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临床试验/NCT07133555
NCT07133555已完成不适用

Expanding Safe Spaces 4 Sexual Health, a Mobile Van HIV/STI Testing and Care Linkage Strategy, for MSM in Online Spaces

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Feasibility of adding care linkage assessed by retention rate

研究概览

简要总结

In an earlier study, the study team carried out an HIV/Sexually transmitted infection (STI) testing approach which found men who have sex with men (MSM) at-risk of getting or spreading HIV in online spaces and linked them to testing services on a mobile van. The goal of this present study is to add on to this approach by connecting participants (MSM aged 18-49 residing in the Baltimore area) with a peer health navigator to support them with getting pre-exposure prophylaxis (PrEP) or HIV care services after testing. Researchers will compare using a peer health navigator approach to using a referrals-only approach to get PrEP or HIV care services. Participants will be assigned to either Arm A (group that receives peer health navigator help) or Arm B (group that gets referred) to get PrEP or HIV care.

详细描述

In the SS4SH pilot study, utilizing a data-driven approach in partnership with the local health department, the investigators analyzed local public health surveillance data to identify online sex partner meeting spaces frequently reported by (majority Black) MSM newly diagnosed with HIV and/or syphilis. The identified online spaces were used to advertise mobile van HIV/STI testing for MSM > 18 years of age and less than 49 years of age over a 14-month period. The strategy and advertisements were informed by a community advisory board (CAB) of MSM hosted at a local Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) community-based organization to ensure local relevance, acceptability and feasibility.

研究设计

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

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18-49 years of age
  • Ability to read and speak English
  • Baltimore area resident
  • Report sex with a male in the past 12 months

排除标准

  • not male-self identified individual

研究组 & 干预措施

Control group receiving standard of care referral

No Intervention

Participants randomly assigned to Arm B will go through the standard of care referral process to a local community site providing PrEP or HIV care after discussing their test results with a navigator. During this discussion with a navigator, participants will receive information about the PrEP/HIV care sites where the participants can go for services. Six weeks following this initial follow-up, participants will meet virtually with the navigator to complete a PrEP/care linkage status assessment to determine if the participants attended the initial PrEP/HIV provider appointment.

Intervention group receiving peer health navigation follow-up

Experimental

Participants randomly assigned to Arm A will receive a navigation/care linkage needs assessment followed by peer navigation once weekly after discussing their test results with the navigator to support their linkage to PrEP or HIV care over a six-week period. Navigators will complete the following care linkage steps: 1) assess interest in linkage, 2) identify preferred clinic for care linkage, and 3) assist with scheduling initial PrEP/HIV provider appointment. Additionally, the investigators will use the qualitative data collected from in-depth interviews (IRB00375934) of Black MSM and key informant interviews of care linkage stakeholders on barriers and facilitators to HIV prevention and care linkage strategies to inform the peer navigation that Arm A receives.

干预措施: Healthcare counseling service (Other)

结局指标

主要结局

Feasibility of adding care linkage assessed by retention rate

时间窗: 6 weeks

Feasibility of adding care linkage will be measured based on the retention rate during follow-up period of Arm A participants in need of PrEP/HIV care linkage. Retention rate of 75% will be used as a feasibility threshold. Linkage is defined as completing a PrEP/HIV care related medical visit within 30 days of enrollment.

Acceptability as assessed by participant satisfaction

时间窗: 6 weeks

A satisfaction rate of 75% or greater will be used as the acceptability threshold.

Acceptability as assessed by number of participants with intent to repeat use of SS4SH

时间窗: 6 weeks

Acceptability will be measured as intention for repeat use of SS4SH testing/care linkage modality.

Effectiveness as assessed by the number of Black MSM linked to HIV/PrEP

时间窗: 30 days

Preliminary data on effectiveness will be assessed by number of Black MSM linked to HIV care and PrEP within 30 days of enrollment. Linkage is defined as completing a PrEP/HIV care related medical visit.

Effectiveness as assessed by number of Black MSM lost to followup

时间窗: 30 days

Preliminary data on Effectiveness assessed by number of Black MSM lost to follow up. Linkage is defined as completing a PrEP/HIV care related medical visit.

次要结局

  • Reach/awareness of the geotargeted advertisement campaign assessed by cost per 1,000 impressions (CPM)(12 weeks)
  • Website traffic of the geotargeted advertisement campaign assessed by cost per click (CPC)(12 weeks)
  • Cost per action conversion rate of the geotargeted advertisement campaign(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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