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临床试验/NCT04222504
NCT04222504已完成不适用

Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2021年2月8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
436
试验地点
1
主要终点
Uptake of Preventative Sexual Health Services

研究概览

简要总结

The investigators propose to offer a package of evidence-based health services to women in two hair salons in the Umlazi township of Durban. Based on community feedback in previous survey and qualitative work, the package has been designed to include daily PrEP, family planning/contraceptives, and STI screening. Interested salon clients at intervention salons will elect which services to use. An additional salon will serve as control, offering no health services to clients. Surveys will be conducted in both salon groups. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services. Recruitment in intervention salons will conclude when 100 clients uptake PrEP, not inclusive of clients who enroll at intervention salons who accept other services through the study. Approximately 250 participants will be recruited in control salons. The study team anticipates an overall total enrollment of 500.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years or older
  • English or Zulu speaking
  • Able and willing to consent

排除标准

  • Symptoms of acute HIV viral syndrome
  • Known pregnancy at baseline

研究组 & 干预措施

Control Salon

No Intervention

No Intervention

Intervention Salons

Experimental

Intervention: Behavioral: Provision of sexual health preventative services in the salon setting

干预措施: Provision of sexual health preventative services in the salon setting (Behavioral)

结局指标

主要结局

Uptake of Preventative Sexual Health Services

时间窗: Months 4 to 16

We will measure uptake of the intervention as the proportion of eligible women who agree to salon-based contraception (first-time users and new users) and separately to salon-based PrEP.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid V. Bassett, MD, MPH

Professor of Medicine

Massachusetts General Hospital

研究点 (1)

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