Dataset Information

Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women.

ABSTRACT: Introduction: Dual point-of-care tests (POCTs) for detecting antibodies to HIV and syphilis have been developed for use with venous whole blood, serum/plasma or finger-prick capillary whole blood. Several tests are commercially available showing encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, data on their performance in the field are limited. This prospective cross-sectional study will conduct a clinic-based evaluation to assess the performance characteristics and acceptability to end-users of two dual HIV/syphilis POCTs for the screening of HIV and syphilis among men who have sex with men (MSM), sex workers (SWs) and pregnant women (PW). This master protocol outlines the overall research approach that will be used in seven countries.

Method and analysis: MSM, SWs and PW presenting at clinic evaluation sites in high, low and middle-income countries will be enrolled. The (WHO preapproved) POCTs to be evaluated are SD Bioline HIV/Syphilis Duo (Abbott) and Dual Path Platform HIV-Syphilis Assay (Chembio). Finger-prick blood will be collected to perform POCTs and compared with laboratory results (venepuncture blood). Procedures will be carried out by trained healthcare staff and tests performed according to the manufacturers' directions. Sample size was calculated based on local prevalence of HIV and syphilis. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid to late 2021.

Ethics and dissemination: This core protocol was independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The protocol has been adapted to individual countries and approved by RP2, ERC and institutional review boards at each site. Results will be disseminated through peer-reviewed journals and relevant conferences.

SUBMITTER: ProSPeRo Network

PROVIDER: S-EPMC7692839 | BioStudies | 2020-01-01

REPOSITORIES: biostudies

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:HIV, syphilis, malaria and anaemia are leading preventable causes of adverse pregnancy outcomes in sub-Saharan Africa yet testing coverage for conditions other than HIV is low. Availing point-of-care tests (POCTs) at rural antenatal health facilities (dispensaries) has the potential to improve access and timely treatment. Fundamental to the adoption of and adherence to new diagnostic approaches are healthcare workers' and pregnant women's (end-users) buy-in. A qualitative approach was used to capture end-users' experiences of using POCTs for HIV, syphilis, malaria and anaemia to assess the appropriateness, acceptability and feasibility of integrated testing for ANC. METHODS:Seven dispensaries were purposively selected to implement integrated point-of-care testing for eight months in western Kenya. Semi-structured interviews were conducted with 18 healthcare workers (14 nurses, one clinical officer, two HIV testing counsellors, and one laboratory technician) who were trained, had experience doing integrated point-of-care testing, and were still working at the facilities 8-12?months after the intervention began. The interviews explored acceptability and relevance of POCTs to ANC, challenges with testing, training and supervision, and healthcare workers' perspectives of client experiences. Twelve focus group discussions with 118 pregnant women who had attended a first ANC visit at the study facilities during the intervention were conducted to explore their knowledge of HIV, syphilis, malaria, and anaemia, experience of ANC point-of-care testing services, treatments received, relationships with healthcare workers, and experience of talking to partners about HIV and syphilis results. RESULTS:Healthcare workers reported that they enjoyed gaining new skills, were enthusiastic about using POCTs, and found them easy to use and appropriate to their practice. Initial concerns that performing additional testing would increase their workload in an already strained environment were resolved with experience and proficiency with the testing procedures. However, despite having the diagnostic tools, general health system challenges such as high client to healthcare worker volume ratio, stock-outs and poor working conditions challenged the delivery of adequate counselling and management of the four conditions. Pregnant women appreciated POCTs, but reported poor healthcare worker attitudes, drug stock-outs, and fear of HIV disclosure to their partners as shortcomings to their ANC experience in general. CONCLUSION:This study provides insights on the acceptability, appropriateness, and feasibility of integrating POCTs into ANC services among end-users. While the innovation was desired and perceived as beneficial, future scale-up efforts would need to address health system weaknesses if integrated testing and subsequent effective management of the four conditions are to be achieved.

