Self-Management Intervention for HIV+ Asian Pacific Americans

Recruiting at 1 trial location

Overseen By Wei-Ti Chen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: ART

Disqualifiers: Neurological, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to be currently taking ART (antiretroviral therapy), so you will need to continue with this medication. The protocol does not specify about other medications.

What data supports the effectiveness of the treatment Self-Management for HIV-positive Asian Pacific Americans?

Research shows that self-management programs can lead to short-term improvements in physical health, mental well-being, and health knowledge for people living with HIV. These programs help individuals manage their condition better, although long-term benefits are not yet clear. ^{1 2 3 4 5}

How is the Self-Management Intervention for HIV+ Asian Pacific Americans different from other treatments for HIV?

This treatment is unique because it is culturally tailored to Asian Pacific Americans, involving family-informed self-management strategies that incorporate cultural values and social customs, which can improve engagement and effectiveness in managing HIV. ^{2 6 7 8 9}

Eligibility Criteria

This trial is for HIV-positive Asian Pacific American men who are at least 18 years old, currently on antiretroviral therapy (ART), and healthy enough to attend counseling sessions. They must be able to give informed consent and communicate in English or a major Asian language.

Inclusion Criteria

I am physically able to attend counseling sessions and follow-up visits.

I identify as a man.

I am currently on antiretroviral therapy.

Exclusion Criteria

I cannot communicate in English or any major Asian language.

I do not have a severe neurological or heart condition that would prevent me from participating fully in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Adaptation

Researchers analyze qualitative data to revise the conceptualization of family-informed self-management and adapt an evidence-based intervention using the ADAPT-ITT model.

Not specified

Phase 2 - Treatment

Participants undergo a 4-session, 4-week family-informed self-management intervention. This phase includes a pilot waitlist-controlled clinical trial with immediate and delayed treatment groups.

4 weeks

4 sessions

Follow-up

Participants are monitored for quality of life and biomarker outcomes after the self-management intervention.

6 weeks

Treatment Details

Interventions

• Self-Management for HIV-positive Asian Pacific Americans

Trial Overview The study is testing a family-informed self-management intervention over four weeks, designed to help these individuals secure family support and promote health. The goal is to see if this approach can improve health outcomes for HIV-positive APA men.

Participant Groups

Group I: Immediate Treatment (IT) Experimental Treatment 1 Intervention

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 II: Delay Treatment (DT) Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Apait Health Center

Collaborator

Trials

1

Recruited

30+

Findings from Research

Self-management education programs for adults living with HIV/AIDS have been shown to lead to short-term improvements in physical health, psychosocial well-being, and health knowledge, based on a systematic review of 8 studies involving 1178 participants.

While these programs demonstrated statistically significant benefits compared to control groups, there is not enough evidence to determine the long-term effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management education programs for people living with HIV/AIDS: a systematic review. Millard, T., Elliott, J., Girdler, S.[2022]

The systematic review of 52 studies on self-management interventions for people living with HIV in sub-Saharan Africa revealed a significant lack of research, indicating that chronic care models have not been a priority in this region.

Current practices for long-term support of HIV patients remain the best approach for promoting self-management until more targeted studies can assess their effectiveness and the applicability of chronic care models from high-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the literature on self-management interventions and discussion of their potential relevance for people living with HIV in sub-Saharan Africa. Aantjes, CJ., Ramerman, L., Bunders, JF.[2018]

A study of 868 people living with HIV in China identified three levels of self-management behavior: poor (12.1%), moderate (56.1%), and good (31.7%), indicating that overall self-management is inadequate among this population.

Key predictors of self-management behavior included antiretroviral therapy (ART) status, infection route, and educational level, suggesting that those with lower education, those infected through blood or injecting drugs, and those not on ART are at higher risk for poor self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Self-Management Behavior Clusters Among People Living with HIV in China: A Latent Class Profile Analysis. Zhang, H., Yin, Y., Wang, H., et al.[2022]

A self-management program significantly improved the quality of life (QOL) for people living with HIV in Indonesia, with notable increases in overall QOL (8.7%) and psychological well-being (23.5%) after a four-week intervention involving 57 participants.

