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
Open accessAbstract
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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In two RCTs and pooled analysis, there was little to no difference between self-testing and standard testing in proportion with reactive syphilis result.
“In the same two RCTs (64, 66), there appeared to be little to no difference between these groups, and the same was true in the pooled analysis combining data from both studies (64, 66).”
From Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (syphilis) and new recommendations on syphilis testing and partner services (2024) · cites this paper as [66]
The Results (page unavailable) report five newly identified syphilis infections: one in standard care and two in each self-testing arm. This gives some support for similar numbers of new diagnoses, but the paper does not report a comparison of the proportions with reactive results or a pooled analysis of two RCTs. (LLM, conf=0.76)
Experimental — accuracy not yet measuredUptake could potentially be higher when offering dual HIV/syphilis self-testing versus self-testing only for syphilis.
“Some evidence from these two RCTs suggested that uptake could potentially be higher when offering dual HIV/syphilis self-testing versus self-testing only for syphilis (64, 66).”
From Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (syphilis) and new recommendations on syphilis testing and partner services (2024) · cites this paper as [66]
The Discussion says that using a dual HIV/syphilis self-test might have increased uptake because participants were interested in HIV testing. This supports the possibility behind the claim, but the trial did not compare dual self-testing with syphilis-only self-testing; its Results compare dual-test arms with standard care. (LLM, conf=0.82)
Experimental — accuracy not yet measuredSeveral studies showed that most participants were able to correctly self-test.
“Several studies showed that most participants were able to correctly self-test (62, 64, 66-69).”
From Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (syphilis) and new recommendations on syphilis testing and partner services (2024) · cites this paper as [66]
The Results report that 93.5% of uploaded test-result photos matched participants’ self-reported results, supporting correct interpretation among those who uploaded photos. But only 48.2% of participants uploaded a photo, and the paper does not establish that most participants performed the entire self-test correctly. (LLM, conf=0.82)
Experimental — accuracy not yet measuredSome users had difficulties with steps to collect and transfer their sample, particularly finger pricking and using a capillary tube to transfer blood from the finger to the cassette.
“Some users had difficulties with the steps to collect and transfer their sample, particularly with finger pricking and using the capillary tube to transfer blood from the finger to the cassette (62, 66).”
From Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (syphilis) and new recommendations on syphilis testing and partner services (2024) · cites this paper as [66]
The Results (page unavailable) say eight men asked for help using the self-test or interpreting its result, which offers limited support for users needing assistance. The paper does not say they had difficulty with finger pricking or transferring blood with a capillary tube; searches for those terms found no such report. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe systematic review included 12 publications of about seven different studies, of which two were RCTs.
“Overall, the review included 12 publications of about seven different studies (61-72), of which two were RCTs (64, 66).”
In both China and Zimbabwe, cost per person tested with syphilis self-tests or dual HIV/syphilis self-tests was less than half the cost of standard syphilis testing.
“In both China and Zimbabwe, the cost per person tested with syphilis self-tests or dual HIV/syphilis self-tests was less than half the cost of standard syphilis testing (64, 66).”
No social harm or adverse events were identified or reported in the RCT publications.
“No social harm or adverse events were identified or reported in the RCT publications (64, 66).”
From Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum (syphilis) and new recommendations on syphilis testing and partner services (2024) · cites this paper as [66]
The Methods > Outcomes and Results passages do not report whether social harms or adverse events occurred. Searches for “social harm” and “adverse events” found the adverse-event statement only in the abstract, which is not admissible evidence under the specified rubric; no eligible passage settles the claim. (LLM, conf=0.70)
Experimental — accuracy not yet measured
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- Authors
- Wang, C., Ong, J. J., Zhao, P., Weideman, A. M., Tang, W., Smith, M. K., Marks, M., Fu, H., Cheng, W., Terris-Prestholt, F., Zheng, H., Tucker, J. D., & Yang, B.
- Affiliations
- Southern Medical University (CN)
- London School of Hygiene & Tropical Medicine (GB)
- University of North Carolina at Chapel Hill (US)
- University of Minnesota (US)
- Eastern Virginia Medical School (US)
- Corresponding author
- Wang, Cheng
- Tucker, Joseph D.
- Yang, Bin
- ORCID
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2022-03-02
- Volume
- 19
- Issue
- 3
- Pages
- e1003930
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC8890628
- OpenAlex
- W4214881936
- Cited by
- 33
- References
- 40
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 3 · 2023: 12 · 2022: 7
- FWCI
- 4.18
- Type
- journal article
- Language
- en
- Update notices
- correction (2022-08-04)
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- Warwick Research Archive Portal (University of Warwick) (submittedVersion)
- UNC Libraries
- Funders
- national natural science foundation of china (81772240)
- Topics
- Health Sciences › Medicine › Physiology › Syphilis Diagnosis and Treatment
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Keywords
- HIV self-testing, men who have sex with men, lottery incentives, rapid diagnostic tests, condomless anal sex, sexually transmitted infections, China, cost-effectiveness, health care utilization, syphilis screening, sexual health services
- MeSH terms
- Sexual and Gender Minorities, Self-Testing, COVID-19, SARS-CoV-2, Adolescent, Adult, China, Follow-Up Studies, Health Services Accessibility, Humans, Immunoassay, Male, Mass Screening, Middle Aged, Motivation, Patient Participation, Reagent Kits, Diagnostic, Syphilis, HIV Infections, Homosexuality, Male, Young Adult, Pandemics
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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