Project description:<h4>Background</h4>Dual HIV and syphilis testing might help to prevent mother-to-child transmission (MTCT) of HIV and syphilis through increased case detection and treatment. We aimed to model and assess the cost-effectiveness of dual testing during antenatal care in four countries with varying HIV and syphilis prevalence.<h4>Methods</h4>In this modelling study, we developed Markov models of HIV and syphilis in pregnant women to estimate costs and infant health outcomes of maternal testing at the first antenatal care visit with individual HIV and syphilis tests (base case) and at the first antenatal care visit with a dual rapid diagnostic test (scenario one). We additionally evaluated retesting during late antenatal care and at delivery with either individual tests (scenario two) or a dual rapid diagnosis test (scenario three). We modelled four countries: South Africa, Kenya, Colombia, and Ukraine. Strategies with an incremental cost-effectiveness ratio (ICER) less than the country-specific cost-effectiveness threshold (US$500 in Kenya, $750 in South Africa, $3000 in Colombia, and $1000 in Ukraine) per disability-adjusted life-year averted were considered cost-effective.<h4>Findings</h4>Routinely offering testing at the first antenatal care visit with a dual rapid diagnosis test was cost-saving compared with the base case in all four countries (ICER: -$26 in Kenya,-$559 in South Africa, -$844 in Colombia, and -$454 in Ukraine). Retesting during late antenatal care with a dual rapid diagnostic test (scenario three) was cost-effective compared with scenario one in all four countries (ICER: $270 in Kenya, $260 in South Africa, $2207 in Colombia, and $205 in Ukraine).<h4>Interpretation</h4>Incorporating dual rapid diagnostic tests in antenatal care can be cost-saving across countries with varying HIV prevalence. Countries should consider incorporating dual HIV and syphilis rapid diagnostic tests as the first test in antenatal care to support efforts to eliminate MTCT of HIV and syphilis.<h4>Funding</h4>WHO, US Agency for International Development, and the Bill & Melinda Gates Foundation.

Project description:INTRODUCTION:Paediatric consultations form a significant proportion of all consultations in ambulatory care. Point-of-care tests (POCTs) may offer a potential solution to improve clinical outcomes for children by reducing diagnostic uncertainty in acute illness, and streamlining management of chronic diseases. However, their clinical impact in paediatric ambulatory care is unknown. We aimed to describe the clinical impact of all in-vitro diagnostic POCTs on patient outcomes and healthcare processes in paediatric ambulatory care. METHODS:We searched MEDLINE, EMBASE, Pubmed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science from inception to 29 January 2020 without language restrictions. We included studies of children presenting to ambulatory care settings (general practice, hospital outpatient clinics, or emergency departments, walk-in centres, registered drug shops delivering healthcare) where in-vitro diagnostic POCTs were compared to usual care. We included all quantitative clinical outcome data across all conditions or infection syndromes reporting on the impact of POCTs on clinical care and healthcare processes. Where feasible, we calculated risk ratios (RR) with 95% confidence intervals (CI) by performing meta-analysis using random effects models. RESULTS:We included 35 studies. Data relating to at least one outcome were available for 89,439 children of whom 45,283 had a POCT across six conditions or infection syndromes: malaria (n = 14); non-specific acute fever 'illness' (n = 7); sore throat (n = 5); acute respiratory tract infections (n = 5); HIV (n = 3); and diabetes (n = 1). Outcomes centred around decision-making such as prescription of medications or hospital referral. Pooled estimates showed that malarial-POCTs (Plasmodium falciparum) better targeted antimalarial treatment by reducing over-treatment by a third compared to usual care (RR 0.67; 95% CI [0.58 to 0.77], n = 36,949). HIV-POCTs improved initiating earlier antiretroviral therapy compared to usual care (RR, 3.11; 95% CI [1.55 to 6.25], n = 912). Across the other four conditions, there was limited evidence for the benefit of POCTs in paediatric ambulatory care except for acute respiratory tract infections (RTI) in low-and-middle-income countries (LMICs), where POCT C-Reactive Protein (CRP) may reduce immediate antibiotic prescribing by a third (risk difference, -0.29 [-0.47, -0.11], n = 2,747). This difference was shown in randomised controlled trials in LMICs which included guidance on interpretation of POCT-CRP, specific training or employed a diagnostic algorithm prior to POC testing. CONCLUSION:Overall, there is a paucity of evidence for the use of POCTs in paediatric ambulatory care. POCTs help to target prescribing for children with malaria and HIV. There is emerging evidence that POCT-CRP may better target antibiotic prescribing for children with acute RTIs in LMIC, but not in high-income countries. Research is urgently needed to understand where POCTs are likely to improve clinical outcomes in paediatric settings worldwide.

