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临床试验/NCT03271424
NCT03271424已完成不适用

Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2015年10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
95
试验地点
1
主要终点
Qualitative Summaries of Participant Experience in Focus Group Discussions

研究概览

简要总结

The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

详细描述

Study Description Brief Summary: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

Detailed Description: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, explained in this submission, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Females and males aged 18 - 24
  • Able and willing to provide informed consent
  • Residing in the selected villages
  • Observation Inclusion Criteria:
  • Females and males aged 18 -24
  • Able and willing to provide informed consent
  • Residing in the selected villages
  • Not known to be HIV positive (not reporting a previous positive test)

排除标准

  • 未提供

研究组 & 干预措施

Focus Group Discussions

No Intervention

Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.

In Clinic Observation-Both

Active Comparator

10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both

干预措施: Oraquick HIV Self Test and Atomo HIV Self Test - Both (Diagnostic Test)

In Clinic Observation-Subject Choice

Active Comparator

20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice

干预措施: Oraquick HIV Self Test - Choice (Diagnostic Test)

In Clinic Observation-Subject Choice

Active Comparator

20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice

干预措施: Atomo HIV Self Test - Choice (Diagnostic Test)

结局指标

主要结局

Qualitative Summaries of Participant Experience in Focus Group Discussions

时间窗: 6 months post study start

Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact

Quantitative Summaries of Participants Experience in Observation Sessions

时间窗: 12 month post study start

Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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