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-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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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.

BMJ open 20201126 11

<h4>Introduction</h4>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 ...[more]

PMID: 33243821

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Project description:BackgroundDual point-of-care tests (POCTs) for the simultaneous detection of antibodies to HIV and syphilis have been developed. Since community-based organisations (CBO) are effective providers of HIV and syphilis testing among men who have sex with men (MSM), evaluation of the utility of these dual tests at CBO testing services is a high priority. The aim of this study is to determine the feasibility of performing dual HIV-syphilis POCT testing among both users and providers at these non-clinical sites.MethodsThis evaluation assessed the utility of two lateral flow immunochromatographic antibody technologies for dual screening for HIV/syphilis among MSM seeking testing in four CBO testing services in Spain, Slovenia, Latvia, and Ukraine. The study's conceptual framework divides the concept of feasibility into two inter-related domains, acceptability, and usability and further breaks it down into six subdomains: learnability, willingness, suitability, satisfaction, efficacy, and effectiveness. The feasibility analysis was performed by calculating the median score in 3 stages (for individual questions, subdomains, and domains), using a summated scores method.ResultsThe final sample included 844 participants, 60 of which were found to be HIV test positive (7.1%) and 61 (7.2%) positive on testing for syphilis. There was a small difference (1.1%) when comparing the results of the two dual POCTs under evaluation to the tests routinely used at each site. The inter-rater agreement showed a high concordance between two independent readings. The analysis of the feasibility for the users of the services indicated good satisfaction, suitability, and willingness. In addition, among 18 providers the total mean score showed good acceptability and usability, good willingness, easy learnability, high suitability, and good efficacy, but lower satisfaction and effectiveness. The operational characteristics of both dual study POCTs were well evaluated by providers.ConclusionsThe introduction of dual HIV and syphilis POCTs in CBO testing services for screening of MSM is feasible, with a high acceptability and usability both for users and providers. Implementation of dual POCTs for HIV and syphilis in CBO testing services is an opportunity for scaling up integrated HIV/syphilis testing for MSM.

Project description:BackgroundSocial network-based strategies can expand HIV/syphilis self-tests among men who have sex with men (MSM). Sexual health influencers are individuals who are particularly capable of spreading information about HIV and other sexually transmitted infections (STIs) within their social networks. However, it remains unknown whether a sexual health influencer can encourage their peers to self-test for HIV/syphilis.ObjectiveThe aims of this study were to examine the impact of MSM sexual health influencers on improving HIV/syphilis self-test uptake within their social networks compared to that of nonsexual health influencers.MethodsIn Zhuhai, China, men 16 years or older, born biologically male, who reported ever having had sex with a man, and applying for HIV/syphilis self-tests were enrolled online as indexes and encouraged to distribute self-tests to individuals (alters) in their social network. Indexes scoring >3 on a sexual health influencer scale were considered to be sexual health influencers (Cronbach α=.87). The primary outcome was the mean number of alters encouraged to test per index for sexual health influencers compared with the number encouraged by noninfluencers.ResultsParticipants included 371 indexes and 278 alters. Among indexes, 77 (20.8%) were sexual health influencers and 294 (79.2%) were noninfluencers. On average, each sexual health influencer successfully encouraged 1.66 alters to self-test compared to 0.51 alters encouraged by each noninfluencer (adjusted rate ratio 2.07, 95% CI 1.59-2.69). More sexual health influencers disclosed their sexual orientation (80.5% vs 67.3%, P=.02) and were community-based organization volunteers (18.2% vs 2.7%, P<.001) than noninfluencers. More alters of sexual health influencers came from a rural area (45.5% vs 23.8%, P<.001), had below-college education (57.7% vs 37.1%, P<.001), and had multiple casual male sexual partners in the past 6 months (25.2% vs 11.9%, P<.001).ConclusionsBeing a sexual health influencer was associated with encouraging more alters with less testing access to self-test for HIV/syphilis. Sexual health influencers can be engaged as seeds to expand HIV/syphilis testing coverage.

Project description:BackgroundThe epidemiology of incident syphilis infection among HIV-1-infected men who have sex with men (MSM) largely remains unknown.MethodsThe incidence and risk factors for incident syphilis (positive TPHA and RPR> = 1:8) among HIV-1-infected MSM who visited a large HIV clinic in Tokyo for the first time between 2008 and 2013 were determined, using clinical data and stored blood samples taken every three months for screening and determination of the date of incident syphilis. Poisson regression compared the incidence of syphilis at different observation periods.ResultsOf 885 HIV-1-infected MSM with baseline data, 34% either presented with active syphilis at baseline (21%) or became infected with syphilis during follow-up (13%). After excluding 214 patients (MSM with syphilis at baseline (n = 190) and no follow-up syphilis test (n = 24)), of 671 men, 112 (17%) developed incident syphilis with an incidence of 43.7/1,000 person-years [95% CI, 36.5-52.3]. The incidence decreased slightly during observation period although the trend was not significant (2008-2009: 48.2/1,000 person-years, 2010-2011: 51.1/1,000 person-years, 2012-2013: 42.6/1,000 person-years, 2014 to 2015: 37.9/1,000 person-years, p = 0.315). Multivariable analysis identified young age (<33 years versus >40, HR 4.0, 95%CI 2.22-7.18, p<0.001), history of syphilis at baseline (HR 3.0, 95%CI 2.03-4.47, p<0.001), positive anti-amoeba antibody (HR 1.8, 95%CI 1.17-2.68, p = 0.006), and high baseline CD4 count (CD4 ≥350 /μL versus CD4 <200, HR 1.6, 95%CI 1.00-2.53, p = 0.050) as risk factors for incident syphilis. Incidence of syphilis was particularly high among young patients (age <33 years: 60.1/1,000 person-years). Interestingly, 37% of patients with incident syphilis were asymptomatic.ConclusionsAlthough incidence of syphilis did not increase during the observation period, it was high among HIV-1-infected MSM, especially among young HIV-1-infected MSM and those with history of syphilis, in Tokyo. Regular screening for syphilis needs to be strictly applied to this population.

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.

Publications

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.

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