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

NCT ID: NCT04353739

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Self-management

Keywords

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family-informed self-management Asian Pacific Americans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention Core Modules: Developed upon the results of the prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has been fully manualized, and 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. The intervention will be delivered via four face-to-face, one-on-one counseling sessions to the participants over 4 weeks. Each module will take on 30 minutes for delivery and each session will deliver two modules in sequence. The primary desired outcome is improved quality of life and diminished viral load.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Immediate Treatment (IT)

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).

Group Type EXPERIMENTAL

Self-Management for HIV-positive Asian Pacific Americans

Intervention Type BEHAVIORAL

Developed upon the results of our prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has been fully manualized and 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.

Delay Treatment (DT)

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).

Group Type ACTIVE_COMPARATOR

Self-Management for HIV-positive Asian Pacific Americans

Intervention Type BEHAVIORAL

Developed upon the results of our prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has been fully manualized and 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.

Interventions

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Self-Management for HIV-positive Asian Pacific Americans

Developed upon the results of our prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has been fully manualized and 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apait Health Center

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Weiti Chen, RN, CNM, PhD, FAAN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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APAIT

Los Angeles, California, United States

Site Status RECRUITING

Chinese-American Planning Council., Inc.

New York, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Wei-Ti Chen, PhD

Role: CONTACT

Phone: 310-206-8539

Email: [email protected]

Facility Contacts

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Jury Candelario, LCSW

Role: primary

Judy Ah-Yune

Role: primary

Other Identifiers

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IRB#20-000580

Identifier Type: -

Identifier Source: org_study_id