Brothers Building Brothers by Breaking Barriers for Telehealth Delivery (Tele-B6)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The research team has developed an interventional group program for young men living with HIV and will be adapting it for telehealth delivery. The purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. The study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. Participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. The community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.
详细描述
Subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over five weeks. Sessions will include engaging educational components and interactive activities, including discussions of case scenarios and sharing of personal experiences where desired. At the end of each videoconference session, participants will be asked to complete a brief session evaluation form rating the content, facilitation, and overall experience for the week. The long-term goal is to improve engagement across the HIV continuum of care (HIV-CoC) by enhancing individual- and community-level resilience processes among young Black gay, bisexual, and other men who have sex with men (YB-GBMSM) living with HIV. To this end, the research team has used community-based participatory research methods to develop Brothers Building Brothers by Breaking Barriers (B6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among YB-GBMSM. The goal of this current study is to adapt and pilot B6 for telehealth delivery (creating tele-B6) within the context of an established community-based organization (CBO), as a strategy to enhance feasibility and scalability before a larger efficacy trial.
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
- 否
入选标准
- •Black race, inclusive of multiracial identities male gender, inclusive of transgender men
- •self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men
- •HIV-positive serostatus
- •age 18-29 years inclusive
- •residence in the Atlanta Metropolitan Statistical Area
- •available and interested in meeting for two hours weekly over five weeks.
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 criterion for enrollment in other phases
研究组 & 干预措施
Tele-B6
The tele-B6 intervention includes five group sessions delivered over the course of five weeks. Survey assessments for the intervention group will be conducted at enrollment (baseline), 2 months (immediate post-intervention survey), 4 months (interim-survey, post-intervention), and 6 months (endline).
干预措施: Tele-B6 (Behavioral)
Wait-list control -delayed intervention
A wait-list control design to safeguard ethical treatment of participants by ensuring that a potentially impactful intervention will be available to all after a brief waiting period.
干预措施: Delayed intervention (waitlist control) (Behavioral)
结局指标
主要结局
Acceptability
时间窗: Study Exit (up to 8* months)
Qualitative interviews: Open-ended questions adapted from the original B6 exit interview guide. \*8-month timepoint only applies to waitlist control participants
Safety (adverse events)
时间窗: During study participation up to 8* months
Review of Adverse event tracking forms \*8-month timepoint only applies to waitlist control participants
Change in retention
时间窗: 2, 4, 6, up to 8* months
Attendance logs during each visit. \*8-month timepoint only applies to waitlist control participants
Change in the Acceptability Surveys
时间窗: 2, 4, 6, up to 8* months
Post-session evaluation forms (adapted from original B6) after each group session. \*8-month timepoint only applies to waitlist control participants
Change in Recruitment Rates
时间窗: 2, 4, 6, up to 8* months
Rates of participation from screened and eligible participants. \*8-month timepoint only applies to waitlist control participants
Change in the intervention fidelity
时间窗: 2, 4, 6, up to 8* months
Review of the Structured intervention logs (adapted from original B6) \*8-month timepoint only applies to waitlist control participants
Acceptability Scale
时间窗: Study Exit (up to 6 months)
Post-session evaluation forms were administered after each intervention session and were evaluated collectively at the end of the study. This evaluation form included 7 statements (examples: "I felt comfortable in this virtual space", "I am confident I can apply the tools we learned today to my life") to be answered on a 5-point Likert scale (e.g., 5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree) as well as open ended questions (e.g., what did you like most?)
Number of Attended Sessions
时间窗: During intervention sessions up to 5 weeks (5 weeks total)
Attendance was assessed using session logs recorded at each intervention visit, capturing the number of sessions attended during the five-week intervention period. For the immediate intervention arm (Tele-B6), attendance was recorded from baseline through completion of the five-week intervention (up to 2 months post-enrollment). For the delayed intervention (wait-list control) arm, attendance was recorded during the five-week intervention delivered between months 2 and 4 of study participation.
Number of Participants Reporting Adverse Events (Safety)
时间窗: During study participation up to 6 months
Review of Adverse Event Tracking Forms during study participation up to six months.
次要结局
- Change in intersectional stigma(Exit of study (up to 8 months))
- Qualitative description of logistical barriers(Exit of study (up to 8 months))
- Change in Perception of HIV stigma(0, 2, 4, 6, up to 8* months)
- Qualitative description of intersectional stigma(Exit of study (up to 8 months))
- Change in logistical barriers(0, 2, 4, 6, up to 8* months)
- Changes in the perception of minority stress: depression(0, 2, 4, 6, up to 8* months)
- Change in Perception of discrimination(0, 2, 4, 6, up to 8* months)
- Change in Perception of internalized homonegativity inventory(0, 2, 4, 6, up to 8* months)
- Qualitative description individual resilience process: Identity Affirmation(Exit of study (up to 8 months))
- Changes in the community resilience process: social capital(0, 2, 4, 6, up to 8* months)
- Qualitative description of the community resilience process: social capital(Exit of study (up to 8 months))
- Change in Perception of Structural Racism and Discrimination.(0, 2, 4, 6, 8* months)
- Changes in perception of individual resilience process: Identity Affirmation(0, 2, 4, 6, up to 8* months)
- Changes in the perception of minority stress: general well-being(0, 2, 4, 6, up to 8* months)
- Qualitative description of the minority stress(Exit of study (up to 8 months))
- The Material Resources Survey(0, 2, 4, 6 months)
- Everyday Discrimination Scale(0, 2, 4 months)
- Perception of HIV Stigma Scale(0, 2, 4, 6 months)
- Personal Social Capital Scale(0, 2, 4, 6 months)
- Number of Participants With Studies Depression Scale Greater Than 16(0, 2, 4, 6 months)
- General Well-being (GWB) Survey(0, 2, 4, 6 months)
研究者
Sophia Hussen
Associate Professor of Public Health and Medicine
Emory University