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

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: Self-management

Treatments: Behavioral: Self-Management for HIV-positive Asian Pacific Americans

Study type: Interventional

Funder types: Other

Identifiers

NCT04353739

IRB#20-000580

Details and patient eligibility

About

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 men with HIV (APAMHIV). Family-informed self-management is a promising intervention to assist APAMHIV in securing family support and promoting health, and hence help address HIV epidemics in this understudied population.

Full 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 men with HIV (APAMHIV). 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 APAMHIV and 20 family members to explore self- and family- management strategies. The hypothesis is that APAMHIV 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 APAMHIV that simultaneously address the needs of APAMHIV with support from their families. The long-term goal is to implement a comprehensive, family-informed self-management intervention for APAMHIV. 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 using a modified ADAPT-ITT model. In Phase 2, researchers will conduct a pilot waitlist-controlled clinical trial to test the feasibility, acceptability, and preliminary efficacy of the adapted family-informed self-management intervention among 30 APAMHIV without explicitly involving their family members. This small RCT will contain two arms, with participants randomly assigned to either the immediate treatment group (IT Group) or the delayed treatment group (DT Group). Researchers will evaluate feasibility, acceptability, and preliminary effect sizes, and use the data to revise this family-informed self-management intervention protocol. This will provide the basis for future applications for a fully powered Randomized Controlled Trial of the protocol in the future. 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, and preliminary efficacy with a randomized waitlist-controlled trial. And, 3. Finalize the study protocols for future project operations by documenting emerging difficulties and solutions throughout this project implementation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Immediate Treatment (IT)

Experimental group

Description:

This small RCT will contain two arms, with participants randomly assigned to either the immediate treatment group (IT Group) or the delayed treatment group (DT Group).

Treatment:

Behavioral: Self-Management for HIV-positive Asian Pacific Americans

Delay Treatment (DT)

Active Comparator group

Description:

This small RCT will contain two arms, with participants randomly assigned to either the immediate treatment group (IT Group) or the delayed treatment group (DT Group).

Treatment:

Behavioral: Self-Management for HIV-positive Asian Pacific Americans