expanding syphilis test uptake using rapid dual self testing for syphilis and hiv CORD-Papers-2022-06-02 (Version 1)

Title: Expanding syphilis test uptake using rapid dual self-testing for syphilis and HIV among men who have sex with men in China: A multiarm randomized controlled trial
Abstract: BACKGROUND: Low syphilis testing uptake is a major public health issue among men who have sex with men (MSM) in many low- and middle-income countries. Syphilis self-testing (SST) may complement and extend facility-based testing. We aimed to evaluate the effectiveness and costs of providing SST on increasing syphilis testing uptake among MSM in China. METHODS AND FINDINGS: An open-label parallel 3-arm randomized controlled trial (RCT) was conducted between January 7 2020 and July 17 2020. Men who were at least 18 years of age had condomless anal sex with men in the past year reported not testing for syphilis in the last 6 months and had a stable residence with mailing addresses were recruited from 124 cities in 26 Chinese provinces. Using block randomization with blocks of size 12 enrolled participants were randomly assigned (1:1:1) into 3 arms: standard of care arm standard SST arm and lottery incentivized SST arm (1 in 10 chance to win US$15 if they had a syphilis test). The primary outcome was the proportion of participants who tested for syphilis during the trial period and confirmed with photo verification and between arm comparisons were estimated with risk differences (RDs). Analyses were performed on a modified intention-to-treat basis: Participants were included in the complete case analysis if they had initiated at least 1 follow-up survey. The Syphilis/HIV Duo rapid test kit was used. A total of 451 men were enrolled. In total 136 (907% 136/150) in the standard of care arm 142 (940% 142/151) in the standard of SST arm and 137 (913% 137/150) in the lottery incentivized SST arm were included in the final analysis. The proportion of men who had at least 1 syphilis test during the trial period was 63.4% (95% confidence interval [CI]: 55.5% to 71.3% p = 0.001) in the standard SST arm 65.7% (95% CI: 57.7% to 73.6% p = 0.0002) in the lottery incentivized SST arm and 14.7% (95% CI: 8.8% to 20.7% p < 0.001) in the standard of care arm. The estimated RD between the standard SST and standard of care arm was 48.7% (95% CI: 37.8% to 58.4% p < 0.001). The majority (78.5% 95% CI: 72.7% to 84.4% p < 0.001) of syphilis self-testers reported never testing for syphilis. The cost per person tested was US$26.55 for standard SST US$28.09 for the lottery incentivized SST and US$66.19 for the standard of care. No study-related adverse events were reported during the study duration. Limitation was that the impact of the Coronavirus Disease 2019 (COVID-19) restrictions may have accentuated demand for decentralized testing. CONCLUSIONS: Compared to standard of care providing SST significantly increased the proportion of MSM testing for syphilis in China and was cheaper (per person tested). TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1900022409.
Published: 2022-03-02
Journal: PLoS Med
DOI: 10.1371/journal.pmed.1003930
DOI_URL: http://doi.org/10.1371/journal.pmed.1003930
Author Name: Wang Cheng
Author link: https://covid19-data.nist.gov/pid/rest/local/author/wang_cheng
Author Name: Ong Jason J
Author link: https://covid19-data.nist.gov/pid/rest/local/author/ong_jason_j
Author Name: Zhao Peizhen
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zhao_peizhen
Author Name: Weideman Ann Marie
Author link: https://covid19-data.nist.gov/pid/rest/local/author/weideman_ann_marie
Author Name: Tang Weiming
Author link: https://covid19-data.nist.gov/pid/rest/local/author/tang_weiming
Author Name: Smith M Kumi
Author link: https://covid19-data.nist.gov/pid/rest/local/author/smith_m_kumi
Author Name: Marks Michael
Author link: https://covid19-data.nist.gov/pid/rest/local/author/marks_michael
Author Name: Fu Hongyun
Author link: https://covid19-data.nist.gov/pid/rest/local/author/fu_hongyun
Author Name: Cheng Weibin
Author link: https://covid19-data.nist.gov/pid/rest/local/author/cheng_weibin
Author Name: Terris Prestholt Fern
Author link: https://covid19-data.nist.gov/pid/rest/local/author/terris_prestholt_fern
Author Name: Zheng Heping
Author link: https://covid19-data.nist.gov/pid/rest/local/author/zheng_heping
Author Name: Tucker Joseph D
Author link: https://covid19-data.nist.gov/pid/rest/local/author/tucker_joseph_d
Author Name: Yang Bin
Author link: https://covid19-data.nist.gov/pid/rest/local/author/yang_bin
sha: 4418f1695fdb63a24486f57aed488fbb715b741c
license: cc-by
license_url: https://creativecommons.org/licenses/by/4.0/
source_x: Medline; PMC; WHO
source_x_url: https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/https://www.who.int/
pubmed_id: 35235573
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/35235573
pmcid: PMC8890628
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8890628
url: https://doi.org/10.1371/journal.pmed.1003930 https://www.ncbi.nlm.nih.gov/pubmed/35235573/
has_full_text: TRUE
Keywords Extracted from Text Content: MSM men Syphilis self-testing Blued's portal website cell isotypes TP human serum SST services US$ syphilis self-testers patients a1111111111 a1111111111 CIs a1111111111 US$5 human papillomavirus Fig A man FMI max m HIV/syphilis Coronavirus Disease 2019 HIV/STIs China [4 herpes simplex virus men participants SST [4] immunoglobulin M Pleasenotetha gG syphilis [7] [27] ) 8/18 SST VCT SST arm FCS 2,713 people lottery-based blood friends RDs Treponema pallidum AM COVID-19 immunoglobulin A [16] immunoglobulin G [IAU −24.4 SST arm and 117 facility-based CFDA MSM Fig 2 anal US$1 Chan MA SMS −0.3 FMI max /m� STIs Sojump QQ HIV-self PleasenotethatIgAhasbeendefinedasimmunog plasma US$3 volunteer MSM HIV/SST WeChat China-particularly Food −12.2 syphilis
