Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening
试验速览
- 阶段
- 不适用
- 入组人数
- 1,752
- 试验地点
- 2
- 主要终点
- Proportion of male partners who present at clinic and receive syphilis testing
研究概览
简要总结
2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately, the minority of male partners come in for testing and treatment (1%-27%) which has important implications for the roll-out of rapid syphilis testing and the inability to detect reinfection with treponemal antibody test as the test will remain positive despite treatment. The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a health care worker will be more effective than a standard notification slip given to women to bring male partners to antennal clinic for testing and treatment.
详细描述
Title: Comparison of Different Partner Notification Strategies after Antenatal Syphilis Screening Short Title: Syphilis Treatment of Partners (STOP) Trial Objectives: Primary For pregnant women who test rapid syphilis test positive; to compare the proportion of male partners who report to the clinic for syphilis testing (and treatment) when the women are given only partner notification slips (standard of care) compared to a notification slip plus a weekly automated SMS reminder OR a notification slip plus a weekly nurse phone call reminder.
Secondary
- To compare the proportion of male partners who test positive for syphilis when they report to the clinic after receiving notification in the three groups via their pregnant partners.
- To compare the proportion of male partners who undergo treatment among the three groups.
- To explore factors associated with reporting/not reporting after notification.
- To compare birth outcomes (congenital syphilis, stillbirths, neonatal deaths, preterm or low birth weight) between the three arms (self-reported by women).
- To assess time from syphilis point of care (POC) test to treatment in mothers who test syphilis positive using a rapid treponemal antibody kit.
- To compare the proportion of women who have a 4-fold decrease in RPR titer by intervention arm in each arm at post natal visit.
Study Population and sample size: • Pregnant women from 14years and above reporting to antenatal and subsequently postnatal clinics at the Infectious Disease Institute, Mulago Hospital (antenatal and STI clinics), and Kasangati Health Center IV in Kampala, Uganda who screen positive by rapid treponemal antibody test.
- Male sexual partners to these enrolled syphilis positive pregnant mothers.
- 876participants will be enrolled. Study Design: Individual patient randomized open-label clinical trial of syphilis partner notification interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet all of the following inclusion criteria in order to be eligible to participate:
- •Pregnant women
- •Treponemal antibody rapid positive test
- •Age> 14 years
- •Written informed consent
- •Known sexual partner
- •Access to cell phone and willing and able to use and receive SMS or phone calls In the Uganda guidelines (section 9.3 Mature and Emancipated Minors), "mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection; Mature minors may independently provide informed consent to participate in research if in the view of the IRC the research is not objectionable to parents or guardian (established by the IRC with evidence from the community); and b) The research protocol include clear justification for targeting mature and emancipated." This protocol will recruit pregnant women with a sexually transmitted infection in an intervention with minimal risk and with the potential to prevent future reinfection.
排除标准
- •Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- •Illiterate and unable to read a text message
- •Inability to use a mobile phone
- •Patients with confirmed neuro syphilis treated with IV Benzyl penicillin
结局指标
主要结局
Proportion of male partners who present at clinic and receive syphilis testing
时间窗: 2 years
Proportion of male partners who present at clinic and receive syphilis testing
次要结局
- Male partners tested (standard vs. intervention in 3 arm randomization)(2 years)
- Proportion of male partners who test positive for syphilis when they report to the clinic after notification.(2 years)
- Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.(2 years)
- Factors associated with partners reporting/not reporting after notification.(2 years)
- Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)(2 years)
- Mother reported birth outcomes (by standard vs. intervention arm)(2 years)
研究者
Infectious Diseases Institute
Head of Prevention Care & Treatment, IDI
Makerere University