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临床试验/NCT02876926
NCT02876926已完成不适用

Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)

Brown University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年7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
已完成
入组人数
65
试验地点
1
主要终点
Number of Participants Who Received HIV Testing

研究概览

简要总结

This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

研究设计

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

入排标准

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

入选标准

  • •Sex with a partner met online in the past year
  • •Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
  • •Own a smartphone (iOS or Android) with a service contract and data plan
  • •Have a stable address where mail can be received
  • •Speak English fluently

排除标准

  • •Having tested for HIV in the last year

研究组 & 干预措施

"Enhanced" home-based testing

Experimental

These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.

干预措施: "Smart" home-based test for HIV (Behavioral)

Home-based testing alone

Active Comparator

These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.

干预措施: Home-based testing only (Behavioral)

Reminders for clinic-based testing

Sham Comparator

Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.

干预措施: Reminder letters for clinic-based testing (Behavioral)

结局指标

主要结局

Number of Participants Who Received HIV Testing

时间窗: Up to 28 weeks

Count of the number of participants who reported receiving HIV testing.

Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis

时间窗: Up to 28 weeks

Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.

Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis

时间窗: Up to 28 weeks

Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.

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

Tyler Wray

Assistant Professor (Research)

Brown University

研究点 (1)

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