (79.9%) HIVST kits to their beneficiaries. The NGOs collected feedback on 111 kit results, of which two were HIV-positive. Feedback about HIVST results from beneficiaries was low (111/1103) due to noncompliance of beneficiaries and the lack of human and financial resources in the NGOs. From January through May 2020, a total of 625/780 HIVST kits (80.1%) were distributed. This period was divided into pre-COVID-19 and during COVID-19. The follow-up with the beneficiaries during COVID-19 was much improved because of the absence of on-site activities, shifting more efforts towards HIVST (449/625). There have been no reports of social harm related to HIVST. CONCLUSION: HIVST implementation in Lebanon serves as an example of introducing a self-care intervention as part of a community-led effort. In order to maintain HIVST services at the same improved level, reorganization of care is needed within each NGO following the adaptation process due to COVID-19, along with continuous monitoring and evaluation of HIVST reported data.


Subject(s)
COVID-19 , HIV Infections/diagnosis , Homosexuality, Male , Mass Screening , Pandemics , Self-Testing , Sexual and Gender Minorities , Adolescent , Adult , Government Programs , HIV Testing , Humans , Lebanon , Male , Middle Aged , Organizations , SARS-CoV-2 , Young Adult
17.
BMC Infect Dis ; 21(1): 617, 2021 Jun 29.
Article in English | MEDLINE | ID: covidwho-1285993

ABSTRACT

BACKGROUND: Seasonal influenza leads to significant morbidity and mortality. Rapid self-tests could improve access to influenza testing in community settings. We aimed to evaluate the diagnostic accuracy of a mobile app-guided influenza rapid self-test for adults with influenza like illness (ILI), and identify optimal methods for conducting accuracy studies for home-based assays for influenza and other respiratory viruses. METHODS: This cross-sectional study recruited adults who self-reported ILI online. Participants downloaded a mobile app, which guided them through two low nasal swab self-samples. Participants tested the index swab using a lateral flow assay. Test accuracy results were compared to the reference swab tested in a research laboratory for influenza A/B using a molecular assay. RESULTS: Analysis included 739 participants, 80% were 25-64 years of age, 79% female, and 73% white. Influenza positivity was 5.9% based on the laboratory reference test. Of those who started their test, 92% reported a self-test result. The sensitivity and specificity of participants' interpretation of the test result compared to the laboratory reference standard were 14% (95%CI 5-28%) and 90% (95%CI 87-92%), respectively. CONCLUSIONS: A mobile app facilitated study procedures to determine the accuracy of a home based test for influenza, however, test sensitivity was low. Recruiting individuals outside clinical settings who self-report ILI symptoms may lead to lower rates of influenza and/or less severe disease. Earlier identification of study subjects within 48 h of symptom onset through inclusion criteria and rapid shipping of tests or pre-positioning tests is needed to allow self-testing earlier in the course of illness, when viral load is higher.


Subject(s)
Influenza A virus/immunology , Influenza B virus/immunology , Influenza, Human/diagnosis , Mobile Applications , Self-Testing , Adult , Cross-Sectional Studies , Data Accuracy , Enzyme-Linked Immunosorbent Assay/methods , Feasibility Studies , Female , Humans , Influenza, Human/virology , Male , Middle Aged , Sensitivity and Specificity
18.
Lancet Glob Health ; 9(7): e977-e988, 2021 07.
Article in English | MEDLINE | ID: covidwho-1275796

