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临床试验/NCT04846946
NCT04846946撤回不适用

Conducting the Preparation Phase of a Multiphase Optimization Strategy (MOST) to Develop a Modular HIV Prevention and PrEP Intervention for Sexual and Gender Minority Adolescents and Parents: "Hey, Friend"

University of Alabama at Birmingham1 个研究点 分布在 1 个国家开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
HIV Knowledge

研究概览

简要总结

In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South.

详细描述

In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South. To do so, in Aim 1, we will assess stakeholders' knowledge, sentiments, and beliefs related to HIV risk, HIV stigma, and HIV prevention including preferences related to modality of PrEP and PrEP acceptability. Then, in Aim 2, we will use Aim 1 data, applying the 4-step intervention mapping framework, to inform the development of intervention modules targeting 14-18 year old SGM adolescents (rationale for this age range presented later in this proposal). We will also, develop corollary modules for parents or guardians. After intervention modules have been finalized, in Aim 3, we will conduct a 4-arm randomization to assess each module's acceptability, feasibility, and clinical signal of effectiveness as compared to a time-attention control.

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
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adolescents aged 14-18
  • •Parental or guardian consent
  • •SGM identity
  • •English speaking

排除标准

  • •Does not fit the inclusion criteria

研究组 & 干预措施

Control

No Intervention

Time attention control condition.

Intervention, Module 1 - Knowledge

Experimental

20-minute module that aims to improve HIV prevention knowledge.

干预措施: Hey, Friend (Behavioral)

Intervention, Module 1 - Stigma

Experimental

20-minute module that aims to reduce SGM- and HIV- related stigma.

干预措施: Hey, Friend (Behavioral)

Intervention, Module 1 - Prevention

Experimental

20-minute module that aims to promote HIV prevention strategies including testing and PrEP.

干预措施: Hey, Friend (Behavioral)

结局指标

主要结局

HIV Knowledge

时间窗: Year 2

HIV Knowledge Questionnaire (HIV-K-Q), Scored 0-18 with 18 indicating thorough HIV knowledge and 0 indicating no HIV knowledge

SGM Related Stigma

时间窗: Year 2

Perceived Racism Scale (PRS). Scores for the PRS frequency of exposure scale can range from 0 to 301; higher scores indicate more frequent perceptions of exposure to racism.

HIV Testing Behaviors

时间窗: Year 2

Binary Yes or No to Accept an HIV Test after Module

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

Henna Budhwani

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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