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临床试验/NCT05947266
NCT05947266进行中(未招募)不适用

Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes

Florida International University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
66
试验地点
2
主要终点
Viral suppression

研究概览

简要总结

The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are:

  • Does this intervention result in measurable engagement and retention in care?
  • Does this intervention result in measurable viral suppression within 6 months?

Participants will

  • participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment.
  • Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.

详细描述

Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.

Procedures to be used:

AIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.

AIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.

AIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Seropositive for HIV
  • Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.
  • Migrated to the US from Haiti

排除标准

  • 1. Virally suppressed

研究组 & 干预措施

Haitian immigrant iENGAGE (H-iENGAGE) intervention

Experimental
  1. Enrollment;
  2. Baseline assessment;
  3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4
  4. Following Session 4, conduct Process evaluation;
  5. Post-intervention assessment;
  6. Six-month follow up assessment*

*Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods. 7. End of study participation

干预措施: an adaptation of the iENGAGE (Behavioral)

结局指标

主要结局

Viral suppression

时间窗: Baseline, 6-month post-baseline follow up

Change in HIV load measurement toward a target of less than 200 copies/ml

Care of Engagement Index Score

时间窗: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up

Change in Engagement in Care score over time, including comfort and communication with provider

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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