跳至主要内容
临床试验/NCT05541081
NCT05541081已完成不适用

Investigating Point-of-care Diagnostics for Sexually Transmitted Infections and Antimicrobial Resistance in Primary Care in Zimbabwe

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 1,005 人开始时间: 2023年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,005
试验地点
1
主要终点
Composite STI prevalence

研究概览

简要总结

A prospective interventional study to evaluate a strategy of point-of-care testing for sexually transmitted infections including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management including partner notification in antenatal settings in Harare province, Zimbabwe.

详细描述

Sexually transmitted infections (STIs) can cause serious morbidity including pelvic inflammatory disease, infertility, poor mental health, adverse pregnancy outcomes and an increased risk of HIV transmission. In low and middle-income countries (LMICs), STIs are treated using syndromic management, which has poor sensitivity and specificity, leading to considerable levels of both underdiagnosis and overtreatment. In recent years, simpler diagnostic platforms for STIs have been developed. Development and evaluation of strategies for provision of diagnostic testing in LMICs are needed and the World Health Organization (WHO) has called for evidence to inform replacement of syndromic management by diagnostic testing.

The aim of this project is to evaluate a strategy of point-of-care (POC) testing for STIs including chlamydia, gonorrhoea, trichomoniasis, syphilis, and Hepatitis B with comprehensive case management including partner notification in antenatal settings in Harare province, Zimbabwe.

The objectives are to:

  1. Determine the uptake, prevalence and yield of chlamydia, gonorrhoea, trichomoniasis, syphilis and hepatitis B testing, and risk factors for infection among women attending for antenatal care
  2. Assess the acceptability and feasibility of this intervention
  3. Estimate the cost and cost-effectiveness of POC STI testing
  4. Investigate the prevalence of antimicrobial resistance for Neisseria gonorrhoeae to inform the development of a gonococcal antimicrobial resistance surveillance programme
  5. Assess an incentives-based approach to optimize uptake of client-referral partner notification.

A prospective interventional study will be conducted in three primary healthcare clinics (PHCs) in Harare province, Zimbabwe. 1000 pregnant women will be recruited over a nine month period when registering for routine antenatal care. Testing will be staggered across sites so that testing will be available at each site for three months within the nine-month study period. All Identified STIs will be managed comprehensively including treatment and/or referral if required according to national guidelines, and partner notification and risk reduction counselling.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Point-of-care STI testing

Other

Provision of point-of-care testing for chlamydia, gonorrhoea, trichomoniasis, syphilis, HIV, and hepatitis B, with comprehensive case management including partner notification

干预措施: Point-of-care STI testing (Diagnostic Test)

结局指标

主要结局

Composite STI prevalence

时间窗: Through study completion, up to 1 year

Composite % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and/or hepatitis B

Individual STI prevalences

时间窗: Through study completion, up to 1 year

Individual % of participants with chlamydia, gonorrhoea, trichomoniasis, syphilis, and hepatitis B

次要结局

  • Prevalence of adverse birth outcomes(Through study completion, up to 2 years)
  • Uptake of STI testing(Through study completion, up to 1 year)
  • Prevalence of antimicrobial resistance in gonococcal isolates(Through study completion, up to 1 year)
  • Yield of STI testing(Through study completion, up to 1 year)
  • Uptake of treatment(Through study completion, up to 1 year)
  • Uptake of partner notification(Through study completion, up to 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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