Clinical trial NCT04353739: Testing a Self-management Intervention in HIV+ Asian Pacific Americans
Official title: Testing a Self-management Intervention in HIV+ Asian Pacific Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-management
Keywords: family-informed self-management
Asian Pacific Americans
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Apait Health Center
First posted: 2020-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life after Self-management intervention
timeFrame: Week 10
measure: Biomarker
timeFrame: Week 10
measure: Biomarker
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: APAIT
state: California
city: New York
country: United States
facility: Chinese-American Planning Council., Inc.
state: New York
Study officials:
References: