Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive

Cheng, Weibin; Wang, Cheng Yee; Tang, Weiming; Ong, Jason J.; Fu, Hongyun; Marks, Michael; Smith, M. Kumi; Li, Changchang; Nie, Juan; Zhao, Peizhen; Zheng, Heping; Yang, Bin; Tucker, Joseph D.

doi:10.1186/s12879-020-05188-z

Cited by 11 publications

(11 citation statements)

References 31 publications

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“…Hence, additional efforts (searching the patients' medical history) are still required. Although development and implementation for syphilis home sampling is promising [23,26,27], it is also challenging. A large study from the UK with home sampling using capillary blood sampling found that only 54% of the samples contained sufficient blood for syphilis testing [28].…”

Section: Discussionmentioning

confidence: 99%

Pilot implementation of a home-care programme with chlamydia, gonorrhoea, hepatitis B, and syphilis self-sampling in HIV-positive men who have sex with men

et al. 2020

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Background 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. Methods 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. Results 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. Conclusion 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.

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Section: Discussionmentioning

confidence: 99%

Pilot implementation of a home-care programme with chlamydia, gonorrhoea, hepatitis B, and syphilis self-sampling in HIV-positive men who have sex with men

et al. 2020

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“…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 ].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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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 (90·7%, 136/150) in the standard of care arm, 142 (94·0%, 142/151) in the standard of SST arm, and 137 (91·3%, 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.

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“…Syphilis remains a global health priority. The WHO estimated that the prevalence of syphilis among men who have sex with men (MSM) is 5% or more in at least 42 countries in 2018 [ 1 ]. From 2006 to 2012, the incidence of syphilis was 9.6 per 100 person-years among MSM living in China [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Social network distribution of syphilis self-testing among men who have sex with men in China: study protocol for a cluster randomized control trial

et al. 2021

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Background Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China. Methods We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm. Discussion The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network. Trial registration Chinese Clinical Trial Registry, ChiCTR2000036988. Registered 26 August 2020 - Retrospectively registered.

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Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive

Cited by 11 publications

References 31 publications

Pilot implementation of a home-care programme with chlamydia, gonorrhoea, hepatitis B, and syphilis self-sampling in HIV-positive men who have sex with men

Pilot implementation of a home-care programme with chlamydia, gonorrhoea, hepatitis B, and syphilis self-sampling in HIV-positive men who have sex with men

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

Social network distribution of syphilis self-testing among men who have sex with men in China: study protocol for a cluster randomized control trial

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