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Completed

NCT Number: NCT04353739

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

APAIT, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)

Behavioral

The study intervention (SOFIAA) is delivered during a series of 4-sessions over a 4-week period via one-on-one format. The sessions are held either via Zoom or in-person. Intervention Core Modules: Developed on the basis of the results of the investigators' prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has eight modules: (1) psycho-education, (2) cognitive-behavioral management skills training, (3) preparation for disclosure, (4) family relations and support management, (5) anxiety and depressive symptom management, (6) brief mindfulness training, (7) symptom reduction, and (8) the Life-Steps program. Each module will take about 30 minutes for delivery and each session will deliver two modules in sequence for a total time of about 60 minutes per week over a span of four weeks.

Primary outcomes

  1. Acceptability of Intervention

    Time frame: 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.

  2. Appropriateness of Intervention

    Time frame: 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.

  3. Feasibility of Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Apait Health Center
  • Chinese-American Planning Council., Inc.

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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