The program's benefits were sustained over time, as improvements in QOL were still evident two months after the intervention, suggesting that self-management training could be an effective strategy for enhancing the well-being of PLWH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management: A comprehensive approach to improve quality of life among people living with HIV in Indonesia. Fauzi, A., Anggraini, N., Fatkhurohman, N.[2023]

Providing personalized feedback on health outcomes did not significantly improve the specificity of self-management goals among 176 participants living with chronic HIV, as both feedback and control groups formulated similar numbers of specific goals.

Text mining techniques revealed that while both groups used some specific nouns and actionable verbs, they largely lacked measurable and time-bound elements in their goals, indicating a need for better goal-setting strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a personalized health profile on specificity of self-management goals among people living with HIV in Canada: findings from a blinded pragmatic randomized controlled trial. Mozafarinia, M., Rajabiyazdi, F., Brouillette, MJ., et al.[2023]

A systematic review identified 41 studies evaluating 28 mHealth interventions for HIV self-management, with most focusing on improving medication adherence and delivered primarily through SMS messaging.

These interventions showed significant positive effects on various outcomes, including adherence and viral load, but were often limited in scope and did not fully address the diverse needs of people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Cooper, V., Clatworthy, J., Whetham, J., et al.[2022]

Adolescents and emerging adults are a significant group among new HIV diagnoses and face challenges in managing their condition, which is crucial for maintaining health.

The article reviews theoretical frameworks and interventions aimed at improving HIV self-management in youth, highlighting the importance of retention in care, medication adherence, and healthy behaviors for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management Frameworks for Youth Living with Human Immunodeficiency Virus. MacDonell, KK., Naar, S.[2023]

A scoping review of 103 articles revealed a 74% increase in the use of 'self-management' (SM) in relation to HIV in low- and middle-income countries since 2015, indicating growing recognition of its importance.

The term 'self-management' is used variably, with many articles describing it as a collaborative process between patients and healthcare providers, while others view it as an individual strategy for managing care, highlighting the need for tailored approaches in these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How the Term 'Self-Management' is Used in HIV Research in Low- and Middle-Income Countries: A Scoping Review. Davis, VH., Nixon, SA., Murphy, K., et al.[2022]

Culturally-tailored interventions for Chinese Americans with chronic diseases, which include both surface (linguistic) and deep (cultural values) structures, have shown significant effectiveness in improving self-management skills and health outcomes.

Out of eight interventions reviewed, six demonstrated notable improvements in health-related outcomes, and participants expressed high satisfaction and retention rates, indicating the importance of culturally sensitive approaches in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally-tailored interventions for chronic disease self-management among Chinese Americans: a systematic review. Huang, YC., Garcia, AA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-management education programs for people living with HIV/AIDS: a systematic review. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

A systematic review of the literature on self-management interventions and discussion of their potential relevance for people living with HIV in sub-Saharan Africa. [2018]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Identification of Self-Management Behavior Clusters Among People Living with HIV in China: A Latent Class Profile Analysis. [2022]

4. Indonesia pubmed.ncbi.nlm.nih.gov

Self-management: A comprehensive approach to improve quality of life among people living with HIV in Indonesia. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of a personalized health profile on specificity of self-management goals among people living with HIV in Canada: findings from a blinded pragmatic randomized controlled trial. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

mHealth Interventions To Support Self-Management In HIV: A Systematic Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Self-Management Frameworks for Youth Living with Human Immunodeficiency Virus. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

How the Term 'Self-Management' is Used in HIV Research in Low- and Middle-Income Countries: A Scoping Review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Culturally-tailored interventions for chronic disease self-management among Chinese Americans: a systematic review. [2022]