| 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:
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SST [4]
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| 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
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HIV-self
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Treponema pallidum
US$66.19
Fig B in S1 Appendix
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US$1
[16]
China [4
volunteer MSM
−24.4
syphilis [7]
Food
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isotypes
HIV/syphilis
human papillomavirus
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's
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Blued's portal
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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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