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临床试验/NCT03664817
NCT03664817已完成不适用

Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV

Emory University2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2018年7月26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
77
试验地点
2
主要终点
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention

研究概览

简要总结

The study is a randomized controlled trial to evaluate the social capital intervention versus a general health promotion intervention (Health for Life; H4L) among groups of Young black men who have sex with men (YBMSM) and to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 months.

详细描述

Young black men who have sex with men (YBMSM) have high rates of HIV infection, and are also at risk for falling out of clinical care. Social capital, which refers to the resources in a person's social network, has been shown to be beneficial for people living with HIV in other places. The study wants to understand and build upon social capital in the YBMSM population in Atlanta, with the goal of ultimately improving HIV-related outcomes for these youth.

To achieve this study is conducted in 3 phases. In Phase I, study will conduct interviews with YBMSM and community leaders to get advice about developing a social capital intervention that will improve social capital. Phase II is a randomized controlled trial of groups of YBMSM implementing the social capital intervention versus groups of YBMSM receiving a general health promotion intervention (Health for Life; H4L). This is followed by Phase III which is mainly to measure the social capital and engagement in care with the HIV-positive YBMSM at 3 and 9 month timepoints.

The study plan to enroll 180 total participants (120 in the randomized controlled trial and 60 in preliminary interviews) over the four year study period.

研究设计

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

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age <= 29 years and >= 18 years
  • Self-identify as Black/African-American (inclusive of multiracial identities)
  • Male sex at birth
  • Endorse history of sex with men ever (inclusive of gay and bisexual men)
  • HIV-positive (self-reported by participant and confirmed by medical record)
  • Able and willing to provide written consent and participate in surveys, interviews, and/or group intervention

排除标准

  • Age < 18 years or >= 30 years
  • Unwilling or unable to provide written informed consent
  • Enrollment in one phase of the study is an exclusion criteria for enrollment in other phases

结局指标

主要结局

Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention

时间窗: Baseline, 4 months after beginning intervention, 10 months after beginning intervention

Modified Social Capital Scale (MSCS) is an In-Depth Interview Guide that asks questions about social capital and engagement in care. The scale is recently modified, pilot tested, and validated Chen's Social Capital Scale. The instrument contained 10 composite items based on 42 items for assessing personally owned social capital, including bonding and bridging capitals. The questionnaire is a open ended questionnaire with probe questions. The scale contains subscales for bonding and bridging capital, and it also contains items that specify sources (including family, friends, and lesbian, gay, bisexual, and transgender (LGBT) organizations) and types of support (e.g. emotional support, instrumental support and informational support). The data will be transcribed verbatim by a professional business transcription service. Thematic analysis using a combination of inductive and deductive coding will be conducted to analyze the score.

次要结局

  • Number of HIV visits at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention(Up to 10 months)
  • Number of viral load tests at post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention(Up to 10 months)
  • Change in number of receiving two or more cluster of differentiation 4 (CD4) tests at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention(Up to 10 months)
  • Change in viral load suppression measured as copies/ml at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention(Baseline, 4 months and 10 months)
  • Change in subjects self report to question at baseline, post-intervention 3 months and 9 months between the social capital intervention group and group-based health promotion intervention(Baseline and 10 months)

研究者

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

Sophia Hussen

Assistant Professor

Emory University

研究点 (2)

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