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

NCT04353739 | Completed DMC

• 1 other identifier: IRB#20-000580
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Self-management

Keywords

family-informed self-management; Asian Pacific Americans

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

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

Interventions

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.

SOFIAA

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese-American Planning Council., Inc.: collaborator
• University of California, Los Angeles: lead
• Apait Health Center: collaborator

Study Sites (2)

APAIT

Los Angeles, California, 90095, United States

Location

Chinese-American Planning Council., Inc.

New York, New York, 90012, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The intervention, called the Social justice Oriented, Family-Informed self-management intervention for APAWH (SOFIAA), is delivered via four one-on-one counseling sessions to participants over 4 weeks. Implementation Assessment Outcomes including Exit Interview, Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) will be used to assess the appropriateness, feasibility and acceptability of the intervention among APAWH.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 20, 2020
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (2)