跳至主要内容
临床试验/NCT05129345
NCT05129345招募中不适用

Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for Persons Living With HIV in the Southeastern United States

Duke University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Aim 1: Number of social determinants of cardiometabolic health identified from interviews

研究概览

简要总结

This study has 3 aims. Aim 1: Identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals.

Aim 2: Assess PLWH knowledge, skills, and confidence for self-management of cardiometabolic disorders.

Aim 3: Tailor a self-management support and education intervention with stakeholder input to address barriers to achieving treatment goals for cardiometabolic disorders in PLWH at the study sites.

详细描述

Aim 1: 20 PLWH ages 35 years and older with at least one cardiometabolic disorder (hypertension, dyslipidemia, or type 2 diabetes) will participate in in-depth interviews (IDIs) using photo elicitation to capture the social environment and contextual determinants of cardiometabolic disorders for PLWH. Prior to IDIs, PLWH will take photographs of facilitators and barriers to reaching their cardiometabolic health goals. During IDIs we will discuss the content of the photographs and explore the most salient facilitators and barriers that an intervention (Aim 3) must address to achieve treatment goals for cardiometabolic disorders at the study sites.

Aim 2: 120 PLWH with the same eligibility criteria as Aim 1 across the study sites will complete a Patient Activation Measure survey to assess knowledge, skills, and confidence for self-management of their cardiometabolic disorders. Logistic regression models will assess the predictors of knowledge, skills and confidence for self management of these disorders in order to inform the tailoring of the intervention in Aim 3.

Aim 3: Guided by the Behavior Change Wheel model and using the human-centered design approach, we will engage key stakeholders (healthcare providers, community advisory board members, and PLWH with cardiometabolic disorders) in the tailoring of a self-management support and education intervention that has been found to be effective in the general population. We will engage stakeholders in an iterative process spanning three months by first developing understanding of the self-management and education intervention, reviewing the results from Aim 1 and 2 and brainstorming possible tailoring options within the context in which PLWH live and receive care in order to arrive at an intervention that is desirable, feasible, and viable. A final recommendation of the tailored intervention will be presented to the participating HIV providers, Ending the HIV Epidemic Committee in Mecklenburg County, and the Duke Center for AIDS Research Community Advisory Board. The completion of these aims will provide the data for publication, an adapted evidence-based intervention, and community and healthcare collaborations necessary to launch an R21 application to assess the acceptability, fidelity, and appropriateness of the intervention.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Aims 1 and 2
  • People living with HIV who are at least 35 years of age and who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes.
  • Participants recruited from the participating clinics and community based organizations and may include, HIV providers, nurses, pharmacists, people living with HIV who have cardiometabolic disorders, and representatives of the community advisory boards, and any other key stakeholders. Age 18 or older.

排除标准

  • Those who don't understand English and those who are blind.

结局指标

主要结局

Aim 1: Number of social determinants of cardiometabolic health identified from interviews

时间窗: 2 weeks after enrollment

Interviews with PLWH who have cardiometabolic disorders to determine salient barriers and facilitators of achieving treatment goals for cardiometabolic disorders

Aim 2: Patient engagement in healthcare as measured by the Patient Activation Measure (PAM)

时间窗: Baseline

Assess PLWH knowledge, skills, and confidence for self-management using the PAM which is a 13 item survey, Likert scale from strongly disagree to agree strongly.

Aim 3: Number of strategies modified in the self-management support and education

时间窗: Up to 3 months

Tailoring of self-management support and education intervention using stakeholder engagement strategies

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)

Loading locations...

相似试验

Addressing Barriers to Achieving Cardiometabolic... | 临床试验