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.

Study Overview

• Status: Completed
• Conditions: Self-management
• Intervention / Treatment: Behavioral: Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • APAIT
  • New York
    • New York, New York, United States, 90012
      • Chinese-American Planning Council., Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must:

1. be at least 18 years of age,
2. be self-identifying as APA,
3. be self-identifying as men,
4. be able to give informed consent to the study,
5. are currently taking ART and
6. be physically well enough to attend counseling sessions and follow-up visits.

Exclusion Criteria:

Participants who:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Behavioral: Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention	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.	Week 10
Appropriateness of Intervention	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.	Week 10
Feasibility of Intervention	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.	Week 10

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Apait Health Center; Chinese-American Planning Council., Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: family-informed self-management; Asian Pacific Americans
• Other Study ID Numbers: IRB#20-000580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will make sure CPC and study participants are willing to share their personal data with researchers. Then, the investigators can release the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No