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临床试验/NCT01154907
NCT01154907Unknown不适用

Prevention of HIV and Improved Diagnosis of Adolescent Genital Disease in Bilharzia Endemic KwaZulu-Natal, South Africa

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 6,500 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
6,500
试验地点
1
主要终点
HIV prevalence after anti-schistosomal treatment in adolescents

研究概览

简要总结

Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that 200 million people world wide. Infection with Schistosoma haematobium may cause Female Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract, especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of young women in endemic poor tropical countries, deserving further attention. A cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were unchanged two years after praziquantel treatment in adult women whereas in those who had been treated with praziquantel in childhood the prevalence of genital lesions was significantly lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to those without. The proposed project aims at achieving a better understanding of how annual distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This information can be of use in current schistosomiasis control programs in the near term resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and genital lesions will lead to improved reproductive health among in women living in schistosomiasis endemic areas.

Project Goal: Contribute to a reduction of the global burden of female genital schistosomiasis (FGS) through improved knowledge about the prevention of gynecological lesions and through improved diagnosis of FGS.

详细描述

Provide a more extensive description, if desired. Avoid duplication of information to be recorded elsewhere, such as eligibility criteria or outcome measures

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 23 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Females in Schistosoma haematobium endemic areas

排除标准

  • Pregnancy
  • Allergic to praziquantel
  • Severe disease

研究组 & 干预措施

Girls ages 10-12

In 18 rural schools in Ugu District, South Africa. Undergoing mass-treatment provided by the Department of Health.

Praziquantel was administered at 40mg/kg in annual mass-treatment

干预措施: Praziquantel (Drug)

Young adult women

In rural schools in three districts, South Africa. Undergoing mass-treatment provided by the Departments of Health.

Praziquantel was administered at 40mg/kg in annual mass-treatment

干预措施: Praziquantel (Drug)

结局指标

主要结局

HIV prevalence after anti-schistosomal treatment in adolescents

时间窗: 31. December 2021

HIV prevalence

次要结局

  • Clinical and laboratory indicators of urogenital schistosomiasis(31. December 2018)
  • FGS prevalence and severity after anti-schistosomal treatment in adolescents(31. December 2021)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eyrun Floerecke Kjetland

MD

Oslo University Hospital

研究点 (1)

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