Project description:<h4>Introduction</h4>The human treponematoses comprise venereal syphilis and the three non-venereal or endemic treponematoses yaws, bejel, and pinta. Serological assays remain the most common diagnostic method for all treponemal infections. Point-of-care tests (POCTs) for syphilis and yaws allow testing without further development of infrastructure in populations where routine laboratory facilities are not available. Alongside the test's performance characteristics assessed through diagnostic evaluation, it is important to consider broader issues when rolling out a POCT. Experience with malaria POCT roll-out in sub-Saharan Africa has demonstrated that both healthcare worker and patient beliefs may play a major role in shaping the real-world use of POCTs. We conducted a qualitative study evaluating healthcare worker and patient perceptions of using a syphilis/yaws POCT in clinics in the East Malaita region of Malaita province in the Solomon Islands. Prior to the study serology was only routinely available at the local district hospital.<h4>Methods</h4>The POCT was deployed in the outpatient and ante-natal departments of a district hospital and four rural health clinics served by the hospital. Each site was provided with training and an SOP on the performance, interpretation and recording of results. Treatment for those testing positive was provided, in line with Solomon Islands Ministry of Health and Medical Services' guidelines for syphilis and yaws respectively. Alongside the implementation of the POCT we facilitated semi-structured interviews with both nurses and patients to explore individuals' experiences and beliefs in relation to use of the POCT.<h4>Results and discussion</h4>Four main themes emerged in the interviews: 1) training and ease of performing the test; 2) time taken and ability to fit the test into a clinical workflow; 3) perceived reliability and trustworthiness of the test; and 4) level of the health care system the test was most usefully deployed. Many healthcare workers related their experience with the POCT to their experience using similar tests for malaria. Although the test was considered to take a relatively long time to perform the benefits of improved access to testing were considered positive by most healthcare workers. Qualitative data is needed to help inform better training packages to support the implementation of POCT in low-resource settings.

Project description:<b>Background: </b>Not all men who have sex with men (MSM) at risk for sexually transmitted infections (STIs) and human immunodeficiency virus (HIV) infection currently receive sexual healthcare. To increase the coverage of high-quality HIV/STI care for MSM, we developed a home-care programme, as extended STI clinic care. This programme included home sampling for testing, combined with treatment and sexual health counselling. Here, we pilot implemented the programme in a hospital setting (HIV-positive MSM) to determine the factors for the successful implementation of STI home sampling strategies.<br><br><b>Methods: </b>Healthcare providers from the HIV hospital treatment centre (Maastricht) were invited to offer free STI sampling kits (syphilis, hepatitis B, [extra]genital chlamydia and gonorrhoea laboratory testing) to their HIV-positive MSM patients (March to May 2018). To evaluate implementation of the program, quantitative and qualitative data were collected to assess adoption (HIV care providers offered sampling kits to MSM), participation (MSM accepted the sampling kits) and sampling-kit return, STI diagnoses, and implementation experiences.<br><br><b>Results: </b>Adoption was 85.3% (110/129), participation was 58.2% (64/110), and sampling-kit return was 43.8% (28/64). Of the tested MSM, 64.3% (18/28) did not recently (<?3?months) undergo a STI test; during the programme, 17.9% (5/28) were diagnosed with an STI. Of tested MSM, 64.3% (18/28) was vaccinated against hepatitis B. MSM reported that the sampling kits were easily and conveniently used. Care providers (hospital and STI clinic) considered the programme acceptable and feasible, with some logistical challenges. All (100%) self-taken chlamydia and gonorrhoea samples were adequate for testing, and 82.1% (23/28) of MSM provided sufficient self-taken blood samples for syphilis screening. However, full syphilis diagnostic work-up required for MSM with a history of syphilis (18/28) was not possible in 44.4% (8/18) of MSM because of insufficient blood sampled.<br><br><b>Conclusion: </b>The home sampling programme increased STI test uptake and was acceptable and feasible for MSM and their care providers. Return of sampling kits should be further improved. The home-care programme is a promising extension of regular STI care to deliver comprehensive STI care to the home setting for MSM. Yet, in an HIV-positive population, syphilis diagnosis may be challenging when using self-taken blood samples.

Dataset Information

Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure