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临床试验/NCT06063083
NCT06063083进行中(未招募)不适用

Addressing Latino Men Who Have Sex With Men (MSM) Health Disparities by Increasing Engagement With Behavioral and HIV Prevention Services: An Implementation Science Approach

University of Miami1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Change in PrEP Engagement, as measured by the PrEP cascade questionnaire

研究概览

简要总结

This study will be used to develop a program to help Latino men who have sex with men obtain pre-exposure prophylaxis (PrEP), HIV testing, and behavioral health services. The project will then involve a pilot test of this program with a community partner.

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 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Identify as Latino/Hispanic
  • identify as a sexual minority man (e.g., gay, bisexual) and/or a man who has sex with men
  • age 18 years or older
  • English and/or Spanish speaking
  • self-report an HIV-negative or unknown HIV status
  • currently reside in the greater Miami area
  • PrEP eligible (based on Centers for Disease Control (CDC) criteria) and not currently taking PrEP adherently
  • self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and/or are not currently receiving behavioral health services or self-report an unmet need for behavioral health services

排除标准

  • Unable to provide consent
  • Opinion of the PI that the participant would be at risk for harm to self or others
  • Have a medical or psychiatric condition that would interfere with ability to participate in study procedures in the opinion of the PI
  • Involvement in any other HIV prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the PI on a case-by-case basis)

研究组 & 干预措施

Tell Me More ("Dime Mas") group

Experimental

Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.

干预措施: Tell Me More ("Dime Mas") (Behavioral)

Tell Me More ("Dime Mas") group

Experimental

Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.

干预措施: Peer Ambassador Stories [Listen Miami ("Oye Miami")] (Behavioral)

Tell Me More ("Dime Mas") group

Experimental

Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.

干预措施: Standard Community Outreach (Behavioral)

Peer Ambassador Stories [Listen Miami ("Oye Miami")] group

Experimental

Participants will get the Peer Ambassador Stories [Listen Miami ("Oye Miami")] within up to 6 months.

干预措施: Peer Ambassador Stories [Listen Miami ("Oye Miami")] (Behavioral)

Peer Ambassador Stories [Listen Miami ("Oye Miami")] group

Experimental

Participants will get the Peer Ambassador Stories [Listen Miami ("Oye Miami")] within up to 6 months.

干预措施: Standard Community Outreach (Behavioral)

Standard Community Outreach group

Active Comparator

Participants will receive standard community outreach within up to 6 months.

干预措施: Standard Community Outreach (Behavioral)

结局指标

主要结局

Change in PrEP Engagement, as measured by the PrEP cascade questionnaire

时间窗: Baseline, 3 months, 6 months

This will be assessed using the PrEP cascade measure, which specified five "levels" of PrEP engagement (i.e., pre-contemplation, contemplation, preparation, action, and maintenance). We will evaluate this outcome as an ordered-categorical outcome.

次要结局

  • Change in Recent (within the last 3 months) HIV testing(Baseline, 3 months, 6 months)
  • Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)(Baseline, 3 months, 6 months)

研究者

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

Audrey Harkness

Assistant Professor

University of Miami

研究点 (1)

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