Extracted Text Content in Record: First 5000 Characters:Background AU : Pleaseconfirmthatallheadinglevelsarerepresentedcorrectly: Low syphilis testing uptake is a major public health issue among men who have sex with men (MSM) in many low-and middle-income countries. Syphilis self-testing (SST) may complement and extend facility-based testing. We aimed to evaluate the effectiveness and costs of providing SST on increasing syphilis testing uptake among MSM in China. a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 There were an estimated 6.3 million new cases of syphilis globally in 2016 [1] . Countries have noted syphilis increasing particularly among men who have sex with men (MSM) [2] . This higher risk may be related to structural factors such as denser sexual networks and stigma leading to poorer access to health services and individual factors such as condomless sex with multiple partners [3, 4] . In China, syphilis incidence has increased from 1.0 to 32.2 per 100,000 between 1995 and 2016 [5] . Regular syphilis testing is a key strategy for syphilis control [6, 7] . Earlier diagnosis and treatment prevents morbidity, mortality, and onward transmission [7] . In most countries, syphilis testing occurs in health facilities [8] , but existing facility-based syphilis testing and management resources and services are inadequate to curb the spread of syphilis. Studies suggest that only 30% of MSM in China have ever received a syphilis test [9] . Anticipated stigma associated with syphilis, lack of sexual behavior disclosure to health professionals [8] , and the Coronavirus Disease 2019 (COVID-19) restrictions make facility testing more difficult. Syphilis self-testing (SST) may be an effective method to address these barriers by complementing and extending facility-based testing [9] . There are efforts to decentralize syphilis testing, including venue-based testing, self-sampling (sending a specimen to a laboratory), and self-testing [9, 10] . SST is a process whereby an individual collects their own specimen, performs the test, and interprets the result themselves [4] . An immunochromatographic test uses blood to detect treponemal antibodies using a rapid test [11] , similar to blood-based HIV self-testing. Evidence from a large body of bloodbased HIV self-testing programs worldwide demonstrates the feasibility, acceptability, and efficacy of decentralized sexually transmitted infections (STIs) testing and increasing testing uptake among MSM [12] . A cross-sectional study of 699 MSM from 21 provinces in China found 48% of MSM who had tested for syphilis used self-testing [4] . This study also reported that 52% of MSM reported that SST was their first syphilis test. Thus, decentralizing syphilis testing by providing more options for home-testing can open up new possibilities to deliver syphilis testing to those in greatest need. However, the policy context for SST and HIV selftesting is different. Although 59 countries have policies supporting the use of HIV self-testing among key populations [13] , none have guidelines supporting SST. In recent years, there is growing interest in using social innovation methods to solve complex problems [14] . For example, crowdsourcing (where a group of individuals solve a problem and solutions are shared with the public) [15] could be combined with the insight that financial incentives could enhance healthy behaviors [16] . There is evidence that financial incentives may improve uptake of HIV/STI testing [17] . We previously reported that MSM living in China-particularly those at higher risk for syphilis-reported that they were more likely to test for syphilis if a lottery-based incentive was available [18] . A lottery-based incentive is a form of financial incentive whereby an individual who receives a syphilis test is enrolled in a chance to win a monetary reward. We conducted a crowdsourcing call with MSM in China to design a lottery-based incentive to examine if the addition of this would further enhance the appeal of SST. The combination of the implementation of SST with lottery-based financial incentives has not been explored. This study aimed to evaluate the effectiveness and cost of providing SST on increasing syphilis testing uptake among MSM in China compared with standard of care. The primary null hypothesis was no difference between standard SST and the standard of care among MSM in China. Our secondary objective was to examine the difference between lottery incentivized SST and standard SST. Before implementing this trial, we assessed the acceptability, benefits, and harms associated with SST [4] , examined participants' ability to follow test instructions and interpret results [19] , and evaluated the study design, recruitment process, and materials [19] . The full study protocol has been published elsewhere (S1 Study Protocol) [19] . This is an open-label, parallel 3-arm randomized controlled trial (RCT) with individuals randomized in a 1:1:1 ratio to 3 study arms: control arm (standard of care); stan
