Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,247
- 试验地点
- 2
- 主要终点
- Frequency of adverse birth outcomes among study arms
研究概览
简要总结
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women.
Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3).
Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes
详细描述
Prevalence of STIs is high among pregnant women in South Africa and most infections remain untreated. Untreated infections impact on pregnancy and birth outcomes. Good diagnostic and point-of-care (POC) tests are available, such as the GeneXpert platform. The health impact, cost-effectiveness and approaches to optimization of STI diagnostic screening during pregnancy are unknown.
In order to 1) identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes, 2) informs evidence to WHO's guidelines to introduce aetiologic STI screening globally and 3) elucidate the role of the vaginal microbiome in STI treatment outcomes, the investigators propose three Specific Aims:
- Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse birth outcomes
- Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted
- Investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women
STI screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis will be offered to HIV-infected and non-infected women (age >18 years) whom present for first antenatal care services. An effectiveness-implementation hybrid type 1 three-arm (1:1:1) randomized controlled trial (RCT), will be employed to evaluate different screening strategies to decrease the burden of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis among pregnant women, and reduce adverse birth outcomes.
The costs of the different STI screening strategies relative to control will be estimated based on literature review and performance/implementation characteristics and compared, in addition to the costs of managing adverse birth outcomes. Decision analytic modelling will estimate the cost-effectiveness per STI, and DALY averted (Aim 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
The allocation of study arm is concealed to study staff during randomization
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for pregnant women:
- •Age≥18 years
- •Currently pregnant based on positive urine pregnancy test
- •Attending first ANC visit for current pregnancy
- •Gestational age <20 weeks (Amended to <27 weeks, after 328 participants (14%) had been enrolled, to mitigate COVID-19 delays and align with similar studies)
- •Agreeing to nurse-collected specimens
- •Resident in Buffalo City Municipality (BCM)
- •Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM
- •Gestational age will be confirmed via ultrasound
排除标准
- •Planning to relocate during pregnancy or deliver in an MOU outside of BCM
- •Unknown HIV status (e.g. refusal, invalid test result)
- •Currently participating in another ANC/HIV study
- •When the ultrasound confirms ≥27 weeks gestation at first ANC
- •Inclusion criteria for Neonates:
- •1) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs
研究组 & 干预措施
Syndromic Management (Control)
Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Test at 1st ANC + Test-of-Cure (Treatment 1)
Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment
干预措施: First antenatal care + test-of-cure (Diagnostic Test)
Test at 1st ANC + 30-34 gestation (Treatment 2)
Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation
干预措施: First antenatal care + week 30-34 gestation (no test-of-cure) (Diagnostic Test)
结局指标
主要结局
Frequency of adverse birth outcomes among study arms
时间窗: Recorded within 2 weeks of delivery
Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records
Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms
时间窗: Recorded within 2 weeks of delivery
Adverse birth outcomes as defined by the proportion of participants (pregnant women) with live birth who experienced preterm birth (born alive before 37 completed weeks of gestation) or low birth weight (less than 2500g) as recorded in the maternity case records
次要结局
- Incidence of Preterm birth among study arms(At delivery)
- Incidence of STI in infants exposed to infection in their mothers(STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery)
- Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.(Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery))
- Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection(Assessed through study completion)
- Frequency of fetal loss (miscarriage or stillbirth) among study arms(Assessed through study completion)
- Incidence of Low birthweight infants among study arms(Within 2 weeks post-delivery)
- Incidence of Preterm Birth Among Study Arms Measured in Pregnant Women Who Had a Live Birth(Recorded within 2 weeks of delivery)
- Incidence of Low Birthweight Among Study Arms Measured in Pregnant Women Who Had a Live Birth(Recorded within 2 weeks of delivery)