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.

BACKGROUND: Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China. METHODS: Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months. DISCUSSION: Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally. TRIAL REGISTRATION: ChiCTR1900022409 (10 April, 2019).

Subsequent pregnancies in women with previous gestational syphilis.

This study included data on syphilis-positive pregnant women seen for delivery or miscarriage, between 1997 and 2004, in Sao Lucas Hospital, Porto Alegre, RS. Their subsequent obstetric outcomes were studied, until December 2011, to see if the disease recurred. From 450 pregnant women with positive syphilis serology, seen from 1997 to 2004, 166 had at least one more obstetric attendance until December 2011, with 266 new obstetric outcomes. Congenital syphilis (CS) was demonstrated in 81.9% of the initial pregnancies and in 68.4% of the subsequent ones. The main causes of CS in subsequent pregnancies were a negative VDRL that turned positive at delivery, and undocumented treatment. VDRL titers were higher than 1:4 in 50.4% of the initial and 13.3% of the subsequent pregnancies (p < 0.01). Perinatal mortality rate was 119/1000 in initial and 41/1000 in subsequent pregnancies (p < 0.01). CS recurrence was frequent in subsequent pregnancies of women who tested positive for syphilis in a preceding pregnancy. No or inadequate prenatal care was the main risk factor for CS, both in initial and in subsequent pregnancies. These data suggest that non-infected neonates could have been defined as CS cases because of insufficient information about the mother's history.

Gestações subsequentes em mulheres que tiveram sífilis na gestação / Subsequent pregnancies in women with previous gestational syphilis

ResumoEste estudo incluiu gestantes positivas para sífilis atendidas por parto ou aborto, entre 1997 e 2004, no Hospital São Lucas, Porto Alegre, RS. Foram levantados desfechos obstétricos subsequentes das mesmas, até dezembro 2011, para investigar a recorrência da doença. De 450 gestantes com sorologia positiva, atendidas de 1997 a 2004, 166 tiveram pelo menos mais um atendimento obstétrico até dezembro de 2011, sendo incluídos 266 novos desfechos obstétricos. A sífilis congênita (SC) foi evidenciada em 81,9% das gestações iniciais e em 68,4% das subsequentes. As principais causas da SC nas gestações subsequentes foram positivação do VDRL no parto e tratamento não documentado. Os títulos de VDRL foram superiores a 1:4, em 50,4% nas gestações iniciais, e em 13,3% nas subsequentes (p < 0,001). A taxa de natimortalidade foi de 119/1000, nas gestações iniciais, e de 41/1000, nas subsequentes (p < 0,01). A recorrência da SC foi frequente em gestações sucessivas da mesma paciente. A ausência ou inadequação de pré-natal foi o principal fator de risco para SC, tanto nas gestações iniciais quanto nas subsequentes. Os dados obtidos sugerem que, nas gestações subsequentes, mais neonatos não infectados podem ter sido definidos como casos de SC, pela insuficiência de informação sobre os antecedentes pré-natais da gestante.

AbstractThis study included data on syphilis-positive pregnant women seen for delivery or miscarriage, between 1997 and 2004, in Sao Lucas Hospital, Porto Alegre, RS. Their subsequent obstetric outcomes were studied, until December 2011, to see if the disease recurred. From 450 pregnant women with positive syphilis serology, seen from 1997 to 2004, 166 had at least one more obstetric attendance until December 2011, with 266 new obstetric outcomes. Congenital syphilis (CS) was demonstrated in 81.9% of the initial pregnancies and in 68.4% of the subsequent ones. The main causes of CS in subsequent pregnancies were a negative VDRL that turned positive at delivery, and undocumented treatment. VDRL titers were higher than 1:4 in 50.4% of the initial and 13.3% of the subsequent pregnancies (p < 0.01). Perinatal mortality rate was 119/1000 in initial and 41/1000 in subsequent pregnancies (p < 0.01). CS recurrence was frequent in subsequent pregnancies of women who tested positive for syphilis in a preceding pregnancy. No or inadequate prenatal care was the main risk factor for CS, both in initial and in subsequent pregnancies. These data suggest that non-infected neonates could have been defined as CS cases because of insufficient information about the mother's history.

Evaluation of syphilis serostatus on the safety of IVF treatment.

An increasing number of infertile syphilis-infected individuals have turned to assisted reproductive technology; however, the safety of syphilis carrier serostatus on IVF and embryo transfer outcomes has not been evaluated. Data from 482 patients who delivered singletons were analysed. In the retrospective study, the rate of IVF and intracytoplasmic sperm injection fertilization was 79.50% ± 17.57%/78.72% ± 16.66% in the Treponema pallidum particle agglutination assay negative (TPPA-negative) and rapid plasma reagin negative (RPR-negative) group, 76.12% ± 22.99%/74.05% ± 20.31% in the TPPA-positive and RPR-negative group, and 75.66% ± 21.72%/70.90% ± 16.11% in the TPPA-positive and RPR-positive group. The clinical pregnancy rate was 39.79% in the TPPA-negative and RPR-negative group, 46.30% in the TPPA-positive and RPR-negative group, and 36.59% in the TPPA-positive and RPR-positive group. No significant differences were found between the groups. The neonatal gestational age and mean birth weight were not significantly different between the TPPA-negative and TPPA-positive groups. Multiple linear regression analysis also showed no association between TPPA serostatus and newborn birth weight and gestational age. The present retrospective study showed that TPPA and RPR serostatus did not affect the outcomes of IVF and embryo transfer. Syphilis-infected individuals can undergo IVF and embryo transfer cycles after penicillin treatment.