Keywords Extracted from PMC Text: RDs TP HIV-self [27]) Treponema pallidum US$66.19 Fig B in S1 Appendix US$ SST services US$1 [16] China [4 volunteer MSM −24.4 syphilis [7] Food CFDA VCT Fig 2 WeChat FMImax immunoglobulin M US$3 syphilis— plasma cell HIV/STIs AM m syphilis self-testers low- 2,713 lottery-based −0.3 man COVID-19 anal SMS STIs SST [4] FCS immunoglobulin A facility-based isotypes HIV/syphilis human papillomavirus Fig A 8/18 people HIV/SST CIs immunoglobulin G QQ 's men MSM MA Chan friends SST arm Blued's portal SST patients blood IgM Coronavirus Disease 2019 FMImax/m≈0.01 US$5 " participants syphilis Sojump human serum −12.2 herpes simplex virus SST arm and 117
Extracted PMC Text Content in Record: First 5000 Characters:There were an estimated 6.3 million new cases of syphilis globally in 2016 [1]. Countries have noted syphilis increasing particularly among men who have sex with men (MSM) [2]. This higher risk may be related to structural factors such as denser sexual networks and stigma leading to poorer access to health services and individual factors such as condomless sex with multiple partners [3,4]. In China, syphilis incidence has increased from 1.0 to 32.2 per 100,000 between 1995 and 2016 [5]. Regular syphilis testing is a key strategy for syphilis control [6,7]. Earlier diagnosis and treatment prevents morbidity, mortality, and onward transmission [7]. In most countries, syphilis testing occurs in health facilities [8], but existing facility-based syphilis testing and management resources and services are inadequate to curb the spread of syphilis. Studies suggest that only 30% of MSM in China have ever received a syphilis test [9]. Anticipated stigma associated with syphilis, lack of sexual behavior disclosure to health professionals [8], and the Coronavirus Disease 2019 (COVID-19) restrictions make facility testing more difficult. Syphilis self-testing (SST) may be an effective method to address these barriers by complementing and extending facility-based testing [9]. There are efforts to decentralize syphilis testing, including venue-based testing, self-sampling (sending a specimen to a laboratory), and self-testing [9,10]. SST is a process whereby an individual collects their own specimen, performs the test, and interprets the result themselves [4]. An immunochromatographic test uses blood to detect treponemal antibodies using a rapid test [11], similar to blood-based HIV self-testing. Evidence from a large body of blood-based HIV self-testing programs worldwide demonstrates the feasibility, acceptability, and efficacy of decentralized sexually transmitted infections (STIs) testing and increasing testing uptake among MSM [12]. A cross-sectional study of 699 MSM from 21 provinces in China found 48% of MSM who had tested for syphilis used self-testing [4]. This study also reported that 52% of MSM reported that SST was their first syphilis test. Thus, decentralizing syphilis testing by providing more options for home-testing can open up new possibilities to deliver syphilis testing to those in greatest need. However, the policy context for SST and HIV self-testing is different. Although 59 countries have policies supporting the use of HIV self-testing among key populations [13], none have guidelines supporting SST. In recent years, there is growing interest in using social innovation methods to solve complex problems [14]. For example, crowdsourcing (where a group of individuals solve a problem and solutions are shared with the public) [15] could be combined with the insight that financial incentives could enhance healthy behaviors [16]. There is evidence that financial incentives may improve uptake of HIV/STI testing [17]. We previously reported that MSM living in China—particularly those at higher risk for syphilis—reported that they were more likely to test for syphilis if a lottery-based incentive was available [18]. A lottery-based incentive is a form of financial incentive whereby an individual who receives a syphilis test is enrolled in a chance to win a monetary reward. We conducted a crowdsourcing call with MSM in China to design a lottery-based incentive to examine if the addition of this would further enhance the appeal of SST. The combination of the implementation of SST with lottery-based financial incentives has not been explored. This study aimed to evaluate the effectiveness and cost of providing SST on increasing syphilis testing uptake among MSM in China compared with standard of care. The primary null hypothesis was no difference between standard SST and the standard of care among MSM in China. Our secondary objective was to examine the difference between lottery incentivized SST and standard SST. Before implementing this trial, we assessed the acceptability, benefits, and harms associated with SST [4], examined participants' ability to follow test instructions and interpret results [19], and evaluated the study design, recruitment process, and materials [19]. The full study protocol has been published elsewhere (S1 Study Protocol) [19]. This is an open-label, parallel 3-arm randomized controlled trial (RCT) with individuals randomized in a 1:1:1 ratio to 3 study arms: control arm (standard of care); standard SST arm; and lottery incentivized SST arm. Control arm participants received information on self-referral pathways for free facility-based syphilis testing. Both self-testing arms were offered access to dual syphilis/HIV self-test kits for free at monthly intervals via mail. Recruitment took place from January 7, 2020 to January 17, 2020. Participants in each arm were followed every 3 months for 6 months. The trial follow-up and data collection were completed on July 17, 2020. The follow-u
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