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临床试验/NCT04710784
NCT04710784已完成不适用

The 4 Youth by Youth Project: a Pragmatic Stepped-wedge Cluster Randomized Controlled Trial to Expand Youth-friendly HIV Self-testing Services in Nigeria

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
2
主要终点
Uptake of HIV Self-testing

研究概览

简要总结

The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).

详细描述

Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have the potential to impact HIV testing as well as uptake of sexually transmitted infections (STI) testing among young people in Nigeria. As a result, the investigators identified key components from the four interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, youth-developed intervention on HIV testing and other HIV prevention outcomes (i.e. condom use, PrEP referral, STI testing).

Using a stepped-wedge cluster randomized controlled trial design, the I-TEST intervention package will be implemented sequentially across 32 local government areas (LGA) whereby each LGA will be exposed to a pre-intervention (control), intervention (implementing the intervention), and post-intervention condition, according to a randomized schedule. Young people between the ages of 14-24 years will be recruited from the selected 32 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. We included two additional LGAs in November 2021 to account for civil unrest activities that are taking place across two other study sites. Due to the civil unrest, the implementation of the intervention has been affected hence the addition of the two new sites. Upon enrollment, the study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes from the study participants. Two trained youth alongside one trained supervisor will implement the I-TEST intervention at the LGAs.

研究设计

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

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 14-24
  • Self-reported HIV negative or unknown HIV status
  • Currently and planning on residing in one of the 30 areas during the next 12 months
  • Able to complete the survey in English (the national language of Nigeria)
  • All participants must agree to informed consent and provide their cell mobile number for follow-up and retention

排除标准

  • Younger than 14 and older than 24
  • Inability to comply with the study protocol
  • Illness, cognitive impairment, or threatening behavior with acute risk to self or others
  • No informed consent
  • No contact phone number

结局指标

主要结局

Uptake of HIV Self-testing

时间窗: Up to 24 months

The number of persons who tested with an HIV self-test. We will assess the number of persons who tested with an HIV self-test among the total number of participants in the study. The primary outcome will be ascertained using a photographic verification approach via a mobile application or a USSD (Unstructured Supplementary Service Data) system. We will also use self-reported data on HIVST results for those unable to use both systems accurately.

次要结局

  • Uptake of Facility-Based HIV testing(Up to 24 months)
  • Sexually Transmitted Infection (STI) Testing(Up to 24 months)
  • PrEP Referral(Up to 24 months)
  • 100% Condom Use(Up to 24 months)
  • Youth Engagement(Up to 24 months)
  • Sexually Transmitted Infection (STI) Treatment(Up to 24 months)
  • Cost effectiveness of the intervention(Up to 24 months)

研究者

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

Juliet Iwelunmor, PhD

Professor of Medicine

Washington University School of Medicine

研究点 (2)

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