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临床试验/NCT04210271
NCT04210271已完成不适用

Testing an Intervention to Increase HIV Self-Testing Among Young, Black MSM

New York Blood Center0 个研究点目标入组 402 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
402
主要终点
Consistent HIV self-testing

研究概览

简要总结

The investigators propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

  1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
  2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly over 12 months using a 2-arm randomized, controlled study design.

详细描述

Increasing HIV testing rates among young, Black men who have sex with men (YBMSM) is critical to reducing the disproportionate disease burden in the Black community. MSM comprised almost two-thirds of new HIV diagnoses in the United States (US) in 2010. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In our model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction. We propose a study to design and test a brief intervention to increase uptake of consistent HIV self-testing among YBMSM using a novel and culturally-relevant "buddy system" approach. In the model, peer educators train pairs of YBMSM (or "buddies") to initiate self-testing and support each other in consistent self-testing (past 3 months) and sexual and AOD use risk reduction.

The specific aims of this developmental R01 study are:

  1. To conduct qualitative formative research to adapt couples testing for self-testing with a buddy;
  2. To assess the preliminary efficacy of the intervention to increase the proportion of YBMSM who self-test regularly (i.e., past three months) over 12 months using a 2-arm randomized, controlled study design.

The investigators will achieve the aims of the study in three phases, recruiting YBMSM using web- and app-based approaches. In Phase 1, the investigators conducted 30 in-depth interviews to identify barriers to, facilitators of, perceptions of and preferences for regular HIV self-testing, describe how AOD use and sexual behavior influence HIV self-testing behaviors, and assess participant perspectives on the proposed buddy intervention. In Phase 2, based on the formative research, the investigators adapted couples testing, integrating enhanced motivational interviewing techniques to create a brief, peer educator-delivered, face-to-face intervention. In Phase 3, for which the investigators currently seek IRB approval, the investigators will use web- and app-based, face-to-face and word-of-mouth approaches to recruit 376 HIV-negative, BMSM aged 18 to 34 who will be randomized as pairs to either the intervention arm (HIV testing together, HIV self-testing screening information and skills training; free test kits on demand; tailored booster messages) or the control arm (HIV testing separately, generic health screening information; free test kits on demand) and followed for 12 months to estimate the intervention's efficacy in increasing regular HIV self-testing according to self-report. If demonstrated to be efficacious, this innovative and efficient approach can be adapted easily for widespread distribution, with the potential to diffuse along naturally occurring, social networks among YBMSM.

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
None

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • biological male at birth
  • between 18 and 34 years of age
  • self-identify Black, African American, Caribbean Black, African Black, multiethnic Black OR Latino/Hispanic
  • reside in the NYC metropolitan area
  • not HIV-infected (self-report)
  • report insertive or receptive anal intercourse with another man in the past year
  • ability to communicate in English
  • provide informed consent for the study.
  • willing to participate in the study with a friend or buddy.

排除标准

  • currently enrolled in any other HIV research study involving HIV testing or an HIV vaccine trial

结局指标

主要结局

Consistent HIV self-testing

时间窗: 12 months

One or more HIV self-test in past three months

Consistent HIV testing

时间窗: 12 months

One or more HIV test (any type) in past three months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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