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临床试验/NCT06661356
NCT06661356尚未招募不适用

Determining the Impact of Peer-led Community-based PrEP Delivery Among Youth in Brazil: A Randomized Controlled Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,400
试验地点
2
主要终点
PrEP Uptake

研究概览

简要总结

The goal of this project is to conduct a series of studies to refine, test, and understand experiences with a peer-led community-based intervention in which youth will be integrated into health care teams and trained to deliver HIV pre-exposure prophylaxis (PrEP) to their peers. The study team will conduct a randomized trial to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in health facilities.

详细描述

HIV is declining in many parts of the world, but rising in Latin America, including Brazil. The HIV epidemic in Brazil, including the number of new infections, is concentrated among youth aged 15-24. Youth in Brazil face obstacles to HIV prevention. Use of HIV pre-exposure prophylaxis (PrEP) lags far behind PrEP need in Brazil. There is international momentum to promote PrEP as prevention and to increase access to low barrier care. Peer lay workers are a promising approach to address the unmet need for PrEP uptake and adherence among youth in Brazil.

COMPrEP is a multi-site randomized controlled trial designed to determine if peer delivery of PrEP to youth aged 15-24 in Brazil will increase PrEP uptake, persistence, and adherence compared to standard PrEP care provided in affirming health facilities. Eligible youth (N=1400) in two municipalities in Brazil (i.e., Salvador and São Paulo) will be randomized to 1:1 to either the COMPrEP intervention arm (PrEP access through peer lay workers in community venues) or the standard care arm (PrEP access through health providers at health facilities). It is anticipated that approximately 245 and 140 youth will initiate PrEP in intervention and standard care arms, respectively, and these will be followed for 12 months, facilitating measurement of PrEP adherence and persistence outcomes on this subset.

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
Single (Outcomes Assessor)

盲法说明

Blinding will not be possible for participants, peer lay workers, and health providers, but the data management and analysis teams will be blinded to the study arm.

入排标准

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

入选标准

  • •Eligibility Criteria:
  • •Aged 15-24 years
  • •Candidate for HIV prevention
  • •Sexually active
  • •Not currently using PrEP
  • •Willing to discuss oral PrEP
  • •Agree to be randomized to either intervention or standard care arm

排除标准

  • •HIV positive test result
  • •Not currently sexually active
  • •Currently using PrEP

研究组 & 干预措施

Standard Care Arm

No Intervention

Participants randomized to the standard care arm will receive PrEP at a health facility from a physician or nurse.

COMPrEP Intervention

Experimental

Participants randomized to the COMPrEP intervention will receive PrEP from peer lay workers at private community locations.

干预措施: COMPrEP (Behavioral)

结局指标

主要结局

PrEP Uptake

时间窗: Within 1 month of enrollment

Received at least one PrEP prescription

次要结局

  • PrEP Adherence Biomarker(1 month)
  • PrEP Adherence Self-Report(At 1, 5, 9, and 13 months)
  • PrEP Persistence(5 months and 13 months)

研究者

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

Katia J. Bruxvoort

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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