ABSTRACT

BACKGROUND: Secondary distribution of HIV self-testing (HIVST) kits by patients attending clinic services to their partners could improve the rate of HIV diagnosis. We aimed to investigate whether secondary administration of HIVST kits, with or without an additional financial incentive, via women receiving antenatal care (ANC) or via people newly diagnosed with HIV (ie, index patients) could improve the proportion of male partners tested or the number of people newly diagnosed with HIV. METHODS: We did a three-arm, open-label, pragmatic, cluster-randomised trial of 27 health centres (clusters), eligible if they were a government primary health centre providing ANC, HIV testing, and ART services, across four districts of Malawi. We recruited women (aged ≥18 years) attending their first ANC visit and whose male partner was available, not already taking ART, and not already tested for HIV during this pregnancy (ANC cohort), and people (aged ≥18 years) with newly diagnosed HIV during routine clinic HIV testing who had at least one sexual contact not already known to be HIV-positive (index cohort). Centres were randomly assigned (1:1:1), using a public selection of computer-generated random allocations, to enhanced standard of care (including an invitation for partners to attend HIV testing services), HIVST only, or HIVST plus a US$10 financial incentive for retesting. The primary outcome for the ANC cohort was the proportion of male partners reportedly tested, as ascertained by interview with women in this cohort at day 28. The primary outcome for the index cohort was the geometric mean number of new HIV-positive people identified per facility within 28 days of enrolment, as measured by observed HIV test results. Cluster-level summaries compared intervention with standard of care by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03705611. FINDINGS: Between Sept 8, 2018, and May 2, 2019, nine clusters were assigned to each trial arm, resulting in 4544 eligible women in the ANC cohort (1447 [31·8%] in the standard care group, 1465 [32·2%] in the HIVST only group, and 1632 [35·9%] in HIVST plus financial incentive group) and 708 eligible patients in the index cohort (234 [33·1%] in the standard care group, 169 [23·9%] in the HIVST only group, and 305 [42·9%] in the HIVST plus financial incentive group). 4461 (98·2%) of 4544 eligible women in the ANC cohort and 645 (91·1%) of 708 eligible patients in the index cohort were recruited, of whom 3378 (75·7%) in the ANC cohort and 439 (68·1%) in the index cohort were interviewed after 28 days. In the ANC cohort, the mean proportion of reported partner testing per cluster was 35·0% (SD 10·0) in the standard care group, 73·0% in HIVST only group (13·1, adjusted risk ratio [RR] 1·71, 95% CI 1·48-1·98; p<0·0001), and 65·2% in the HIVST plus financial incentive group (11·6, adjusted RR 1·62, 1·45-1·81; p<0·0001). In the index cohort, the geometric mean number of new HIV-positive sexual partners per cluster was 1·35 (SD 1·62) for the standard care group, 1·91 (1·78) for the HIVST only group (incidence rate ratio adjusted for number eligible as an offset in the negative binomial model 1·65, 95% CI 0·49-5·55; p=0·3370), and 3·20 (3·81) for the HIVST plus financial incentive group (3·11, 0·99-9·77; p=0·0440). Four self-resolving, temporary marital separations occurred due to disagreement in couples regarding HIV self-test kits. INTERPRETATION: Although administration of HIVST kits in the ANC cohort, even when offered alongside a financial incentive, did not identify significantly more male patients with HIV than did standard care, out-of-clinic options for HIV testing appear more acceptable to many male partners of women with HIV, increasing test uptake. Viewed in the current context, this approach might allow continuation of services despite COVID-19-related lockdowns. FUNDING: Unitaid, through the Self-Testing Africa Initiative.


Subject(s)
HIV Infections/diagnosis , HIV Testing/methods , Prenatal Care , Self-Testing , Sexual Partners , Adult , Cluster Analysis , Female , HIV Infections/epidemiology , HIV Testing/economics , Humans , Malawi/epidemiology , Male , Motivation , Pregnancy , Reagent Kits, Diagnostic , Young Adult
19.
Front Public Health ; 9: 653612, 2021.
Article in English | MEDLINE | ID: covidwho-1264394

ABSTRACT

Despite significant progress on the proportion of individuals who know their HIV status in 2020, Côte d'Ivoire (76%), Senegal (78%), and Mali (48%) remain far below, and key populations (KP) including female sex workers (FSW), men who have sex with men (MSM), and people who use drugs (PWUD) are the most vulnerable groups with a HIV prevalence at 5-30%. HIV self-testing (HIVST), a process where a person collects his/her own specimen, performs a test, and interprets the result, was introduced in 2019 as a new testing modality through the ATLAS project coordinated by the international partner organisation Solthis (IPO). We estimate the costs of implementing HIVST through 23 civil society organisations (CSO)-led models for KP in Côte d'Ivoire (N = 7), Senegal (N = 11), and Mali (N = 5). We modelled costs for programme transition (2021) and early scale-up (2022-2023). Between July 2019 and September 2020, a total of 51,028, 14,472, and 34,353 HIVST kits were distributed in Côte d'Ivoire, Senegal, and Mali, respectively. Across countries, 64-80% of HIVST kits were distributed to FSW, 20-31% to MSM, and 5-8% to PWUD. Average costs per HIVST kit distributed were $15 for FSW (Côte d'Ivoire: $13, Senegal: $17, Mali: $16), $23 for MSM (Côte d'Ivoire: $15, Senegal: $27, Mali: $28), and $80 for PWUD (Côte d'Ivoire: $16, Senegal: $144), driven by personnel costs (47-78% of total costs), and HIVST kits costs (2-20%). Average costs at scale-up were $11 for FSW (Côte d'Ivoire: $9, Senegal: $13, Mali: $10), $16 for MSM (Côte d'Ivoire: $9, Senegal: $23, Mali: $17), and $32 for PWUD (Côte d'Ivoire: $14, Senegal: $50). Cost reductions were mainly explained by the spreading of IPO costs over higher HIVST distribution volumes and progressive IPO withdrawal at scale-up. In all countries, CSO-led HIVST kit provision to KP showed relatively high costs during the study period related to the progressive integration of the programme to CSO activities and contextual challenges (COVID-19 pandemic, country safety concerns). In transition to scale-up and integration of the HIVST programme into CSO activities, this model shows large potential for substantial economies of scale. Further research will assess the overall cost-effectiveness of this model.


Subject(s)
COVID-19 , HIV Infections , Sex Workers , Sexual and Gender Minorities , Cote d'Ivoire/epidemiology , Female , HIV Infections/diagnosis , Homosexuality, Male , Humans , Male , Mali/epidemiology , Pandemics , SARS-CoV-2 , Self-Testing , Senegal
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