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临床试验/NCT04225832
NCT04225832终止不适用

A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men

RAND2 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
RAND
入组人数
289
试验地点
2
主要终点
HIV Test at Least Annually

研究概览

简要总结

This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM).

详细描述

This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.

The Specific Aims are:

Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.

Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).

Aim 3. To conduct a cost-effectiveness analysis of the intervention.

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
Single (Outcomes Assessor)

盲法说明

Outcomes assessor does not randomize participant until after the baseline assessment

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

  • at least 18 years-old
  • biologically male at birth
  • identify as male
  • identify as Latino
  • is an immigrant
  • report having sex with men in the past 12 months
  • report HIV-negative or unknown serostatus
  • anticipate being available for the next 12 months to attend study visits
  • able to interact and communicate in spoken Spanish or English.

排除标准

  • HIV-positive
  • cisgender women
  • transgender women

结局指标

主要结局

HIV Test at Least Annually

时间窗: from baseline to 12-months

Participants report being tested for HIV at least once in the 12 months after baseline

Took PrEP in the Past 12 Months

时间窗: from baseline to 12-months

Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)

次要结局

  • Level of Adaptive Coping(measured at 4-months, 8-months, and 12-months post baseline)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (2)

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