跳至主要内容
临床试验/NCT03464422
NCT03464422已完成不适用

Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (ESTEEM-conneCT)

Yale University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年9月9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
21
试验地点
2
主要终点
Depression

研究概览

简要总结

The purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas.

详细描述

This study has two specific aims. Aim 1 will focus on the modification of an existing intervention manual (created by the study PI) using feedback from previous qualitative interviews with MSM in New Haven and Hartford, CT. Also incorporated will be recent qualitative research on MSM of color's resilience. Specifically, the ways in which racial minority stigma impacts the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in the face of these health threats.

Aim 2, will consist of the deliver of the adapted intervention to approximately 30 young MSM (15 HIV-negative and 15 HIV-positive) to gather data on the feasibility and acceptability of the newly adapted program. The evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement.

This project integrates expertise in culturally-sensitive evidence-based interventions for MSM's HIV risk into a community-based HIV prevention and care context at the Fair Haven Community Health Center, where the intervention will be delivered to the existing patient population.

As of April, 2019, the study protocol was updated and approved by the Yale IRB such that the two intervention cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process. Thus, there was no group assignment based on HIV serostatus.

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must:
  • Report anticipated 6-month residential stability in New Haven county
  • Self-identify as a gay or bisexual man or report being a man who has had past-12-month sex with a man
  • Self-identify as an ethnic or racial minority, including Black, African American, Caribbean American, Hispanic, and Latinx
  • Speak fluent English

排除标准

  • Participants not meeting the inclusion criteria will not be eligible to participate.

结局指标

主要结局

Depression

时间窗: 3 months

To measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60.

HIV Transmission Risk

时间窗: 90 days

Risk of HIV transmission was assessed through the Past-90-day Timeline Follow-back interview (TLFB; Sobell \& Sobell, 1992). HIV risk behavior was calculated as the number of past-90-day sex acts in which key harm-reduction strategies were not employed (e.g., condom, PrEP, viral load suppression) and calculated by dividing the total number of sex acts at risk for HIV transmission by the total number of sex acts. Sex acts range from 0 to (theoretically) infinite.

次要结局

  • Overall Depression Severity and Impairment Scale(3 months)
  • Overall Anxiety Severity and Impairment Scale(3 months)
  • Brief Symptom Inventory(3 months)
  • Condom-use Self-Efficacy Questionnaire(3 months)
  • Suicidal Ideation Attributes Scale(3 months)
  • Gay-Related Rejection Sensitivity Scale(3 months)
  • Self-concealment Scale(3 months)
  • Alcohol Use Disorders Identification Test(3 months)
  • Internalized Homophobia Scale(3 months)
  • Sexual Compulsivity Scale(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验