跳至主要内容
临床试验/NCT04353739
NCT04353739已完成不适用

Testing a Self-management Intervention in HIV+ Asian Pacific Americans

University of California, Los Angeles3 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年7月1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
19
试验地点
3
主要终点
Quality of life after Self-management intervention

研究概览

简要总结

HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, with 80% of new infects being men. The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA people living with HIV (APAWH). Family-informed self-management is a promising intervention to assist APAWH in securing family support and promoting health, and hence help address HIV epidemics in this understudied population.

详细描述

HIV infection rates are on a rapid rise within Asian Pacific Americans (APA) communities, 17% annually, with men comprising 80% of new infections in the United States. Optimal self-management is a key to HIV treatment success, because it may alleviate physical and mental symptoms, promote health behaviors, and therefore enhance quality of life and suppress virus replication. Studies suggested that securing assistance from family members in self-management may be effective in addressing these challenges in APA communities.

The purpose of this study is to adapt and evaluate the feasibility of a 4-session, 4-week family-informed self-management intervention protocol to promote health among APA living with HIV (APAWH). The scientific premise is, regardless of Asian ethnicity, APA communities often share a more collectivist orientation, such that APA prioritizing their responsibilities to their families over their own individual needs. To preserve the harmony in family, HIV disclosure is often indirect. In previous projects, investigators interviewed an ethnically diverse sample of 40 APAWH and 20 family members to explore self- and family- management strategies. The hypothesis is that APAWH will receive greater levels of family support and health following the family-informed self-management intervention. This study addresses the critical need to optimize self-management skills among APAWH that simultaneously address the needs of APAWH with support from their families. The long-term goal is to implement a comprehensive, family-informed self-management intervention for APAWH.

In this project, researchers will conduct a mixed-methods study with two study phases. In Phase 1, researchers will analyze the available qualitative data from the prior projects to revise the conceptualization of family-informed self-management. Based on the revised conceptualization, researchers will adapt an evidence-based self-management intervention (Social justice Oriented, Family Informed, also known as SOFI) using a modified ADAPT-ITT model. In Phase 2, researchers will conduct an implementation study to test the appropriateness, acceptability, feasibility, and preliminary efficacy of the Social justice Oriented, Family Informed self-management intervention among APAWH (SOFIAA) without explicitly involving their family members. Researchers will use study findings to revise this family-informed self-management intervention protocol for a future fully powered randomized controlled trial to test its efficacy. Aims are to: 1. Follow the ADAPT-ITT model to culturally adapt an evidence-based family-informed self-management intervention 2. Evaluate the feasibility, acceptability, appropriateness and preliminary efficacy of the SOFIAA. And, 3. Finalize the study protocols for future project operations by documenting emerging difficulties and solutions throughout this project's implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None (Participant)

盲法说明

There are four data collection points: week 1 (before intervention for immediate treatment (IT) group), week 4 (right after intervention for the IT group, but before intervention for delayed treatment (DT) group), week 7 (after intervention for the DT group), and week 10. Therefore, in this data collection schedule, the IT group will have one-baseline (week 1), two-post-intervention evaluation (week 4), and three and four- follow-ups with 3-week intervals (week 7 and week 10), while the DT group will have 2 baselines (week 1 & week 4), 1 post-intervention evaluation (week 7), and 1 follow-up with a 3-week interval (week 10). Assessment consists of surveying at two times and a dried blood spot test at week 1 and 4.

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

  • Participants must:
  • be at least 18 years of age,
  • be self-identifying as APA,
  • be self-identifying as men,
  • be able to give informed consent to the study,
  • are currently taking ART and
  • be physically well enough to attend counseling sessions and follow-up visits.

排除标准

  • Participants who:
  • have a significant condition such as neurological or cardiovascular diseases that prevents them from fully participating the study, or
  • are unable to communicate in English or a major Asian language.

研究组 & 干预措施

SOFIAA

Experimental

This single arm implementation study will evaluate the appropriateness, acceptability, and feasibility of the SOFIAA intervention protocol among Asian Americans living with HIV.

干预措施: Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA) (Behavioral)

结局指标

主要结局

Quality of life after Self-management intervention

时间窗: Week 10

To measure eight domains of health. Questions are a sampling of items from each of the eight domains of health from the SF-36. Each indicator variable is weighted for each of the response choices, minus one.

Biomarker

时间窗: Week 10

CD4- CD4 will be obtained from self-report surveys.

Acceptability of Intervention

时间窗: Week 10

The Acceptability of Intervention Measure (AIM) is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. AIM uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability.

Appropriateness of Intervention

时间窗: Week 10

The Intervention Appropriateness Measure (IAM) is designed to assess the suitability and relevance of an intervention. It aims to provide a generalizable assessment of the appropriateness of interventions by capturing individual perspectives on the alignment of the intervention with professional values and perceived efficacy in meeting patient needs. IAM is a 4-item instrument that uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater appropriateness.

Feasibility of Intervention

时间窗: Week 10

The Feasibility of Intervention Measure (FIM) measures the feasibility or extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. FIM is a 4-item instrument uses a Response Scale that includes: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater feasibility.

次要结局

未报告次要终点

研究者

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

Weiti Chen, RN, CNM, PhD, FAAN

Professor

University of California, Los Angeles

研究点 (3)

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