Social Capital and Engagement in Care Among Young Black Men Who Have Sex With Men Living With HIV
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University 1518 Clifton Rd
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:social capital intervention
This group will receive intervention developed from Phase 1 study and based on photovoice project
|
The social capital intervention will focus on developing skills and group-work that culminate in participant-derived photovoice projects.
Each group of YBMSM will be encouraged to complete a 30 day photovoice challenge.
The 30 day challenge is based on a prior community action project done as a part of our Centers for AIDS Research (CFAR)-funded research, which was a Photovoice project conducted by Dr. Hussen.
Photovoice is a participatory action research methodology in which groups of individuals from a population of interest are given cameras to document events, people and places of significance in their lives.
|
有源比较器:group-based health promotion intervention
The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan)
|
The control arm will participate in a health education intervention that will be delivered in a group, but without a specific goal of creating group cohesion or social capital.
The intervention will be a modified version of "Health for Life" or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Modified Social Capital Scale (MSCS) between the social capital intervention group and group-based health promotion intervention
大体时间: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.
|
Baseline, 4 months after beginning intervention, 10 months after beginning intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
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
大体时间:Baseline, 4 months and 10 months
|
Viral load values will be extracted from the participants' electronic medical records (EMR).
Viral load refers to the number of viral particles found in each millilitre of blood.
Viral load tests measure the amount of HIV's genetic material in a blood sample.
The results of a viral load test are described as the number of copies of HIV RNA in a millilitre of blood.
The viral load test should consistently detect and measure virus levels down to 50 copies/mL, have a high specificity and provide reproducible results.
The technologies used are advanced and very sensitive for measuring the amount of HIV genetic material present in the blood.
|
Baseline, 4 months and 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
大体时间:Up to 10 months
|
Retention in Care will be measured by determining receiving two or more cluster of differentiation 4 (CD4) tests.
This information will be gathered from subject's electronic medical record
|
Up to 10 months
|
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
大体时间:Up to 10 months
|
Retention in Care will be measured by determining participation in continuous care, that is, at least two or more routine HIV visits at least three months apart.
This information will be gathered from subject's electronic medical record
|
Up to 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
大体时间:Baseline and 10 months
|
Adherence to antiretroviral medications will be measured using a composite of single item self-report question and pharmacy refill records that will be conducted and evaluated at baseline and at 9 months.
|
Baseline and 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
大体时间:Up to 10 months
|
Retention in Care will be measured by determining receiving two or more viral load tests.
This information will be gathered from subject's electronic medical record.
|
Up to 10 months
|
合作者和调查者
调查人员
- 首席研究员:Sophia Hussen, M.D., M.P.H.、Emory University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
艾滋病毒感染的临床试验
-
Hospital Clinic of Barcelona完全的
-
Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
-
National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
-
AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
-
ANRS, Emerging Infectious DiseasesInstitut National de la Santé Et de la Recherche Médicale, France; University of Bergen; Centre... 和其他合作者完全的
-
Hospital Universitari Vall d'Hebron Research InstituteGilead Sciences完全的
-
Hospital Universitari Vall d'Hebron Research InstituteUniversity Hospital, Ghent; IrsiCaixa完全的
social capital intervention的临床试验
-
University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
-
University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)招聘中