跳至主要内容
临床试验/NCT03680729
NCT03680729已完成不适用

Adapting and Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama

Florida State University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
1
主要终点
Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention

研究概览

简要总结

The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims.

详细描述

This study was developed in the spirit of the K01 mechanism, thoughtfully linking training to research. The research study proposed in this K01-application includes the conduct of three specific aims that are aligned with four training objectives.

Objective 1 outlines an intensive training and mentoring plan on social theory including theories of intersectionality and emerging masculinities.

Objective 2 provides in-depth training on qualitative research methods including how to conduct focus groups, in-depth interviews, and qualitative data analysis. Aim 1, which will be conducted after Objective 2, is to elucidate experiences, beliefs, and predictors related to delivery and utilization of HIV testing and prevention services for black YMSM using qualitative research methods, namely in-depth interviews with HIV prevention and outreach staff, focus groups with black YMSM, and in-depth interviews with other members of key population sub-groups such as transgender women and black YMSM who are no longer on PrEP, to inform the adaptation of BSB. Aim 1 will include 6 focus groups with black YMSM to explore perceptions and experiences with testing, prevention services, and PrEP as these relate to the adaptation of the intervention (estimated N=36-48). Aim 1 will include in-depth interviews with transgender women, black YMSM who have not taken an HIV-test in the past 6-months, black YMSM who are on PrEP, and black YMSM who were on PrEP but are no longer on PrEP (estimated N=16-24). This first aim will also include in-depth interviews with HIV prevention and outreach staff to document inner and outer contexts of community-based testing and clinical settings (estimated N=10). Thematic coding and analysis methods will be used to elucidate ways in which the intervention will need to be modernized and revised to be culturally acceptable to the target population and to address locally relevant structural barriers.

Objective 3 provides robust training on how to scientifically and iteratively adapt HIV behavioral interventions using validated frameworks, such as intervention mapping. Aim 2 is to adapt the Brothers Saving Brothers (BSB) intervention to include two HIV prevention tools (rapid testing and PrEP), to address structural barriers, and to be acceptable to black YMSM in Alabama. In Aim 2, I will use intervention mapping, informed by Aim 1 data, to iteratively adapt BSB to include the aforementioned updates. Since BSB will require extensive revisions, I have selected an intervention development framework (rather than an adaptation model) to guide the scientific adaptation process. After each cycle, the adapted intervention will be shared with CBO outreach staff and black YMSM to solicit their feedback. I anticipate 2-4 iterations (adaptations).

Objective 4 offers methodical training and mentoring in the field of implementation science. Aim 3, which concludes the proposed research study and K01 project, is to conduct a hybrid type 1 effectiveness-implementation pilot study of the adapted intervention in which the investigators will a) assess acceptability and feasibility of the adapted BSB (aBSB); b) preliminarily estimate effects on HIV prevention outcomes; and c) collect data on real-world implementation. I will pilot-test aBSB with black YMSM in Alabama (N=60); half will be randomized to the control condition; half will receive aBSB. I will collect effectiveness data (including acceptability and feasibility) pre-intervention/control, immediately post-intervention/control, 3-months after initial contact, and 6-months after initial contact. Toward the end of the study-period, I will collect implementation data from staff interviewed in Aim 1 (N=10) and from study participants to assess how aBSB was experienced and internalized (N=12).

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimally 18 years and 0 months of age
  • Interacts with youth routinely
  • Conducts or supervises community outreach and community-based HIV testing
  • English speaking
  • Can read English text
  • Able and willing to provide informed consent
  • Inclusion Criteria for youth participants:
  • Youth aged 18 years, 0 months to 29 years, 11 months
  • Identifies as Black (or African American)
  • Identifies as biologically male
  • Is sexually active with male partners (MSM)
  • Hasn't taken an HIV test in 6-months
  • Is not currently on PrEP
  • English speaking
  • Able and willing to provide informed consent

排除标准

  • Does not meet inclusion criteria

研究组 & 干预措施

aBSB

Experimental

aBSB is the adaptation of BSB. BSB a two part intervention to improve rates of community-based HIV testing and prevention education in black young MSM (YMSM). BSB was developed on Information Motivation Behavioral Skills (IMB) theory. The first part of BSB uses Motivational Interviewing in a culturally appropriate way to encourage participants to accept testing and return for test results. The second part is conducted after the participant has received his result, assuming it was not reactive and offers prevention education.

干预措施: Adapted Brothers Saving Brothers (aBSB) (Behavioral)

Street Outreach

Active Comparator

Standard street outreach was used as the control in the original BSB trial.

干预措施: Standard Street Outreach (Behavioral)

结局指标

主要结局

Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention

时间窗: 36 months

Participants rate their satisfaction with the intervention by positive response to "I like this app," scale of 1-4. Scores across participants in each arm were averaged to produce a mean score. Higher scores indicate higher acceptability.

Did the Study Participant Accept a Rapid HIV Test After the Delivery of the Kings or Standard Outreach Intervention?

时间窗: 18 months

This information will be assessed by the return of an HIV test result.

次要结局

  • Did the Study Participant Secure a Prescription for PrEP?(6 months)

研究者

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

Henna Budhwani

Professor

Florida State University

研究点 (1)

Loading locations...

相似试验