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临床试验/NCT04289116
NCT04289116已完成不适用

Enhancing Sexual Safety: Couples' Communication and HIV Testing Among YMSM

Florida State University4 个研究点 分布在 1 个国家目标入组 71 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
已完成
入组人数
71
试验地点
4
主要终点
HIV Transmission Risk Behavior

研究概览

简要总结

The purpose of this study is to compare different ways to deliver the couples HIV Testing and Counseling (CHTC) intervention that is suited for adolescents and young adults.

详细描述

Investigators will conduct a comparative effectiveness trial (CET) of CHTC for adolescent-age (15-24 years) same-sex male couples. This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the individual or couple together and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC. Youth will be randomized to receive one of two conditions: Condition 1: watch videos on ACT, participate in Communication Skills Training (MI-CST), and complete an individual HIV test, or if participating as a couple will receive CHTC, and Condition 2: Individual HIV Testing (IHTC) as usual. Youth have the choice of attending the baseline visit alone or with their partner and have the option to bring their partner in later after completing the baseline alone. Youth in this CET will complete follow-up assessments at 1, 3, and 6 months.

研究设计

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

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • At least one partner must be HIV-negative or status unknown
  • THE INDEX PARTNER must be 15-24 years old
  • YMSM under age 18 MUST HAVE AN AGE CONCORDANT PARTNER TO PARTICIPATE IN THIS STUDY, I.E., MINORS may only participate in the study with a partner within 2 years of age OF THE MINOR SUBJECT'S AGE. THE AGE CONCORDANT PARTNER MUST BE AT LEAST FIFTEEN YEARS OLD.
  • INDEX PARTNER MUST BE SEXUALLY ACTIVE (ANY ACTIVITY THAT COULD LEAD TO ORGASM)
  • CURRENTLY SEEING SOMEONE, DATING, EXPERIMENTING WITH RELATIONSHIPS OR IN A RELATIONSHIP
  • HAVE HAD SEX, HOOKED UP WITH OR MADE OUT WITH THAT PERSON
  • Both partners must be able to communicate in English.
  • LIVE IN OR NEAR NEW YORK CITY OR DETROIT OR SAN DIEGO
  • GENDER IDENTITY AS MALE OR nonbinary, GENDERQUEER, agender OR GENDER NONCOMFORMING

排除标准

  • Unstable, serious psychiatric symptoms
  • Current suicidal/homicidal ideation
  • Current or prior Intimate Partner Violence (IPV) on the part of either relationship partner
  • IF EITHER PARTICIPATING PARTNER FELT PRESSURED OR COERCED TO PARTICIPATE IN THE STUDY OR FELT ANYONE MADE THEM FEEL THEY HAD TO PARTICIPATE IN THEY STUDY WHEN THEY DID NOT WANT TO.

结局指标

主要结局

HIV Transmission Risk Behavior

时间窗: baseline, month 3, month 6

Self-reported Condomless anal sex with a casual partner

次要结局

  • Communication Skills(baseline, month 3, month 6)

研究者

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

Sylvie Naar

Principal Investigator

Florida State University

研究点 (4)

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