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临床试验/NCT03107910
NCT03107910已完成不适用

Novel Stigma/Structural Interventions for HIV/STI Testing

University of Connecticut2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年12月最近更新:
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
500
试验地点
2
主要终点
HIV/STI testing uptake

研究概览

简要总结

The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.

详细描述

This research is aimed at conducting structural and stigma-focused interventions to increase HIV and STI testing uptake among Black men who have sex with men (BMSM). The research is focused on this population due to the alarmingly high rates of HIV/STI (sexually transmitted infections) among BMSM- this group has experienced elevated rates of HIV incidence and prevalence since the beginning of the US epidemic, and current estimates demonstrate that although BMSM make up only 0.2% of the population they make up 22% of new HIV infections. The investigator have documented a 5.1% annual HIV incidence and a 35% HIV prevalence among BMSM. Health care models are failing to engage BMSM at all points of the HIV care continuum including the seek and test components. The CDC recommends that individuals at substantial risk for HIV be tested for HIV/STI every three to six months; however, this goal is not being achieved and, therefore, a new approach to engaging BMSM is needed. To address these shortcomings and based on preliminary studies, the investigators are conducting a 2 x 2 factorial design study to evaluate a model that is aimed at increasing HIV/STI testing uptake among BMSM. The investigators will test a stigma-focused intervention as stigma is a known deterrent to HIV/STI testing, yet little has been done to address this factor; and, the investigators will evaluate HIV/STI test counseling delivered online (in conjunction with at-home HIV/STI test kits) as this delivery of testing may remove key barriers to reaching BMSM in need of HIV/STI related care services. Specific Aim 1: Assess HIV/STI testing uptake at scheduled HIV/STI test counseling appointments during the 12 month follow-up period. 500 BMSM will be randomly assigned to one of four conditions: (a) receive CDC-based risk reduction counseling and scheduled for in-office HIV/STI test counseling appointments, (b) receive HIV stigma-enhanced intervention and scheduled for in-office HIV/STI test counseling appointments, (c) receive CDC-based risk reduction counseling and scheduled for online, via video calling, HIV/STI test counseling appointments, or (d) receive HIV stigma-enhanced intervention and scheduled for online, via video calling, HIV/STI test counseling appointments. Specific Aim 2: Evaluate mediating (key theoretical stigma variables) factors collected via assessments at 3, 6, and 12 month follow-ups. Specific Aim 3: Conduct an economic evaluation to determine the costs of the office-based and online-based HIV/STI test delivery formats from both a community-based payer perspective and a comprehensive societal perspective that includes all costs. This project has the potential to exert a sustained and powerful impact not only on approaches to engaging BMSM, but to improving HIV/STI testing uptake which will likely improve multiple health outcomes among BMSM. If effective, this approach to improving HIV/STI testing uptake would be available for dissemination immediately and would fit within resource limited settings such as community based organizations and health departments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Investigator)

盲法说明

Participants and investigator are masked to study intervention assignment. Participants are informed that they are randomly assigned to conditions.

入排标准

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

入选标准

  • Men who have sex with men
  • Transgender women who have sex with men
  • 18 years of age and older
  • Reside in Atlanta metro area.
  • Other criteria may apply

排除标准

  • 未提供

研究组 & 干预措施

Control Health Information

Other

Single session, online health information seeking and evaluation. HIV/STI testing appointments are provided online. Stigma and Structural Interventions

干预措施: Health Information Seeking (Behavioral)

Experimental Stigma Counseling

Other

Single session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing.

干预措施: Stigma and Structural Interventions (Behavioral)

Experimental Stigma Counseling

Other

Single session, stigma focused, anticipated HIV stigma counseling will be provided. Intervention will include a focus on barriers to testing.

干预措施: Health Information Seeking (Behavioral)

Control Health Information

Other

Single session, online health information seeking and evaluation. HIV/STI testing appointments are provided online. Stigma and Structural Interventions

干预措施: Stigma and Structural Interventions (Behavioral)

结局指标

主要结局

HIV/STI testing uptake

时间窗: 12 months

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

Lisa Eaton

Associate Professor

University of Connecticut

研究点 (2)

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