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临床试验/NCT04504981
NCT04504981已完成不适用

HIV Prevention for High Risk African American Young Men

Children's Hospital Los Angeles2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年1月22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
27
试验地点
2
主要终点
Alcohol and illincit drug use

研究概览

简要总结

The goal of this clinical trial is to pilot test a group level intervention, called Y2Prevent, which aims to decrease drug use and HIV/STI risk among Black/African American young men who have sex with men (AAYMSM). The main question it aims to answer is:

• determine if Y2Prevent is possible to engage in easily and is accepted by the participants, for potential expansion to other cities.

Participants will engage in 7 weekly group sessions focused on helping AAYMSM identify life goals and safeguard their health to achieve those goals. This intervention will also include:

  • HIV/STI testing and treatment referral
  • drug screening and treatment referral
  • positive youth development and future planning through a mentorship program

详细描述

The overarching aim is to develop a culturally tailored and developmentally appropriate HIV prevention intervention for African American young men who have sex with men (AAYMSM), ages 18 to 24 years. No group is at greater risk for acquiring HIV than YMSM, especially those living in inner cities, with AAYMSM now accounting for the largest number of new HIV infections detected in cities each year. If these trends continue, it is estimated that as many as 1 in 2 AAYMSM will be diagnosed with HIV in their lifetime.

The investigators propose to further refine and pilot test an intervention, called Young Men's Adult Identity Mentoring (YM-AIM). Adapted from an existing CDC Diffusing Effective Behavioral Intervention (DEBI), YM-AIM is a theory-driven, group-level intervention designed to help AAYMSM develop a healthy vision for their future (or "possible future self") by defining a set of short- and long-term goals in the areas of education, health, family and intimate relationships. Through the facilitated activities, participants consider how their involvement in risky behaviors (e.g., illicit drug use, condomless sex, multiple sex partners) would interfere with achieving those goals. With funding from NIDA (R21 DA024588), the investigators developed YM-AIM in response to findings from our own research, as well as those reported in the literature, which demonstrate that experiences of minority stress (e.g., racism, homophobia) and exposure to violence and victimization (family, intimate partner, community) put AAYMSM at significantly greater risk for illicit drug use, HIV/STI sexual risk (condomless anal sex), and mental health problems (e.g., depression) as compared to Caucasian and Hispanic/Latino YMSM.

During our initial pilot, participants (n=36) were enormously enthusiastic about their participation in YM-AIM (all participants attended all six weekly sessions), they provided positive feedback about the various components, activities, and exercises, and they reported that YM-AIM should continue to be delivered using a group-based intervention because they enjoyed the support provided by other group members. Participants also reported they wanted (and needed) ongoing social support after completing the intervention, to help them achieve their short- and long-term goals and maintain positive changes in sexual risk behaviors. This feedback is consistent with the literature that suggests mentors are immensely beneficial, particularly for youth and young adults, because they can share their worldviews, experiences, knowledge, support and advice, as well as provide a positive influence. By introducing youth to new experiences and sharing positive values, mentors can help young people avoid negative behaviors and achieve success. Having a mentor has also been found to reduce youths' risk for delinquency, aggression and drug use and lead to increased academic satisfaction and performance. Based on this, the investigators propose to further strengthen and refine YM-AIM by adding a youth mentoring/support component, called Youth Initiated Mentoring (YIM). YIM uses a positive youth development framework to help young, low-income ethnic/racial minorities: a) build social capital to achieve immediate and long-term life goals, b) build social support networks, c) identify and engage natural mentors in their networks to address structural barriers encountered in their lives, and d) develop relationships with supportive adults.

YM-AIM was developed in 2011, before widespread availability of PrEP/PEP. The investigators are therefore also proposing to add three new components: 1) biomedical HIV prevention strategies (PrEP, PEP), 2) HIV/STI testing and treatment referral, and 3) drug screening and treatment referral. This new intervention, which is called Y2Prevent, will then be evaluated for its feasibility and acceptability. Intervention outcomes include drug use in past 30 days and 3 months, alcohol use, condomless sex, number of partners, condom use intention, condom use self-efficacy, HIV testing recency/frequency, and linkage to care. The specific aims are to:

SPECIFIC AIM 1: Conduct formative research to develop Y2Prevent and refine our assessment measures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

This is a pilot study with no comparison/control group so masking is not relevant.

入排标准

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

入选标准

  • 18-24 years old;
  • identify as a cisgender male;
  • identify as Black/African American;
  • identify as gay, bisexual, or some other same-sex identity, and/or report having had sex with a man;
  • HIV-negative;
  • not currently enrolled in an HIV prevention study;
  • living in the Los Angeles metro area;
  • has access to a device (laptop, tablet or phone) with internet access in order to participate in virtual group sessions, complete online surveys, and receive payment via Venmo or Cash App; and
  • has access to a telephone in order to be able to participate in and complete the qualitative exit interview, which will be conducted via telephone.

排除标准

  • outside age 18-24 years old;
  • identify as a transgender man or woman;
  • identify as White/Caucasian, Latino/Hispanic, Asian/Pacific Islander, Native American, Indigenous, or any other ethnicity besides African American;
  • identify as straight;
  • HIV-positive;
  • currently enrolled in an HIV prevention study;
  • currently living outside the Los Angeles metro area;
  • does not have access to a device (laptop, tablet or phone) with internet access, which is necessary to participate in weekly group sessions, complete online surveys and receive payment for participation via Venmo or Cash App; and
  • does not have access to a telephone, which is necessary to participate in the qualitative exit interview at the end of the seventh and final study session.

结局指标

主要结局

Alcohol and illincit drug use

时间窗: 6 months post intervention

Frequency of acohol and illiict drug use including cocain, ecstasy, methamphetamines, psychedilic drugs (e.g., LSD, shrooms); heroin, opiates, prescription drugs without a prescription; marijuana

Sexual risk behaviors

时间窗: 6 months post intervention

Condomless anal intercourse; frequency of this behavior during reporting period; # of sexual partners during the reporting period; use of PrEP/PEP during reporting period

Illincit drug use

时间窗: urine analysis for recent drug use (up to 1 week) at time of assessment (6 months post intervention)

Presence of marijuana, methamphetamines, cocaine, heroin, opiates, barbituates, benzodiazepines, ecstasty, GHB, PCP

次要结局

  • PrEP Uptake(Current PrEP use at time of assessment (6 months post))

研究者

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

Michele D. Kipke

Profrssor of Pediatrics

Children's Hospital Los Angeles

研究点 (2)

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