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临床试验/NCT04155320
NCT04155320已完成不适用

Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年1月27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
55
试验地点
1
主要终点
Notified

研究概览

简要总结

Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index patients recruited from two all-male prisons in Indonesia to assess the acceptability and feasibility of provider-assisted HIV partner notification (provider referral) and examine its potential to increase the number of partners who are tested for HIV and subsequently linked to prevention and treatment services.

详细描述

This study compares three options for partner notification:

  • Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his partner(s) and given information about sites where his partner(s) can receive free HIV testing.
  • Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a counselor (project staff) present. Counselor refers the partner to HIV testing, including a study-affiliated HIV testing site.
  • Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). Partners are offered immediate HIV testing in their home or at a study-affiliated HIV testing site.

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
Single (Outcomes Assessor)

盲法说明

Outcomes assessor is blinded as to treatment allocation during analyses.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for HIV-positive Prisoners (N=65): Index patients must beat least 18 years of age, HIV-seropositive and aware of their HIV+ status; (HIV-infection documented by a rapid HIV test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. We will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified.
  • •Inclusion Criteria for Partners: Eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. No named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.

排除标准

  • 未提供

研究组 & 干预措施

Group A

Active Comparator

Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).

干预措施: Standard Care (Behavioral)

Group B

Experimental

Subjects may choose to notify their partners themselves, with or without a counselor present (Options 1 & 2), or choose to have one or more partners notified anonymously by project staff (Option 3).

干预措施: IMPART (Behavioral)

结局指标

主要结局

Notified

时间窗: 6 weeks from index patient enrollment

Number of partners who are notified of shared HIV exposure

Tested

时间窗: 6 weeks from index patient enrollment

Number of partners who receive HIV testing subsequent to notification

Diagnosed

时间窗: 6 weeks from index patient enrollment

Number of partners who are HIV diagnosed subsequent to testing

次要结局

  • Linked to Care(6 weeks from index patient enrollment)
  • Initiated ART(6 weeks from index patient enrollment)

研究者

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

Gabriel John Culbert

Assistant Professor

University of Illinois at Chicago

研究点 (1)

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